Clause No.

4.1 a

4.1 b

4.1.2

4.2.1 a

4.2.1 b

4.2.1 c

4.2.2

4.3.1 a

4.3.1 b

4.3.2 a

4.3.2 b

4.3.3

4.3.4
4.3.5

4.4.1

4.4.1.1

4.4.1.2

4.4.2
a
b
c
d
e
f
g
h

4.4.3
Question

Has the organization determined external and internal issues relevant to its purpose and strategic direction? If yes, how?

Additional Info:
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.

Do these issues affect the ability to achieve the intended result of the QMS? If yes, how so?
Additional Info:
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.

Do you monitor and review information about these internal and external issues? If so, how are they monitored?
Additional Info:

The organization shall monitor and review the information about these external and internal issues.

Have you determined what interested parties are relevant to the QMS? How have you determined these?
Additional Info:

Due to their 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.

Have you determined what requirements those parties have that are relevant to the QMS? How have you determined these?
Additional Info:
Due to their 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 impact or potential impact been determined? How has it been determined?
Additional Info:
Due to their 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.

Do you monitor and review the information about interested parties and their relevant requirements? How do you monitor this information?
Additional Info:
The organization shall monitor and review the information about these interested parties and their relevant requirements.

Are supporting functions, whether on-site or remote (such as design centres, corporate headquarters, and distribution centres), included in the scope of the Quality Management
System (QMS)? The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. Is the
exclusion justified and maintained as documented information (see ISO 9001, Section 7.5)? Permitted exclusions do not include manufacturing process design

Have the boundaries and applicability of the QMS been used to establish the scope of the organization? How have they been used?
Additional Info:
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

Have: The external and internal issues; The requirements of relevant interested parties and; The products and services of the organization been considered when determining the scope
of the organization? How have they been considered?
Additional Info:
When determining this scope, the organization shall consider: 
a) the external and internal issues referred to in 4.1; 
b) the requirements of relevant interested parties referred to in 4.2; 
c) the products and services of the organization.

Are customer - specific requirements evaluated and included in the scope of the organization's quality management system?

Has the application of the International Standard within the scope been determined? How has it been determined and how has it been applied by the organization?
Additional Info:
Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization.

Have any requirements of the International Standard been determined as not applicable? How were they determined as not applicable? Show how conformity of products and services
are not affected by this.
Additional Info:
If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services.
Where is the scope available? Where is it maintained as documented information? 
Does it state what products and services are covered by the QMS? Does it justify how instances of requirements of the QMS cannot be applied?
Additional Info:
The scope shall be available and be maintained as documented information stating the: 
- products and services covered by the quality management system; 
- justification for any instance where a requirement of this International Standard cannot be applied.

How has the QMS been established? Show how this is implemented. How is it maintained and continually improved? How 
have the processes been determined and how do they interact?
Additional Info:
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 the organization ensured conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory
requirements (see Section 8.4.2.2)?

Does the organization have documented processes for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the
following, where applicable?:
a) identification by the organization of statutory and regulatory product - safety requirements;

b) customer notification of requirements in item a)

c) special approvals for design FMEA;

d) identification of product safety - related characteristics;

e) identification and controls of safety - related characteristics of product and at the point of manufacture;

f) special approval of control plans and process FMEAs;

g) reaction plans (see Section 9.1.1.1);

h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification;

i) training identified by the organization or customer for personnel involved in product - safety related products and associated manufacturing processes;
j) changes of product or process 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);
k) transfer of requirements with regard to product safety throughout the supply chain, including customer - designated sources (see Section 8.4.3.1);
l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8.5.2.1);
m) lessons learned for new product introduction.

How have the processes been determined for the QMS? 

What are the inputs and outputs for those processes? 
What is the sequence and interaction of the processes? 
What are the criteria, methods, measurement and related performance indicators needed to operate and control those processes?
What resources are needed and how are these made available?
What methods are used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve intended results?
How are opportunities to improve the processes and the QMS determined?
How are responsibilities and authorities assigned for those processes?
How are risks and opportunities considered and what plans are made to implement actions to address them?
Additional Info:

The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine:  

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

What documented information exists to support the operation of processes? How is this documented information retained? How is confidence that the processes are being carried out
as planned determined?
Additional Info:
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 confidence that the processes are being carried out as planned.
 Magnifico Training and Consulting Services
C-1, Nisarg Nirmiti, Kokane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Applicable Documents to look for Observations

All Process

All Process

All Process

Management

Management

Management

Management

Management

Management

Management

Management

Management
Management

Management

All Process

All Process

All Process
Clause No.

5.1.1.1
a

c
d
e
f
g
h
i
j
k
l

m
5.1.1.1.1

5.1.1.1.2

5.1.1.1.3

5.1.2.1

5.2.1
a
b
c
d
e

5.2.2.1
a
 b
c
d

5.3.1. a

5.3.1. b

5.3.2 a
Question

Show how top management demonstrates leadership and commitment w.r.t. the QMS by taking accountability of the
effectiveness of the QMS.
How is the quality policy and objectives established for the QMS and how are they compatible with the strategic dire
and the organizational context? 
How is the quality policy communicated within the organization?
Show how this is understood and applied. 
How are the requirements of the QMS integrated into the business processes? 
How do you promote awareness of the process approach? 
How do you ensure that resources needed for the QMS are available? 
How do you communicate the importance of effective quality management? 
How do you communicate the importance of conforming to the QMS requirements?
How do you ensure that the QMS achieves its intended results?
How do you engage, direct and support people to contribute to the effectiveness of the QMS? 
How do you promote continual improvement?

How do you support other relevant management roles to demonstrate leadership in their areas of responsibility?

Additional Info:

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 process

e) promoting awareness of the process approach; f) ensuring that the resources needed for the quality managemen
system are available; 
g) communicating the importance of effective quality management and of conforming to the quality management sys
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.
Has the organization defined and implemented corporate responsibility policies, including at a minimum an anti-bribe
policy, an employee code of conduct, and an ethics escalation policy ("whistle - blowing policy")?

Has top management reviewed the product realization processes and support processes to evaluate and improve th
effectiveness and efficiency?
Are the results of the process review activities included as input to the management review (see Section 9.3.2.1)?
Has top management identified process owners who are responsible for managing the organization's processes and
related outputs?

Do process owners understand their roles and are they competent to perform those roles (see ISO 9001, Section 7.

Show how top management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements
applicable statutory and regulatory requirements are determined and met.
How are risks and opportunities that can affect conformity of products and services determined?
How is the ability to enhance customer satisfaction determined and addressed?
How is the focus on consistently providing products and services that meet customer and applicable statutory and
regulatory requirements maintained?
How is customer satisfaction maintained?
Additional Info:
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 custome
satisfaction are determined and addressed; 
c) the focus on consistently providing products and services that meet customer and applicable statutory and regula
requirements is maintained; 
d) the focus on enhancing customer satisfaction is maintained.

How does top management establish, review and maintain a quality policy?

How is it determined to be appropriate to the purpose and context of the organization? 
Does it provide a framework for setting and reviewing quality objectives? 
Does it contain a commitment to satisfy applicable requirements? 
Does it include a commitment to continual improvement of the QMS?
Additional Info:
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.

Where is the quality policy available as documented information? 

How is it communicated? 
Show me how it is understood and applied within the organization. 
How have you made it available to relevant interested parties?
Additional Info:
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.

How does top management ensure that responsibilities and authorities for relevant roles are assigned, communicate
and understood within the organization?
Additional Info:
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicate
and understood within the organization.
Has top management assigned personnel with the responsibility and authority to ensure that customer requirements
met?
Have these assignments been documented?
This includes but is not limited to the selection of special characteristics, setting quality objectives and related trainin
corrective and preventive actions, product design and development, capacity analysis, logistics information, custome
scorecards, and customer portals.
Has top management ensured that:
a) personnel responsible for conformity to product requirements have the authority to stop shipment and stop produ
to correct quality problems?;If it not possible to stop production immediately then the affected batch must be contain
and shipment to the customer prevented.
b) personnel with authority and responsibility for corrective action are promptly informed of products or processes th
not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all poten
nonconforming product is identified and contained;
c) production operations across all shifts are staffed with personel in charge of, or delegated responsibility for, ensur
conformity to product requirements.
 Magnifico Training and Consulting Services
C-1, Nisarg Nirmiti, Kokane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Documents to Observations

Applicable look for

Management

Management

All Processes
All Processes
Management
All Processes
All Processes
All Processes
All Processes
Management
Management
All Processes

Management
Management

Management

Management

Management

All Processes

All Processes
All Processes
Clause No.

6.1.1.1
a
b

6.1.2.1
a
b
c
6.1.2.2

6.1.2.3

6.1.2.2

6.2.2.1 b

6.2.2.1 a
6.2.2.1 c

6.2.2.2

6.3.1
 Magni
C-1, Nisarg Nirmiti,

Question

How are the internal and external issues and interested parties considered when planning for the QMS?
How are risks and opportunities determined and addressed so that the QMS can::
a) achieve its intended results;
b) Prevent or reduce undesired effects;
c) Achieve continual improvement?

Additional Info:
When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and
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.

How are actions planned to address risks and opportunities?

How are actions integrated and implemented into the QMS processes?
How do you evaluate the effectiveness of the actions?
Additional Info:
The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.

