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4 Context of the Organisation

4.1 Understanding the Organisation and its Context

NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and
economic environments, whether international, national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the
intended result(s) of its quality management system.

Has Best Bars determined external and internal issues relevant to its purpose and strategic direction?

Compliant Non-Compliant N/A

Do these Issues affect the ability to achieve the intended result of the QMS?

Compliant Non-Compliant N/A

4.2 Understanding the needs and expectations of interested parties

Has Best Bars conducted a study to determine the impact or potential impact on the organization’s ability to consistently provide products and services that
meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) The interested parties that are relevant to the quality management system;
b) The requirements of these interested parties that are relevant to the quality management system.

Has Best Bars determined what requirements those parties have that are relevant to the QMS?

Compliant Non-Compliant N/A


Has Best Bars determined the impact or potential impact?

Compliant Non-Compliant N/A

The organization shall monitor and review the information about these interested parties and their relevant requirements.

Does Best Bars monitor and review the information about interested parties and their relevant requirements?

Compliant Non-Compliant N/A

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

Has Best Bars set the boundaries and applicability of the QMS been used to establish the scope of the organization?

Compliant Non-Compliant N/A

4.3.1 (TS) Determining the scope of the QMS - Supplementary

Supporting functions, whether of site or remote (Such as design centers, corporate headquarters and distributions centers) shall be included in the scope of the
QMS.
The only permitted exclusion permitted for the Automotive QMS standard relates to the production design and development requirements within ISO 9001:2015,
Section 8.3. The exclusion shall be justi\ed and maintain as documented information (See ISO 9001, Section 7.5_)
Permitted exclusions do not include manufacturing process design.

4.3.2 (TS) Customer SpeciFc Requirements

Customer speci\c requirements shall be evaluated and included in the scope of the Organisations QMS

Is the customers speci\c requirements included in the scope of Best Bars QMS?

Compliant Non-Compliant N/A

4.4 Quality management system and its processes

4.4.1

The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their
interactions, in accordance with the requirements of this International Standard.

Has Best Bars established a QM System that meets these above requirements?

Compliant Non-Compliant N/A


The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall
determine:
a) the inputs required and the outputs expected from these processes;
b) the sequence and interaction of these processes;
c) the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes;
d) the resources needed and ensure their availability;
e) the assignment of the responsibilities and authorities for these processes;
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve
intended results;
h) opportunities for improvement of the processes and the quality management system.

Has Best Bars determined the processes for the QMS?

Compliant Non-Compliant N/A

Does Best Bars determine sequence and interaction of the processes?

Compliant Non-Compliant N/A

Does Best Bars determine the inputs and outputs for those processes?

Compliant Non-Compliant N/A

Does Best Bars determine the criteria, methods, measurement and related performance indicators needed to operate and control
those processes?

Compliant Non-Compliant N/A

Does Best Bars determine what resources are needed and how are these made available?

Compliant Non-Compliant N/A

Does Best Bars assign responsibilities and authorities for those processes?

Compliant Non-Compliant N/A

Does Best Bars determine risks and opportunities considered and plans are made to implement actions to address them?

Compliant Non-Compliant N/A

Does Best Bars measure and evaluate processes and, if needed, make changes to achieve intended results?

Compliant Non-Compliant N/A

The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to
the extent necessary to have con\dence that the processes are being carried out as planned.
Does Best Bars maintain documented information to support the operation of processes?

Compliant Non-Compliant N/A

Is Best Bars con\dence that the processes are being carried out as planned determined?

Compliant Non-Compliant N/A

4.4.1.1 (TS) Conformance of products and processes

The organisation shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customers,
statutory requirements (See Sections 8.4.2.2)

Does Best Bars conduct a risk assessment in terms of all the Statutory and regulatory requirements?

Compliant Non-Compliant N/A

4.4.1.2 (TS) Product Safety

The organisation shall have documented processes for the Management of Product Safety related products and manufacturing processes which shall include
but not limited to the following, where applicable:

Does Best Bars identify the organisational statutory and regulatory product safety requirements?

Compliant Non-Compliant N/A

Does Best Bars notify the customer of requirements?

Compliant Non-Compliant N/A

Special approvals by design FMEA?

Compliant Non-Compliant N/A

Reaction plans? (See Section 9.1.1.1)

Compliant Non-Compliant N/A

Identi\cation of product safety related characteristics?

Compliant Non-Compliant N/A

Identi\cation and controls of safety related characteristics of product and at the point of manufacturing?

Compliant Non-Compliant N/A


Special approval of control plans and process FMEA's?

Compliant Non-Compliant N/A

De\ne responsibilities, de\nition of escalation processes and eow of information, including top management and customer
noti\cation?

Compliant Non-Compliant N/A

Training identi\ed by Best Bars or customer for personnel involved in product safety related products and associated manufacturing
processes?

Compliant Non-Compliant N/A

Changes of product or processes shall be approved prior to implementation, including evaluation of potential effects on product
safety from process and product changes (See ISO 9001 Section 8.3.6)

Compliant Non-Compliant N/A

Transfer of requirements with regards to product safety throughout the supply chain, including customer designated sources (See
section 8.4.3.1)

Compliant Non-Compliant N/A

Product trace-ability by manufactured lot (At a minimum) throughout the supply chain (See section 8.5.2.1

Compliant Non-Compliant N/A

Lessons learned for new product introduction

Compliant Non-Compliant N/A

4.4.2

To the extent necessary, the Best Bars shall:

Does Best Bars maintain documented information to support the operation of its processes?

Compliant Non-Compliant N/A

Does Best Bars retain documented information to have con\dence that the processes are being carried out as planned?

Compliant Non-Compliant N/A

5 Leadership

5.1 Leadership and commitment


5.1.1 Leadership and commitment for the quality management system

Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability of the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and
the context of the organization;
c) ensuring that the quality policy is communicated, understood and applied within the organization;
d) ensuring the integration of the quality management system requirements into the organization’s business processes;
e) promoting awareness of the process approach;
f) ensuring that the resources needed for the quality management system are available;
g) communicating the importance of effective quality management and of conforming to the quality management system requirements;
h) ensuring that the quality management system achieves its intended results;
i) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
j) promoting continual improvement;
k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the
organization’s existence; whether the organization is public, private, for pro\t or not for pro\t.

Does Best Bars top management demonstrates leadership and commitment w.r.t. the QMS by taking accountability of the
effectiveness of the QMS.

Compliant Non-Compliant N/A

Does Best Bars make use of the quality policy and objectives established for the QMS and are they compatible with the strategic
direction and the organizational context?

Compliant Non-Compliant N/A

Does Best Bars communicate the quality policy within the organization?

Compliant Non-Compliant N/A

Are Best Bars requirements of the QMS integrated into the business processes?

Compliant Non-Compliant N/A

Does Best Bars communicate the importance of effective quality management?

Compliant Non-Compliant N/A

Does Best Bars ensure that the QMS achieves its intended results?

Compliant Non-Compliant N/A


Does Best Bars engage, direct and support people to contribute to the effectiveness of the QMS?

Compliant Non-Compliant N/A

Does Best Bars promote continual improvement?

Compliant Non-Compliant N/A

Does Best Bars support other relevant management roles to demonstrate leadership in their areas of responsibility?

Compliant Non-Compliant N/A

5.1.1.1 (TS) Corporate responsibility

Does Best Bars de\ne and implement corporate responsibility policies, including at a minimum abd anti-bribery policy, an employee
code of conduct, and an ethics escalation policy (Whistle blowing policy)

Compliant Non-Compliant N/A

5.1.1.2 (TS) Process effectiveness and eMciency

Does Best Bars Top Management review product realisation processes and support processes to evaluate and improve their
effectiveness and ejciency?
The results of the process review activities shall be included as a input into the Management Review (See Section 9.3.2.1)

Compliant Non-Compliant N/A

5.1.1.3 (TS) Process owners

Does Best Bars top management identify process owners who are responsible for managing the organisations processes and related
outputs? The process owners shall understand their roles and competent to perform those roles (See ISO 9001, Section 9.3.2.1)

Compliant Non-Compliant N/A

5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) customer requirements and applicable statutory and regulatory requirements are determined and met;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and
addressed;
c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;
d) the focus on enhancing customer satisfaction is maintained.

Does Best Bars top management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements and
applicable statutory and regulatory requirements are determined and met.

Compliant Non-Compliant N/A


Does Best Bars determine the risks and opportunities that can affect conformity of products and services?

Compliant Non-Compliant N/A

Does Best Bars consistently provide products and services that meet customer and applicable statutory and regulatory requirements?

Compliant Non-Compliant N/A

Does Best Bars provide customer satisfaction?

Compliant Non-Compliant N/A

5.2 Quality policy

5.2.1

Top management shall establish, review and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization;
b) provides a framework for setting and reviewing quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.

Does Best Bars top management establish, review and maintain a quality policy?

Compliant Non-Compliant N/A

Does Best Bars determine the Quality Policy to be appropriate to the purpose and context of the organization?

Compliant Non-Compliant N/A

Does it provide a framework for setting and reviewing quality objectives?

Compliant Non-Compliant N/A

Does it contain a commitment to satisfy applicable requirements?

Compliant Non-Compliant N/A

Does it include a commitment to continual improvement of the QMS?

Compliant Non-Compliant N/A

5.2.2
The quality policy shall:
a) be available as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.

Is the quality policy available as documented information?

Compliant Non-Compliant N/A

Is it communicated?

Compliant Non-Compliant N/A

Is the Policy available to relevant interested parties?

Compliant Non-Compliant N/A

5.3 Organisational roles, responsibility and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially
for reporting to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Does top management ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood
within the organization?

Compliant Non-Compliant N/A

Does top management assign the responsibility and authority for ensuring that the QMS conforms to the International standard?

Compliant Non-Compliant N/A

Does top management assign the responsibility and authority for ensuring processes are delivering their intended outputs?

Compliant Non-Compliant N/A

Is the performance of the QMS, opportunities for improvement and the need for change or innovation reported to top management?

Compliant Non-Compliant N/A


Does top management promote customer focus within the organization?

Compliant Non-Compliant N/A

Is the integrity of the QMS maintained when changes to the QMS are planned and implemented?

Compliant Non-Compliant N/A

5.3.1 (TS) Organisational roles, responsibilities and authorities

Does Best Bars top Management assign personnel with the responsibility and authority to ensure that customer requirements are
met? These assignments shall be documented. This includes but is not limited to the selection of special characteristics, setting
quality objectives and related training, corrective and preventive actions, product design and development, capacity analysis, logistics
information, customer scorecards and customer portals.

Compliant Non-Compliant N/A

5.3.2 (TS) Responsibility and authority for product requirements and corrective actions

Does Best Bars top Management ensure:


Personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct
quality problems?

Compliant Non-Compliant N/A

Does Best Bars production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring
conformity to product requirements?

Compliant Non-Compliant N/A

Does Best Bars personnel with authority and responsibility for corrective actions are promptly informed of products or processes that
do not conform to requirements to ensure that nonconforming products is not shipped to the customers and that all potential
nonconforming product is identi\ed and contained?

Compliant Non-Compliant N/A

6 Planning for the Quality Management System

6.1 Actions to address risks and opportunities

6.1.1

When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and
determine the risks and opportunities that
need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) prevent, or reduce, undesired effects;
c) Achieve continual improvement.
Are the internal and external issues and interested parties considered when planning for the QMS?

Compliant Non-Compliant N/A

Are risks and opportunities determined and addressed so that the QMS can achieve its intended results?

Compliant Non-Compliant N/A

Are risks and opportunities determined and addressed so that the QMS can prevent or reduce undesired effects?

Compliant Non-Compliant N/A

Are risks and opportunities determined and addressed so that the QMS can achieve continual improvement?

Compliant Non-Compliant N/A

6.1.2

NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the
likelihood or consequences, sharing the risk, or retaining risk by informed decision.

The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools
and techniques.
Applicable tools and techniques shall be identi\ed by the organization.

Are actions planned to address risks and opportunities?

Compliant Non-Compliant N/A

Are actions integrated and implemented into the QMS processes?

Compliant Non-Compliant N/A

Does Best Bars evaluate the effectiveness of the actions?

Compliant Non-Compliant N/A

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

Does Best Bars take actions to address risks and opportunities determined as being appropriate to the potential impact on the
conformity of products and services?

Compliant Non-Compliant N/A

Product design skills


The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools
and techniques.
Applicable tools and techniques shall be identi\ed by the organization.

Does Best Bars determine that personnel with product design responsibility are competent to achieve design requirements?

Compliant Non-Compliant N/A

Does Best Bars determine skills required in applicable tools and techniques?

Compliant Non-Compliant N/A

Does Best Bars identify applicable tools and techniques?

Compliant Non-Compliant N/A

NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the
likelihood or consequences, sharing the risk, or retaining risk by informed decision.

6.1.2.1 (TS) Risk Analysis

Does Best Bars at a minimum include in its risk analysis lessons learned from product recalls, product audits, \eld returns and repairs,
complaints and scrap and rework?

Compliant Non-Compliant N/A

6.1.2.2 (TS) Preventive action

Does Best Bars determine and implement actions to eliminate the causes of potential non conformity in order to prevent their
occurrences? Preventive actions shall be appropriate to the severity of the potential issues?

Compliant Non-Compliant N/A

Does Best Bars establish a process to lessen the impact of negative effects of risk which includes the following:
Determining potential non-conformity and their causes?

Compliant Non-Compliant N/A

Evaluating the need for action to prevent occurrences of non-conformity?

