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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?
Do these Issues affect the ability to achieve the intended result of the QMS?
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?
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?
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?
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.
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?
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?
Does Best Bars determine the inputs and outputs for those processes?
Does Best Bars determine the criteria, methods, measurement and related performance indicators needed to operate and control
those processes?
Does Best Bars determine what resources are needed and how are these made available?
Does Best Bars assign responsibilities and authorities for those processes?
Does Best Bars determine risks and opportunities considered and plans are made to implement actions to address them?
Does Best Bars measure and evaluate processes and, if needed, make changes to achieve intended results?
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?
Is Best Bars con\dence that the processes are being carried out as planned determined?
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?
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?
Identi\cation and controls of safety related characteristics of product and at the point of manufacturing?
De\ne responsibilities, de\nition of escalation processes and eow of information, including top management and customer
noti\cation?
Training identi\ed by Best Bars or customer for personnel involved in product safety related products and associated manufacturing
processes?
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)
Transfer of requirements with regards to product safety throughout the supply chain, including customer designated sources (See
section 8.4.3.1)
Product trace-ability by manufactured lot (At a minimum) throughout the supply chain (See section 8.5.2.1
4.4.2
Does Best Bars maintain documented information to support the operation of its processes?
Does Best Bars retain documented information to have con\dence that the processes are being carried out as planned?
5 Leadership
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.
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?
Does Best Bars communicate the quality policy within the organization?
Are Best Bars requirements of the QMS integrated into the business processes?
Does Best Bars ensure that the QMS achieves its intended results?
Does Best Bars support other relevant management roles to demonstrate leadership in their areas of 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)
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)
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)
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.
Does Best Bars consistently provide products and services that meet customer and applicable statutory and regulatory requirements?
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?
Does Best Bars determine the Quality Policy to be appropriate to the purpose and context of the organization?
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 it communicated?
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?
Does top management assign the responsibility and authority for ensuring that the QMS conforms to the International standard?
Does top management assign the responsibility and authority for ensuring processes are delivering their intended outputs?
Is the performance of the QMS, opportunities for improvement and the need for change or innovation reported to top management?
Is the integrity of the QMS maintained when changes to the QMS are planned and implemented?
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.
5.3.2 (TS) Responsibility and authority for product requirements and corrective actions
Does Best Bars production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring
conformity to product requirements?
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?
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?
Are risks and opportunities determined and addressed so that the QMS can achieve its intended results?
Are risks and opportunities determined and addressed so that the QMS can prevent or reduce undesired effects?
Are risks and opportunities determined and addressed so that the QMS can achieve continual improvement?
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.
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?
Does Best Bars determine that personnel with product design responsibility are competent to achieve design requirements?
Does Best Bars determine skills required in applicable tools and techniques?
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.
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?
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?
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?
Utilising lessons learned to prevent re-occurrences in similar processes (See ISO 9001. Section 7.1.6)
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?
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?
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?
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?
Conduct contingency plan reviews (At a minimum Annually) using multidisciplinary team including top Management, and update as
required?
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?
6.2.1
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?
Are they relevant to the conformity of products and services and do they enhance customer satisfaction?
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?
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)
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.
Can Best Bars demonstrate how responsibility and authority is allocated or reallocated?
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?
Can Best Bars demonstrate how the capabilities and constraints on internal resources are considered?
Can Best Bars demonstrate how needs from external providers are considered.
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?
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?
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
In designing plant layouts, Does Best Bars optimise material eow, material handling, and value added use of eoor space including
control of nonconforming products?
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.
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)
Note 1: These requirements should include the application of lean manufacturing principles.
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?
NOTE Environment for the operation of processes can include physical, social, psychological, environmental and other factors (such as temperature, humidity,
ergonomics and cleanliness).
Does Best Bars maintain its premises is a state of order, cleanliness and repair that is consistent with the product and manufacturing
process needs?
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?
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?
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.
Does Best Bars Verify or calibrate at speci\ed intervals against national or international measurement standards;
If there are no standards does Best Bars document information which is used as the basis used for calibration or veri\cation
Are Best Bars measurement instruments identi\ed to determine their calibration status.
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.
Note: Prioritisation of MSA studies should focus on critical or special product or process characteristics.
Does Best Bars ensure that calibration /veri\cation activities and records shall include the following details:
Revisions following engineering changes that impact measuring systems?
An assessment of the risk of the intended use of the product caused by the out of spec condition?
