Professional Documents
Culture Documents
(Revise the policies expressed in this template to be appropriate for your quality management system)
(Add references within this manual to procedures and other related documents or edit the attachment)
Quality
Manual
Contents
1. Company Name.......................................................................................................................................9
1.1 Company Overview............................................................................................................................9
1.2 Organization Chart.............................................................................................................................9
1.3 Management Responsibilities............................................................................................................9
2. Management System...............................................................................................................................9
2.1 System Scope.....................................................................................................................................9
2.2 Scope Map.........................................................................................................................................9
2.3 System Exclusions..............................................................................................................................9
3. Policies and Objectives............................................................................................................................9
3.1 Quality Principles...............................................................................................................................9
3.1.1 Customer Focus........................................................................................................................10
3.1.2 Management Leadership..........................................................................................................10
3.1.3 Engagement of People..............................................................................................................10
3.1.4 Process Approach.....................................................................................................................10
3.1.5 Improvement............................................................................................................................10
3.1.6 Evidence-based Decision Making..............................................................................................10
3.1.7 Relationship Management........................................................................................................10
3.2 Quality Policy...................................................................................................................................10
3.3 Quality Objectives............................................................................................................................10
4. Context of the Organization...................................................................................................................11
4.1 Understanding the Organization and its Context.............................................................................11
4.2 Understanding the Needs and Expectations of Interested Parties...................................................11
4.3 Determining the Scope of the Quality Management System...........................................................11
4.3.1 Determining Scope of the Quality Management System – Supplemental................................12
4.3.2 Customer-Specific Requirements..............................................................................................12
4.4 Quality Management System and its Processes...............................................................................12
4.4.1 (untitled)...................................................................................................................................12
4.4.1.1 Conformance of Products and Process..............................................................................13
4.4.1.2 Product Safety....................................................................................................................13
4.4.2 (untitled)...................................................................................................................................14
5. Leadership.............................................................................................................................................14
5.1 Leadership and Commitment..........................................................................................................14
5.1.1 General.....................................................................................................................................14
5.1.1.1 Corporate Responsibility....................................................................................................14
5.1.1.2 Process Effectiveness and Efficiency...................................................................................15
5.1.1.3 Process Owners..................................................................................................................15
5.1.2 Customer Focus........................................................................................................................15
5.2 Policy...............................................................................................................................................15
5.2.1 Establishing the Quality Policy..................................................................................................15
5.2.2 Communicating the Quality Policy............................................................................................15
5.3 Organizational Roles, Responsibilities, and Authorities...................................................................15
5.3.1 Organizational Roles, Responsibilities, and Authorities – Supplemental...................................16
5.3.2 Responsibility and Authority for Product Requirements and Corrective Actions......................16
6. Planning.................................................................................................................................................17
6.1 Actions to Address Risks and Opportunities....................................................................................17
6.1.1 (untitled)...................................................................................................................................17
6.1.2 (untitled)...................................................................................................................................17
6.1.2.1 Risk Analysis.......................................................................................................................17
6.1.2.2 Preventive Action...............................................................................................................18
6.1.2.3 Contingency Plans..............................................................................................................18
6.2 Quality Objectives and Planning to Achieve Them...........................................................................19
6.2.1 (untitled)...................................................................................................................................19
6.2.2 (untitled)...................................................................................................................................19
6.2.2.1 Quality Objectives and Planning to Achieve Them - Supplemental....................................19
6.3 Planning for Changes.......................................................................................................................20
7. Support..................................................................................................................................................20
7.1 Resources.........................................................................................................................................20
7.1.1 General.....................................................................................................................................20
7.1.2 People.......................................................................................................................................20
7.1.3 Infrastructure............................................................................................................................20
7.1.3.1 Plant, Facility, and Equipment Planning.................................................................................21
7.1.4 Environment for the Operation of Processes............................................................................21
1. Company Name
1.1 Company Overview
(add description from website or marketing brochure)
2. Management System
2.1 System Scope
(Replace with your scope statement)
We design, manufacture, and maintain XXX products at our XXX site for the automotive industry. We
have not excluded any requirements of the IATF 16949:2016 standard.
(note that supporting functions such as design centers, corporate headquarters, and distribution centers,
whether onsite or remote, must be included in the Scope of your quality management system)
Our quality management system is guided by, and management is committed to, these seven Quality
Management Principles on which ISO 9001:2015, and therefore IATF 16949:2016, are based:
3.1.5 Improvement
Management is committed to improvement, because it is essential for us to maintain current levels of
performance, to react to changes in internal and external conditions, and to create new opportunities.
We are committed to meeting customer requirements, providing on-time delivery, supplying high quality
products and services, and continually improving the effectiveness of our QMS.
on-time delivery;
on-target cost;
high quality.
Specific, measurable targets have been established for these quality objectives and the trends are
analyzed at our management review meetings.
NOTE: The policies in this manual related to ISO 9001:2015 requirements are expressed in regular font.
The additional policies unique to IATF 16949:2016 requirements are shown in italics.
We monitor and review information about these external and internal issues, and discuss their changes
and impacts at our management review meetings. We consider issues that may be positive and negative
factors or conditions.