Has the organization included in its risk analysis, at a minimum, lessons learned from product recalls, product audits
returns and repairs, complaints, scrap, and rework?
Has the organization retained documented information as evidence of the results of risk analysis?
Has the organization determined and implemented action(s) to eliminate the causes of potential nonconformities in o
prevent their occurrence?
Are preventive actions appropriate to the severity of the potential issues?
Has the organization established a process to lessen the impact of negative effects of risk including the following:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities
c) determining and implementing action needed;
d) documented information of action taken;
e) reviewing the effectiveness of the preventive action taken;
f) utilizing lessons learned to prevent recurrence in similar processes (see ISO 9001, Section 7.1.6)?
How are actions taken to address risks and opportunities determined as being appropriate to the pote
impact on the conformity of products and services?
Additional Info:
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
of products and services.

Has the organization:

a) identified and evaluated internal and external risks to all manufacturing processes and infrastructu
equipment essential to maintain production output and to ensure that customer requirements are me
b) defined contingency plans according to risk and impact to the customer;
c) prepared contingency plans for continuity of supply in the event of any of the following: key equipm
failures (also see Section 8.5.6.1.1); interruption from externally provided products, processes, and se
recurring natural disasters; fire; utility interruptions; labor shortages; or infrastructure disruptions;
d) included, as a supplement to the contingency plans, a notification process to the customer and oth
interested parties for the extent and duration of any situation impacting customer operations;
e) periodically tested the contingency plans for effectiveness (e.g. simulations, as appropriate);
f) conducted contingency plan reviews (at a minimum annually) using a multidisciplincary team includ
management, and updated as required;
g) documented the contingency plans and retained documented information describing any revision(s
including the person(s) who authorized the change(s).
Do the contingency plans include provisions to validate that the manufactured product continues to m
customer specifications after the re-start of production following an emergency in which production w
and if the regular shutdown processes were not followed?

How are actions taken to address risks and opportunities determined as being appropriate to the potential impact on
conformity of products and services?
Additional Info:
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of p
services.

How do you determine that personnel with product design responsibility are competent to achieve design requireme

How do you determine skills required in applicable tools and techniques?

How do you identify applicable tools and techniques?
Additional Info:
The organization shall ensure that personnel with product design responsibility are competent to achieve design req
and are skilled in applicable tools and techniques.
Applicable tools and techniques shall be identified by the organization.

Where are the quality objectives and are these at all relevant functions, levels and processes? 
Are they consistent with the quality policy? 
Are they measureable? 
Do they consider applicable requirements? 
Are they relevant to the conformity of products and services and do they enhance customer satisfacti
Are they monitored? How? How often? 
How are they communicated? 
How are they updated? 
Where is the documented information on the quality objectives?
Additional Info:
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 an
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.

Has top management ensured that quality objectives to meet customer requirements are defined, established, and m
for relevant functions, processes, and levels throughout the organization?
Are the results of the organization's review regarding interested parties and their relevant requiremen
considered when the organization establishes its annual (at a minimum) quality objectives and related
performance targets (internal and external)?

How does the organization determine what will be done, with what resources, when completed and ho
results be evaluated for quality objectives?

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

How are changes to the QMS planned systematically? 

Demonstrate the purpose and potential consequences of changes; 
Demonstrate the integrity of the QMS; 
Demonstrate how resources are made available? 
Demonstrate how responsibility and authority is allocated or reallocated.
Additional Info:
Where the organization determines the need for change to the quality management system (see 4.4)
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.
co Training and Consulting Services
kane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Documents Observations

Applicable to look for
Clause No.

7.1.1.1

7.1.2.1

7.1.3.1
a

7.1.3.1 b
7.1.4.1
a

7.1.5.1

7.1.5.1.1

7.1.5.2

7.1.5.2.1
7.1.5.3

7.1.5.3.1

7.1.5.3.2
7.1.5.4

7.1.5.5

7.1.6.1

7.1.6.2
7.1.6.3

7.2.1

7.2.1.1

7.2.2

7.2.3
7.2.4

7.3.1 a

7.3.1
b

7.3.2

7.4.1
7.5.1.1

7.5.1.1

7.5.2

7.5.3.1
7.5.3.2.1

7.5.3.2.1

7.5.3.2.2

7.5.3.2.2
 Magnifico
C-1, Nisarg Nirmiti, Kokan

Question

Demonstrate how resources are determined for the establishment, implementation, maintenance and

continual improvement of the QMS.
Show me how the capabilities and constraints on internal resources are considered. 
Show me how needs from external providers are considered.
 

Additional Info:
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.

How do you provide persons necessary to consistently meet customer, applicable statutory and
regulatory requirements for the QMS including the necessary processes?

Additional Info:
To ensure that the organization can consistently meet customer and applicable statutory and regulato
requirements, the organization shall provide the persons necessary for the effective operation of the
quality management system, including the processes needed.

How do you determine, provide and maintain the infrastructure for the operation of processes to achie
products and service conformity?

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

Has the organization used a multidisciplinary approach including risk identification and risk mitigation
methods for developing and improving plant, facility, and equipment plans?

In designing plant layouts, has the organization:

a) optimized material flow, material handling, and value-added use of floor space including control of
nonconforming product, and
b) facilitated synchronous material flow, as applicable?
Are methods developed and implemented to evaluate manufacturing feasibility for new product or ne
operations?
Do manufacturing feasibility assessments include capacity planning?

Are these methods also applicable for evaluating proposed changes to existing operations?

Has the organization maintained 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 verification of job set-ups (see Section 8.5.1.3)?
Are assessments of manufacturing feasibility and evaluation of capacity planning inputs to manageme
reviews (see ISO 9001, Section 9.3)?

How do you determine, provide and maintain the environment for the operation of processes to achie
products and service conformity?
Additional Info:
The organization shall determine, provide and maintain the environment necessary for the operation
its processes and to achieve conformity of products and services.
Has the organization maintained its premises in a state of order, cleanliness, and repair that is consistent with the
product and manufacturing process needs?

How are the resources determined for ensuring valid and reliable monitoring and measuring results,
where used?
Additional Info:
Where monitoring or measuring is used for evidence of conformity of products and services to specifie
requirements the organization shall determine the resources needed to ensure valid and reliable
monitoring and measuring results.

Have statistical studies been conducted to analyse the variation present in the results of each type of inspection,
measurement, and test equipment system identified in the control plan?

Do the analytical methods and acceptance criteria used conform to those in reference manuals on measurement
systems analysis?

Other analytical methods and acceptance criteria may be used if approved by the customer.

Are records of customer acceptance of alternative methods retained along with results from alternative measureme
systems analysis (see Section 9.1.1.1)?

How do you ensure that resources provided are suitable for the specific monitoring and measurement
activities and are maintained to ensure continued fitness for purpose?

Additional Info:
The organization shall ensure that the resources provided: 
a) are suitable for the specific type of monitoring and measurement activities being undertaken; 
b) are maintained to ensure their continued fitness for their purpose.

Does the organization have a documented process for managing calibration / verification records?
Are records of the calibration / verification activity for all gauges and measuring and test equipment (including emplo
- owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) need
to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer
-defined requirements retained?
Has the organization ensured that calibration / verification activities and records include the following details:

a) revisions following engineering changes that impact measurement systems;

b) any out-of-specification readings as received for calibration / verification;
c) an assessment of the risk of the intended use of the product caused by the out-of-specification condition;

d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during i
planned verification or calibration or during its use, documented information on the validity of previous measurement
results obtained with this piece of inspection measurement and test equipment shall be retained, including the
associated standard's last calibration date and the next due date on the calibration report;

e) notification to the customer if suspect product or material has been shipped;

f) statements of conformity to specification after calibration / verification;
g) verification that the software version used for product and process controls is as specified;
h) records of the calibration and maintenance activities for all gauging (including employee-owned equipment,
customer-owned equipment, or on-site supplier-owned equipment);
i) production-related software verification used for product and process control (including software installed on
employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment).

Show the documented information which is evidence of fitness for purpose of monitoring and
measurement resources.
Additional Info:
The organization shall retain appropriate documented information as evidence of fitness for purpose o
monitoring and measurement resources.

Does the organization's internal laboratory facility have a defined scope that includes its capability to perform the
required inspection, test, or calibration services?
Is this laboratory scope included in the quality management system documentation?
Has the laboratory specified and implemented, as a minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc
when no national or international standard(s) is available, has the organization defined and implemented a methodo
to verify measurement system capability;
e) customer requirements, if any; f) review of the related records?
Do external/commercial/independent laboratory facilities used for inspection, test, or calibration servi
by the organization have a defined laboratory scope that includes the capability to perform the requir
inspection, test, or calibration, and either: - the laboratory is accredited to ISO / IEC 17025 or national
equivalent and includes the relevant inspection, test, or calibration service in the scope of the
accreditation (certificate); the certificate of calibration or test report includes the mark of a national
accreditation body; or - there is evidence that the external laboratory is acceptable to the customer?

Where applicable, show how measurement instruments are: 

Verified or calibrated at specified intervals against national or international measurement standards; 
If there are no standards, show me the documented information which is used as the basis used for
calibration or verification. 
Show me how measurement instruments are identified to determine their calibration status. 
Show me how they are safeguarded from adjustments. 
Show me how they are safeguarded from damage and deterioration.
Additional Info:
Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant
interested party expectation; or considered by the organization to be an essential part of providing
confidence in the validity of measurement results; measuring instruments shall be: 
-verified or calibrated at specified intervals or prior to use against measurement standards traceable t
international or national measurement standards. Where no such standards exist, the basis used for
calibration or verification shall be retained as documented information; 
-identified in order to determine their calibration status; 
-safeguarded from adjustments, damage or deterioration that would invalidate the calibration status a
subsequent measurement results.