Compliant Non-Compliant N/A

Determining and implementing actions needed?

Compliant Non-Compliant N/A


Documented information of action taken?

Compliant Non-Compliant N/A

Reviewing the effectiveness of the preventive action taken?

Compliant Non-Compliant N/A

Utilising lessons learned to prevent re-occurrences in similar processes (See ISO 9001. Section 7.1.6)

Compliant Non-Compliant N/A

6.1.2.3 (TS) Contingency Plans

Does Best Bars

Identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain
production output and to ensure that customer requirements are met?

Compliant Non-Compliant N/A

De\ne contingency plans according to risk and impact to the customer?

Compliant Non-Compliant N/A

Prepare contingency plans for continuity of supply in the event of any of the following key equipment failures (Also see section
8.5.6.1.1), interruption from externally provided products, processes and services, recurring natural disasters, \re, utility interruptions,
labor shortages and infrastructure disruptions?

Compliant Non-Compliant N/A

Include, as a supplement to the contingency plans, a noti\cation process to the customer and other interested parties for the extent
and duration of any situation impacting customers operations?

Compliant Non-Compliant N/A

Periodically test the contingency plans, a noti\cation process to the customer and other interested parties for the extent and duration
of any situation impacting customers operations?

Compliant Non-Compliant N/A

Conduct contingency plan reviews (At a minimum Annually) using multidisciplinary team including top Management, and update as
required?

Compliant Non-Compliant N/A


Document the contingency plans and retain documented information describing and revision, including the person who authorised the
change?

Compliant Non-Compliant N/A

The contingency plan shall include provisions to validate that the manufactured product continues to meet customer speci\cations after the restart of
production following and emergency in which production was stopped and if the regular shutdown processes were not followed?

6.2 Quality objectives and planning to achieve them

6.2.1

The organization shall establish quality objectives at relevant functions, levels and processes.
The quality objectives shall:
a) be consistent with the quality policy,
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and the enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall retain documented information on the quality objectives.

Does Best Bars have quality objectives and are these at all relevant functions, levels and processes?

Compliant Non-Compliant N/A

Are they consistent with the quality policy?

Compliant Non-Compliant N/A

Do they consider applicable requirements?

Compliant Non-Compliant N/A

Are they relevant to the conformity of products and services and do they enhance customer satisfaction?

Compliant Non-Compliant N/A

Are they monitored? How? How often?

Compliant Non-Compliant N/A

Are they communicated?

Compliant Non-Compliant N/A


Are they updated?

Compliant Non-Compliant N/A

Are there documented information on the quality objectives?

Compliant Non-Compliant N/A

6.2.2

When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated

Does Best Bars determine what will be done, with what resources, when completed and how will results be evaluated for quality
objectives?

Compliant Non-Compliant N/A

6.2.2.1 (TS) Quality Objectives and planning to achieve them

Does Best Bars top Management ensure that quality objectives to meet customer requirements are de\ned, established and
maintained for relevant functions, processes and levels throughout the organisation?
The results of the organisations review regarding interested parties and their relevant requirements shall be considered when Best
Bars establishes its annual (At a minimum) quality objectives and related performance targets (Internal and External)

Compliant Non-Compliant N/A

6.3 Planning of changes

Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic
manner.
The organization shall consider:
a) the purpose of the change and any of its potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.

Are changes to the QMS planned systematically?

Compliant Non-Compliant N/A


Can Best Bars demonstrate the purpose and potential consequences of changes?

Compliant Non-Compliant N/A

Can Best Bars demonstrate the integrity of the QMS?

Compliant Non-Compliant N/A

Can Best Bars demonstrate how resources are made available?

Compliant Non-Compliant N/A

Can Best Bars demonstrate how responsibility and authority is allocated or reallocated?

Compliant Non-Compliant N/A

7 Support

7.1 Resources

7.1.1 General

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the
quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.

Can Best Bars demonstrate how resources are determined for the establishment, implementation, maintenance and continual
improvement of the QMS?

Compliant Non-Compliant N/A

Can Best Bars demonstrate how the capabilities and constraints on internal resources are considered?

Compliant Non-Compliant N/A

Can Best Bars demonstrate how needs from external providers are considered.

Compliant Non-Compliant N/A

7.1.2 People

To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons
necessary for the effective
operation of the quality management system, including the processes needed.
Does Best Bars provide persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the
QMS including the necessary processes?

Compliant Non-Compliant N/A

7.1.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services

Does Best Bars determine, provide and maintain the infrastructure for the operation of processes to achieve products and service
conformity?

Compliant Non-Compliant N/A

7.1.3.1 (TS) Plant, facility and equipment planning

Does Best Bars use a multidisciplinary approach including a risk identi\cation and risk mitigation methods when developing and
improving plant, facility and equipment plans

Compliant Non-Compliant N/A

In designing plant layouts, Does Best Bars optimise material eow, material handling, and value added use of eoor space including
control of nonconforming products?

Compliant Non-Compliant N/A

Does Best Bars facilitate synchronous material eow, as applicable?

Compliant Non-Compliant N/A

Does Best Bars develop and implement methods to evaluate manufacturing feasibility for new product or new operations?
Manufacturing feasibility assessments shall include capacity planning. These methods shall also be applicable for evaluating
proposed changes to existing operations.

Compliant Non-Compliant N/A

Does Best Bars maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made
during process approval, control plan maintenance (See section 8.5.1.1) and veri\cation of job set-ups (see section 8.5.1.3)

Compliant Non-Compliant N/A

Note 1: These requirements should include the application of lean manufacturing principles.

Note 2: These requirements should apply to on-site supplier activities, as applicable.

Health and Safety


Where third party certi\cation to ISO 45001 (or equivalent) is recognised, it may be used to demonstrate the organisations conformity to the personnel safety
aspects of this requirement.

7.1.4 Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and
services.

Does Best Bars determine, provide and maintain the environment for the operation of processes to achieve products and service
conformity?

Compliant Non-Compliant N/A

NOTE Environment for the operation of processes can include physical, social, psychological, environmental and other factors (such as temperature, humidity,
ergonomics and cleanliness).

7.1.4.1 (TS) Environment for the operation of processes

Does Best Bars maintain its premises is a state of order, cleanliness and repair that is consistent with the product and manufacturing
process needs?

Compliant Non-Compliant N/A

7.1.5 Monitoring and measuring resources

Where monitoring or measuring is used for evidence of conformity of products and services to speci\ed requirements the organization shall determine the
resources needed to ensure valid and reliable monitoring and measuring results.

Are the resources determined for ensuring valid and reliable monitoring and measuring results, where used?

Compliant Non-Compliant N/A

The organization shall ensure that the resources provided:


a) are suitable for the speci\c type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continued \tness for their purpose.

Does Best Bars ensure that resources provided are suitable for the speci\c monitoring and measurement activities and are
maintained to ensure continued \tness for purpose?

Compliant Non-Compliant N/A

The organization shall retain appropriate documented information as evidence of \tness for purpose of monitoring and measurement resources.

Does Best Bars have documented information which is evidence of \tness for purpose of monitoring and measurement resources.

Compliant Non-Compliant N/A


Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization
to be an essential part of providing con\dence in the validity of measurement results; measuring instruments shall be:
-veri\ed or calibrated at speci\ed intervals or prior to use against measurement standards traceable to international or national measurement standards. Where
no such standards exist, the basis used for calibration or veri\cation shall be retained as documented information;
-identi\ed in order to determine their calibration status;
-safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

Does Best Bars Verify or calibrate at speci\ed intervals against national or international measurement standards;

Compliant Non-Compliant N/A

If there are no standards does Best Bars document information which is used as the basis used for calibration or veri\cation

Compliant Non-Compliant N/A

Are Best Bars measurement instruments identi\ed to determine their calibration status.

Compliant Non-Compliant N/A

Are safeguarded from adjustments

Compliant Non-Compliant N/A

Are they safeguarded from damage and deterioration

Compliant Non-Compliant N/A

7.1.5.1.1 (TS) Measurement System Analysis

Does Best Bars conduct statistical studies to analyse the variation present in the results of each type of inspection, measurement and
test equipment system identi\ed in the control plan? The analytical methods and acceptance criteria used shall conform to those in
reference manuals on measurement system analysis. Other analytical methods and acceptance criteria may be used if approved by
the customer.

Compliant Non-Compliant N/A

Note: Prioritisation of MSA studies should focus on critical or special product or process characteristics.

7.1.5.2.1 (TS) Calibration/VeriFcation records


Does Best Bars have a documented process for managing calibration/veri\cation records?
Records for the calibration/veri\cation activity for all gauges and measuring and test equipment (including employee owned
equipment relevant for measuring, customer owned equipment, or on-site supplier owned equipment) needed to provide evidence of
conformity to internal requirements, legislative and regulatory requirements and customer de\ned requirements shall be retained.

Compliant Non-Compliant N/A

Does Best Bars ensure that calibration /veri\cation activities and records shall include the following details:
Revisions following engineering changes that impact measuring systems?

Compliant Non-Compliant N/A

Any out of speci\cation readings received for calibration/veri\cation?

Compliant Non-Compliant N/A

An assessment of the risk of the intended use of the product caused by the out of spec condition?

Compliant Non-Compliant N/A

When a piece of inspection measurement and test equipment is found to be out of calibration or defective during planned veri\cation
or calibration or during use, documented information on the validity of previous measurement results obtained with this piece of
inspection measurement and test equipment shall be retained, including associated standards last calibration date and the next due
date on the calibration report.

Compliant Non-Compliant N/A

Noti\cation to the customer if suspect product or material is shipped

Compliant Non-Compliant N/A

Statements of conformity to speci\cation after calibration/veri\cation

Compliant Non-Compliant N/A

Veri\cation that software version used for product and process control is speci\ed

Compliant Non-Compliant N/A

Records of the calibration and maintenance activities for all gauging

Compliant Non-Compliant N/A

Production related software veri\cation used for product and process control

Compliant Non-Compliant N/A

7.1.5.3 (TS) Laboratory Requirements


7.1.5.3.1 (TS) Internal Laboratory

Does Best Bars internal laboratory facility have a de\ned scope that includes its capacity to perform the required inspection, test or
calibrated service?

Compliant Non-Compliant N/A

The laboratory shall specify and implement as a minimum, requirements for:


Adequacy of the laboratory technical procedures

Compliant Non-Compliant N/A

Competency of the laboratory personnel

Compliant Non-Compliant N/A

Testing of the product

Compliant Non-Compliant N/A

Capability to perform these services correctly, traceable to the relevant process standard (ASTM etc.)

Compliant Non-Compliant N/A

Customer requirements, if any

Compliant Non-Compliant N/A

Review of the related records

Compliant Non-Compliant N/A

Note: Third party accreditation to ISO 17025 may be used to demonstrate the organisations in-house laboratory conformity to this requirement.

7.1.5.3.2 (TS) External Laboratory

Does Best Bars de\ne the scope used for inspections, test and calibration services used for external laboratory facilities that includes
the capacity to perform the required inspection, test, calibration?

Compliant Non-Compliant N/A

Does Best Bars ensure that the laboratory is ISO 17025 accredited or national equivalent and includes the relevant inspections, tests
and calibration services in the scope of the accreditation Certi\cate?

Compliant Non-Compliant N/A


Does Best Bars ensure that the external laboratory is accredited by the customer?

Compliant Non-Compliant N/A

Note, Such evidence may be demonstrated by customer assessment, for example, or by the customer approved third party assessment that the laboratory meets
the intent of ISO 17025 or national equivalent. The second party assessment may be performed by the organisation assessing the laboratory using a customer
approved method of assessment.

Use of calibration services, other than quali\ed (Or customer accepted) laboratories may be subject to government regulatory con\rmation, if required.

7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

Does Best Bars determine necessary knowledge for the operation of processes?

Compliant Non-Compliant N/A

Does Best Bars determine necessary knowledge to achieve conformity of products and services?

Compliant Non-Compliant N/A

This knowledge shall be maintained, and made available to the extent necessary.

Does Best Bars maintain this knowledge and how do you make it available to the extent necessary?

Compliant Non-Compliant N/A

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary
additional knowledge

How does Best Bars consider current knowledge

Compliant Non-Compliant N/A

How does Best Bars acquire additional knowledge when addressing changing needs and trends?

Compliant Non-Compliant N/A

NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
NOTE 2 To obtain the knowledge required, the organization can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the
organization);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or
providers).
7.2 Competence

The organization shall:


a) determine the necessary competence of person(s) doing work under its control that affects its quality performance;
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence

Does Best Bars determine the necessary competence of people doing work under your control that affects quality performance;

Compliant Non-Compliant N/A

Does Best Bars determine competence on the basis of appropriate education, training or experience?

Compliant Non-Compliant N/A

Does Best Bars take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those
actions?

Compliant Non-Compliant N/A

Does Best Bars have documented information where appropriate of competence

Compliant Non-Compliant N/A

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring
or contracting of competent persons.

7.2.1 (TS) Competence

Does Best Bars establish and maintain a documented process for identifying training need including awareness (See section 7.3.1)
and achieve competence of all personnel performing activities affecting conformity to product and process requirements? Personnel
performing speci\c assigned tasks shall be quali\ed, as required, with particular attention to the satisfaction of customer
requirements.

Compliant Non-Compliant N/A

7.2.2 (TS) Competence - On the jib training

Does Best Bars provide on the job training (Which shall include customer requirements training) for personnel new or modi\ed
responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements which
include contract or agency personnel?