We understand that external issues can arise from legal, technological, competitive, market, cultural,
social, and economic environments, whether international, national, regional, or local. We also
understand that internal issues can relate to our values, culture, knowledge, and performance.
We monitor and review information about these interested parties and their relevant requirements. We
consider feedback from these interested parties at our management review meetings.
We have applied all the IATF 16949:2016 requirements that are applicable within the scope of our QMS.
The scope statement is documented, maintained, and available within our organization and to all
relevant interested parties.
The scope statement in section 2.1 includes the types of products and services covered, and provides
justification for any IATF 16949:2016 requirements that were determined as not applicable for our QMS.
We have determined that the excluded requirements (see 2.3) in our scope statement (see 2.1) do not
affect our ability, or responsibility, to ensure the conformity of our products and services, as well as, the
enhancement of customer satisfaction.
We understand that the only permitted scope exclusion is for product design and development, see
section 8.3. That exclusion must be justified and maintained as documented information.
We have determined the processes needed for our QMS and their application throughout our
organization. Our approach has been to:
a) determine the inputs required and the outputs expected from these processes;
c) determine and apply the criteria and methods (including monitoring, measurements, and related
performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes (and ensure their availability);
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes
achieve their intended results;
See the Scope Map in section 2.2 for a description of the process sequence and interaction.
h) defined responsibilities, definition of escalation process and flow of information, including top
management, and customer notification;
k) transfer of requirements regarding product safety throughout the supply chain, including
customer-designated sources (see 8.4.3.1);
l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see 8.5.2.1);
We understand that special approval is an additional approval by the function (typically the customer)
that is responsible to approve such documents with safety-related content.
4.4.2 (untitled)
To the extent necessary, we:
b) retain documented information (records) to have confidence that the processes are being carried
out as planned.
5. Leadership
5.1 Leadership and Commitment
5.1.1 General
Our top management demonstrates its leadership and commitment with respect to our QMS by:
b) ensuring that the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of our QMS requirements into our business processes;
e) ensuring that the resources needed for our QMS are available;
f) communicating the importance of effective quality management and of conforming to the QMS
requirements;
h) engaging, directing, and supporting persons to contribute to the effectiveness of the QMS;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.
a) customer and applicable legal requirements are determined, understood, and consistently met;
b) risks and opportunities that can affect conformity of products and services, and the ability to
enhance customer satisfaction, are determined and addressed;
5.2 Policy
5.2.1 Establishing the Quality Policy
Top management has established, implemented, and maintains a quality policy that:
a) is appropriate to the purpose and context of our organization and supports its strategic direction;
c) reporting on the performance of the QMS and on opportunities for improvement (see 10.1),
especially to top management;
e) ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and
implemented.
5.3.2 Responsibility and Authority for Product Requirements and Corrective Actions
Top management ensures that:
a) personnel responsible for conformity to product requirements have authority to stop shipment and
stop production to correct quality problems;
If it is not possible to stop production immediately, the affected batch will be contained and shipment
to the customer prevented.
b) personnel with authority and responsibility for corrective action are promptly informed of
products or processes that do not conform to requirements to ensure that nonconforming product is
not shipped to the customer and all potential nonconforming product is identified and contained;
c) production operations across all shifts are staffed with personnel in charge of, or delegated
responsibility for, ensuring conformity to product requirements.
6. Planning
6.1 Actions to Address Risks and Opportunities
6.1.1 (untitled)
We have considered the issues referred to in 4.1, and the requirements referred to in 4.2, and
determined the risks and opportunities that need to be addressed to:
a) give assurance that our QMS can achieve its intended result(s);
d) achieve improvement.
6.1.2 (untitled)
We plan:
b) how to:
1) integrate and implement the actions into our QMS processes (see 4.4);
The actions taken to address these risks and opportunities will be proportionate to the potential impact
on the conformity of our products and services.
Our options to address risks can include avoiding risk, taking risk to pursue an opportunity, eliminating
the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed
decision.
We understand that opportunities can lead to adopting new practices, launching new products, opening
new markets, addressing new customers, building partnerships, using new technology, and other
desirable and viable possibilities to address our needs or those of our customers.
We have established a process to lessen the impact of negative effects of risk, including the following:
a) Identify and evaluate internal and external risks to all manufacturing processes and infrastructure
equipment essential to maintain production output and to ensure that customer requirements are
met;
c) Prepare contingency plans for continuity of supply in event of any of the following:
d) include as a supplement to our contingency plans, a notification process to customer and other
interested parties for the extent and duration of any situation impacting customer operations;
f) conduct contingency plan reviews (at least annually) using a multi-disciplinary team including top
management, and update the plan as required;
g) document the contingency plans and retain documented information (records) describing any
revisions, including the persons who authorized the changes.
Our contingency plans include validating that the manufactured product continues to meet customer
specifications after restart of production following an emergency in which production was stopped and if
the regular shutdown processes were not followed.
b) measurable;
e) monitored;
f) communicated;
g) updated as appropriate.
6.2.2 (untitled)
When planning how to achieve our quality objectives, we determine:
We consider the results of our review of relevant interested parties (and their relevant requirements)
when establishing our annual quality objectives and related performance targets (internal and external).