How do you determine the validity of previous measurements if you find an instrument to be defective
during verification or calibration?
What appropriate actions can you take?
Additional Info:
The organization shall determine if the validity of previous measurement results has been adversely
affected when an instrument is found to be defective during its planned verification or calibration, or
during its use, and take appropriate corrective action as necessary.

How do you determine necessary knowledge for the operation of processes?

How do you determine necessary knowledge to achieve conformity of products and services?
Additional Info:
The organization shall determine the knowledge necessary for the operation of its processes and to
achieve conformity of products and services.

How do you maintain this knowledge and how do you make it available to the extent necessary?
Additional Info:
This knowledge shall be maintained, and made available to the extent necessary.
How do you consider current knowledge and how do you acquire additional knowledge when addressi
changing needs and trends?
Additional Info:
When addressing changing needs and trends, the organization shall consider its current knowledge an
determine how to acquire or access the necessary additional knowledge.

Show how: You determine the necessary competence of people doing work under your control that
affects quality performance; How do you determine competence on the basis of appropriate education
training or experience?
How do you take actions to acquire necessary competence where applicable and how do you evaluate
the effectiveness of those actions? Show documented information where appropriate of competence.
Additional Info:
The organization shall: 
a) determine the necessary competence of person(s) doing work under its control that affects its qual
performance; 
b) ensure that these persons are competent on the basis of appropriate education, training, or
experience; 
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectivenes
of the actions taken; 
d) retain appropriate documented information as evidence of competence.

Has the organization established and maintained a documented process(es) for identifying training needs including
awareness (see Section 7.3.1) and achieving competence of all personnel performing activities affecting conformity
product and process requirements?
Are personnel performing specific assigned tasks qualified, as required, with particular attention to the satisfaction o
customer requirements?

Does the organization provide on-the-job training (which shall include customer requirements training) for personnel
any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or
legislative requirements; this shall include contract or agency personnel?
Is the level of detail required for on-the-job training commensurate with the level of education the personnel possess
and the complexity of the task(s) they are required to perform for their daily work?
Are persons whose work can affect quality informed about the consequences of nonconformity to customer
requirements?
Are persons whose work can affect quality informed about the consequences of nonconformity to customer
requirements?

Does the organization have a documented process(es) to verify that internal auditors are competent, taking into acc
any customer-specific requirements?
For additional guidance on auditor competencies, refer to ISO 19011. Does the organization maintain a list of qualifi
internal auditors?
Are quality management system auditors, manufacturing process auditors, and product auditors all able to demonst
the following minimum competencies:
a) understanding of the automotive process approach for auditing, including risk-based thinking;
b) understanding of applicable customer-specific requirements;
c) understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
d) understanding of applicable core tool requirements related to the scope of the audit;
e) understanding how to plan, conduct, report, and close out audit findings. Additionally, do manufacturing process
auditors demonstrate techincal understanding of the relevant manufacturing process(es) to be audited, including
process risk analysis (such as PFMEA) and control plan?
Do product auditors demonstrate competence in understanding product requirements and use of relevant measuring
and test equipment to verify product conformity?
Where training is provided to achieve competency, is documented information retained to demonstrate the trainer's
competency with the above requirements?
Is maintenance of and improvement in internal auditor competence demonstrated through:
f) executing a minimum number of audits per year, as defined by the organization; and
g) maintaining 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 specific requirements)?

Does the organization demonstrate the competence of the auditors undertaking the second-party audits?

Do second-party auditors meet customer specific requirements for auditor qualification and demonstrate the minimu
following core competencies, including understanding of:
a) the automotive process approach to auditing, including risk based thinking;
b) applicable customer and organization specific requirements;
c) applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
d) applicable manufacturing process(es) to be audited, including PFMEA and control plan;
e) applicable core tool requirements related to the scope of the audit;
f) how to plan, conduct, prepare audit reports, and close out audit findings?

How are people aware of: The quality policy? Relevant quality objectives? Their contribution to the effectiveness of t
QMS? The benefits of improved performance? The implications of not conforming with the QMS requirements?
Additional Info:
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 benefits of improved qualit
performance;
d) the implications of not conforming with the quality management system requirements.

Does the organization maintain documented information that demonstrates that all employees are aware of their imp
on product quality and the importance of the activities in achieving, maintaining, and improving quality, including
customer requirements and the risks involved for the customer with non-conforming product?

Does the organization maintain a documented process(es) to motivate employees to achieve quality objectives, to m
continual improvements, and to create an environment that promotes innovation?
Does the process include the promotion of quality and technological awareness throughout the whole organization?
How do you determine internal and external communications relevant to the QMS?
How do you determine: What? When? With Whom? How?
Additional Info:
The organization shall determine the internal and external communications relevant to the quality management syste
including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate.

What documented information do you have as required by this standard? What documented informati
do you have as being necessary for the effectiveness of your QMS?
Additional Info:
The organization’s quality management system shall include: 
a) documented information required by this 
International Standard; 
b) documented information determined by the organization as being necessary for the effectiveness o
the quality management system.

Is the organization's quality management system documented and includes a quality manual, which can be a series
documents (electronic or hard copy)?
Is the format and structure of the quality manual at the discretion of the organization and does it
depend on the organization's size, culture, and complexity?
If a series of documents is used, is a list retained of the documents that comprise the quality manual
the organization?
Does the quality manual include, at a minimum, the following:
a) the scope of the quality management system, including details of and justification for any exclusion
b) documented processes established for the quality management system, or reference to them;
c) the organization's processes and their sequence and interactions (inputs and outputs), including typ
and extent of control of any outsourced processes;
d) a document (ie. matrix) indicating where within the organization's quality management system the
customer-specific requirements are addressed?

Show that your documented information contains: Identification; Description; In what media format?
Show how the documented information is reviewed and approved for suitability and adequacy.
Additional Info:
When creating and updating documented information the organization shall ensure appropriate:
a) identification 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.

Show how you control documented information. Show how you make it available and suitable for use.
How do you protect your documented information?
Additional Info:
Documented information required by the quality management system and by this International Stand
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 confidentiality, improper use, or loss of integrity).

When controlling documented information, how do you address: 

Distribution; Access; Retrieval; Use; 
Storage and preservation; Legibility; 
Control of changes; Retention and disposition.
Additional Info:
For the control of documented information, the organization shall address the following activities, as
applicable: 
a) distribution, access, retrieval and use; b) storage and preservation, including preservation of
legibility; 
c) control of changes (e.g. version control); 
d) retention and disposition.

Does the organization define, document, and implement a record retention policy?
Do the control of records satisfy statutory, regulatory, organizational, and customer requirements?
Are production part approvals, tooling records (including maintenance and ownership), product and
process design records, purchase orders (if applicable), or contracts and amendments retained for the
length of time that the product is active for production and service requirements, plus one calendar y
unless otherwise specified by the customer or regulatory agency?

How do you identify as appropriate and control documented information of external origin which you
have determined as necessary for the QMS
Additional Info:
Documented information of external origin determined by the organization to be necessary for the
planning and operation of the quality management system shall be identified as appropriate, and
controlled.

Does the organization have a documented process describing the review, distribution, and implementation of all
customer engineering standards/specifications and related revisions based on customer schedules, as required?

When an engineering standard/specification change results in a product design change, refer to the requirements in
9001, Section 8.3.6. When an engineering standard/specification change results in a product realization process
change, refer to the requirements in Section 8.5.6.1.

Does the organization retain a record of the date on which each change is implemented in production?
Does implementation include updated documents?
Is review completed within 10 working days of receipt of notification of engineering standards/specification changes?
fico Training and Consulting Services
Kokane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Documents Observations

Applicable to look for
Clause No.

8.1.1

8.1.1

8.1.2

8.1.2

8.1.3
8.1.4

8.2.1.1

8.2.2.1

8.2.2.2

8.2.2.1

8.2.3.1
8.2.3.1.1

8.2.3.1.2

8.2.3.2

8.2.3.3

8.2.3.4

8.2.4

8.3.1.

8.3.1.1
8.3.2

8.3.2.1

8.3.2.2
8.3.2.2

8.3.2.3

8.3.3.1

8.3.3.2

8.3.3.2
8.3.3.3

8.3.4.1

8.3.4.1

8.3.4.2

8.3.4.3
8.3.4.4

8.3.5.1

8.3.5.1

8.3.5.2
8.3.6.1

8.3.6.1

8.3.6.2

8.4.1

8.4.1.1

8.4.1.2
8.4.1.2

8.4.1.3

8.4.1.3

8.4.1.4

8.4.2.1

8.4.2.1
8.4.2.2

8.4.2.2

8.4.2.3

8.4.2.3

8.4.2.3.1
8.4.3.1
a
b
c
d
e
f
g

8.4.3.2

8.5.1.1
8.5.1.2
8.5.1.3

8.5.1.4

8.5.1.5

8.5.1.6
8.5.1.7

8.5.2.1

8.5.2.2

8.5.2.3

8.5.3.1
8.5.3.2

8.5.4

8.5.5.1

8.5.5.2
8.5.6.1

8.5.6.1.1
8.5.6.2

8.6.1

8.6.2

8.6.2

8.6.3
8.6.4

8.6.5

8.6.6

8.7.1

8.7.1.1

8.7.1.2
8.7.1.3

8.7.1.3

8.7.1.4
8.7.1.5

8.7.1.6

8.7.1.7

8.7.2

8.7.3

8.7.4
8.7.5
 M
C-1, Nisarg

Question

How are processes needed to meet requirements for provision of products and services planned, implemented a

How are requirements for products and services determined?