Compliant Non-Compliant N/A


Does Best Bars administer the level of detail required for on-the-job training with the level of education the personnel posses and the
complexity of the tasks they are required to perform for their daily work? Persons who can effect quality shall be informed about the
consequences of non-conformity to customer requirements.

Compliant Non-Compliant N/A

7.2.3 (TS) Internal auditor competency

Does Best Bars have a documented process to verify that the internal auditors are competent, taking into account any customer
speci\c requirements? For additional guidance on auditor competencies, refer to ISO 19011.

Compliant Non-Compliant N/A

Does Best Bars maintain a list of quali\ed internal auditor?

Compliant Non-Compliant N/A

Does Best Bars QMS auditors, manufacturing process auditors and product auditors able to demonstrate the following minimum
competencies:
Understanding of the automotive process approach for auditing, including risk thinking?

Compliant Non-Compliant N/A

Understanding of applicable customer speci\c requirement?

Compliant Non-Compliant N/A

Understanding of the ISO 9001 and IATF 16949 requirements related to the scope of the auditing?

Compliant Non-Compliant N/A

Understanding applicable core tools requirements related to the scope of the audit?

Compliant Non-Compliant N/A

Understanding how to plan, conduct, report and close out audit \ndings?

Compliant Non-Compliant N/A

Does Best Bars auditors demonstrate manufacturing process technical understanding of the relevant manufacturing process to be
audited, including process risk analysis (PFMEA) and control plan.

Compliant Non-Compliant N/A

Does Best Bars product auditors demonstrate competence in the understanding of product requirements and use the relevant
measuring and test equipment to verify product conformity?

Compliant Non-Compliant N/A


Does Best Bars provide training to achieve competency, documented information shall be retained to demonstrate the trainers
competency with the above requirements?

Compliant Non-Compliant N/A

Does Best Bars auditors execute a minimum number of audits per year as de\ned by the organisation?

Compliant Non-Compliant N/A

Does Best Bars maintain knowledge of relevant requirements based on internal changes (e.g Process technology, product technology)
and external changes (E.g ISO 9001, IATF 16949, Core tools and customer speci\c requirements)?

Compliant Non-Compliant N/A

7.2.4 (TS) Second Part auditor competency

Does Best Bars demonstrate the competencies of the auditors undertaking second party audits?

Compliant Non-Compliant N/A

Second part auditors shall meet customer speci\c requirements for auditing quali\cation and demonstrate at a minimum the
following core competencies, including understanding of the following:
The automotive process approach to auditing, including risk base thinking?

Compliant Non-Compliant N/A

Understanding of applicable customer speci\c requirement?

Compliant Non-Compliant N/A

Understanding of the ISO 9001 and IATF 16949 requirements related to the scope of the auditing?

Compliant Non-Compliant N/A

Understanding applicable core tools requirements related to the scope of the audit?

Compliant Non-Compliant N/A

Understanding how to plan, conduct, report and close out audit \ndings?

Compliant Non-Compliant N/A

7.3 Awareness
Persons doing work under the organization’s control shall be aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality management system, including the bene\ts of improved quality performance;
d) the implications of not conforming with the quality management system requirements.

Does Best Bars make their workers aware of their quality policy?

Compliant Non-Compliant N/A

Does Best Bars make their employees aware of their relevant quality objectives?

Compliant Non-Compliant N/A

Does Best Bars make their employees aware of their contribution to the effectiveness of the QMS?

Compliant Non-Compliant N/A

Does Best Bars make their employees aware of the bene\ts of improved performance?

Compliant Non-Compliant N/A

Does Best Bars make their employees aware of the implications of not conforming with the QMS requirements?

Compliant Non-Compliant N/A

7.3.1 (TS) Awareness

Does Best Bars maintain documented information that demonstrate that all employees are aware of their impact on product quality
and the importance of their activities in achieving, maintaining and improving quality, including customer speci\c requirements and
the risks involved for the customer with non-conforming product?

Compliant Non-Compliant N/A

7.3.2 (TS) Employee motivated and empowerment

Does Best Bars maintain a documented process to motivate employees to achieving quality objectives, to make continual
improvements and to create an environment that promotes innovation? The process shall include the promotion of quality and
technology awareness throughout the entire organisation

Compliant Non-Compliant N/A

7.4 Communication
The organization shall determine the internal and external communications relevant to the quality management system including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate.

Does Best Bars show you how to determine internal and external communications relevant to the QMS?

Compliant Non-Compliant N/A

Does Best Bars show you how to determine What?

Compliant Non-Compliant N/A

Does Best Bars show you how to determine When?

Compliant Non-Compliant N/A

Does Best Bars show you how to determine With Whom?

Compliant Non-Compliant N/A

Does Best Bars show you how to determine How?

Compliant Non-Compliant N/A

7.5 Documented information

7.5.1 General

The organization’s quality management system shall include:


a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

What documented information does Best Bars have as required by this standard?

Compliant Non-Compliant N/A

What documented information does Best Bars have as being necessary for the effectiveness of your QMS?

Compliant Non-Compliant N/A

NOTE The extent of documented information for a quality management system can differ from one
organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.
7.5.1 (TS) Quality Management System Documentation

Is Best Bars QMS documented and includes a quality manual which can be a series of documents (Electronic or hard copy)?

Compliant Non-Compliant N/A

Does the quality manual include, at a minimum, the scope of the quality management system, including details of and justi\cation for
any exclusions?

Compliant Non-Compliant N/A

Does the quality manual include, at a minimum, documented processes established for the QMS or reference them?

Compliant Non-Compliant N/A

Does the quality manual include, at a minimum, the organisations processes and their sequence and interactions (inputs and outputs)
including type and extent of control of any outsourced processes?

Compliant Non-Compliant N/A

Does the quality manual include, at a minimum, a document (i.e Matrix) indicating where within the organisations QMS their customer
speci\c requirements are addressed?

Compliant Non-Compliant N/A

Note: A matrix of how the requirements of this QMS standard are addressed by the organisations processes may be used to assist the linkages of the
organisations processes and this automotive QMS.

7.5.2 Creating and updating

When creating and updating documented information the organization shall ensure appropriate:
a) identi\cation and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.

Does Best Bars have documented information that contains:


Identi\cation;
Description;
and in what media format?

Compliant Non-Compliant N/A

Does Best Bars have documented information that can be reviewed and approved for suitability and adequacy.

Compliant Non-Compliant N/A

7.5.3 Control of documented information


7.5.3.1

Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of con\dentiality, improper use, or loss of integrity).

Compliant Non-Compliant N/A

Does Best Bars show how to control documented information.

Compliant Non-Compliant N/A

Does Best Bars show how to make it available and suitable for use.

Compliant Non-Compliant N/A

How does Best Bars protect their documented information?

Compliant Non-Compliant N/A

7.5.3.2

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system
shall be identi\ed as appropriate, and controlled.

How does Best Bars identify as appropriate and control documented information of external origin which has been determined as
necessary for the QMS

Compliant Non-Compliant N/A

NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the
documented information.

7.5.3.2.1 (TS) Record Retention

Does Best Bars de\ne, document and implement a record retention policy? The control of records shall satisfy statutory, regulatory,
organisational and customer requirements.

Compliant Non-Compliant N/A

Does the record retention policy include production part approvals, tooling records (Including maintenance and ownership), product
and process design records, purchase ordeers (if applicable), or controls and amendments shall be retained for the length of time that
the product is active for production and service requirements, plus one calendar year, unless otherwise speci\ed by the customer or
regulatory agency?

Compliant Non-Compliant N/A


Note: Production Part Approval documented information may include approved product, applicable test equipment records or approved test data.

7.5.3.2.2 (TS) Engineering SpeciFcations

Does Best Bars have a documented process describing the review, distribution and implementation of all customer engineering
standards/speci\cations and related revisions based upon customer schedules as required?

Compliant Non-Compliant N/A

When an engineering standard/speci\cation change results in a product design change, refer to the requirements in ISO 9001, section 8.3.6. When and
engineering standard/speci\cation change results in a product realisation process change, refer to the requirements in Section 8.5.6.1.

Does Best Bars retain a record of the date on which each change is implemented in production? Implementation shall include updated
documents.

Compliant Non-Compliant N/A

Review should be completed within 10 working days of receipt of noti\cation of engineering standards/speci\cations changes.

Note: A change in these standards/speci\cations may require and update record of customer product part approval when these speci\cations are referenced on
the design record or if they effect documents of the PPAP, such as controls, risk analysis (Such as FMEAs) etc.

8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and
to implement the actions determined in 6.1, by:
a) determining requirements for the product and services;
b) establishing criteria for the processes and for the acceptance of products and services;
c) determining the resources needed to achieve conformity to product and service requirements;
d) implementing control of the processes in accordance with the criteria;
e) retaining documented information to the extent necessary to have con\dence that the processes have been carried out as planned and to demonstrate
conformity of products and services to requirements.

Are there processes at Best Bars needed to meet requirements for provision of products and services planned, implemented and
controlled?

Compliant Non-Compliant N/A

Does Best Bars have requirements for products and services determined?

Compliant Non-Compliant N/A


At Best Bars is there a criteria for processes and acceptance for products and services determined?

Compliant Non-Compliant N/A

Does Best Bars have a way of determining resources

Compliant Non-Compliant N/A

At Best Bars is process control implemented?

Compliant Non-Compliant N/A

At Best Bars can you show the documented information that shows con\dence in that the processes have been carried out as
planned and can demonstrate conformity of products and services.

Compliant Non-Compliant N/A

The output of this planning shall be suitable for the organization's operations.

At Best Bars have you determined that the output from the planning process is suitable for your operations?

Compliant Non-Compliant N/A

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as
necessary.

Does Best Bars have a way to control planned changes?

Compliant Non-Compliant N/A

Does Best Bars review the consequences of unintended changes?

Compliant Non-Compliant N/A

Does Best Bars have an action that is taken to mitigate any adverse effects?

Compliant Non-Compliant N/A

The organization shall ensure that outsourced processes are controlled in accordance with 8.4.

At Best Bars can you show how you control outsourced processes?

Compliant Non-Compliant N/A

8.1.1 (TS) Operational Planning and Control


When planning product realisation, is the topic included, with regards to, customer product requirements and technical speci\cations?

Compliant Non-Compliant N/A

When planning product realisation, is the topic included, with regards to, logistics requirements?

Compliant Non-Compliant N/A

When planning product realisation, is the topic included, with regards to, manufacturing feasibility?

Compliant Non-Compliant N/A

When planning product realisation, is the topic included, with regards to, project planning (Refer to ISO 9001, section 8.3.2)?

Compliant Non-Compliant N/A

When planning product realisation, is the topic included, with regards to, acceptance criteria?

Compliant Non-Compliant N/A

The resources identi\ed is ISO 9001, section 8.1 C refer to the required veri\cation, validation, monitoring, measurement, inspection and test activities speci\c to
the product and the criteria for product acceptance.

8.1.2 (TS) ConFdentiality

Does Best Bars ensure con\dentiality of customer contracted products anbd projects under development, including related product
information?

Compliant Non-Compliant N/A

8.2 Determination of requirements for products and services

8.2.1 Customer communication

The organization shall establish the processes for communicating with customers in relation to:
a) information relating to products and services;
b) enquiries, contracts or order handling, including changes;
c) obtaining customer views and perceptions, including customer complaints;
d) the handling or treatment of customer property, if applicable;
e) speci\c requirements for contingency actions, when relevant.

Does Best Bars have


processes for communicating with customers?

Compliant Non-Compliant N/A


Does Best Bars communicate information relating to:
Products;
Services;
Enquiries;
Contracts;
Order handling;
Customer views, perceptions and complaints;
Handling or treatment of customer property;

Compliant Non-Compliant N/A

Does Best Bars have speci\c requirements for contingency actions?

Compliant Non-Compliant N/A

8.2.1.1 (TS) Customer communication

Does Best Bars ensure that the written and verbal communication shall be in the language agreed by the customer? The organisation
shall have the ability to communicate necessary information, including data in a customer speci\ed computer language and format
(e.g. Computer aided design data, electronic data interchange)

Compliant Non-Compliant N/A

8.2.2 Determination of requirements related to products and services

The organization shall establish, implement and maintain a process to determine the requirements for the products and services to be offered to potential
customers.

Does Best Bars have a process to determine the requirements for products and services to be offered to potential customers?

Compliant Non-Compliant N/A

Does Best Bars establish, implement and maintain this process?

Compliant Non-Compliant N/A

The organization shall ensure that:


a) product and service requirements (including those considered necessary by the organization), and applicable statutory and regulatory requirements, are
de\ned;
b) it has the ability to meet the de\ned requirements and substantiate the claims for the products and services it offers.

Does Best Bars show how to de\ne product and service requirements including statutory and regulatory requirements?

Compliant Non-Compliant N/A

8.2.2.1 (TS) Determining the requirements for product and services


Does Best Bars include recycling, environmental impact, and characteristics identi\ed as a result of the organisations knowledge of
the product and manufacturing processes?

Compliant Non-Compliant N/A

Does Best Bars compliance to ISO 9001, section 8.2.2 item A 1 include applicable government, safety and environmental regulations
related to acquisition, storage, handling, recycling, elimination, or disposal or material?

Compliant Non-Compliant N/A

8.2.3.1.1 (TS) Review of the requirements for products and services

Does Best Bars retain documented evidence of a customer authorised waiver for the requirements stated in ISO 9001 section 8.2.3.1
for a formal review?

Compliant Non-Compliant N/A

8.2.3.1.2 (TS) Customer designated special characteristics

Does Best Bars conform to customer requirements for designation, approval documentation and control of special characteristics?