We consider the:
c) availability of resources;
7. Support
7.1 Resources
7.1.1 General
We determine and provide the resources needed for the establishment, implementation, maintenance,
and continual improvement of our quality management system.
We consider:
7.1.2 People
We determine and provide the persons necessary for the effective implementation of our QMS and for
the operation and control of its processes.
7.1.3 Infrastructure
We determine, provide, and maintain the infrastructure necessary for the operation of our processes
and to achieve conformity of our products and services.
c) transportation resources;
a) optimize material flow, materials handling, and value-added use of floor space, including control of
nonconforming product, and
We develop and implement methods to evaluate manufacturing feasibility for new products or new
operations. These assessments include capacity planning. Our methods are applicable for evaluating the
proposed changes to existing operations.
We maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any
changes made during process approval, control plan maintenance (see 8.5.1.1), and verification of job
set-ups (see 8.5.1.3).
These assessments of manufacturing feasibility, and evaluation of capacity planning, are inputs to
management reviews (see 9.3).
We apply lean manufacturing principles during our plant, facility, and equipment planning. We also apply
the policies in 7.1.3.1 to onsite supplier activities, as applicable.
A suitable operating environment may be a combination of human and physical factors, such as:
We understand that where third-party ISO 45001 certification is recognized, it may be used to
demonstrate our conformity to the personnel safety aspects of this IATF 16949:2016 requirement.
a) suitable for the specific type of monitoring and measurement activities being undertaken;
We retain appropriate documented information (records) as evidence of fitness for purpose of the
monitoring and measurement resources.
We use analytical methods and acceptance criteria that conform to those in reference manuals on
Measurement Systems Analysis (MSA). We may use other analytical methods and acceptance criteria if
they are approved by the customer.
We retain records of customer acceptance of alternative methods, along with results from alternative
measurement systems analysis (see 9.1.1.1).
We focus our prioritization of MSA studies on critical or special product or process characteristics.
c) safeguarded from adjustments, damage, or deterioration that would invalidate the calibration
status and subsequent measurement results.
We determine if the validity of previous measurement results has been adversely affected when
measuring equipment is found to be unfit for its intended purpose, and we take appropriate action as
necessary.
We understand that a number or another identifier traceable to the device calibration record meets the
intent of this ISO 9001:2015 requirement.
We retain records of calibration/verification activity for all gauges and measuring and test equipment
(including employee-owned equipment relevant for measuring, and customer-owned or on-site supplier-
owned equipment) needed to provide evidence of conformity to internal, legislative and regulatory, and
customer-defined requirements.
We ensure that calibration/verification activities and records include the following details:
c) an assessment of the risk of intended use of product caused by the out-of-specification condition;
g) verification that the software version used for product and process control is as specified;
h) records of calibration and maintenance activities for all gauging (including employee-owned,
customer-owned, or onsite 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.
c) test of product;
d) capability to perform these services correctly, traceable to relevant process standard (e.g., ASTM);
We understand that third-party accreditation to ISO 17025 (or equivalent) may be used to demonstrate
in-house laboratory conformity to this IATF 16949:2016 requirement.
accreditation to ISO 17025 or national equivalent and include relevant inspection, test, or
calibration service in the scope of the accreditation; the certificate of calibration or test report
must include the mark of national accreditation body, or
We understand that such evidence may be demonstrated by customer assessment, for example, or by
customer-approved second-party assessment that laboratory meets the intent of ISO 17025 or national
equivalent. The second-party assessment may be performed by the organization assessing the laboratory
using a customer-approved method of assessment.
The equipment manufacturer may perform the calibration services when a qualified laboratory is not
available for a given piece of equipment. In such cases, we ensure that the requirements in section
7.1.5.3.1 have been met.
We understand that use of calibration services other than by qualified (or customer accepted)
laboratories, may be subject to government regulatory confirmation.
When addressing changing needs and trends, we consider our current knowledge and determine how to
acquire or access any necessary additional knowledge and required updates.
a) internal sources (e.g., intellectual property; knowledge gained from experience; lessons learned
from failures and successful projects; capturing and sharing undocumented knowledge and
experience; and the results of improvements in processes, products, and services);
b) external sources (e.g., standards; academia; conferences; and gathering knowledge from
customers or external providers).
7.2 Competence
We ensure the necessary level of competence for our organization by:
a) determining the necessary competence of persons doing work under our control that affects the
performance and effectiveness of our quality management system;
b) ensuring that these persons are competent based on appropriate education, training, or
experience;
c) where applicable, taking actions to acquire the necessary competence, and evaluating the
effectiveness of the actions taken;
Our actions may include, for example, the provision of training to, the mentoring of, or the reassignment
of currently employed persons; or the hiring or contracting of competent persons.
We qualify, as required, the personnel performing specific assigned tasks, with particular attention to the
satisfaction of customer requirements.
The level of detail required for the OJT is commensurate with the level of education of the personnel and
the complexity of tasks they are required to perform for their daily work.
We inform the persons whose work can affect quality about the consequences of a nonconformity to
customer requirements.