How is criteria for processes and acceptance for products and services determined?

How are resources determined?

How is process control implemented?

Show me the documented information that shows confidence in that the processes have been carried out as plan
demonstrate conformity of products and services.
Additional Info:
The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requiremen
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
processes in accordance with the criteria; 
e) retaining documented information to the extent necessary to have confidence that the processes have been c
planned and to demonstrate conformity of products and services to requirements.

When planning for product realization, are the following topics included:
a) customer product requirements and technical specifications;
b) logistics requirements;
c) manufacturing feasibility;
d) project planning (refer to ISO 9001, Section 8.3.2);

e) acceptance criteria? The resources identified in ISO 9001, Section 8.1 c), refer to the required verification, val
monitoring, measurement, inspection, and test activities specific to the product and the criteria for product accep

How have you determined that the output from the planning process is suitable for your operations?
Additional Info:
The output of this planning shall be suitable for the organization's operations.

Has the organization ensured the confidentiality of customer-contracted products and projects under developmen
related product information?

How do you control planned changes? How do you review the consequences of unintended changes? What acti
mitigate any adverse effects?
Additional Info:
The organization shall control planned changes and review the consequences of unintended changes, taking act
any adverse effects, as necessary.
How do you control outsourced processes?
Additional Info:
The organization shall ensure that outsourced processes are controlled in accordance with 8.4.

What are your processes for communicating with customers? How do you communicate information relating to:
Products; Services; Enquiries; Contracts; Order handling; Customer views, perceptions and complaints; Handling
of customer property; Specific requirements for contingency actions?
Additional Info:
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) specific requirements for contingency actions, when relevant.

Is written or verbal communication in the language agreed with the customer?

Does the organization have the ability to communicate necessary information, including data in a customer-spec
language and format (e.g. computer-aided design data, electronic data interchange)?

What is your process to determine the requirements for products and services to be offered to potential custome
do you establish, implement and maintain this process?

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

How do you define product and service requirements including statutory and regulatory requirements?
How do you ensure that you have the ability to meet the defined requirements and substantiate any claims for yo
and services?
Additional Info:
The organization shall ensure that: 
a) product and service requirements (including those considered necessary by the organization), and applicable
regulatory requirements, are defined; 

b) it has the ability to meet the defined requirements and substantiate the claims for the products and services it

Do these requirements include recycling, environmental impact, and characteristics identified as a result of the o
knowledge of the product and manufacturing processes?

Does compliance to ISO 9001, Section 8.2.2 item a) 1), include but not limited to the following: all applicable gov
safety, and environmental regulations related to acquisiton, storage, handling, recycling, elimination, or disposal

How do you review: Customer requirements for delivery and post-delivery?

Requirements necessary for customers’ specified or intended use, where known; Additional statutory and regula
requirements applicable to products and services; Any other contract or order requirements.
Additional Info:
The organization shall review, as applicable:
a) requirements specified by the customer, including the requirements for delivery and post- delivery activities; 
b) requirements not stated by the customer, but necessary for the customers' specified or intended use, when kn
c) additional statutory and regulatory requirements applicable to the products and services; 
d) contract or order requirements differing from those previously expressed.
Does the organization retain documented evidence of a customer-authorized waiver for the requirements stated
Section 8.2.3.1, for a formal review?
Does the organization conform to customer requirements for designation, approval documentation, and control o
characteristics?
Does the organization utilize a multidisciplinary approach to conduct an analysis to determine if it is feasible that
organization's manufacturing processes are capable of consistently producing product that meets all of the engin
capacity requirements specified by the customer?
Does the organization conduct this feasibility analysis for any manufacturing or product technology new to the or
for any changed manufacturing process or product design?
Additionally, does the organization validate through production runs, benchmarking studies, or other appropriate
ability to make product to specifications at the required rate?

Show me that the review is conducted prior to your commitment to supply products and services to your custome
you resolve contract or order requirements which differ from those previously defined?
Additional Info:
This review shall be conducted prior to the organization’s commitment to supply products and services to the cus
shall ensure contract or order requirements differing from those previously defined are resolved.

How do you confirm customer requirements where the customer does not provide a documented statement?

Additional Info:
Where the customer does not provide a documented statement of their requirements, the customer requirements
confirmed by the organization before acceptance.

Show me where you retain documented information which describes results of the review including any new or c
requirements.
Additional Info:
Documented information describing the results of the review, including any new or changed requirements for the
services, shall be retained.

Show me the documented information containing changes to products and services. How do you ensure that rele
personnel are made aware of those changes?
Additional Info:

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

How do you establish, implement and maintain a design and development process (where detailed requirements
products and services are not already established or defined by the customer or other parties).

Additional Info:

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

Do the requirements of ISO 9001, Section 8.3.1, apply to product and manufacturing process design and develo
focus on error prevention rather than detection?
Does the organization document the design and development process?

When determining the stages and control for design and development, show how you consider: The nature, dura
complexity of the activities; Requirements that specify particular process stages including applicable reviews; Re
verification and validation; Responsibilities and authorities; How interfaces are controlled between individuals and
The need for involvement of customer and user groups. Show documented information that confirms design and
requirements have been met.

Additional Info:
In determining the stages and controls for design and development, the organization shall consider: a) the nature
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 verification 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 necessa
documented information to confirm that design and development requirements have been met.

Does the organization ensure that design and development planning includes all affected stakeholders within the
and, as appropriate, its supply chain?
Examples of areas for using such a multidisciplinary approach include but are not limited to the following:
a) project management (for example, APQP or VDA - RGA);
b) product and manufacturing process design activities (for example, DFM and DFA), such as consideration of th
alternative designs and manufacturing processes;
c) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks;
d) development and review of manufacturing process risk analysis (for example, FMEAs, process flows, control p
standard work instructions).
Additional Info:
NOTE: A multidisciplinary approach typically includes the organization's design, manufacturing, engineering, qua
production, purchasing, supplier, maintenance, and other appropriate functions.

When determining the stages and control for design and development, show how you consider: The nature, dura
complexity of the activities; Requirements that specify particular process stages including applicable reviews; Re
verification and validation; Responsibilities and authorities; How interfaces are controlled between individuals and

The need for involvement of customer and user groups. Show documented information that confirms design and
requirements have been met.
Additional Info:
In determining the stages and controls for design and development, the organization shall consider: a) the nature
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 verification 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 necessa
documented information to confirm that design and development requirements have been met.
Does the organization ensure that personnel with product design responsibilty are competent to achieve design r
and are skilled in applicable product design tools and techniques?
Are applicable tools and techniques identified by the organization?

Does the organization use a process for quality assurance for their products with internally developed embedded

Is a software development assessment methodology utilized to assess the organization's software development

Using prioritization based on risk and potential impact to the customer, does the organization retain documented
a software development capability self-assessment?

Does the organization include software development within the scope of their internal audit programme (see Sec

Can you show how you determine: 

Requirements essential for the type of products and services being designed and developed, including as applica

Functional & performance requirements; Statutory and regulatory requirements; Standards or codes of practice w
a commitment to implement; Internal and external resources needed for the design and development of products
Potential consequences of failure; Level of control expected of the design and development process by custome
relevant parties.
Additional Info:
The organization shall determine: 
a) requirements essential for the specific type of products and services being designed and developed, including
applicable, functional and performance requirements; 
b) applicable statutory and regulatory requirements; 
c) standards or codes of practice that the organization has committed to implement; 
d) internal and external resource needs for the design and development of products and services; e) the potentia
consequences of failure due to the nature of the products and services; 

f) the level of control expected of the design and development process by customers and other relevant intereste

How do you determine that inputs are adequate, complete and unambiguous for design and development?
How do you resolve conflicts among inputs?
Additional Info:
Inputs shall be adequate for design and development purposes, complete, and unambiguous. Conflicts among in
resolved.

Does the organization identify, document, and review manufacturing process design input requirements including
limited to the following:

a) product design output data including special characteristics;

b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;
d) customer requirements, if any;
e) experience from previous developments;
f) new materials;
g) product handling and ergonomic requirements; and

h) design for manufacturing and design for assembly? Does the manufacturing process design include the use o
methods to a degree appropriate to the magnitude of the problem(s) and commensurate with the risks encounter
Does the organization use a multidisciplinary approach to establish, document, and implement its process(es) to
special characteristics, including those determined by the customer and the risk analysis performed by the organ
does it include the following:
a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), contro
standard work/operator instructions; special characteristics identified with specific markings and cascaded throug
these documents;

b) development of control and monitoring strategies for special characteristics of products and production proces
c) customer-specified approvals, when required;

d) compliance with customer-specified definitions and symbols or the organization's equivalent symbols or notati
defined in a symbol conversion table? Is the symbol conversion table submitted to the customer, if required?