Compliant Non-Compliant N/A

8.2.3.1.3 (TS) Organisational Manufacturing feasibility

Does Best Bars utilise a multidisciplinary approach to conduct an analysis if it is feasible that the organisation's manufacturing
processes are capable of consistently producing product that meets all of the engineering and capacity requirements speci\ed by the
customer?

Compliant Non-Compliant N/A

Does Best Bars conduct this feasibility analysis for all manufacturing or product technology new to the organisation and for any
changed manufacturing process or product design?

Compliant Non-Compliant N/A

Does Best Bars validate through production runs, bench-marking studies or other appropriate methods their ability to make product to
speci\cations at the required rate?

Compliant Non-Compliant N/A

8.2.3 Review of requirements related to products and services

The organization shall review, as applicable:


a) requirements speci\ed by the customer, including the requirements for delivery and post-delivery activities;
b) requirements not stated by the customer, but necessary for the customers' speci\ed or intended use, when known;
c) additional statutory and regulatory requirements applicable to the products and services;
d) contract or order requirements differing from those previously expressed.
Does Best Bars have in place a review of Customer requirements for delivery and post-delivery?
Requirements necessary for customers’ speci\ed or intended use, where known;
Additional statutory and regulatory requirements applicable to products and services;
Any other contract or order requirements.

Compliant Non-Compliant N/A

NOTE Requirements can also include those arising from relevant interested parties.

This review shall be conducted prior to the organization’s commitment to supply products and services to the customer and shall ensure contract or order
requirements differing from those previously de\ned are resolved.

Does Best Bars show that the review is conducted prior to their commitment to supply products and services to their customers.

Compliant Non-Compliant N/A

Does Best Bars show how they resolve contract or order requirements which differ from those previously de\ned?

Compliant Non-Compliant N/A

Where the customer does not provide a documented statement of their requirements, the customer requirements shall be con\rmed by the organization before
acceptance.

Does Best Bars con\rm customer requirements where the customer does not provide a documented statement?

Compliant Non-Compliant N/A

Documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained.

Can Best Bars show where they retain documented information which describes results of the review including any new or changed
requirements.

Compliant Non-Compliant N/A

Where requirements for products and services are changed, the organization shall ensure that relevant documented information is amended and that relevant
personnel are made aware of the changed requirements.

Does Best Bars show the documented information containing changes to products and services

Compliant Non-Compliant N/A


Does Best Bars ensure that relevant personnel are made aware of those changes?

Compliant Non-Compliant N/A

8.3 Design and development of products and services

8.3.1 General

Where the detailed requirements of the organization’s products and services are not already established or not de\ned by the customer or by other interested
parties, such that they are adequate for subsequent production or service provision, the organization shall establish, implement and maintain a design and
development process.

Does Best Bars establish, implement and maintain a design and development process (where detailed requirements of their products
and services are not already established or de\ned by the customer or other parties).

Compliant Non-Compliant N/A

NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for production and services provision.
NOTE 2 For services, design and development planning can address the whole service delivery process. The organization can therefore choose to consider the
requirements of clauses 8.3 and 8.5 together.

8.3.1.1 (TS) Design development of products and services

The requirements of ISO 9001, section 8.3.1 shall apply to product and manufacturing process design and development and shall
focus on error proo\ng prevention rather than detection. Does Best bars conduct error proo\ng studies?

Compliant Non-Compliant N/A

Does Best Bars document the design and development process?

Compliant Non-Compliant N/A

8.3.2 Design and development planning

In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) requirements that specify particular process stages, including applicable design and development reviews;
c) the required design and development veri\cation and validation;
d) the responsibilities and authorities involved in the design and development process;
e) the need to control interfaces between individuals and parties involved in the design and development process;
f) the need for involvement of customer and user groups in the design and development process;
g) the necessary documented information to con\rm that design and development requirements have been met.
Does Best Bars determine the stages and control for design and development and show how they consider:
The nature, duration and complexity of the activities;
Requirements that specify particular process stages including applicable reviews;
Required veri\cation and validation;
Responsibilities and authorities;
How interfaces are controlled between individuals and parties;
The need for involvement of customer and user groups.

Compliant Non-Compliant N/A

Does Best Bars show documented information that con\rms design and development requirements have been met.

Compliant Non-Compliant N/A

8.3.2.1 (TS) Design and development planning

Does Best Bars ensure that the design and development planning includes all effected stakeholders within the organisation and, as
appropriate, its supply chain?

Compliant Non-Compliant N/A

Examples of areas for using such a multidisciplinary approach include but are not limited to the following:
Project management (APQP of VDA-RGA)
Product and manufacturing process design activities (DFM and DFA), such consideration of the use of alternative designs and manufacturing processes
Development and review of product design risk analysis (FMEAs) including actions to reduce potential risks
Development and review of manufacturing process risk analysis (E.g, FMEAs, Process eows, control plans and standardised work instructions)

8.3.2.2 (TS) Product design skills

Does Best Bars ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled
in applicable product design tools and techniques? Applicable design techniques and tools shall be identi\ed by the organisation

Compliant Non-Compliant N/A

Note: An example of product design skills is the application of digitised mathematically based data.

8.3.2.3 (TS) Development of products with embedded software

Does Best Bars ensure the use of a process for quality assurance for their products with internally developed embedded software?

Compliant Non-Compliant N/A

Does Best Bars conduct a software development assessment methodology use to assess the organisations software development
process?

Compliant Non-Compliant N/A


Does Best Bars include software development within the scope of their internal audit program (See section 9.2.2.1)

Compliant Non-Compliant N/A

8.3.3 Design and development inputs

The organization shall determine:


a) requirements essential for the speci\c type of products and services being designed and developed, including, as applicable, functional and performance
requirements;
b) applicable statutory and regulatory requirements;
c) standards or codes of practice that the organization has committed to implement;
d) internal and external resource needs for the design and development of products and services;
e) the potential consequences of failure due to the nature of the products and services;
f) the level of control expected of the design and development process by customers and other relevant interested parties.

Does Best Bars show how they determine:


Requirements essential for the type of products and services being designed and developed, including as applicable:
Functional & performance requirements;
Statutory and regulatory requirements;
Standards or codes of practice where there is a commitment to implement;
Internal and external resources needed for the design and development of products and services;
Potential consequences of failure;
Level of control expected of the design and development process by customers and other relevant parties.

Compliant Non-Compliant N/A

Inputs shall be adequate for design and development purposes, complete, and unambiguous. Coneicts among inputs shall be resolved.

Does Best Bars determine that inputs are adequate, complete and unambiguous for design and development?

Compliant Non-Compliant N/A

Does Best Bars resolve coneicts among inputs?

Compliant Non-Compliant N/A

8.3.3.1 (TS) Product design inputs

Does Best Bars identify, document and review product design input requirements as a result of contract reviews?

Compliant Non-Compliant N/A


Product design input requirements include, but not limited to the following:
Product speci\cations including but not limited to special characteristics (See Section 8.3.3.3)
Boundary and interface requirements
Identi\cation, trace-ability and packaging
Consideration of design alternatives
Assessment of risks with the input requirements and the organisations ability to mitigate/manage the risks, including a feasibility analysis
Targets for conformity to product requirements including preservation, reliability, durability, serviceability, health and safety, environmental, development timing
and cost
Applicable statutory and regulatory requirements of the customer identi\ed country of destination, if approved
Embedded software requirements

Best Bars shall have a process to deploy information gained from previous design projects, competitive product analysis (Bench-marking), supplier feedback,
internal input, \eld data and othe relevant sources for current and future projects of a similar nature.

Note: One approach for considering design alternatives is the use of trade-off curves

8.3.3.2 (TS) Manufacturing process design input

Does Best Bars identify, document and review manufacturing process design inputs with regards to product design output data
including special characteristics?

Compliant Non-Compliant N/A

Does Best Bars identify, document and review manufacturing process design inputs with regards to targets for productivity, process
capability, timing and cost?

Compliant Non-Compliant N/A

Does Best Bars identify, document and review manufacturing process design inputs with regards to manufacturing technology
alternatives

Compliant Non-Compliant N/A

Does Best Bars identify, document and review manufacturing process design inputs with regards to customer requirements, if any?

Compliant Non-Compliant N/A

Does Best Bars identify, document and review manufacturing process design inputs with regards to experience from previous
developments ?

Compliant Non-Compliant N/A

Does Best Bars identify, document and review manufacturing process design inputs with regards to raw materials?

Compliant Non-Compliant N/A


Does Best Bars identify, document and review manufacturing process design inputs with regards to product handling and ergonomic
requirements?

Compliant Non-Compliant N/A

Does Best Bars identify, document and review manufacturing process design inputs with regards to design for manufacturing and
design assembly?

Compliant Non-Compliant N/A

Does the manufacturing process design include the use of error proo\ng methods to a degree appropriate to the magnitude of the
problem and commensurate with the risks encountered?

Compliant Non-Compliant N/A

8.3.3.3 (TS) Special Characteristics

Does Best Bars make use of a multidisciplinary approach to establish and implement its processes to identify special characteristics,
including those determined by the customers and the risk analysis performed by the organisation?

Compliant Non-Compliant N/A

Does the risk analysis include a documentation of all special characteristics in the drawing (as required), risk analysis (Such as a
FMEA), control plans, and standardised work/operator instructions, special characteristics are identi\ed with special markings and are
cascaded through each of these documents?

Compliant Non-Compliant N/A

Does the risk analysis include a development of control and monitoring strategies for special characteristics of products and product
processes?

Compliant Non-Compliant N/A

Does the risk analysis include customer speci\ed approval, when required?

Compliant Non-Compliant N/A

Does the risk analysis include compliance with customer speci\ed de\nitions and symbols or the organisations equivalent symbols or
notations, as de\ned in a symbol table? The symbol conversion table shall be submitted to the customer, if required.

Compliant Non-Compliant N/A

8.3.4 Design and development controls


The controls applied to the design and development process shall ensure that:
a) the results to be achieved by the design and development activities are clearly de\ned;
b) design and development reviews are conducted as planned;
c) veri\cation is conducted to ensure that the design and development outputs have met the design and development input requirements;
d) validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the speci\ed application or intended
use (when known).

Does Best Bars have controls that are applied to the design and development process to ensure:
Results achieved by design and development activities are clearly de\ned?

Compliant Non-Compliant N/A

Does Best Bars have Design and development reviews that are conducted as planned?

Compliant Non-Compliant N/A

Does Best Bars outputs meet the input requirements by veri\cation/validation is conducted to ensure that the resulting products and
services are capable of meeting the requirements for the speci\ed application or intended use (when known)?

Compliant Non-Compliant N/A

8.3.4.1 (TS) Monitoring

Does Best Bars make use of measurements at speci\ed stages during the design and development of products and processes that
are de\ned, analysed and reported with summary results as an input to Management review (See section 9.3.2.1)?

Compliant Non-Compliant N/A

When required by the customer, measurements of the product and process development activity shall be reported to the customer at stages speci\ed by the
customer.

Note: When appropriate, these measurements may include quality risks, costs, lead times, critical paths and other measurements.

8.3.4.2 (TS) Design and development validation

Does Best Bars ensure design and development validation is performed according to customer requirements, including any applicable
industry and governmental agency issued regulatory standards?

Compliant Non-Compliant N/A

Does Best Bars ensure timing of the design and development validation shall be planned in alignment with customer speci\ed timing,
as applicable?

Compliant Non-Compliant N/A


Does Best Bars, where contractually agreed with the customer, include evaluation of the interaction of the organisations product,
including embedded software, within the system of the \nal customers product?

Compliant Non-Compliant N/A

8.3.4.3 (TS) Prototype Program

Does Best Bars, when required by the customer, have a prototype program and control plan?

Compliant Non-Compliant N/A

Does Best Bars make use of all the same suppliers, tooling and manufacturing processes as will be used in product when developing
the prototype?

Compliant Non-Compliant N/A

Does Best Bars monitor all performance testing activities for timely completion and conformity to requirements?

Compliant Non-Compliant N/A

Does Best Bars ensure when services are outsourced, the organisation includes the type and extent of control in the scope of its QMS
to ensure that outsourced services conform to requirements (See ISO 9001 section 8.4)?

Compliant Non-Compliant N/A

8.3.4.4 (TS) Product approval process

Does Best Bars establish, implement and maintain product and manufacturing approval process conforming to requirements as
de\ned by the customer?

Compliant Non-Compliant N/A

Does Best Bars approve externally provided product approval prior to shipment, if required by the customer? Records of their part
approval shall be retained.

Compliant Non-Compliant N/A

Note: Product approval should be subsequent to the validation of the manufacturing process.

8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:


a) meet the input requirements for design and development;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, and acceptance criteria, as applicable;
d) ensure products to be produced, or services to be provided, are \t for intended purpose and their safe and proper use.
Does Best Bars ensure that design and development outputs:
Meet the input requirements for design and development?

Compliant Non-Compliant N/A

Does Best Bars ensure they are adequate for the subsequent processes for the provision of products and services?

Compliant Non-Compliant N/A

Does Best Bars include or reference monitoring and measuring requirements, and acceptance criteria, as applicable?

Compliant Non-Compliant N/A

Does Best Bars ensure products to be produced, or services to be provided, are \t for intended purpose and their safe and proper use?

Compliant Non-Compliant N/A

The organization shall retain the documented information resulting from the design and development process.

8.3.5.1 (TS) Design and development outputs

Does Best Bars ensure that the product design output shall be expressed in terms that can be veri\ed and validated against product
design input requirements?