Our QMS, manufacturing process, and product auditors must be able to demonstrate following
competencies (understanding of):
c) applicable ISO 9001:2015 and IATF 16949:2016 requirements related to the audit scope;
Our manufacturing process auditors must also demonstrate a technical understanding of relevant
manufacturing processes to be audited, including process risk analysis (e.g., PFMEA) and control plan.
Our product auditors must also demonstrate competence in understanding product requirements and
use of relevant measuring and test equipment to verify product conformity.
We retain documented information (records) of the trainer’s competency with the above requirements.
We demonstrate maintenance of, and improvement in, internal auditor competence through:
c) applicable ISO 9001 and IATF 16949 requirements related to scope of audit;
7.3 Awareness
We ensure that persons doing work under our control are aware of:
c) their contribution to the effectiveness of our QMS, including the benefits of improved
performance;
• the importance of their activities in achieving, maintaining, and improving quality, including
customer requirements and risks involved for customer with nonconforming product.
This process includes the promotion of quality and technological awareness throughout our organization.
7.4 Communication
We have determined the internal and external communications relevant to our QMS, including:
b) when to communicate;
d) how to communicate;
e) who communicates.
The extent of our documented information may vary from process to process based on their complexity
and the competence of the people that operate or use those processes.
a) the scope of QMS, including details of and justification for any exclusions;
c) our processes and their sequence and interactions (inputs and outputs), including type and extent
of control of any outsourced processes;
d) a matrix indicating where within our QMS their customer-specific requirements are addressed.
b) format (e.g., language, software version, graphics) and media (e.g., paper, electronic);
7.5.3.1 (untitled)
The documented information required by our QMS, and ISO 9001:2015 and IATF 16949:2016, is
controlled to ensure it is:
b) adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity).
7.5.3.2 (untitled)
For our control of documented information, we have addressed the following activities, as applicable:
Documented information of external origin determined as necessary for the planning and operation of
our quality management system has been identified as appropriate, and controlled.
Access can imply a decision regarding the permission to view the documented information only, or the
permission and authority to view and change the documented information.
We retain production part approvals, tooling records (including maintenance and ownership), product
and process design records, purchase orders (if applicable), or contracts and amendments. We keep
these records for the length of time the product is active for production and service requirements, plus
one calendar year, unless otherwise specified by customer or regulatory agency.
Our production part approval documented information may include approved product, applicable test
equipment records, or approved test data.
Refer to 8.3.6 when an engineering specification change results in a product design change. Refer to
8.5.6.1 when an engineering specification change results in a product realization process change.
We retain record of the date on which each change was implemented in production. Our implementation
includes updated documents.
We strive to complete our engineering change review within 10 working days of receipt. We understand
that a change in these specifications may require an updated record of customer production part
approval when these specifications are referenced on the design record, or if they affect documents of
the production part approval process, such as control plan, risk analysis (such as FMEAs).
8. Operation
8.1 Operational Planning and Control
We plan, implement and control the processes (see 4.4) needed to meet the requirements for the
provision of our products and services, and to implement the actions determined in clause 6, by:
1) processes;
c) determining the resources needed to achieve conformity to our product and service
requirements;
e) determining, maintaining, and retaining documented information to the extent necessary to:
1) have confidence that the processes have been carried out as planned;
The output of this planning is in a form suitable for our operations. We control planned changes and
review the consequences of unintended changes, and act to mitigate any adverse effects, as necessary.
We also ensure that any outsourced processes are controlled (see 8.4).
b) logistics requirements;
c) manufacturing feasibility;
e) acceptance criteria.
The resources identified in 8.1.c refer to required verification, validation, monitoring, measurement,
inspection, and test activities specific to product and criteria for product acceptance.
8.1.2 Confidentiality
We ensure confidentiality of customer-contracted products and projects under development, including
related product information.
c) obtaining customer feedback relating to our products and services, including customer
complaints;
a) the requirements for our products and services are defined, including:
Compliance to 8.2.2.a.1 includes, but is not limited to all applicable government, safety, and
environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of
material.
8.2.3.1 (untitled)
We ensure that we can meet the requirements for our products and services to be offered to customers.
We conduct a review before committing to supply products and services to a customer that includes:
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 specified or intended use, when
known;
We ensure that contract or order requirements differing from those previously defined are resolved. We
confirm the customer’s requirements before acceptance, when the customer does not provide a
documented statement of their requirements.
In some situations, such as internet sales, a formal review is impractical for each order. Instead, our
review would cover the relevant product information used during the automated process.
We conduct this feasibility analysis for any manufacturing or product technology new to our organization
and for any changed manufacturing process or product design.
We validate our ability to make product to specification at the required rate through:
• production runs,
• benchmark studies, or
• other appropriate methods.
8.2.3.2 (untitled)
We retain documented information (records), as applicable, on:
e) internal and external resource needs for the design and development of our products and
services;
f) need to control interfaces between persons involved in the design and development process;
g) need for involvement of customers and users in the design and development process;
i) level of control expected for the design and development process by our customers and other
relevant interested parties;
j) documented information needed to demonstrate that design and development requirements have
been met.
b) product and manufacturing process design activities (e.g., DFM and DFA) such as consideration of
the use of 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 (e.g., FMEAs, process flows,
control plans, standard work instructions).