How do controls that are applied to the design and development process ensure: Results achieved
and development activities are clearly defined? Design and development reviews are conducted as
Outputs meet the input requirements by verification/ Validation is conducted to ensure that the res
products and services are capable of meeting the requirements for the specified application or inte
(when known)?
Additional Info:
The controls applied to the design and development process shall ensure that: 
a) the results to be achieved by the design and development activities are clearly defined; 
b) design and development reviews are conducted as planned; 
c) verification is conducted to ensure that the design and development outputs have met the desig
development input requirements; 
d) validation is conducted to ensure that the resulting products and services are capable of meetin
requirements for the specified application or intended use (when known).

Are measurements at specified stages during the design and development of products and process
analysed, and reported with summary results as an input to management review (see Section 9.3.2

When required by the customer, are measurements of the product and process development activity reported to
at stages specified, or agreed to, by the customer?

Is design and development validation performed in accordance with customer requirements, including any applic
and governmental agency-issued regulatory standards?

Is the timing of design and development validation planned in alignment with customer-specified timing, as applic

Where contractually agreed with the customer, does this include evaluation of the interaction of the organization'
including embedded software, within the system of the final customer's product?

When required by the customer, does the organization have a prototype programme and control plan?
Does the organization use, whenever possible, the same suppliers, tooling, and manufacturing processes as use
production?
Are all performance-testing activities monitored for timely completion and conformity to requirements?

When services are outsourced, does the organization include the type and extent of control in the scope of its qu
management sytem to ensure that outsourced services conform to requirements (see ISO 9001, Section 8.4)?
Does the organization establish, implement, and maintain a product and manufacturing approval process conform
requirements defined by the customer(s)?
Does the organization approve externally provided products and services per ISO 9001, Section 8.4.3, prior to su
their part approval to the customer?
Does the organization obtain documented product approval prior to shipment, if required by the customer?
Are records of such approval retained?

How do you ensure that design and development outputs: Meet the input requirements for design
development?
Are adequate for the subsequent processes for the provision of products and services? Include or r
monitoring and measuring requirements, and acceptance criteria, as applicable? 
Ensure products to be produced, or services to be provided, are fit for intended purpose and their s
proper use?
Additional Info:
The organization shall ensure that design and development outputs: 
a) meet the input requirements for design and development; 
b) are adequate for the subsequent processes for the provision of products and services; 
c) include or reference monitoring and measuring requirements, and acceptance criteria, as applic
d) ensure products to be produced, or services to be provided, are fit for intended purpose and the
proper use.

Is the product design output expressed in terms that can be verified and validated against product design input re
Does the product design output include but is not limited to the following, as applicable:
a) design risk analysis (FMEA);
b) reliability study results;
c) product special characteristics;
d) results of product design error-proofing, such as DFSS, DFMA, and FTA;
e) product definition including 3D models, techincal data packages, product manufacturing information, and geom
dimensioning & tolerancing (GD & T);
g) product design review results;
h) service diagnostic guidelines and repair and serviceability instructions;
i) service part requirements;
j) packaging and labeling requirements for shipping.

Show me the documented information which results from the design and development process.
Additional Info:
The organization shall retain the documented information resulting from the design and developme

Does the organization document the manufacturing process design output in a manner that enables verification a
manufacturing process design inputs?
Does the organization verify the outputs against manufacturing process design input requirements?
Does the manufacturing process design output include but is not limited to the following:
a) specifications and drawings;
b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including capability studies of equipment and process(es);
e) manufacturing process flow charts / layout, including linkage of product, process, and tooling;
f) capacity analysis;
g) manufacturing process FMEA;
h) maintenance plans and instructions;
 i) control plan (see Annex A);
j) standard work and work instructions;
k) process approval acceptance criteria;
l) data for quality, reliability, maintainability, and measurability;
m) results of error-proofing identification and verification, as appropriate;
n) methods of rapid detection, feedback, and correction of product/manufacturing process nonconformities?

How do you review, control and identify changes made to the design inputs and outputs during des
development of products and services ensuring no impact on conformity to requirements?
Additional Info:
The organization shall review, control and identify changes made to design inputs and design outp
the design and development of products and services or subsequently, to the extent that there is n
impact on conformity to requirements.

Does the organization evaluate all design changes after initial product approval, including those proposed by the
or its suppliers, for potential impact on fit, form, function, performance, and/or durability?

Are these changes validated against customer requirements and approved internally, prior to production impleme

If required by the customer, does the organization obtain documented approval, or a documented waiver, from th
prior to production implementation?
For products with embedded software, does the organization document the revision level of software and hardwa
the change record?

Show the documented information for design and development changes.

Additional Info:
Documented information on design and development changes shall be retained.

How do you ensure externally provided processes, products and services conform to specified requ
Additional Info:
The organization shall ensure that externally provided processes, products, and services conform t
requirements.

Does the organization include all products and services that affect customer requirements such as sub- assembl
sorting, rework, and calibration services in the scope of their definition of externally provided products, processes
services?

Does the organization have a documented supplier selection process?

Does the selection process include:
a) an assessment of the selected supplier's risk to product conformity and uninterrupted supply of the organizatio
the customers;
b) relevant quality and delivery performance;
c) an evaluation of the supplier's quality management system;
d) multidisciplinary decision making; and
e) an assessment of software development capabilities, if applicable?

Are other supplier selection criteria considered including the following: - volume of automotive business (absolute
percentage of total business); - financial stability; - purchased product, material, or service complexity; - required
(product or process); - adequacy of available resources (e.g. people, infrastructure); - design and development c
(including project management); - manufacturing capability; - change management process; - business continuity
disaster preparedness, contingency planning); - logistics process; - customer service
Show how you apply specified requirements for the control of externally provided products and ser
Products and services are provided by external providers for incorporation into your own products
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
function.
Additional Info:
The organization shall apply the specified requirements for the control of externally provided produ
services when: 
a) products and services are provided by external providers for incorporation into the organization’
products and services; 
b) products and services are provided directly to the customer(s) by external providers on behalf o
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.

Show how you establish and apply criteria for evaluation, selection, monitoring of performance and
evaluation of external providers. How do you assess 
their ability to provide processes or products and services in accordance with specified requiremen
Additional Info:
The organization shall establish and apply criteria for the evaluation, selection, monitoring of perfo
re-evaluation of external providers based on their ability to provide processes or products and serv
accordance with specified requirements.

When specified by the customer, does the organization purchase products, materials, or services from customer
sources?
Are all requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) applicable to the or
control of customer-directed sources unless specific agreements are otherwise defined by the contract between
organization and the customer?

What documented information do you have of the results of evaluations, monitoring of performanc
evaluations of external providers?
Additional Info:
The organization shall retain appropriate documented information of the results of the evaluations,
of the performance and re- evaluations of the external providers.

How do you determine the controls applied to the external provision of processes, products and se
take into consideration:
a) The potential impact of the externally provided processes, products and services on the ability t
consistently meet customer and applicable statutory and regulatory requirements?
b) The perceived effectiveness of the controls applied by the external provider?
Additional Info:
In determining the type and extent of controls to be applied to the external provision of processes,
and services, the organization shall take into consideration: 
a) the potential impact of the externally provided processes, products and services on the organiza
to consistently meet customer and applicable statutory and regulatory requirements; 
b) the perceived effectiveness of the controls applied by the external provider.

Does the organization have a documented process to identify outsourced processes and to select t
extent of controls used to verify conformity of externally provided products, processes, and service
(organizational) and external customer requirements?
Does the process include the criteria and actions to escalate or reduce the types and extent of controls and deve
activites based on supplier performance and assessment of product, material, or service risks?

What verification or other activities do you have to ensure externally provided processes, products
do not adversely affect your ability to consistently deliver conforming products and services to you

Additional Info:
The organization shall establish and implement verification or other activities necessary to ensure
externally provided processes, products and services do not adversely affect the organization's abi
consistently deliver conforming products and services to its customers.

Does the organization document their process to ensure that purchased products, processes, and services confo
current applicable statutory and regulatory requirements in the country of receipt, the country of shipment, and th
identified country of destination, if provided?
If the customer defines special controls for certain products with statutory and regulatory requirements, does the
ensure they are implemented and maintained as defined, including at suppliers?

When processes or functions have been outsourced to external providers, how do you consider a) a
8.4.1 and how do you define the controls intended to be applied to the external provider and to the
process output?
Additional Info:
Processes or functions of the organization which have been outsourced to an external provider rem
the scope of the organization’s quality management system; accordingly, the organization shall co
b) above and define both the controls it intends to apply to the external provider and those it inten
to the resulting process output.

Does the organization require their suppliers of automotive products and services to develop, implement, and im
management sytem certified to ISO 9001, unless otherwise authorized by the customer (e.g. item a) below), with
objective of becoming certified to this Automotive QMS Standard?
Unless otherwise specified by the customer, is the following sequence applied to achieve this requirement:
a) compliance to ISO 9001 through second-party audits;

b) certification to ISO 9001 through third-party audits; unless otherwise specified by the customer, do suppliers t
organization demonstrate conformity to ISO 9001 by maintaining a third-party certification issued by a certificatio
the accreditation mark of a recognized IAF MLA (International Accreditation Forum Multilateral Recognition Arran
member and where the accreditation body's main scope includes management system certification to ISO / IEC

c) certification to ISO 9001 with compliance to other customer-defined QMS requirements (such as Minimum Aut
Quality Management System Requirements for Sub-Tier Suppliers [MAQMSR] or equivalent) through second-pa

d) certification to ISO 9001 with compliance to IATF 16949 through second-party audits; e) certification to 16949
party audits (valid third-party certification of the supplier to IATF 16949 by an IATF-recognized certification body)

Does the organization require their suppliers of automotive product-related software, or automotive products with
software, to implement and maintain a process for software quality assurance for their products?