Compliant Non-Compliant N/A

Does Best Bars product design output include design risk analysis (FMEA)?

Compliant Non-Compliant N/A

Does Best Bars product design output include reliability study results?

Compliant Non-Compliant N/A

Does Best Bars product design output include product special characteristics?

Compliant Non-Compliant N/A

Does Best Bars product design output include results of product design error proo\ng, such as DFSS, DFMA and FTA?

Compliant Non-Compliant N/A

Does Best Bars product design output include product de\nition including 3D models, technical data packages, product
manufacturing information, and geometric dimension and tolerance (GD&T)?

Compliant Non-Compliant N/A


Does Best Bars product design output include product design review results

Compliant Non-Compliant N/A

Does Best Bars product design output include service diagnostics guidelines and repair and serviceability instructions?

Compliant Non-Compliant N/A

Does Best Bars product design output include service parts requirements?

Compliant Non-Compliant N/A

Does Best Bars product design output include packaging and rebelling requirements for shipping?

Compliant Non-Compliant N/A

Note: Interim design outputs should include any engineering problems being resolved through a trade-off process.

8.3.5.2 (TS) Manufacturing process design output

Does Best Bars document the manufacturing process design output in a manner that enables veri\cation against the manufacturing
process design outputs?

Compliant Non-Compliant N/A

Does Best Bars verify the outputs against manufacturing process design input requirements?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include speci\cations and drawing?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include special characteristics for product and manufacturing process?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include identi\cation of process input variables that impact characteristics?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include tooling and equipment for production and control, including capability studies of
equipment and processes?

Compliant Non-Compliant N/A


Does Best Bars manufacturing design output include manufacturing process eow charts/layout, including linkage of product, process
and tooling?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include capacity analysis?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include manufacturing process FMEA?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include maintenance plans and instructions?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include control plan?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include standardised work and work instructions?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include process approval acceptance criteria?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include data for quality, reliability, maintainability and measure-ability?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include results of error proo\ng identi\cation and veri\cation, as appropriate?

Compliant Non-Compliant N/A

Does Best Bars manufacturing design output include methods of rapid detection, feedback and corrections of product.manufacturing
process non-conformity?

Compliant Non-Compliant N/A

8.3.6 Design and development changes

The organization shall review, control and identify changes made to design inputs and design outputs during the design and development of products and
services or subsequently, to the extent that there is no adverse impact on conformity to requirements.
Does Best Bars review, control and identify changes made to the design inputs and outputs during design and development of
products and services ensuring no impact on conformity to requirements?

Compliant Non-Compliant N/A

Documented information on design and development changes shall be retained.

Does Best Bars show the documented information for design and development changes.

Compliant Non-Compliant N/A

8.3.6.1 (TS) Design and development changes

Does Best Bars evaluate all design changes after initial product approval, including those proposed by the organisation or its suppliers
for the potetial impact on \t, form, function, performance and/or durability?
These changes shall be validated against customer requirements and approved internally from the customer prior to production
implementation.

Compliant Non-Compliant N/A

If required by the customer, does Best Bars, obtain documented approval, or a documented waiver from the customer prior to
production implementation?

Compliant Non-Compliant N/A

For products with embedded software, does Best Bars document the revision level of the software and hardware as part of the change
record?

Compliant Non-Compliant N/A

8.4 Control of externally provided products and services

8.4.1 General

The organization shall ensure that externally provided processes, products, and services conform to speci\ed requirements.

Does Best Bars ensure externally provided processes, products and services conform to speci\ed requirements?

Compliant Non-Compliant N/A

The organization shall apply the speci\ed requirements for the control of externally provided products and services when:
a) products and services are provided by external providers for incorporation into the organization’s own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;
c) a process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function.
Does Best Bars show how they apply speci\ed requirements for the control of externally provided products and services when:
Products and services are provided by external providers for incorporation into your own products and services;
You provide products and services directly to customers by external providers on your behalf;
A process or part-process is provided by an external provider as a result of a decision to outsource a process or function.

Compliant Non-Compliant N/A

The organization shall establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their
ability to provide processes or products and services in accordance with speci\ed requirements.

Does Best Bars show how to establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of
external providers.

Compliant Non-Compliant N/A

Does Best Bars assess their ability to provide processes or products and services in accordance with speci\ed requirements?

Compliant Non-Compliant N/A

The organization shall retain appropriate documented information of the results of the evaluations, monitoring of the performance and re-evaluations of the
external providers.

Does Best Bars have documented information with the results of evaluations, monitoring of performance and re-evaluations of
external providers?

Compliant Non-Compliant N/A

8.4.1.1 (TS) General

Does Best Bars include all products and services that effect customer requirements such as sub-assembly, sequencing, sorting,
rework and calibration services in the scope of their de\nition of externally provided products, processes and services?

Compliant Non-Compliant N/A

8.4.1.2 (TS) Supplier selection process

Does Best Bars have a documented supplier selection process?

Compliant Non-Compliant N/A

Does the supplier selection process include an assessment of the selected suppliers risk to product conformity and uninterrupted
supply of the organisations product to their customers?

Compliant Non-Compliant N/A


Does the supplier selection process include relevant quality and delivery performance?

Compliant Non-Compliant N/A

Does the supplier selection process include an evaluation of the suppliers QMS?

Compliant Non-Compliant N/A

Does the supplier selection process include multidisciplinary decision making?

Compliant Non-Compliant N/A

Does the supplier selection process include an assessment of software development capabilities?

Compliant Non-Compliant N/A

Other suppliers selection criteria that should be considered includes the following:
Financial stability
Purchased product, material or service complexity
Required technology (product and process)
Adequacy of available resource. people, infrastructure)
Design and development capabilities
Change management process
Business continuity planning
Logistic process
customer service

8.4.1.3 Customer direct sources (Direct buy)

When speci\ed by the customer, does Best bars purchase products, materials or services from customer directed sources?

Compliant Non-Compliant N/A

All requirements of section 8.4 (except for the requirements in IATF 16949 Section 8.4.1.2) are applicable to the organisations control of customer directed
sources unless speci\c agreements are otherwise de\ned by the contract between the organisation and the customer.

8.4.2 Type and extent of control of external provision

In determining the type and extent of controls to be applied to the external provision of processes, products and services, the organization shall take into
consideration:
a) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable
statutory and regulatory requirements;
b) the perceived effectiveness of the controls applied by the external provider.
Does Best Bars determine the controls applied to the external provision of processes, products and services and take into
consideration the following:
a) The potential impact of the externally provided processes, products and services on the ability to consistently meet customer and
applicable statutory and regulatory requirements?

Compliant Non-Compliant N/A

Does Best Bars determine the controls applied to the external provision of processes, products and services and take into
consideration the following:

Compliant Non-Compliant N/A

The organization shall establish and implement veri\cation or other activities necessary to ensure the externally provided processes, products and services do
not adversely affect the organization's ability to consistently deliver conforming products and services to its customers.

Can Best Bars show what veri\cation or other activities they have to ensure externally provided processes, products and services do
not adversely affect your ability to consistently deliver conforming products and services to your customers?

Compliant Non-Compliant N/A

Processes or functions of the organization which have been outsourced to an external provider remain within the scope of the organization’s quality
management system; accordingly, the organization shall consider a) and b) above and de\ne both the controls it intends to apply to the external provider and
those it intends to apply to the resulting process output.

When Best Bars processes or functions have been outsourced to external providers, how do Best Bars consider a) and b) in 8.4.1 and
how does Best Bars de\ne the controls intended to be applied to the external provider and to the resulting process output?

Compliant Non-Compliant N/A

8.4.2.1 (TS) Type and extent of control

Does Best Bars have a documented process to identify outsourced processes and to select the types and extent of controls used to
verify conformity of externally provided products, processes and the service to internal and external customer requirements?

Compliant Non-Compliant N/A

Does the process include the criteria and actions to escalate or reduce the types and extent of controls and development activities
based on supplier performance and assessment of product material or service risks?

Compliant Non-Compliant N/A

8.4.2.2 Statutory and regulatory requirements


Does Best Bars have a documented process to ensure that purchased products, processes and services conform to the current
applicable statutory and regulatory requirements in the country of receipt, the country of shipment and the customer identi\ed country
of destination, if provided?

Compliant Non-Compliant N/A

If the customer de\nes special controls for certain products with statutory and regulatory requirements, does the Best Bars ensure
they are implemented and maintained as de\ned, including at suppliers?

Compliant Non-Compliant N/A

8.4.2.3 Supplier QMS development

Does Best Bars require their suppliers of automotive products and services to develop, implement and improve a QMS certi\ed to ISO
9001, unless otherwise authorised by the customer, with a ultimate objective of becoming certi\ed to the IATF 16949:2016 QMS
standard.

Compliant Non-Compliant N/A

Unless otherwise speci\ed by the customer, the following sequence should be applied to achieve this requirement:
Compliance to ISO 9001 through second party audits
Certi\cation to ISO 9001 through third party audits, unless otherwise speci\ed by the customers, suppliers to Best Bars shall demonstrate conformity to ISO
9001 by maintaining q third party certi\cation issued a certi\cation body bearing the accreditation mark of a recognised IAF MLA member and where the
accreditation body main scope include management system certi\cation to ISO 17021
Certi\cation to ISO 9001 with compliance to other customer de\ned QMS requirements
Certi\cation to IATF 16949 by an IATF recognised certi\cation body

8.4.2.3.1 Automotive product related software or automotive products with embedded software

Does Best Bars require their suppliers of automated product related software or automotive products with embedded software, to
implement and maintain a process for software quality assurance for their products?

Compliant Non-Compliant N/A

Does Best Bars ensure that a software development assessment methodology shall be utilised to assess the suppliers software
development process? Using a prioritisation based risk and potential impact to the customer, Best Bars shall require the supplier to
retain documented information of a software development capability self-assessment.

Compliant Non-Compliant N/A

8.4.2.4 (TS) Supplier Monitoring

Does Best Bars have a documented process and criteria to evaluate supplier performance in order to ensure conformity to externally
provided products, processes and services to internal and external requirements?

Compliant Non-Compliant N/A


Does Best Bars monitor supplier performance indicators in terms of delivered product conformity to requirements?

Compliant Non-Compliant N/A

Does Best Bars monitor supplier performance indicators in terms of customer disruptions at the receiving plant, including yard holds
and stop ships?

Compliant Non-Compliant N/A

Does Best Bars monitor supplier performance indicators in terms of delivery schedule performance?

Compliant Non-Compliant N/A

Does Best Bars monitor supplier performance indicators in terms of number of premium freight?

Compliant Non-Compliant N/A

Does Best Bars monitor supplier performance indicators in terms of special status customer noti\cations related to quality or delivery
issues?

Compliant Non-Compliant N/A

Does Best Bars monitor supplier performance indicators in terms of dealer returns, warranty, \eld actions and recalls?

Compliant Non-Compliant N/A

8.4.2.4.1 (TS) Second Party Audits

Does Best Bars include a second party audit process in their supplier management process?

Compliant Non-Compliant N/A

Second party audits may be used for the following:


Supplier risk assessment
Supplier monitoring
Supplier QMS development
Product audits
Process audits

Based on a risk assessment analysis, including product safety/regulatory requirements, performance of the supplier and QMS
certi\cation level, at a minimum, does Best Bars document the criteria for determining the need, type, frequency and scope of second
party audits?

Compliant Non-Compliant N/A

Does Best Bars retain records of the second party audit reports?

Compliant Non-Compliant N/A


Note: Guidance may be found in the IATF Auditor Guide and ISO 19011

8.4.2.5 (TS) Supplier Development

The organisation shall determine the priority, type, extent and timing of required supplier development actions for its active suppliers.

Do the determination inputs include performance issues identi\cation through supplier monitoring?

Compliant Non-Compliant N/A

Do the determination inputs include second party audit \ndings?

Compliant Non-Compliant N/A

Do the determination inputs include third party QMS certi\cation status?

Compliant Non-Compliant N/A

Do the determination inputs include risk analysis?

Compliant Non-Compliant N/A

8.4.3 Information for external providers

The organization shall communicate to external providers applicable requirements for the following:
a) the products and services to be provided or the processes to be performed on behalf of the organization;
b) approval or release of products and services, methods, processes or equipment;
c) competence of personnel, including necessary quali\cation;
d) their interactions with the organization's quality management system;
e) the control and monitoring of the external provider’s performance to be applied by the
organization;
f) veri\cation activities that the organization, or its customer, intends to perform at the external provider’s premises.

Does Best Bars show how they communicate to external providers, applicable requirements for:
Products and services to be provided or the processes to be performed on behalf of the organization;
Approval or release of products and services, methods, processes or equipment;
Competence of personnel, including necessary quali\cation;
Their interactions with the organization's quality management system;
The control and monitoring of the external provider’s performance to be applied by the
organization;
Veri\cation activities that the organization, or its customer, intends to perform at the external provider’s premises.

Compliant Non-Compliant N/A

The organization shall ensure the adequacy of speci\ed requirements prior to their communication to the external provider.
Before Best Bars communicates with external providers, do they ensure the adequacy of speci\ed requirements?

Compliant Non-Compliant N/A

8.4.3.1 Information for external providers

Does Best Bars pass down all applicable statutory and regulatory requirements and special product and process characteristics to
their suppliers and require the suppliers to cascade all applicable requirements down the supply chain to the point of manufacturing?

Compliant Non-Compliant N/A

8.5 Production and service provision

8.5.1 Control of production and service provision

The organization shall implement controlled conditions for production and service provision, including delivery and post-delivery activities.