Using prioritization based on risk and potential impact to the customer, we retain documented
information of a software development capability self-assessment.
e) potential consequences of failure due to the nature of our products and services.
The inputs will be adequate for design and development purposes, complete, and unambiguous. Any
conflicting design and development inputs will be resolved.
a) product specifications, including but not limited to special characteristics (see 8.3.3.3);
e) assessment of risks within the input requirements and our ability to mitigate/manage the risks,
including from the feasibility analysis;
We have a process to deploy information gained from previous design projects, competitive product
analysis (benchmarking), supplier feedback, internal input, field data, and other relevant sources for
current and future projects of a similar nature.
f) new materials;
Our manufacturing process design includes the use of error-proofing methods to a degree appropriate to
magnitude of problems and commensurate with risks encountered.
a) documentation of all special characteristics in drawings (as required), risk analysis (e.g., FMEA),
control plans, and standard work/operator instructions; special characteristics are identified with
special markings and are cascaded through each of these documents;
b) development of control and monitoring strategies for special characteristics of products and
production processes;
b) reviews are conducted to evaluate the ability of the results of design and development to meet
requirements;
c) verification activities are conducted to ensure that the design and development outputs meet the
input requirements;
d) validation activities are conducted to ensure that the resulting products and services meet the
requirements for the specified application or intended use;
e) any necessary actions are taken on problems determined during the reviews, or verification and
validation activities;
Design and development reviews, verification, and validation have distinct purposes. They may be
conducted separately, or in any combination, as is suitable for our products and services.
8.3.4.1 Monitoring
We define, analyze, and report measurements (at specified stages during design and development) with
summary results as an input to management review (see 9.3.2.1).
We report measurements of the product and process development activity to the customer at stages
specified, or agreed to, by the customer. When appropriate, these measurements may include quality
risks, costs, lead times, critical paths, and other measurements.
Where contractually agreed with the customer, we include evaluation of interaction of our product,
including embedded software, within system of the final customer’s product.
We monitor all performance-testing activities for timely completion and conformity to requirements.
When services are outsourced, we include the type and extent of control in the scope of our QMS to
ensure outsourced services meet requirements (see 8.4).
We approve externally provided products and services per 8.4.3 prior to submission of part approval to
customer. We obtain documented product approval prior to shipment, if required by the customer, and
retain approval records.
b) are adequate for the subsequent processes for the provision of our products and services;
d) specify the characteristics of our products and services that are essential for their intended
Interim design outputs include any engineering problems being resolved through a trade-off
process.
8.3.5.2 Manufacturing Process Design Output
We document our manufacturing process design output in a manner that enables verification
against the manufacturing process design inputs. We verify the outputs against manufacturing
process design input requirements.
.
Our manufacturing process design output includes, but is not limited to:
d) tooling and equipment for production and control, including capability studies of equipment
and processes;
e) manufacturing process flow charts/layout, including linkage of product, process, and tooling;
f) capacity analysis;
i) control plan;
b) results of reviews;
If required by the customer, we obtain documented approval, or documented waiver, from the customer
prior to production implementation
For products with embedded software, we document the revision level of software and hardware as part
of the change record.
We determine the controls to be applied to externally provided processes, products, and services when:
a) products and services from external providers are intended for incorporation into our own
products and services;
b) products and services are provided directly to our customers by external providers on our behalf;
We determine and apply criteria for the evaluation, selection, monitoring of performance, and re-
evaluation of external providers, based on their ability to provide processes or products and services in
accordance with requirements. We retain documented information (records) of these activities and any
necessary actions arising from the evaluations.
a) assessment of the selected supplier’s risk to product conformity and uninterrupted supply of our
product to customers;
We apply all the 8.4 requirements (except for 8.4.1.2) to the control of customer-directed sources, unless
specific agreements are otherwise defined by contract with the customer.
Our organization:
a) ensures that externally provided processes remain within the control of our QMS;
b) defines both the controls that it intends to apply to an external provider and those it intends to
apply to the resulting output;
1) potential impact of the externally provided processes, products, and services on our ability to
consistently meet customer and applicable legal (statutory and regulatory) requirements;
d) determines the verification, or other activities, necessary to ensure that the externally provided
processes, products, and services meet requirements.
The process includes the criteria and actions to escalate or reduce the types and extent of controls and
development activities based on supplier performance and assessment of product, material, or service
risks.
If the customer defines special controls for certain products with statutory and regulatory requirements,
we ensure they are implemented and maintained as defined, including at suppliers.
Unless otherwise specified by the customer, we apply the following sequence to achieve this
requirement:
Unless otherwise specified by the customer, our suppliers must demonstrate conformity to ISO 9001
by maintaining a third-party certification issued by a certification body bearing the accreditation
mark of a recognized IAF MLA member and where the accreditation body’s main scope includes
management system certification to ISO 17021;
c) certification to ISO 9001 with compliance to other customer-defined QMS requirements through
second-party audits;
d) certification to ISO 9001 with compliance to IATF 16949 through second-party audits;
We use a software development assessment methodology to assess the supplier’s software development
process. Using prioritization based on risk and potential impact to the customer, we require the supplier
to retain documented information of a software development capability self-assessment.
b) customer disruptions at receiving plant, including yard holds and stop ships;
b) supplier monitoring;
d) product audits;
e) process audits.