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.
Veri\cation that software version used for product and process control is speci\ed
Production related software veri\cation used for product and process control
Does Best Bars internal laboratory facility have a de\ned scope that includes its capacity to perform the required inspection, test or
calibrated service?
Capability to perform these services correctly, traceable to the relevant process standard (ASTM etc.)
Note: Third party accreditation to ISO 17025 may be used to demonstrate the organisations in-house laboratory conformity to this requirement.
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?
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?
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.
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?
Does Best Bars determine necessary knowledge to achieve conformity of products and services?
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?
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 acquire additional knowledge when addressing changing needs and trends?
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
Does Best Bars determine the necessary competence of people doing work under your control that affects quality performance;
Does Best Bars determine competence on the basis of appropriate education, training or experience?
Does Best Bars take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those
actions?
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.
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.
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?
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.
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?
Understanding of the ISO 9001 and IATF 16949 requirements related to the scope of the auditing?
Understanding applicable core tools requirements related to the scope of the audit?
Understanding how to plan, conduct, report and close out audit \ndings?
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.
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?
Does Best Bars auditors execute a minimum number of audits per year as de\ned by the organisation?
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)?
Does Best Bars demonstrate the competencies of the auditors undertaking second party audits?
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?
Understanding of the ISO 9001 and IATF 16949 requirements related to the scope of the auditing?
Understanding applicable core tools requirements related to the scope of the audit?
Understanding how to plan, conduct, report and close out audit \ndings?
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?
Does Best Bars make their employees aware of their relevant quality objectives?
Does Best Bars make their employees aware of their contribution to the effectiveness of the QMS?
Does Best Bars make their employees aware of the bene\ts of improved performance?
Does Best Bars make their employees aware of the implications of not conforming with the QMS requirements?
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?
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
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?
7.5.1 General
What documented information does Best Bars have as required by this standard?
What documented information does Best Bars have as being necessary for the effectiveness of your QMS?
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)?
Does the quality manual include, at a minimum, the scope of the quality management system, including details of and justi\cation for
any exclusions?
Does the quality manual include, at a minimum, documented processes established for the QMS or reference them?
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?
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?
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.
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 can be reviewed and approved for suitability and adequacy.
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).
Does Best Bars show how to make it available and suitable for use.
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
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.
Does Best Bars de\ne, document and implement a record retention policy? The control of records shall satisfy statutory, regulatory,
organisational and customer requirements.
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?
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?
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.
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
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?
Does Best Bars have requirements for products and services determined?
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.
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?
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 an action that is taken to mitigate any adverse effects?
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?
When planning product realisation, is the topic included, with regards to, logistics requirements?
When planning product realisation, is the topic included, with regards to, manufacturing feasibility?
When planning product realisation, is the topic included, with regards to, project planning (Refer to ISO 9001, section 8.3.2)?
When planning product realisation, is the topic included, with regards to, acceptance criteria?
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.
Does Best Bars ensure con\dentiality of customer contracted products anbd projects under development, including related product
information?
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 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)
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?
Does Best Bars show how to de\ne product and service requirements including statutory and regulatory requirements?
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?
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?
Does Best Bars conform to customer requirements for designation, approval documentation and control of special characteristics?
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?
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?
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?
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.
Does Best Bars show how they resolve contract or order requirements which differ from those previously de\ned?
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?
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.
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
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).
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.
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?
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.
Does Best Bars show documented information that con\rms design and development requirements have been met.
Does Best Bars ensure that the design and development planning includes all effected stakeholders within the organisation and, as
appropriate, its supply chain?
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)
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
Note: An example of product design skills is the application of digitised mathematically based data.
Does Best Bars ensure the use of a process for quality assurance for their products with internally developed embedded software?
Does Best Bars conduct a software development assessment methodology use to assess the organisations software development
process?
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?
Does Best Bars identify, document and review product design input requirements as a result of contract reviews?
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
Does Best Bars identify, document and review manufacturing process design inputs with regards to product design output data
including special characteristics?
Does Best Bars identify, document and review manufacturing process design inputs with regards to targets for productivity, process
capability, timing and cost?
Does Best Bars identify, document and review manufacturing process design inputs with regards to manufacturing technology
alternatives
Does Best Bars identify, document and review manufacturing process design inputs with regards to customer requirements, if any?
Does Best Bars identify, document and review manufacturing process design inputs with regards to experience from previous
developments ?