Controlled conditions shall include, as applicable:


a) the availability of documented information that de\nes the characteristics of the products and services;
b) the availability of documented information that de\nes the activities to be performed and the results to be achieved;
c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for
products and services, have been met.
d) the use, and control of suitable infrastructure and process environment;
e) the availability and use of suitable monitoring and measuring resources;
f) the competence and, where applicable, required quali\cation of persons;
g) the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output
cannot be veri\ed by subsequent monitoring or measurement;
h) the implementation of products and services release, delivery and post-delivery activities.

Can Best Bars show me controlled conditions for:


a) the availability of documented information de\ning the characteristics of the products and services;
b) the availability of documented information de\ning the activities to be performed and the results to be achieved;
c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs,
and acceptance criteria for products and services, have been met.
d) the use, and control of suitable infrastructure and process environment;
e) the availability and use of suitable monitoring and measuring resources;
f) the competence and, where applicable, required quali\cation of persons;
g) the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision
where the resulting output cannot be veri\ed by subsequent monitoring or measurement;
h) the implementation of products and services release, delivery and post-delivery activities.

Compliant Non-Compliant N/A

8.5.1.1 (TS) Control Plan


Does Best Bars develop control plans at the system, subsystem, component, and/or material level for the relevant manufacturing site
and all product supplied, including those processes producing bulk materials as well as parts?
"Family" control plans are acceptable for bulk material and similar parts using a common manufacturing process.

Compliant Non-Compliant N/A

Does Best Bars have a control plan for pre-launch and production that shows linkage and incorporates information from design risk
analysis, process eow diagram and manufacturing process risk analysis outputs (Such as FMEAs)

Compliant Non-Compliant N/A

Does Best Bars, if required by the customer, provide measurement and conformity data collected during execution of either the pre-
launch or production control plans?

Compliant Non-Compliant N/A

Does the control plans include controls used for the manufacturing process control, including veri\cation of job set ups?

Compliant Non-Compliant N/A

Does the control plans include \rst off/last off part validation, as applicable?

Compliant Non-Compliant N/A

Does the control plans include methods for monitoring or control exercised over special characteristics de\ned in both the customer
and the organisation?

Compliant Non-Compliant N/A

Does the control plans include the customer required information?

Compliant Non-Compliant N/A

Does the control plans include speci\ed reaction plan, when non-conforming product is detected, the process becomes statistically
unstable or not statistically capable?

Compliant Non-Compliant N/A

Does Best Bars review the Control plans for determining it has shipped non conforming product to the customer?

Compliant Non-Compliant N/A

Does Best Bars review the Control plans for when change occurs affecting product, manufacturing process, measurement, logistics,
supply sources, production volume changes or risk analysis (FMEA)?

Compliant Non-Compliant N/A


Does Best Bars review the Control plans after a customer complaint and implementation of the associated corrective actions, when
applicable?

Compliant Non-Compliant N/A

Does Best Bars review the Control plans at a set frequency based on a risk analysis?

Compliant Non-Compliant N/A

8.5.1.2 (TS) Standardised work - Operator instructions and visual standards

Does Best Bars ensure that standardised work documents are communicated to and understood by the employees who are
responsible for performing the work?

Compliant Non-Compliant N/A

Does Best Bars ensure that standardised work documents are legible?

Compliant Non-Compliant N/A

Does Best Bars ensure that standardised work documents are presented in the language understood by the personnel responsible to
follow them?

Compliant Non-Compliant N/A

Does Best Bars ensure that standardised work documents are accessible for use at the designated work area?

Compliant Non-Compliant N/A

The standardised work documents shall also include rules for operator safety

8.5.1.3 (TS) VeriFcation of job set ups

Does Best Bars verify job set-ups when performed, such as initial run of a job, material changeover, or job change that requires a new
sett-up?

Compliant Non-Compliant N/A

Does Best Bars maintain documented information for set-up personnel?

Compliant Non-Compliant N/A

Does Best Bars use statistical methods of veri\cation, where applicable?

Compliant Non-Compliant N/A


Does Best Bars perform \rst off/last off part validation, as applicable, where appropriate, \rst off parts should be retained for
comparison with the last off parts, where appropriate, last off parts should be retained for comparison with \rst off parts in
subsequent runs?

Compliant Non-Compliant N/A

Does Best Bars retain records of process and product approval following set-up and \rst off/last off part validation?

Compliant Non-Compliant N/A

8.5.1.4 (TS) VeriFcation after shut down

Does Best Bars de\ne and implement the necessary actions to ensure product compliance with requirements after planned or
unplanned production shutdown period?

Compliant Non-Compliant N/A

8.5.1.5 Total productive maintenance

Has Best Bars developed, implemented and maintained a document a total productive maintenance system?

Compliant Non-Compliant N/A

At a minimum, does the system include identi\cation of process equipment necessary to produce conforming product at the required
volume?

Compliant Non-Compliant N/A

At a minimum, does the system include availability of replacement parts for the equipment and facility maintenance?

Compliant Non-Compliant N/A

At a minimum, does the system include provision of resources for machine, equipment and facility maintenance?

Compliant Non-Compliant N/A

At a minimum, does the system include packaging and preservation of equipment, tooling and gauging?

Compliant Non-Compliant N/A

At a minimum, does the system include applicable customer speci\c requirements?

Compliant Non-Compliant N/A

At a minimum, does the system include documented maintenance objectives?

Compliant Non-Compliant N/A


At a minimum, does the system include regular review of maintenance plan and objectives and a documented action plan to address
corrective actions where objectives are not achieved?

Compliant Non-Compliant N/A

At a minimum, does the system include the use of preventive maintenance methods?

Compliant Non-Compliant N/A

At a minimum, does the system include a predictive maintenance methods, as applicable?

Compliant Non-Compliant N/A

At a minimum, does the system include periodic overhauling?

Compliant Non-Compliant N/A

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment

Does Best Bars provide resources for tool and gauge design, fabrication, and veri\cation activities for production and service
materials and for bulk materials, as applicable?

Compliant Non-Compliant N/A

Has Best Bars established and implemented a system for production tooling management whether owned by the organisation or the
customer?
Including:
Maintenance and repair facilities and personnel
Storage and recovery
set-up
Tool change programs for perishable tools
Tool design modi\cations documentation
Tool modi\cation and revision to documentation
Tool identi\cation, such as serial or asset number etc

Compliant Non-Compliant N/A

The organisation shall verify that customer owned tools, manufacturing equipment and test/inspection equipment are permanently marked in a visible location
so that the ownership and application of each item can be determined

8.5.1.7 (TS) Production Scheduling

Does Best Bars ensure that production is scheduled in order to meet customer order/demands such as Just In Time and is supported
by an information system that permits access to production information at key stages of the process and is order driven?

Compliant Non-Compliant N/A


Does Best Bars include relevant planning information during production scheduling e.g customer orders, capacity etc?

Compliant Non-Compliant N/A

8.5.2 IdentiFcation and trace-ability

Where necessary to ensure conformity of products and services, the organization shall use suitable means to identify process outputs.

Does Best Bars show ways they use to identify process outputs to ensure conformity of products and services?

Compliant Non-Compliant N/A

Does Best Bars have a way of identifying the status of process outputs?

Compliant Non-Compliant N/A

Where traceability is a requirement, the organization shall control the unique identi\cation of the process outputs, and retain any documented information
necessary to maintain traceability.

Does Best Bars have a way to control the unique identi\cation of process outputs, where applicable?

Compliant Non-Compliant N/A

Can Best Bars show the type of documented information that it retains?

Compliant Non-Compliant N/A

NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s customer or to an internal customer (e.g. receiver of the
inputs to the next process); they can include products, services, intermediate parts, components, etc.

8.5.2.1 IdentiFcation and Traceability

The purpose of traceability is to support identi\cation of clear start and stop points for product received by the customers or in the \eld that may contain quality
and/or safety related non-conformities.

Has Best Bars implemented identi\cation and traceability processes?

Compliant Non-Compliant N/A

Has Best Bars conducted and analysis of internal, customer, and regulatory traceability requirements for all automotive products,
including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers and
consumers?

Compliant Non-Compliant N/A


8.5.3 Property belonging to customers or external providers

The organization shall exercise care with property belonging to the customer or external providers while it is under the organization's control or being used by the
organization. The organization shall identify, verify, protect and safeguard the customer’s or external provider’s property provided for use or incorporation into the
products and services.

Does Best Bars provide care for customer or external provider’s property while under their control?

Compliant Non-Compliant N/A

Does Best Bars identify, verify, protect and safeguard that property which is provided for use or incorporation into their products or
services?

Compliant Non-Compliant N/A

When property of the customer or external provider is incorrectly used, lost, damaged or otherwise found to be unsuitable for use, the organization shall report
this to the customer or external provider.

Does Best Bars have means they use to report to the customer or external provider if their property is incorrectly used, lost, damaged
or found to be unsuitable for use?

Compliant Non-Compliant N/A

8.5.4 Preservation

The organization shall ensure preservation of process outputs during production and service provision, to the extent necessary to maintain conformity to
requirements.

Does Best Bars ensure preservation of process outputs during production and service provision to maintain conformity to product
requirements?

Compliant Non-Compliant N/A

NOTE Preservation can include identi\cation, handling, packaging, storage, transmission or transportation, and protection.

8.5.4.1 (TS) Preservation

Does Best Bars ensure preservation that includes handling, identi\cation contamination control, packaging, storage, transmission or
transportation and protection?

Compliant Non-Compliant N/A

8.5.5 Post-delivery activities

As applicable, the organization shall meet requirements for post-delivery activities associated with the products and services.
Does Best Bars meet the requirements for post-delivery activities associated with products and services?

Compliant Non-Compliant N/A

In determining the extent of post-delivery activities that are required, the organization shall consider:
a) the risks associated with the products and services;
b) the nature, use and intended lifetime of the products and services;
c) customer feedback;
d) statutory and regulatory requirements.

Can Best Bars determine:


Risk;
Nature, use and intended lifetime;
Customer feedback;
Statutory and Regulatory requirements, when determining the extent of post-delivery activities required with products and services?

Compliant Non-Compliant N/A

NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services
such as recycling or \nal disposal.

8.5.5.1 (TS) Feedback of information from service

Does Best Bars ensure that there is a process for communication of information on service concerns to manufacturing, material
handling, logistics, engineering and design activities is established, implemented and maintained?

Compliant Non-Compliant N/A

8.5.5.2 (TS) Service agreements with customers

When there is a service agreement with the customer, Best Bars shall:

Verify that the relevant service centers comply with applicable requirements?

Compliant Non-Compliant N/A

Verify the effectiveness of any special purpose tools or measuring equipment?

Compliant Non-Compliant N/A

Ensure that all service personnel are trained in applicable requirements?

Compliant Non-Compliant N/A

8.5.6 Control of changes


The organization shall review and control unplanned changes essential for production or service provision to the extent necessary to ensure continuing
conformity with speci\ed requirements.

Does Best Bars review and control unplanned changes to ensure continuing conformity with speci\ed requirements?

Compliant Non-Compliant N/A

The organization shall retain documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary
actions.

Does Best Bars have documented information that can be shown which describes the results of reviews of changes, the personnel
authorizing change and any necessary actions?

Compliant Non-Compliant N/A

8.5.6.1 (TS) Control of changes

Does Best Bars have a documented process to control and react to changes that impact product realisation?
The effects of any change, including those changes caused by the organisation, by the customer or any supplier shall be addressed.

Compliant Non-Compliant N/A

Does Best Bars de\ne veri\cation and validation activities to ensure compliance with customer requirements?

Compliant Non-Compliant N/A

Does Best Bars validate changes before implementation?

Compliant Non-Compliant N/A

Does Best Bars document the evidence of related risk analysis?

Compliant Non-Compliant N/A

Does Best Bars retain records of veri\cation and validation?

Compliant Non-Compliant N/A

Changes, including those made at suppliers, should require a production trail run for veri\cation of changes to validate the impact of any changes on the
manufacturing process.

When required by the customer, does Best Bars notify the customer of any planned product realisation changes after the most recent
product approval?

Compliant Non-Compliant N/A


When required by the customer, does Best Bars obtain documented approval prior to implementation of the changes?

Compliant Non-Compliant N/A

When required by the customer, does Best Bars complete additional veri\cation or identi\cation requirements, such as production trail
run and new product validation?

Compliant Non-Compliant N/A

8.5.6.1.1 (TS) Temporary change of process controls

Has Best Bars identi\ed, documented and maintained a list of the process controls, including inspection, measuring, test and error
proo\ng devices, that includes the primary process control and the approved back-up or alternative methods?

Compliant Non-Compliant N/A

Has Best Bars a document for the process that mages the use of alternative control methods?

Compliant Non-Compliant N/A

8.6 Release of products and services

The organization shall implement the planned arrangements at appropriate stages to verify that product and service requirements have been met. Evidence of
conformity with the acceptance criteria shall be retained.

Can Best Bars show how planned arrangements have been implemented at appropriate stages to verify product and service
requirements have been met.

Compliant Non-Compliant N/A

Can Best Bars show what evidence they retain?

Compliant Non-Compliant N/A

The release of products and services to the customer shall not proceed until the planned arrangements for veri\cation of conformity have been satisfactorily
completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Documented information shall provide traceability to the
person(s) authorizing release of products and services for delivery to the customer.

Can Best Bars show how the release of products and services is held until planned arrangements for veri\cation of conformity have
been satisfactorily completed, unless approved by a relevant authority, or the customer if applicable.

Compliant Non-Compliant N/A

Does Best Bars have documented information which shows traceability to the person authorizing release of products and services?