Based on a risk analysis, including product safety/regulatory requirements, performance of supplier, and
QMS certification level, we document the criteria for determining need, type, frequency, and scope of
second-party audits. We retain records of second-party audit reports.
If the scope of the second-party audit is to assess the supplier’s QMS, then the approach must be
consistent with the automotive process approach.
We rely upon the guidance in IATF Auditor Guide and ISO 19011.
d) risk analysis.
We implement the actions necessary to resolve open (unsatisfactory) performance issues and pursue
opportunities for continual improvement.
f) verification or validation activities that we, or our customer, intends to perform at the external
providers’ premises.
2) results to be achieved;
criteria for control of processes or outputs, and acceptance criteria for products and services, have
been met;
f) validation, and periodic revalidation, of the ability to achieve planned results of the processes for
production and service provision, where the resulting output cannot be verified by subsequent
monitoring or measurement;
We understand that family control plans are acceptable for bulk material and similar parts using a
common manufacturing process.
We have a control plan for pre-launch and production that shows linkage and incorporates information
from the design risk analysis (if provided by customer), process flow diagram, and manufacturing process
risk analysis outputs (such as FMEA).
If required by customer, we provide measurement and conformity data collected during execution of
either the pre-launch or production control plans.
a) controls used for manufacturing process control, including verification of job set-ups;
c) methods for monitoring of control exercised over special characteristics defined by both the
customer and our organization;
e) specified reaction plan when nonconforming product is detected, the process becomes statistically
unstable, or not statistically capable.
We review the control plans, and update them as required, for any of the following:
g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply
sources, production volume changes, or risk analysis (FMEA);
h) after customer complaint and implementation of associated corrective action, when applicable;
If required by the customer, we obtain customer approval after review or revision of control plan.
a) communicated to and understood by the employees responsible for the performing work;
b) legible;
a) verify job set-ups when performed, such as initial run of job, material changeover, or job change
that requires a new set-up;
e) retain records of process and product approval following set-up and first-off/last-off part
validations.
g) regular review of maintenance plan and objectives, and a documented action plan to address
corrective actions where objectives are not achieved;
j) periodic overhaul.
8.5.1.6 Management of Production Tooling and Manufacturing, Test, Inspection Tooling and
Equipment
We provide resources for tool and gauge design, fabrication, and verification activities for production
and service materials and for bulk materials, as applicable.
We have established and implemented a system for production tooling management, whether owned by
us or the customer, including:
c) set-up;
e) tool design modification documentation, including engineering change level of the product;
g) tool identification, such as serial or asset number; the status, such as production, repair, or
disposal; ownership; and location.
We verify that customer-owned tools, manufacturing equipment, and test/inspection equipment are
permanently marked in a visible location so that the ownership and application of each item can be
determined. We’ve implemented a system to monitor these activities, if any work is outsourced.
We include relevant planning information during production scheduling, e.g., customer orders, supplier
on-time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level,
preventive maintenance, and calibration.
We control the unique identification of the outputs when traceability is a requirement, and retain the
documented information (records) necessary to enable traceability.
We understand that inspection and test status is not indicated by the location of the product in the
production flow, unless inherently obvious, such as material in an automated production transfer
process. Alternatives are permitted if the status is clearly identified, documented, and achieves the
designated purpose.
We conduct an analysis of internal, customer, and regulatory traceability requirements for all
automotive products, including developing and documenting traceability plans, based on levels
of risk or failure severity for employees, customers, and consumers.
These plans define the appropriate traceability systems, processes, and methods by product,
process, and manufacturing location to:
c) ensure the ability to meet customer and/or regulatory response time requirements;
f) ensure the identification and traceability requirements are extended to externally provided
products with safety/regulatory characteristics.
We identify, verify, protect, and safeguard customers’ or external providers’ property provided for use or
incorporation into our products and services.
When the property of a customer or external provider is lost, damaged, or otherwise found to be
unsuitable for use, we report this to the customer or external provider and retain documented
information (records) on what has occurred.
The property of our customers and external providers may include materials, components, tools and
equipment, premises, intellectual property, and personal data.
8.5.4 Preservation
We preserve the outputs during production and service provision, to the extent necessary to ensure
conformity to requirements.
To detect deterioration, we assess at appropriate planned intervals the condition of product in stock, the
place or type of storage container, and the storage environment.
We use an inventory management system to optimize inventory turns over time and ensure stock
rotation, such as “first-in-first-out” (FIFO).
We ensure that obsolete product is controlled in a manner like that of nonconforming product. We
comply with preservation, packaging, shipping, and labeling requirements as provided by customers.
b) the potential undesired consequences associated with our products and services;
c) the nature, use, and intended lifetime of our products and services;
d) customer requirements;
e) customer feedback.
Post-delivery activities may include actions under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling or final disposal.
Nonconforming products and materials may be identified at the customer location or in the field.