Does Best Bars identify, document and review manufacturing process design inputs with regards to raw materials?
Does Best Bars identify, document and review manufacturing process design inputs with regards to design for manufacturing and
design assembly?
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?
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?
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?
Does the risk analysis include a development of control and monitoring strategies for special characteristics of products and product
processes?
Does the risk analysis include customer speci\ed approval, when required?
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.
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?
Does Best Bars have Design and development reviews that are conducted as planned?
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)?
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)?
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.
Does Best Bars ensure design and development validation is performed according to customer requirements, including any applicable
industry and governmental agency issued regulatory standards?
Does Best Bars ensure timing of the design and development validation shall be planned in alignment with customer speci\ed timing,
as applicable?
Does Best Bars, when required by the customer, have a prototype program and control plan?
Does Best Bars make use of all the same suppliers, tooling and manufacturing processes as will be used in product when developing
the prototype?
Does Best Bars monitor all performance testing activities for timely completion and conformity to requirements?
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)?
Does Best Bars establish, implement and maintain product and manufacturing approval process conforming to requirements as
de\ned by the customer?
Does Best Bars approve externally provided product approval prior to shipment, if required by the customer? Records of their part
approval shall be retained.
Note: Product approval should be subsequent to the validation of the manufacturing process.
Does Best Bars ensure they are adequate for the subsequent processes for the provision of products and services?
Does Best Bars include or reference monitoring and measuring requirements, and acceptance criteria, as applicable?
Does Best Bars ensure products to be produced, or services to be provided, are \t for intended purpose and their safe and proper use?
The organization shall retain the documented information resulting from the design and development process.
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?
Does Best Bars product design output include design risk analysis (FMEA)?
Does Best Bars product design output include reliability study results?
Does Best Bars product design output include product special characteristics?
Does Best Bars product design output include results of product design error proo\ng, such as DFSS, DFMA and FTA?
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)?
Does Best Bars product design output include service diagnostics guidelines and repair and serviceability instructions?
Does Best Bars product design output include service parts requirements?
Does Best Bars product design output include packaging and rebelling requirements for shipping?
Note: Interim design outputs should include any engineering problems being resolved through a trade-off process.
Does Best Bars document the manufacturing process design output in a manner that enables veri\cation against the manufacturing
process design outputs?
Does Best Bars verify the outputs against manufacturing process design input requirements?
Does Best Bars manufacturing design output include speci\cations and drawing?
Does Best Bars manufacturing design output include special characteristics for product and manufacturing process?
Does Best Bars manufacturing design output include identi\cation of process input variables that impact characteristics?
Does Best Bars manufacturing design output include tooling and equipment for production and control, including capability studies of
equipment and processes?
Does Best Bars manufacturing design output include manufacturing process FMEA?
Does Best Bars manufacturing design output include maintenance plans and instructions?
Does Best Bars manufacturing design output include standardised work and work instructions?
Does Best Bars manufacturing design output include process approval acceptance criteria?
Does Best Bars manufacturing design output include data for quality, reliability, maintainability and measure-ability?
Does Best Bars manufacturing design output include results of error proo\ng identi\cation and veri\cation, as appropriate?
Does Best Bars manufacturing design output include methods of rapid detection, feedback and corrections of product.manufacturing
process non-conformity?
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?
Does Best Bars show the documented information for 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.
If required by the customer, does Best Bars, obtain documented approval, or a documented waiver from the customer prior to
production implementation?
For products with embedded software, does Best Bars document the revision level of the software and hardware as part of the change
record?
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?
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.
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.
Does Best Bars assess their ability to provide processes or products and services in accordance with speci\ed requirements?
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?
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?
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?
Does the supplier selection process include an evaluation of the suppliers QMS?
Does the supplier selection process include an assessment of software development capabilities?
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
When speci\ed by the customer, does Best bars purchase products, materials or services from customer directed sources?
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.
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?
Does Best Bars determine the controls applied to the external provision of processes, products and services and take into
consideration the following:
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?
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?
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?
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?
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?
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.
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?
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.
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?
Does Best Bars monitor supplier performance indicators in terms of customer disruptions at the receiving plant, including yard holds
and stop ships?
Does Best Bars monitor supplier performance indicators in terms of delivery schedule performance?
Does Best Bars monitor supplier performance indicators in terms of number of premium freight?
Does Best Bars monitor supplier performance indicators in terms of special status customer noti\cations related to quality or delivery
issues?