Compliant Non-Compliant N/A

8.6.1 (TS) Release of products and services


Does Best Bars ensure that the planned arrangements to verify that the product and services requirements have been met encompass
the control plan and are documented as speci\ed in the control plan?

Compliant Non-Compliant N/A

Does Best Bars ensure that the planned arrangements for initial release of products and services encompass product or service
approval?

Compliant Non-Compliant N/A

Does Best Bars ensure that product or service approval is accomplished after changes following initial release, according to ISO 9001,
section 8.5.6.

Compliant Non-Compliant N/A

8.6.2 (TS) Layout inspection and functional testing

A layout inspection and a functional veri\cation to applicable customer engineering material and performance standards shall be performed for each product as
speci\ed in the control plans.

Are the results available for customer review?

Compliant Non-Compliant N/A

8.6.3 (TS) Appearance Items

Does Best Bars manufacture parts designated by the customers as "appearance Items" and if so, then this section will apply? Refer to
the IATF 16949:2016 standard.

Compliant Non-Compliant N/A

8.6.4 (TS) VeriFcation and acceptance of conformity of externally provided products and services.

Does Best Bars have a process to ensure the quality of externally provided processes, products and services utilizing one or more of
the following methods?:
Receipt and evaluation of statistical data provided by the supplier to the organisation
Receiving inspection and/or testing, such as sampling based on performance
Second party or third party assessments or audits of suppliers sites when coupled with records or acceptable delivered product
conformance to requirements
Part evaluation by a designated laboratory
Another method agreed by the customer

Compliant Non-Compliant N/A

8.6.5 (TS) Acceptance criteria


Does Best Bars have a acceptance criteria that is de\ned by the organisation and, where appropriate or required, approved by the
customer? For attribute data sampling, the acceptance shall be zero defects (See section 9.1.1.1)

Compliant Non-Compliant N/A

8.7 Control of non-conforming process outputs, products and services

The organization shall ensure process outputs, products and services that do not conform to requirements are identi\ed and controlled to prevent their
unintended use or delivery.

Does Best Bars identify and control process outputs, products and services that do not conform to requirements and prevent their
unintended use or delivery?

Compliant Non-Compliant N/A

The organization shall take appropriate corrective action based on the nature of the nonconformity and its impact on the conformity of products and services.
This applies also to nonconforming products and services detected after delivery of the products or during the provision of the service.

Does Best Bars have appropriate corrective actions that are taken based on the nature of the nonconformity and its impact on the
conformity of products and services?

Compliant Non-Compliant N/A

Does Best Bars have away of applying this to nonconformity detected after delivery?

Compliant Non-Compliant N/A

As applicable, the organization shall deal with nonconforming process outputs, products and services in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for:
- use “as-is’;
- release, continuation or re-provision of the products and services;
- acceptance under concession.

Does Best Bars have a way to deal with nonconforming process outputs, products and services in terms of:
Correction;
Segregation, containment, return or suspension of provision of products and services?
Informing the customer?
Obtaining authorization for use as-is?
Release, continuation or re-provision of the products and service?
Acceptance under concession?

Compliant Non-Compliant N/A

Where nonconforming process outputs, products and services are corrected, conformity to the requirements shall be veri\ed.
Does Best Bars have a way of verifying conformance where process outputs, products and services are corrected following
nonconformance?

Compliant Non-Compliant N/A

The organization shall retain documented information of actions taken on nonconforming process outputs, products and services, including on any concessions
obtained and on the person or authority that made the decision regarding dealing with the nonconformity.

Does Best Bars have documented information they keep following actions taken to address nonconformities, including any
concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformance.

Compliant Non-Compliant N/A

8.7.1.1 (TS) Customer authorisation for concession

Does Best Bars obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing
process is different from that which is currently approved?

Compliant Non-Compliant N/A

Does Best Bars obtain customer authorisation prior to further processing for "use as is" and rework dispositions of non-conforming
product?

Compliant Non-Compliant N/A

Does Best Bars maintain a record of the expiration date authorised under concession?

Compliant Non-Compliant N/A

8.7.1.2 (TS) Control of non-conforming product - Customer speciFed process

Does Best Bars comply with applicable customer-speci\ed controls of nonconforming products?

Compliant Non-Compliant N/A

8.7.1.3 (TS) Control of suspect product

Does Best Bars ensure that all appropriate manufacturing personnel receive training for containment of suspect and non-conforming
product?

Compliant Non-Compliant N/A

Does Best Bars ensure that product with unidenti\ed or suspect status is classi\ed and controlled as non conforming product?

Compliant Non-Compliant N/A


8.7.1.4 (TS) Control of rework product

Does Best Bars utilise risk analysis (Such as FMEA) methodology to asses risks in the rework process prior to decision to rework the
product? If required, Best Bars shall obtain approval from the customer prior to commencing rework of the product.

Compliant Non-Compliant N/A

Does Best Bars have a documented process for rework con\rmation in accordance with the control plan or other relevant documented
information to verify compliance to original speci\cations?

Compliant Non-Compliant N/A

Are the instructions for disassembly or rework, including re-inspection and traceability requirements accessible to and utilised by the
appropriate personnel?

Compliant Non-Compliant N/A

8.7.1.5 (TS) Control of repaired product

Does Best Bars utilise risk analysis *Such as FMEA) methodology to assess risks in the repairs process prior to a decision to repair
the product? The organisation shall obtain approval from the customer before commencing repair of the product.

Compliant Non-Compliant N/A

Does Best Bars have a documented process for repair con\rmation in accordance with the control plan or other relevant documented
information?

Compliant Non-Compliant N/A

Does Best Bars have a instructions for disassemble or repair, including re-inspection and traceability requirements that is accessible
to and utilised by the appropriate personnel?

Compliant Non-Compliant N/A

Does Best Bars obtain documented customer authorisation for concession for the product to be repaired?

Compliant Non-Compliant N/A

Does Best Bars obtain documented information on the disposition of repaired product including quantity, disposition, disposition date
and applicable traceability information?

Compliant Non-Compliant N/A

8.7.1.6 (TS) Customer notiFcation


Does Best Bars immediately notify the customer in the event that nonconforming product has been shipped?
Initial communication shall be followed with detailed documentation of the event

Compliant Non-Compliant N/A

8.7.1.7 (TS) Non-conforming product disposition

Does Best Bars have a documented process for disposition of non conforming product not subject to rework or repair?

Compliant Non-Compliant N/A

Does Best Bars verify that product not meeting requirements that a veri\cation process is in place to be scrapped if rendered unusable
prior to disposal?

Compliant Non-Compliant N/A

The organisation shall not divert nonconforming product to service or other use without prior customer approval.

9 Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The organization shall determine:


a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.

Does Best Bars show how to determine what needs


to be monitored and measured?

Compliant Non-Compliant N/A

Does Best Bars show how they determine methods for monitoring, measurement, analysis and evaluation to ensure valid results?

Compliant Non-Compliant N/A

Does Best Bars show how they determine when to perform monitoring and measuring?

Compliant Non-Compliant N/A

Does Best Bars show how they determine when results shall be analysed and evaluated?

Compliant Non-Compliant N/A


The organization shall ensure that monitoring and measurement activities are implemented in accordance with the determined requirements and shall retain
appropriate documented information as
evidence of the results.

Has Best Bars got documented information that can be shown that monitoring and measurement activities have been implemented in
accordance with determined requirements?

Compliant Non-Compliant N/A

The organization shall evaluate the quality performance and the effectiveness of the quality management system.

Does Best Bars show how they evaluate the quality performance and the effectiveness of the QMS.

Compliant Non-Compliant N/A

9.1.1.1 (TS) Monitoring and measurement of manufacturing process

Does Best Bars perform process studies on all new manufacturing processes to verify process capability and to provide additional
input for process control, including those for special characteristics?

Compliant Non-Compliant N/A

Note: For some manufacturing processes, it may not be possible to demonstrate product compliance through process capability. For those processes,
alternative methods such as batch conformance to speci\cation may be used.

Does Best Bars maintain manufacturing capability or performance results as speci\ed by the customer?

Compliant Non-Compliant N/A

Does Best Bars verify that the process eow diagram, PFMEA and control plan are implemented, including adherence to the following:
1) Measurement techniques
2) Sample plans
3) Acceptance criteria
4) Records of actual measurement values and/or test results for variable data
5) Reaction plans and escalation process when acceptance criteria are not met?

Compliant Non-Compliant N/A

Does Best Bars document signi\cant process events, such as tool change or machine repair?
This shall be recorded and retained as documented information

Compliant Non-Compliant N/A


Does Best Bars initiate a reaction plan indicated on the control plan and evaluated impact on compliance to speci\cations for
characteristics that are either not statistically capable or are unstable?
These reaction plans shall include containment of product and 100% inspection, as appropriate.

Compliant Non-Compliant N/A

Is Best Bars corrective action plan developed and implemented by the organisation indicating speci\c actions, timing plan, and
assigned responsibility to ensure that the process becomes stable and statistically capable?

Compliant Non-Compliant N/A

Does Best Bars review corrective action plans with and approved by the customer, when required?

Compliant Non-Compliant N/A

Does Best Bars maintain records of effective dates of process changes?

Compliant Non-Compliant N/A

9.1.1.2 (TS) IdentiFcation of statistical tools

Does Best Bars determine the appropriate use of statistical tools?

Compliant Non-Compliant N/A

Does Best Bars verify that appropriate statistical tools are included as part of the advanced product quality planning (or equivalent)
process and include in the design risk analysis (Such as DFMEA) (Where applicable), the process risk analysis (Such as PFMEA), and
control plan?

Compliant Non-Compliant N/A

9.1.1.3 (TS) Application of statistical concepts

Are Best Bars statistical statistical concepts, such as variation, control (Stability), process capability, and the consequences of over-
adjustment, understood and used by employees involved in the collection, analysis and management of statistical data?

Compliant Non-Compliant N/A

9.1.2 Customer satisfaction

The organization shall monitor customer perceptions of the degree to which requirements have been met.

The organization shall monitor customer perceptions of the degree to which requirements have been met.
Does Best Bars show how they monitor customer perception of the degree to which requirements have been met?

Compliant Non-Compliant N/A

Does Best Bars show how they obtain information relating to customer views and opinions of their products and services?

Compliant Non-Compliant N/A

The methods for obtaining and using this information shall be determined.

Does Best Bars show what methods for obtaining and using this information they have?

Compliant Non-Compliant N/A

NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality,
market-share analysis, compliments, warranty claims and dealer reports.

9.1.2.1 (TS) Customer satisfaction

Does Best Bars monitor customer satisfaction through continual evaluation of internal and external performance indicators to ensure
compliance to the product and process speci\cations and other customer requirements?

Compliant Non-Compliant N/A

Are performance indicators based on objective evidence and include, but not limited to the following:
1) Delivered part quality performance
2) Customer disruptions
3) Field returns, and warranty
4) Delivery schedule performance (Including incidents or premium freight)
5) Customer noti\cations related to quality or delivery issues, including special status?

Compliant Non-Compliant N/A

Does Best Bars monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for
product quality and process ejciency?

Compliant Non-Compliant N/A

Does Best Bars monitoring include the review of customer performance data including on-line customer portals and customer
scorecards, where provided?

Compliant Non-Compliant N/A

9.1.3 Analysis and evaluation

The organization shall analyse and evaluate appropriate data and information arising from monitoring, measurement and other sources.
Does Best Bars show how they analyse and evaluate data and information arising from monitoring, measurement and other sources.

Compliant Non-Compliant N/A

The output of analysis and evaluation shall be used to:


a) demonstrate conformity of products and services to requirements;
b) assess and enhance customer satisfaction;
c) ensure conformity and effectiveness of the quality management system;
d) demonstrate that planning has been successfully implemented;
e) assess the performance of processes;
f) assess the performance of external provider(s);
g) determine the need or opportunities for improvements within the quality management system.

Can Best Bars show how the output of analysis and evaluation is used to:
Demonstrate conformity of products and services to requirements?

Compliant Non-Compliant N/A

Can Best Bars show how the output of analysis and evaluation is used to:
Demonstrate conformity of products and services to requirements?

Assess and enhance customer satisfaction?

Compliant Non-Compliant N/A

Can Best Bars show how the output of analysis and evaluation is used to:
Ensure conformity and effectiveness of the QMS?

Compliant Non-Compliant N/A

Can Best Bars show how the output of analysis and evaluation is used to:
Demonstrate that planning has been successfully implemented?

Compliant Non-Compliant N/A

Can Best Bars show how the output of analysis and evaluation is used to:
Assess process performance?

Compliant Non-Compliant N/A

Can Best Bars show how the output of analysis and evaluation is used to:
Assess performance of external providers?

Compliant Non-Compliant N/A


Can Best Bars show how the output of analysis and evaluation is used to:
Determine the need or opportunities for improvements within the QMS?

Compliant Non-Compliant N/A

The results of analysis and evaluation shall also be used to provide inputs to management review.

Does Best bars show where the results of analysis and evaluation are used to provide inputs to management review.

Compliant Non-Compliant N/A

9.1.3.1 (TS) Prioritisation

Does Best Bars compare operational trends in quality and operational performance with progress towards objectives and lead to
action support prioritisation of actions for improving customer satisfaction?

Compliant Non-Compliant N/A

9.2 Internal audit

9.2.1

The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system;
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.

Does Best Bars have internal audits being conducted at planned intervals?