Service concerns may include the results of field failure test analysis (see 10.2.6), where applicable.
a) verify that the relevant service centers comply with applicable requirements;
We retain documented information (records) describing the results of the review of changes, the persons
authorizing the change, and any necessary actions arising from the review.
As an organization, we:
Changes, including those made at suppliers, require a production trial run for verification of changes
(e.g., changes to part design, manufacturing site, or manufacturing process) to validate the impact of
any changes on the manufacturing process.
e) notify the customer of any planned product realization changes after the most recent product
approval;
g) complete additional verification or identification requirements, e.g., production trial run and new
product validation.
We use a documented process to manage the use of alternate control methods. We have included in this
process, based on risk analysis (such as FMEA), severity, and the internal approvals to 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, obtain
approval from the customer.
We maintain and periodically review a list of approved alternate process control methods that are
referenced in the control plan.
We make standardized work instructions available for each alternate process control method. We review
the operation of alternate process controls on daily basis, at a minimum, to verify implementation of
standard work with goal to return to the standard process as defined by control plan as soon as possible.
We document the restart verification for a defined period based on severity and confirmation that all
features of error-proofing device or process are effectively reinstated.
We implement traceability of all product produced while any alternative process control devices or
processes are being used (e.g., verification and retention of first piece and last piece from every shift).
The release of products and services to the customer does not proceed until the planned arrangements
have been satisfactorily completed, unless otherwise approved by a relevant authority and, as
applicable, by the customer.
We retain documented information (records) on the release of products and services. The documented
information includes:
We ensure that planned arrangements for initial release of products and services encompass product or
service approval. We also ensure that product or service approval is accomplished after changes
following initial release, according to 8.5.6.
Our layout inspection is a complete measurement of all product dimensions shown on the design records.
The frequency of layout inspection is determined by the customer.
b) masters for color, grain, gloss, metallic brilliance, texture, distinctness of image, and haptic
technology, as appropriate;
d) verification that personnel making appearance evaluations are competent and qualified.
8.6.4 Verification and Acceptance of Conformity of Externally Provided Products and Services
We have a process to ensure the quality of externally provided processes, products, and services using
one or more of these methods:
c) second-party or third-party assessments or audits of supplier sites when coupled with records of
acceptable delivered product conformance to requirements;
We take the appropriate action based on the nature of the nonconformity and its effect on the
conformity of our products and services. This also applies to nonconforming products and services
detected after delivery of products, and during or after the provision of services.
a) correction;
We obtain customer authorization prior to further processing for “use as is” and rework dispositions of
nonconforming product. If sub-components are reused in the manufacturing process, we clearly
communicate this reuse to the customer in the concession or deviation permit.
We maintain a record of the expiration date or quantity authorized under concession. We also ensure
compliance with the original or superseding specifications and requirements when the authorization
expires.
We properly identify on each shipping container the materials shipped under concession (this applies
equally to purchased product). We approve any requests from suppliers before submission to the
customer.
We follow a documented process for rework confirmation in accordance with the control plan or other
relevant documented information to verify compliance to original specifications.
We ensure that instructions for disassembly or rework, including re-inspection and traceability
requirements, are accessible to and used by the appropriate personnel.
We follow a documented process for repair confirmation in accordance with the control plan or other
relevant documented information.
We ensure that instructions for disassembly or repair, including re-inspection and traceability
requirements, are accessible to and used by the appropriate personnel.
We obtain a documented customer authorization for concession for the product to be repaired.
We do not divert nonconforming product to service or other use without prior customer approval.
8.7.2 (untitled)
We retain documented information (records) that:
9. Performance Evaluation
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.1 General
We determine:
b) methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results;
d) when the results from monitoring and measurement must be analyzed and evaluated.
We evaluate the performance and the effectiveness of our quality management system. We retain
appropriate documented information (records) as evidence of the results.
For some of our manufacturing processes, it may not be possible to demonstrate product compliance
through process capability. For those processes, we may use alternate methods such as batch
conformance to specification.
We maintain manufacturing process capability or performance results as specified by the customer’s part
approval process requirements. We verify that the process flow diagram, PFMEA, and control plan are
implemented, including adherence to:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and/or test results for variable data;
e) reaction plans and escalation process when acceptance criteria are not met.
We record and retain as documented information any significant process events, such as tool change or
machine repair.
We initiate a reaction plan indicated on the control plan and evaluate for impact on compliance to
specification for characteristics that are either not statistically capable or are unstable. These reaction
plans include product containment and 100 percent inspection, as appropriate.
We develop and implement a corrective action plan indicating specific actions, timing, and assigned
responsibilities to ensure that the process becomes stable and statistically capable. The plans are
reviewed with, and have approved by, the customer, when required.
Examples of monitoring customer perceptions may include customer surveys, customer feedback on
delivered products and services, meetings with customers, market-share analysis, compliments,
warranty claims, and dealer reports.