Does Best Bars monitor supplier performance indicators in terms of dealer returns, warranty, \eld actions and recalls?
Does Best Bars include a second party audit process in their supplier management process?
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?
Does Best Bars retain records of the second party audit reports?
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?
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.
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?
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?
The organization shall implement controlled conditions for production and service provision, including delivery and post-delivery activities.
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)
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?
Does the control plans include controls used for the manufacturing process control, including veri\cation of job set ups?
Does the control plans include \rst off/last off part validation, as applicable?
Does the control plans include methods for monitoring or control exercised over special characteristics de\ned in both the customer
and the organisation?
Does the control plans include speci\ed reaction plan, when non-conforming product is detected, the process becomes statistically
unstable or not statistically capable?
Does Best Bars review the Control plans for determining it has shipped non conforming product to the customer?
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)?
Does Best Bars review the Control plans at a set frequency based on a risk analysis?
Does Best Bars ensure that standardised work documents are communicated to and understood by the employees who are
responsible for performing the work?
Does Best Bars ensure that standardised work documents are legible?
Does Best Bars ensure that standardised work documents are presented in the language understood by the personnel responsible to
follow them?
Does Best Bars ensure that standardised work documents are accessible for use at the designated work area?
The standardised work documents shall also include rules for operator safety
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?
Does Best Bars retain records of process and product approval following set-up and \rst off/last off part validation?
Does Best Bars de\ne and implement the necessary actions to ensure product compliance with requirements after planned or
unplanned production shutdown period?
Has Best Bars developed, implemented and maintained a document a total productive maintenance system?
At a minimum, does the system include identi\cation of process equipment necessary to produce conforming product at the required
volume?
At a minimum, does the system include availability of replacement parts for the equipment and facility maintenance?
At a minimum, does the system include provision of resources for machine, equipment and facility maintenance?
At a minimum, does the system include packaging and preservation of equipment, tooling and gauging?
At a minimum, does the system include the use of preventive maintenance methods?
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?
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
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
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?
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?
Does Best Bars have a way of identifying the status of process outputs?
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?
Can Best Bars show the type of documented information that it retains?
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.
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 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?
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?
Does Best Bars identify, verify, protect and safeguard that property which is provided for use or incorporation into their products or
services?
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?
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?
NOTE Preservation can include identi\cation, handling, packaging, storage, transmission or transportation, and protection.
Does Best Bars ensure preservation that includes handling, identi\cation contamination control, packaging, storage, transmission or
transportation and protection?
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?
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.
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.
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?
When there is a service agreement with the customer, Best Bars shall:
Verify that the relevant service centers comply with applicable requirements?
Does Best Bars review and control unplanned changes to ensure continuing conformity with speci\ed requirements?
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?
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.
Does Best Bars de\ne veri\cation and validation activities to ensure compliance with customer requirements?
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?
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?
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?
Has Best Bars a document for the process that mages the use of alternative control methods?
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.
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.
Does Best Bars have documented information which shows traceability to the person authorizing release of products and services?
Does Best Bars ensure that the planned arrangements for initial release of products and services encompass product or service
approval?
Does Best Bars ensure that product or service approval is accomplished after changes following initial release, according to ISO 9001,
section 8.5.6.
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.
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.
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
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?
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?
Does Best Bars have away of applying this to nonconformity detected after delivery?
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?
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?
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.
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?
Does Best Bars obtain customer authorisation prior to further processing for "use as is" and rework dispositions of non-conforming
product?
Does Best Bars maintain a record of the expiration date authorised under concession?
Does Best Bars comply with applicable customer-speci\ed controls of nonconforming products?
Does Best Bars ensure that all appropriate manufacturing personnel receive training for containment of suspect and non-conforming
product?
Does Best Bars ensure that product with unidenti\ed or suspect status is classi\ed and controlled as non conforming 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.
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?
Are the instructions for disassembly or rework, including re-inspection and traceability requirements accessible to and utilised by the
appropriate personnel?
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.
Does Best Bars have a documented process for repair con\rmation in accordance with the control plan or other relevant documented
information?
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?
Does Best Bars obtain documented customer authorisation for concession for the product to be repaired?
Does Best Bars obtain documented information on the disposition of repaired product including quantity, disposition, disposition date
and applicable traceability information?
Does Best Bars have a documented process for disposition of non conforming product not subject to rework or repair?
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?
The organisation shall not divert nonconforming product to service or other use without prior customer approval.