Is a software development assessment methodology utilized to assess the supplier's software development proc

Using prioritization based on risk and potential impact to the customer, does the organization require the supplie
documented information of a software development capability self-assessment?
Does the organization have a documented process and criteria to evaluate supplier performance in order to ensu
of externally provided products, processes, and services to internal and external customer requirements?

At a minimum, are the following supplier performance indicators monitored:

a) delivered product conformity to requirements;
b) customer disruptions at the receiving plant, including yard holds and stop ships;
c) delivery schedule performance;
d) number of occurrences of premium freight? If provided by the customer, does the organization also include the
appropriate, in their supplier performance monitoring:
e) special status customer notifications related to quality or delivery issues;
f) dealer returns, warranty, field actions, and recalls?

Show me how you communicate to external providers, applicable requirements for: 

Products and services to be provided or the processes to be performed on behalf of the organizatio
Approval or release of products and services, methods, processes or equipment; 
Competence of personnel, including necessary qualification; 
Their interactions with the organization's quality management system; 
The control and monitoring of the external provider’s performance to be applied by the organizatio
Verification activities that the organization, or its customer, intends to perform at the external prov
premises.
Additional Info:
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 orga
b) approval or release of products and services, methods, processes or equipment; 
c) competence of personnel, including necessary qualification; 
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 organiza
f) verification activities that the organization, or its customer, intends to perform at the external pr
premises.

Does the organization pass down all applicable statutory and regulatory requirements and special product and pr
characteristics to their suppliers and require the suppliers to cascade all applicable requirements down the suppl
point of manufacture?

Before you communicate with external providers, how do you ensure the adequacy of specified req

Additional Info:
The organization shall ensure the adequacy of specified requirements prior to their communication
external provider.

What controlled conditions do you have for production and service provision, including delivery and
delivery activities?
Additional Info:
The organization shall implement controlled conditions for production and service provision, includ
and post-delivery activities.
Does the organization develop control plans (in accordance with Annex A) at the system, subsystem, componen
material level for the relevant manufacturing site and all product supplied, including those for processes producin
materials as well as parts?

Are family control plans acceptable for bulk material and similar parts using a common manufacturing process?
Does the organization have a control plan for pre-launch and production that shows linkage and incorporates info
the design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk ana
(such as FMEA)?
Does the organization, if required by the customer, provide measurement and conformity data collected during e
either the pre-launch or production control plans?
Does the organization include in the control plan:
a) controls used for the manufacturing process control, including verification of job set-ups;
b) first-off / last-off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics (see Annex A) defined by both the cus
organization;
d) the customer-required information, if any;
e) specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statisti
or not statistically capable?
Does the organization review control plans, and update as required, for any of the following:
f) the organization determines it has shipped nonconforming product to the customer;
g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, p
volume changes, or risk analysis (FMEA) (see Annex A);
h) after a customer complaint and implementation of the associated corrective action, when applicable;
i) at a set frequency based on a risk analysis?
If required by the customer, does the organization obtain customer approval after review or revision of the contro

Can you show controlled conditions for: 

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

Additional Info:
Controlled conditions shall include, as applicable:
a) the availability of documented information that defines the characteristics of the products and s
b) the availability of documented information that defines the activities to be performed and the re
achieved; 
c) monitoring and measurement activities at appropriate stages to verify that criteria for control of
and process outputs, and acceptance criteria for products and services, have been met. 
d) the use, and control of suitable infrastructure and process environment; 
e) the availability and use of suitable monitoring and measuring resources; 
f) the competence and, where applicable, required qualification of persons; 
g) the validation, and periodic revalidation, of the ability to achieve planned results of any process
production and service provision where the resulting output cannot be verified by subsequent mon
measurement; 
h) the implementation of products and services release, delivery and post-delivery activities.

Does the organization ensure that standardised work documents are:

a) communicated to and understood by the employees who are responsible for performing the work;
b) legible;
c) presented in the language(s) understood by the personnel responsible to follow them;
d) accessible for use at the designated work area(s)?
Do the standardised work documents also include rules for operator safety?

Does the organization:

a) verify job set-ups when performed, such as an initial run of a job, material changeover, or job change that requ
set-up;
b) maintain documented information for set-up personnel;
c) use statistical methods of verification, where applicable;

d) perform first-off/last-off part validation, as applicable; where appropriate, are first-off parts retained for compar
last-off parts; where appropriate, are last-off parts retained for comparison with first-off parts in subsequent runs;

e) retain records of process and product approval following set-up and first-off/last-off part validations?

Does the organization define and implement the necessary actions to ensure product compliance with requireme
planned or unplanned production shutdown period?

Does the organization develop, implement, and maintain a documented total productive maintenance system?
At a minimum, does the system include the following:
a) identification of process equipment necessary to produce conforming product at the required volume;
b) availability of replacement parts for the equipment identified in item a);
c) provision of resource for machine, equipment, and facility maintenance;
d) packaging and preservation of equipment, tooling, and gauging;
e) applicable customer-specific requirements;
f) documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Tim
Failure), and MTTR (Mean Time To Repair), and Preventive Maintenance compliance metrics?

Does performance to the maintenance objectives form an input into management review (see ISO 9001, Section

g) regular review of maintenance plan and objectives and a documented action plan to address corrective action
objectives are not achieved;
h) use of preventive maintenance methods;
i) use of predictive maintenance methods, as applicable; j) periodic overhaul?

Does the organization provide resources for tool and gauge design, fabrication, and verification activities for prod
service materials and for bulk materials, as applicable?
Does the organization establish and implement a system for production tooling management, whether owned by
organization or the customer, including:
a) maintenance and repair facilities and personnel;
b) storage and recovery;
c) set-up;
d) tool-change programmes for perishable tools;
e) tool design modification documentation, including engineering change level of the product;
f) tool modification and revision to documentation;
g) tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership

Does the organization verify that customer-owned tools, manufacturing equipment, and test/inspection equipmen
permanently marked in a visible location so that the ownership and application of each item can be determined?

Does the organization implement a system to monitor these activities if any work is outsourced?

Does the organization ensure that production is scheduled in order to meet customer orders/demands such as J
(JIT) and is supported by an information system that permits access to production information at key stages of th
is order driven?
Does the organization include relevant planning information during production scheduling, e.g. customer orders,
time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive ma
calibration?

What means do you use to identify process outputs to ensure conformity of products and services?
Additional Info:
Where necessary to ensure conformity of products and services, the organization shall use suitable
identify process outputs.

The purpose of traceability is to support identifaction of clear start and stop points for product received by the cus
the field that may contain quality and/or safety-related nonconformities. Therefore, does the organization implem
identification and traceability processes as described below?
Does the organization conduct an analysis of internal, customer, and regulatory traceability requirements for all a
products, including developing and documenting traceability plans, based on the levels of risk or failure severity f
customers, and consumers?
Do these plans define the appropriate traceability systems, processes, and methods by product, process, and m
location that:
a) enable the organization to identify nonconforming and/or suspect product;
b) enable the organization to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the organ
meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to externally provided products with safety
characteristics?

How do you identify the status of process outputs?

Additional Info:
The organization shall identify the status of process outputs with respect to monitoring and measu
requirements throughout production and service provision

How do you control the unique identification of process outputs, where applicable? What document
information do you retain?
Additional Info:
Where traceability is a requirement, the organization shall control the unique identification of the p
outputs, and retain any documented information necessary to maintain traceability.

What care do you provide for customer or external provider’s property while under your control? 
How do you identify, verify, protect and safeguard that property which is provided for use or incorp
your products or services?
Additional Info:
The organization shall exercise care with property belonging to the customer or external providers
under the organization's control or being used by the organization. The organization shall identify,
protect and safeguard the customer’s or external provider’s property 
provided for use or incorporation into the products and services.

What means do you use to report to the customer or external provider if their property is incorrect
damaged or found to be unsuitable for use?
Additional Info:
When property of the customer or external provider is incorrectly used, lost, damaged or otherwise
unsuitable for use, the organization shall report this to the customer or external provider.

How do you ensure preservation of process outputs during production and service provision to mai
conformity to product requirements?

Additional Info:
The organization shall ensure preservation of process outputs during production and service provis
extent necessary to maintain conformity to requirements.

Does preservation include identification, handling, contamination control, packaging, storage, transmission or tra
and protection?
Does preservation apply to materials and components from external and/or internal providers from receipt throug
including shipment and until delivery to/acceptance by the customer?
In order to detect deterioration, does the organization assess at appropriate planned intervals the condition of pro
the place/type of storage container, and the storage environment?
Does the organization use an inventory management system to optimize inventory turns over time and ensure st
such as "first-in-first-out" (FIFO)?

Does the organization ensure that obsolete product is controlled in a manner similar to that of nonconforming pro

Do organizations comply with preservation, packaging, shipping, and labeling requirements as provided by their

How do you meet requirements for post- delivery activities associated with products and services?
Additional Info:
As applicable, the organization shall meet requirements for post-delivery activities associated with
and services.