We base performance indicators on objective evidence that includes, but is not limited to:
b) customer disruptions;
9.1.3.1 Prioritization
We compare trends in quality and operational performance with progress toward objectives and lead to
action to support prioritization of actions for improving customer satisfaction.
a) conforms to:
9.2.2 (untitled)
Our organization:
a) plans, establishes, implements, and maintains an audit program including the frequency, methods,
responsibilities, planning requirements, and reporting, which take into consideration the importance
of the processes concerned, changes affecting the organization, and the results of previous audits;
c) selects auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
d) ensures that the results of the audits are reported to relevant management;
f) retains documented information (records) as evidence of the implementation of the audit program
and the audit results.
We prioritize the audit program based on risk, internal and external performance trends, and criticality of
the processes. We include software development capability assessments in the internal audit program (if
responsible for software development).
We review the frequency of audits and, where appropriate, adjust the frequency based on occurrence of
process changes, internal and external nonconformities, and/or customer complaints.
We also review the effectiveness of the audit program as a part of management review.
Within each individual audit plan, we audit each manufacturing process on all shifts where it occurs,
including the appropriate sampling of shift handover. We include an audit of the effective
implementation of process risk analysis (such as PFMEA), control plan, and associated documents.
b) changes in external and internal issues that are relevant to our quality management system;
c) information on the performance and effectiveness of our QMS, including trends in:
6) audit results;
e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
d) product conformity;
e) assessments of manufacturing feasibility made for changes to existing operations and for new
facilities or new product (see 7.1.3.1);
j) identification of potential field failures identified through risk analysis (e.g., FMEA);
c) resource needs.
Our top management documents and implements an action plan when customer performance targets
are not met.
10. Improvement
10.1 General
We determine and select opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction.
a) improving products and services to meet requirements, as well as, to address future needs and
expectations;
We recognize that improvements may include correction, corrective action, continual improvement,
breakthrough change, innovation, and re-organization.
b) evaluate the need for action to eliminate the causes of the nonconformity, in order that it does
not recur or occur elsewhere, by:
Our corrective actions will be appropriate to the effects of the nonconformities encountered.
10.2.2 (untitled)
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 8.7);
f) reviewing and, where necessary, updating the appropriate documented information, e.g., PFMEA,
control plan.
Where the customer has specific prescribed processes, tools, or systems for problem solving, we use
them unless otherwise approved by customer.
10.2.4 Error-Proofing
We use a documented process to determine the use of appropriate error-proofing methodologies.
Details of the method used are documented in the process risk analysis (e.g., PFMEA) and the test
frequencies are documented in the control plan.
The process includes testing of error-proofing devices for failure or simulated failure, as well as,
maintaining records. Challenge parts, when used, are identified, controlled, verified, and calibrated when
feasible. Error-proofing device failures have a reaction plan.
Where requested by the customer, we include analysis of the interaction of embedded software of our
product within the system of the final customer’s product.
We communicate the results of testing/analysis to the customer and within our organization.
We consider the results of analysis and evaluation, and outputs from management review, to determine
if there are needs or opportunities that should be addressed as part of continual improvement.
b) a manufacturing process improvement action plan with emphasis on the reduction of process
variation and waste;
We implement continual improvement when our manufacturing processes are statistically capable and
stable, or when product characteristics are predictable and meet customer requirements.
Documen Clause
Document Title (edit this table to refer to your procedures and documents)
t Number
(ISO 9001:2015-related in regular font; IATF 16949:2016-related in Italics)
Number
4. Context of the Organization
xxxxxx 4.3 Scope of quality management system
4.3.1 Justification for scope exclusion of product design and development
Processes for management of product-safety related products and manufacturing
4.4.1.2
processes
4.4.2 Documented information to extent necessary to support operation of processes
5. Leadership
5.2.2.a Quality policy
Corporate responsibility policies, including anti-bribery policy, employee code of
5.1.1.1
conduct, and ethics escalation policy
5.3.1 Personnel assignments for responsibility to ensure customer requirements are met
6. Planning
6.1.2.3 Contingency plans
6.2.1 Quality objectives
7. Support
7.1.5.2.1 Process for managing calibration and verification records
7.1.5.3.1 Laboratory scope
7.2.1 Process for identifying training and awareness needs and achieving competence of
personnel
7.2.3 Process to verify internal auditors are competent
7.3.1 Documented information that demonstrates all employees are aware of their impact
on product quality, importance of their activities, and risks for customer with
nonconforming product
7.3.2 Process to motivate employees to achieve quality objectives, make improvements, and
innovate
7.5.1.a Documented information required by the standard
7.5.1.b Documented information determined as necessary for effectiveness of QMS
7.5.1.1 Quality manual
7.5.1.1.a Scope of QMS and details and justification for any exclusions (see 4.3 and 4.3.1)
7.5.1.1.b Documented processes or reference to them
7.5.1.1.c Processes and their sequence and interactions, and control of any outsourced
processes
7.5.1.1.d Matrix indicating where customer-specific requirements are addressed
7.5.3.2 Documented information of external origin needed to plan and operate the QMS
7.5.3.2.1 Record retention policy
7.5.3.2.2 Process to review, distribute, and implement customer engineering specifications and
revisions
8. Operations
8.1.e.1 Documented information necessary to have confidence processes are carried out as
planned
8.1.e.2 Documented information necessary to demonstrate product and service conformity
8.2.4 Amended documents when product and service requirements are changed
8.3.1.1 Process for design and development
Change History