9 Performance Evaluation
9.1.1 General
Does Best Bars show how they determine methods for monitoring, measurement, analysis and evaluation to ensure valid results?
Does Best Bars show how they determine when to perform monitoring and measuring?
Does Best Bars show how they determine when results shall be analysed and evaluated?
Has Best Bars got documented information that can be shown that monitoring and measurement activities have been implemented in
accordance with determined requirements?
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.
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?
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?
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?
Does Best Bars document signi\cant process events, such as tool change or machine repair?
This shall be recorded and retained as documented information
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?
Does Best Bars review corrective action plans with and approved by the customer, when required?
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?
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?
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?
Does Best Bars show how they obtain information relating to customer views and opinions of their products and services?
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?
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.
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?
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?
Does Best Bars monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for
product quality and process ejciency?
Does Best Bars monitoring include the review of customer performance data including on-line customer portals and customer
scorecards, where provided?
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.
Can Best Bars show how the output of analysis and evaluation is used to:
Demonstrate conformity of products and services to requirements?
Can Best Bars show how the output of analysis and evaluation is used to:
Demonstrate conformity of products and services to requirements?
Can Best Bars show how the output of analysis and evaluation is used to:
Ensure conformity and effectiveness of the QMS?
Can Best Bars show how the output of analysis and evaluation is used to:
Demonstrate that planning has been successfully implemented?
Can Best Bars show how the output of analysis and evaluation is used to:
Assess process performance?
Can Best Bars show how the output of analysis and evaluation is used to:
Assess performance of external providers?
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.
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?
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?
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)
Does Best Bars have a way they determine whether the QMS is effectively implemented and maintained? (Review records)
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?
Does Best Bars show where are the audit criteria and scope for each audit?
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?
Can Best Bars sow how the audit results are reported to relevant management?
Can Best Bars demonstrate that necessary correction and corrective actions are taken without undue delay?
Can Best Bars show the documented information of the audit programme and the audit results?
Does Best Bars prioritise the program based on risk, internal and external performance trends and criticality of the processes?
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?
Does Best Bars review the effectiveness of the audit program as part of the management review?
Does Best Bars audit all QMS processes over each three year period, according to a annual plan?
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?
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.
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?
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.
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?
Does Best Bars show how the QMS is deemed suitable, adequate and effective?
The management review shall be planned and carried out taking into consideration the status of actions from previous management
reviews?
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?
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)?
The management review shall be planned and carried out taking into consideration new potential opportunities for continual
improvement?
Does Best Bars show what kinds of information are reviewed in management reviews?
Do the Management reviews include changes to internal/external issues relevant to the QMS?
Do the Management reviews include KPIs for non-conformities and corrective actions?
Do the Management reviews include actions taken to address risks and opportunities and their effectiveness?
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.
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?
Does the inputs to management review include cost of poor quality (Cost of internal and external non conformance)?
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)?
Does the inputs to management review include customer satisfaction (See ISO 9001, Section 9.1.2)?
Does the inputs to management review include review of performance against maintenance objectives?
Does the inputs to management review include warranty performance (Where applicable)?
Does the inputs to management review include identi\cation of potential \eld failures identi\ed through risk analysis (Such as FMEA)?
Does the inputs to management review include actual \eld failures and their impact on safety or the environment?
Does Best Bars Management review outputs include decisions and actions related to opportunities for improvement?
Does Best Bars Management review outputs include decisions and actions related to any need for changes to the QMS?
Does Best Bars Management review outputs include decisions and actions related to resources needed?
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?
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).
10.2.1
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.
Does Best Bars show me how correction actions were appropriate to the effects of the nonconformities encountered.
10.2.2
Does Best Bars have documented information that they can show as evidence of:
The nature of the nonconformities and subsequent actions taken;
Does Best Bars have documented information that they can show as evidence of:
The results of any corrective action.
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)?
Does Best Bars have a documented process for problem solving that includes root cause analysis, methodology used, analysis and
results?
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?
Does Best Bars have a documented process for problem solving that includes veri\cation of the effectiveness of implemented
corrective actions?
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)?
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.
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.
Does Best Bars include the testing of error proo\ng devices for failure or simulated failure?
"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.
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?
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.
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.
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.
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?
Does the process include a manufacturing process improvement action plan with emphasis on the reduction of process variation and
waste?
Note: Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product characteristics are predictable
and meet customer requirements.