Does the organization ensure that a process for communication of information on service concerns
manufacturing, material handling, logistics, engineering, and design activities is established, imple
maintained?
Additional Info:
NOTE 1: The intent of the addition of "service concerns" to this sub-clause is to ensure that the org
aware of nonconforming product(s) and material(s) that may be identified at the customer location
field. NOTE 2: "Service Concerns" should include the results of field failure test analysis (see Sectio
where applicable.

How do you determine: Risk; Nature, use and intended lifetime; Customer feedback; Statutory and
requirements, when determining the extent of post- delivery activities required with products and
Additional Info:
In determining the extent of post-delivery activities that are required, the organization shall consid
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.

When there is a service agreement with the customer, does the organization:
a) verify that the relevant service centres comply with applicable requirements;
b) verify the effectiveness of any special purpose tools or measurement equipment;
c) ensure that all service personnel are trained in applicable requirements?

How do you review and control unplanned changes to ensure continuing conformity with specified
requirements?
Additional Info:
The organization shall review and control unplanned changes essential for production or service pr
the extent necessary to ensure continuing conformity with specified requirements.

Does the organization have a documented process to control and react to changes that impact product realizatio

Are the effects of any change, including those changes caused by the organization, the customer, or any supplie
Does the organization:
a) define verification and validation activities to ensure compliance with customer requirements;
b) validate changes before implementation;
c) document the evidence of related risk analysis;

d) retain records of verification and validation? Do changes, including those made at suppliers, require a product
verification of changes (such as changes to part design, manufacturing location, or manufacturing process) to va
impact of any changes on the manufacturing process? When required by the customer, does the organization: e
customer of any planned product realization changes after the most recent product approval; f) obtain document
prior to implementation of the change; g) complete additional verification or identification requirements, such as p
run and new product validation?

Does the organization identify, document, and maintain a list of the process controls, including inspection, measu
error-proofing devices, that includes the primary process control and the approved back-up or alternate methods

Does the organization document the process that manages the use of alternate control methods?
Does the organization include in this process, based on risk analysis (such as FMEA), severity, and the internal
be obtained prior to production implementation of the alternate control method?
Before shipping product that was inspected or tested using the alternate method, if required, does the organizatio
approval from the customer(s)?
Does the organization maintain and periodically review a list of approved alternate process control methods that
in the control plan?
Are standard work instructions available for each alternate process control method?
Does the organization review the operation of alternate process controls on a daily basis, at a minimum, to verify
implementation of standard work with the goal to return to the standard process as defined by the control plan as
possible?
Example methods include but are not limited to the following:
a) daily quality focused audits (e.g. layered process audits, as applicable);
b) daily leadership meetings. Is restart verification documented for a defined period based on severity and confirm
features of the error-proofing device or process are effectively reinstated?
Does the organization implement traceability of all product produced while any alternate process control devices
are being used (e.g. verification and retention of first piece and last piece from every shift)?

What documented information can you show me which describes the results of reviews of changes
personnel authorizing change and any necessary actions?
Additional Info:
The organization shall retain documented information describing the results of the review of chang
personnel authorizing the change, and any necessary actions.

Show how planned arrangement have been implemented at appropriate stages to verify product a
requirements have been met. Show me what evidence you retain.
Additional Info:
The organization shall implement the planned arrangements at appropriate stages to verify that pr
service requirements have been met. Evidence of conformity with the acceptance criteria shall be

Does the organization ensure that the planned arrangements to verify that the product and service requirements
met encompass the control plan and are documented as specified in the control plan (see Annex A)?

Does the organization ensure that the planned arrangements for the intial release of products and services enco
or service approval?
Does the organization ensure that product or service approval is accomplished after changes following initial rele
to ISO 9001, Section 8.5.6?

Show how the release of products and services is held until planned arrangements for verification o
have been satisfactorily completed, unless approved by a relevant authority, or the customer if app
Show documented information which shows traceability to the person authorizing release of produ
services.
Additional Info:
The release of products and services to the customer shall not proceed until the planned arrangem
verification of conformity have been satisfactorily completed, unless otherwise approved by a relev
authority and, as applicable, by the customer. Documented information shall provide traceability to
person(s) authorizing release of products and services for delivery to the customer.

Is a layout inspection and a functional verification to applicable customer engineering material and
performance standards performed for each product as specified in the control plans? Are results av
customer review?
Additional Info:
NOTE 1: Layout inspection is the complete measurement of all product dimensions shown on the d
record(s).
NOTE 2: The frequency of layout inspection is determined by the customer.

For organizations manufacturing parts designated by the customer as "appearance items", does the organization
following:
a) appropriate resources, including lighting, for evaluation;
b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), and haptic technology
appropriate;
c) maintenance and control of appearance masters and evaluation equipment;
d) verification that personnel making appearance evaluations are competent and qualified to do so?
Does the organization have a process to ensure the quality of externally provided processes, products, and serv
one or more of the following methods:
a) receipt and evaluation of statistical data provided by the supplier to the organization;
b) receiving inspection and/or testing, such as sampling based on performance;
c) second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable d
product conformance to requirements;
d) part evaluation by a designated laboratory;
e) another method agreed with the customer?

Prior to release of externally provided products into its production flow, does the organization confirm and is it ab
evidence that externally provided processes, products, and services conform to the latest applicable statutory, re
other requirements in the countries where they are manufactured and in the customer-identified countries of des
provided?

Is acceptance criteria defined by the organization and, where appropriate or required, approved by the customer
attributed data sampling, is the acceptance level zero defects (see Section 9.1.1.1)?

How do you identify and control process outputs, products and services that do not conform to req
and prevent their unintended use or delivery?
Additional Info:
The organization shall ensure process outputs, products and services that do not conform to requir
identified and controlled to prevent their unintended use or delivery.

Does the organization obtain a customer concession or deviation permit prior to further processing whenever the
manufacturing process is different from that which is currently approved?
Does the organization obtain customer authorization prior to further processing for "use as is" and rework dispos
nonconforming product?
If sub-components are reused in the manufacturing process, is that sub-component reuse clearly communicated
customer in the concession or deviation permit?
Does the organization maintain a record of the expiration date or quantity authorized under concession?
Does the organization also ensure compliance with the original or superseding specifications and requirements w
authorization expires?
Is material shipped under concession properly identified on each shipping container (this applies equally to purch
product)?
Does the organization approve any requests from suppliers before submission to the customer?

Does the organization comply with applicable customer-specified controls for nonconforming product(s)?
Does the organization ensure that product with unidentified or suspect status is classified and controlled as nonc
product?
Does the organization ensure that all appropriate manufacturing personnel receive training for containment of su
nonconforming product?

Does the organization utilize risk analysis (such as FMEA) methodology to assess risks in the rework process pr
decision to rework the product?
If required by the customer, does the organization obtain approval from the customer prior to commencing rewo
product?
Does the organization have a documented process for rework confirmation in accordance with the control plan o
documented information to verify compliance to original specifications?
Are instructions for disassembly or rework, including re-inspection and traceability requirements, accessible to an
the appropriate personnel?
Does the organization retain documented information on the disposition of reworked product including quantity, d
disposition date, and applicable traceability information?
Does the organization utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prio
to repair the product?
Does the organization obtain approval from the customer before commencing repair of the product?
Does the organization have a documented process for repair confirmation in accordance with the control plan or
documented information?
Are instructions for disassembly or repair, including re-inspection and traceability requirements, accessible to and
the appropriate personnel?

Does the organization obtain a documented customer authorization for concession for the product to be repaired

Does the organization retain documented information on the disposition of repaired product including quantity, di
disposition date, and applicable traceability information?
Does the organization immediately notify the customer(s) in the event that nonconforming product has been ship
communication followed with detailed documentation of the event?

Does the organization have a documented process for disposition of nonconforming product not subject to rewor

For product not meeting requirements, does the organization verify that the product to be scrapped is rendered u
to disposal?

The organization shall not divert nonconforming product to service or other use without prior customer approval.
What appropriate corrective actions are taken based on the nature of the nonconformity and its im
conformity of products and services? How do you apply this to nonconformity detected after delive
Additional Info:
The organization shall take appropriate corrective action based on the nature of the nonconformity
impact on the conformity of products and services. This applies also to nonconforming products an
detected after delivery of the products or during the provision of the service.

How you 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?
Additional Info:
As applicable, the organization shall deal with nonconforming process outputs, products and services in one or m
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.

How do you verify conformance where process outputs, products and services are corrected follow
nonconformance?
Additional Info:
Where nonconforming process outputs, products and services are corrected, conformity to the requ
shall be verified.
What documented information do you keep following actions taken to address nonconformities, inc
concessions obtained and on the person or authority that made the decision regarding dealing with
nonconformance.
Additional Info:
The organization shall retain documented information of actions taken on nonconforming process o
products and services, including on any concessions obtained and on the person or authority that m
decision regarding dealing with the nonconformity.
gnifico Training and Consulting Services
miti, Kokane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Documents to Observations

Applicable look for
Manufacuring production plan,
Production process, Docs

Customer schedule /PO

Quality plan, Product std
Capacity planning, Org
chart, List machines, List
of instrument, RM
Process audit, Product audit
Clause No.

9.1.1.1

9.1.1.2

9.1.1.2

9.1.1.3

9.1.2q1
9.1.2q2

9.1.2q3

9.1.3q1

9.1.3q2

9.1.3q3
9.2.1q1

9.2.2q1

9.2.2.2

9.2.2.3
9.2.2.4

9.3.1q1

9.3.1q2

9.3.2q1

9.3.2q2
 Magnifico Tra
C-1, Nisarg Nirmiti, Kokane Ci

Question

Show how you determine: What needs to be monitored and measured? 