Compliant Non-Compliant N/A

Does Best Bars have a way they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements
established by Organization? (Review records to demonstrate conformance)

Compliant Non-Compliant N/A

Does Best Bars have a way they determine whether the QMS is effectively implemented and maintained? (Review records)

Compliant Non-Compliant N/A

9.2.2
The organization shall:
a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which
shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes
impacting on the organization, and the results of previous audits;
b) de\ne the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take necessary correction and corrective actions without undue delay;
f) retain documented information as evidence of the implementation of the audit programme and the audit results.

Can Best Bars show audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer
feedback, changes impacting the organization and the results of previous audits?

Compliant Non-Compliant N/A

Does Best Bars show where are the audit criteria and scope for each audit?

Compliant Non-Compliant N/A

Can Best Bars demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t
audit their own work?

Compliant Non-Compliant N/A

Can Best Bars sow how the audit results are reported to relevant management?

Compliant Non-Compliant N/A

Can Best Bars demonstrate that necessary correction and corrective actions are taken without undue delay?

Compliant Non-Compliant N/A

Can Best Bars show the documented information of the audit programme and the audit results?

Compliant Non-Compliant N/A

NOTE See ISO 19011 for guidance.

9.2.2.1 (TS) Internal audit program

Does Best Bars have a documented internal audit process?

Compliant Non-Compliant N/A


Does the internal audit process include the development and implementation of an internal audit program that covers the entire quality
management system including quality management system audits, manufacturing process audits, and product audits?

Compliant Non-Compliant N/A

Does Best Bars prioritise the program based on risk, internal and external performance trends and criticality of the processes?

Compliant Non-Compliant N/A

Where the organisation is responsible for software development, the organisation shall include software development capability assessments in their internal
audit program.

Does Best bars review the audit frequency and, where appropriate, adjust based on occurrence or process changes, internal and
external non conformities, and/or customer complaints?

Compliant Non-Compliant N/A

Does Best Bars review the effectiveness of the audit program as part of the management review?

Compliant Non-Compliant N/A

9.2.2.2 (TS) QMS Audit

Does Best Bars audit all QMS processes over each three year period, according to a annual plan?

Compliant Non-Compliant N/A

Does Best Bars, according to an annual program, using the process approach to verify compliance with the IATF 16949 QMS standard,
sample customer speci\c QMS requirements for effective implementation?

Compliant Non-Compliant N/A

9.2.2.3 (TS) Manufacturing process audit

Does Best Bars audit all manufacturing processes over a three year calendar period to determine the effectiveness and ejciency
using customer speci\c approaches for process audit?
Where not de\ned by the customer, the organisation shall determine the approach to be used.

Compliant Non-Compliant N/A

Within each individual audit plan, does Best Bars audit each manufacturing process, on all shifts where it occurs, including the
appropriate sampling of the shift handover?

Compliant Non-Compliant N/A


Does Best Bars ensure that the manufacturing process audits the effective implementation of the process risk analysis (Such as
PFMEA), control plan and associated documentation?

Compliant Non-Compliant N/A

9.2.2.4 (TS) Product audit

Does Best Bars audit products using customer speci\c required approaches at appropriate stages of production and delivery to verify
conformity to speci\ed requirements?
Where not de\ned by the customer, the organisation shall de\ne the approach to be used.

Compliant Non-Compliant N/A

9.3 Management Review

9.3.1

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and
effectiveness.

Does Best Bars show the frequency that top management reviews the organization's QMS?

Compliant Non-Compliant N/A

Does Best Bars show how the QMS is deemed suitable, adequate and effective?

Compliant Non-Compliant N/A

The management review shall be planned and carried out taking into consideration the status of actions from previous management
reviews?

Compliant Non-Compliant N/A

The management review shall be planned and carried out taking into consideration changes in external and internal issues that are
relevant to the quality management system including its strategic direction?

Compliant Non-Compliant N/A


The management review shall be planned and carried out taking into consideration information on the quality performance, including
trends and indicators for:
1) nonconformities and corrective actions;
2) monitoring and measurement results;
3) audit results;
4) customer satisfaction;
5) issues concerning external providers and other relevant interested parties;
6) adequacy of resources required for maintaining an effective quality management system;
7) process performance and conformity of products and services?

Compliant Non-Compliant N/A

The management review shall be planned and carried out taking into consideration the effectiveness of actions taken to address risks
and opportunities (see clause 6.1)?

Compliant Non-Compliant N/A

The management review shall be planned and carried out taking into consideration new potential opportunities for continual
improvement?

Compliant Non-Compliant N/A

Does Best Bars show what kinds of information are reviewed in management reviews?

Compliant Non-Compliant N/A

Do the Management reviews include actions status of previous reviews?

Compliant Non-Compliant N/A

Do the Management reviews include changes to internal/external issues relevant to the QMS?

Compliant Non-Compliant N/A

Do the Management reviews include issues that affect strategy?

Compliant Non-Compliant N/A

Do the Management reviews include KPIs for non-conformities and corrective actions?

Compliant Non-Compliant N/A

Do the Management reviews include monitor and measurement of results?

Compliant Non-Compliant N/A


Do the Management reviews include audit results?

Compliant Non-Compliant N/A

Do the Management reviews include customer satisfaction?

Compliant Non-Compliant N/A

Do the Management reviews include issues concerning external providers?

Compliant Non-Compliant N/A

Do the Management reviews include issues concerning other relevant parties?

Compliant Non-Compliant N/A

Do the Management reviews include adequacy of resources and effectiveness of QMS?

Compliant Non-Compliant N/A

Do the Management reviews include process performance?

Compliant Non-Compliant N/A

Do the Management reviews include actions taken to address risks and opportunities and their effectiveness?

Compliant Non-Compliant N/A

Do the Management reviews include conformity of products and services?

Compliant Non-Compliant N/A

Do the Management reviews include opportunities for continual improvement?

Compliant Non-Compliant N/A

9.3.2 Management review inputs

The management review frequency shall be increased based on risk to compliance with customer requirements resulting from internal or external changes
impacting the QMS and performance related issues

The outputs of the management review shall include decisions and actions related to:
a) continual improvement opportunities;
b) any need for changes to the quality management system, including resource needs.
Does Best Bars show that their management reviews include decisions and actions relating to:
Continual improvement opportunities;
The need for changes to the QMS including resource needs.

Compliant Non-Compliant N/A

The organization shall retain documented information as evidence of the results of management reviews.

Can Best Bars show what documented information they have as evidence of management reviews?

Compliant Non-Compliant N/A

9.3.2.1 (TS) Management review inputs

Does the inputs to management review include cost of poor quality (Cost of internal and external non conformance)?

Compliant Non-Compliant N/A

Does the inputs to management review include measures of process effectiveness?

Compliant Non-Compliant N/A

Does the inputs to management review include measures of process ejciency?

Compliant Non-Compliant N/A

Does the inputs to management review include product conformance?

Compliant Non-Compliant N/A

Does the inputs to management review include assessments of manufacturing feasibility made of changes to existing operations and
for new facilities or new product (See Section 7.1.3.1)?

Compliant Non-Compliant N/A

Does the inputs to management review include customer satisfaction (See ISO 9001, Section 9.1.2)?

Compliant Non-Compliant N/A

Does the inputs to management review include review of performance against maintenance objectives?

Compliant Non-Compliant N/A

Does the inputs to management review include warranty performance (Where applicable)?

Compliant Non-Compliant N/A


Does the inputs to management review include review of customer scorecards (Where applicable)?

Compliant Non-Compliant N/A

Does the inputs to management review include identi\cation of potential \eld failures identi\ed through risk analysis (Such as FMEA)?

Compliant Non-Compliant N/A

Does the inputs to management review include actual \eld failures and their impact on safety or the environment?

Compliant Non-Compliant N/A

9.3.3 Management review outputs

Does Best Bars Management review outputs include decisions and actions related to opportunities for improvement?

Compliant Non-Compliant N/A

Does Best Bars Management review outputs include decisions and actions related to any need for changes to the QMS?

Compliant Non-Compliant N/A

Does Best Bars Management review outputs include decisions and actions related to resources needed?

Compliant Non-Compliant N/A

9.3.3.1 (TS) Management review - Supplement

Does Best Bars conduct a Management Review at least annually?

Compliant Non-Compliant N/A

10 Improvement

10 Improvement

10.1 General

The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance
customer satisfaction.

Does Best Bars show how they determine and select opportunities for improvement?

Compliant Non-Compliant N/A


Can Best Bars show what necessary actions they have implemented so that they have met customer requirements and enhanced
customer satisfaction?

Compliant Non-Compliant N/A

This shall include, as appropriate:


a) improving processes to prevent nonconformities;
b) improving products and services to meet known and predicted requirements;
c) improving quality management system results.

Can Best Bars show how they have:


Improved processes to prevent nonconformities;
Improved products and services to meet known and predicted requirements;
Improved QMS results.

Compliant Non-Compliant N/A

NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g. breakthrough), creatively
(e.g. innovation) or by re-organization (e.g. transformation).

10.2 Nonconformity and corrective action

10.2.1

When a nonconformity occurs, including those arising from complaints, the organization shall:
a) react to the nonconformity, and as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
1) reviewing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) make changes to the quality management system, if necessary.
When nonconformities occur can Best Bars show how;
they react;
Take action to control and correct it;
Deal with the consequences;
Evaluate the need for action to eliminate the cause so that it does not recur or occur elsewhere by:
Reviewing the nonconformity;
Determining the cause of the nonconformity;
Determining if similar nonconformities exist or could potentially occur;
Actions needed are implemented;
Review the effectiveness of corrective actions taken, if any;
Make necessary changes to the QMS.

Compliant Non-Compliant N/A

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Does Best Bars show me how correction actions were appropriate to the effects of the nonconformities encountered.

Compliant Non-Compliant N/A

NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.


NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.

10.2.2

The organization shall retain documented information as evidence of:


a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.

Does Best Bars have documented information that they can show as evidence of:
The nature of the nonconformities and subsequent actions taken;

Compliant Non-Compliant N/A

Does Best Bars have documented information that they can show as evidence of:
The results of any corrective action.

Compliant Non-Compliant N/A

10.2.3 (TS) Problem solving

Does Best Bars have a documented process for problem solving that includes a de\ned approach for various types and scales of
problems (e.g new product development, current manufacturing issues, \eld failures, audit \ndings)?

Compliant Non-Compliant N/A


Does Best Bars have a documented process for problem solving that includes containment, interim actions, and related activities
necessary for control of nonconforming outputs (See ISO 9001, Section 8.7)

Compliant Non-Compliant N/A

Does Best Bars have a documented process for problem solving that includes root cause analysis, methodology used, analysis and
results?

Compliant Non-Compliant N/A

Does Best Bars have a documented process for problem solving that includes implementation of systemic corrective actions,
including correspondence of the impact on similar processes and products?

Compliant Non-Compliant N/A

Does Best Bars have a documented process for problem solving that includes veri\cation of the effectiveness of implemented
corrective actions?

Compliant Non-Compliant N/A

Does Best Bars have a documented process for problem solving that includes reviewing and, where necessary, updating the
appropriate documented information (E.g FMEA, Control plan)?

Compliant Non-Compliant N/A

Where the organisation has speci\ed prescribed processes, tools, or systems for problem solving, the organisation shall use those processes, tools, or systems
unless otherwise approved by the customer.

10.2.4 (TS) Error ProoFng

Does Best Bars have a documented process to determine the use of appropriate error-proo\ng methodologies?
Details of the method used shall be documented in the process risk analysis (Such as a PFMEA) and test frequencies shall be
documented in the control plan.

Compliant Non-Compliant N/A

Does Best Bars include the testing of error proo\ng devices for failure or simulated failure?

Compliant Non-Compliant N/A

Does Best Bars maintain records?

Compliant Non-Compliant N/A

"Challenged" parts, when used, shall be identi\ed, controlled, veri\ed, and calibrated were feasible.
Do error proo\ng device failures shall have a action plan.

Compliant Non-Compliant N/A

10.2.5 (TS) Warranty management systems

Does Best Bars perform an analysis on customer complaints and \eld failures, including any return parts, and shall initiate problem
solving and corrective action to prevent re-occurrence?

Compliant Non-Compliant N/A

When requested by the customer, this shall include analysis of the interaction of embedded software of the organisations product within the system of the \nal
customers product.

Does Best Bars communicate the results of testing/analysis to the customer and also within the organisation.

Compliant Non-Compliant N/A

10.3 Continual improvement

The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.

Can Best Bars demonstrate that they continually improve the suitability, adequacy and effectiveness of the QMS.

Compliant Non-Compliant N/A

The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to con\rm if there are areas of
underperformance or opportunities that shall be addressed as part of continual improvement.

Does Best Bars demonstrate that the outputs of analysis and evaluation and the outputs from management review are considered to
con\rm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.

Compliant Non-Compliant N/A

Where applicable, the organization shall select and utilise applicable tools and methodologies for investigation of the causes of underperformance and for
supporting continual improvement.

Can Best Bars show what applicable tools and methodologies for investigation of the causes of underperformance and to support
continual improvement are selected?

Compliant Non-Compliant N/A

10.3.1 (TS) Continual Improvement - Supplemental

Does Best Bars have a documented process for continual improvement?

Compliant Non-Compliant N/A


Does the process include identi\cation of the methodology used, objectives, measurement, effectiveness and documented
information?

Compliant Non-Compliant N/A

Does the process include a manufacturing process improvement action plan with emphasis on the reduction of process variation and
waste?

Compliant Non-Compliant N/A

Does the process include risk analysis (FMEA)?

Compliant Non-Compliant N/A

Note: Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product characteristics are predictable
and meet customer requirements.

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