Methods for monitoring, measurement, analysis and evaluation to ensure valid results? 
When to perform monitoring and measuring? 
When results shall be analysed and evaluated?
Additional Info:
The organization shall determine: 
a) what needs to be monitored and measured; b) the methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results; 
c) when the monitoring and measuring shall be performed; 
d) when the results from monitoring and measurement shall be analysed and evaluated.

Does the organization perform process studies on all new manufacturing (including assembly or sequencing)
processes to verify process capability and to provide additional input for process control, including those for special
characteristics?

What documented information can you show that monitoring and measurement activities have been implemented in
accordance with determined requirements?
Additional Info:
The organization shall ensure that monitoring and measurement activities are implemented in accordance with the
determined requirements and shall retain appropriate documented information as evidence of the results. 

Does the organization determine the appropriate use of statistical tools?

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

Are 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?

Show how you evaluate the quality performance and the effectiveness of the QMS.
Additional Info:
The organization shall evaluate the quality performance and the effectiveness of the quality management system.

How do you monitor customer perception of the degree to which requirements have been met?
Is customer satisfaction with the organization monitored through continual evaluation of internal and external
performance indicators to ensure compliance to the product and process specifications and other customer
requirements?
Are performance indicators based on objective evidence and include but not limited to the following:
a) delivered part quality performance;
b) customer disruptions;
c) field returns, recalls, and warranty (where applicable);
d) delivery schedule performance (including incidents of premium freight);
e) customer notifications related to quality or delivery issues, including special status?
Does the organization monitor the performance of manufacturing processes to demonstrate compliance with
customer requirements for product quality and process efficiency?
Does the monitoring include the review of customer performance data including online customer portals and
customer scorecards, where provided

How do you obtain information relating to customer views and opinions of your products and services?
Additional Info:
The organization shall obtain information relating to customer views and opinions of the organization and its
products and services.
What methods for obtaining and using this information do you have?

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

Show me how you analyse and evaluate data and information arising from monitoring, measurement and other
sources.
Show me how the output of analysis and evaluation is used to:
Demonstrate conformity of products and services to requirements?
Assess and enhance customer satisfaction?
Ensure conformity and effectiveness of the QMS?
Demonstrate that planning has been successfully implemented?
Assess process performance?
Assess performance of external providers? Determine the need or opportunities for improvements within the QMS?

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

Show me where the results of analysis and evaluation are used to provide inputs to management review.
Additional Info:
The results of analysis and evaluation shall also be used to provide inputs to management review.

Are internal audits being conducted at planned intervals? Do 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)

Do they determine whether the QMS is effectively implemented and maintained? (Review records)

Can you show me 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?

Where are the audit criteria and scope for each audit?
Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial and that
auditors don’t audit their own work?
How are audit results reported to relevant management?
Can you demonstrate that necessary correction and corrective actions are taken without undue delay?
Can you show me documented information of the audit programme and the audit results?

Does the organization have a documented internal audit process?

Does the process include the development and implementation of an internal audit programme that covers the entire
quality management system including quality management system audits, manufacturing process audits, and
product audits?
Is the audit programme prioritized based upon risk, internal and external performance trends, and criticality of the
process(es)?
Where the organization is responsible for software development, does the organization include software
development capability assessments in their internal audit programme?
Is the frequency of audits reviewed and, where appropriate, adjusted based on occurrence of process changes,
internal and external nonconformities, and/or customer complaints?
Is the effectiveness of the audit programme reviewed as a part of management review?

Does the organization audit all quality management system processes over each three-year calendar period,
according to an annual programme, using the process approach to verify compliance with this Automotive QMS
Standard?
Integrated with these audits, does the organization sample customer-specific quality management system
requirements for effective implementation?

Does the organization audit all manufacturing processes over each three-year calendar period to determine their
effectiveness and efficiency using customer-specified required approaches for process audits?

Where not defined by the customer, does the organization determine the approach to be used?
Within each individual audit plan, is each manufacturer process audited on all shifts where it occurs, including the
appropriate sampling of the shift handover?
Does the manufacturing process audit include an audit of the effective implementation of the process risk analysis
(such as PFMEA), control plan, and associated documents?
Does the organization audit products using customer-specific required approaches at appropriate stages of
production and delivery to verify conformity to specified requirements?
Where not defined by the customer, does the organization define the approach to be used?

What is the frequency that top management reviews the organization's QMS? How is the QMS deemed suitable,
adequate and effective?

Is management review conducted at least annually?

Is the frequency of management review(s) increased based on risk to compliance with customer requirements
resulting from internal or external changes impacting the quality management system and performance-related
issues?

What kinds of information are reviewed in management reviews? These must include: actions status of previous
reviews; changes to internal/external issues relevant to the QMS;
issues that affect strategy;
KPIs for nonconformities and corrective actions;
monitor and measurement of results; audit results;
customer satisfaction;
issues concerning external providers; issues concerning other relevant parties; adequacy of resources and
effectiveness of QMS;
process performance;
conformity of products and services; actions taken to address risks and opportunities and their effectiveness; new
potential opportunities for continual improvement.

Show me that management reviews include decisions and actions relating to: Continual improvement opportunities;
The need for changes to the QMS including resource needs.

Does input to management review include:

a) cost of poor quality (cost of internal and external nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new
product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001, Section 9.1.2); g) review of performance against maintenance objectives;

h) warranty performance (where applicable);

i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment?

Show me what documented information you have as evidence of management reviews.

fico Training and Consulting Services
okane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Documents Observations

Applicable to look for
Clause
No.
10.1.1

10.1.2

10.2.1.1
10.2.1.2

10.2.2.1

10.2.3

10.2.4

10.2.5
10.2.6

10.3.1

10.3.2

10.3.3
 Magnifico Training
C-1, Nisarg Nirmiti, Kokane Circle, P

Question

How do you determine and select opportunities for improvement? What necessary actions have you
implemented so that you have met customer requirements and enhanced customer satisfaction?

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

Show how you have: Improved processes to prevent nonconformities; 

Improved products and services to meet known and predicted requirements; Improved QMS
results.
Additional Info:
This shall include, as appropriate: a) improving processes to prevent nonconformities; 
b) improving products and services to meet known and predicted requirements; 
c) improving quality management system results.

When nonconformities occur, show how; You 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.

Additional Info:
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.

Show how correction actions were appropriate to the effects of the nonconformities encountered.

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

What documented information can you show as evidence of: 

The nature of the nonconformities and subsequent actions taken; 
The results of any corrective action.

Additional Info:
The organization shall retain documented information as evidence of: 
a) the nature of the nonconformities and any subsequent actions taken; 
b) the results of any corrective action.

Does the organization have a documented process(es) for problem solving including:
a) defined approaches for various types and scale of problems (e.g. new product development, current
manufacturing issues, field failures, audit findings);
b) containment, interim actions, and related activities necessary for control of nonconforming outputs (see ISO
9001, Section 8.7);
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on similar processes
and products;
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the apppropriate documented information (e.g. PFMEA, control
plan).
Where the customer has specified prescribed processes, tools, or systems for problem solving, does the
organization use those processes, tools, or systems, unless otherwise approved by the customer?

Does the organization have a documented process to determine the use of appropriate error-proofing
methodologies?
Are details of the method used documented in the process risk analysis (such as PFMEA) and are test
frequencies documented in the control plan?
Does the process include the testing of error-proofing devices for failure or simulated failure?
Are records maintained? Are challenge parts, when used, identified, controlled, verified, and calibrated where
feasible?
Do error-proofing device failures have a reaction plan?

When the organization is required to provide warranty for their product(s), does the organization implement a
warranty management process?
Does the organization include in the process a method for warranty part analysis, including NTF (no trouble
found)?
 When specified by the customer, does the organization implement the required warranty management
process?

Does the organization perform analysis on customer complaints and field failures, including any returned parts,
and does it intiate problem solving and corrective action to prevent recurrence?
Where requested by the customer, does this include analysis of the interaction of embedded software of the
organization's product within the system of the final customer's product?
Does the organization communicate the results of testing/analysis to the customer and also within the
organization?

Demonstrate that you continually improve the suitability, adequacy and effectiveness of the
QMS.
Additional Info:
The organization shall continually improve the suitability, adequacy, and effectiveness of the
quality management system.

Does the organization have a documented process for continual improvement?

Does the organization include in this process the following:
a) identification of the methodology used, objectives, measurement, effectiveness, and documented
information;
b) a manufacturing process improvement action plan with emphasis on the reduction of process variation and
waste;
c) risk analysis (such as FMEA)?

Demonstrate that outputs of analysis and evaluation and the outputs from management review
are considered to confirm if there are areas of underperformance or opportunities that shall be
addressed as part of continual improvement.
Additional Info:
The organization shall consider the outputs of analysis and evaluation, and the outputs from
management review, to confirm if there are areas of underperformance or opportunities that
shall be addressed as part of continual improvement.

What applicable tools and methodologies for investigation of the causes of underperformance
and to support continual improvement are selected?
Additional Info:
Where applicable, the organization shall select and utilise applicable tools and methodologies for
investigation of the causes of underperformance and for supporting continual improvement.
co Training and Consulting Services
kane Circle, Pimple Saudagar ,Pune- 411027 ,401
Ph: 020-27201449, 9881069515

Process Documents Observations

Applicable to look for