Tiêu chuẩn iso ts 16949 2009

Microsoft Word C052844e doc Reference number ISO/TS 16949 2009(E) © ISO 2009 TECHNICAL SPECIFICATION ISO/TS 16949 Third edition 2009 06 15 Quality management systems — Particular requirements for the[.]

General

ISO 9001:2008, Quality management systems — Requirements

Adopting a quality management system is a strategic decision for organizations, shaped by factors such as the organizational environment and its changes, associated risks, specific needs, objectives, product offerings, employed processes, and overall size and structure.

It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation

The quality management system requirements specified in this International Standard are complementary to requirements for products Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement

This International Standard serves as a tool for both internal and external stakeholders, including certification bodies, to evaluate an organization's capability to fulfill customer, legal, and regulatory obligations related to its products, as well as its internal requirements.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard

Copyright International Organization for Standardization

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Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements

To ensure effective organizational functioning, it is essential to identify and manage interconnected activities A process can be defined as a series of activities that utilize resources to transform inputs into outputs Typically, the output of one process serves as the input for the subsequent process.

The "process approach" refers to the implementation of a systematic set of processes within an organization, focusing on the identification, interaction, and management of these processes to achieve the desired outcomes.

The process approach offers continuous control over the connections and interactions between individual processes within a system In the context of a quality management system, this approach highlights the significance of understanding and fulfilling requirements, viewing processes through the lens of added value, assessing process performance and effectiveness, and fostering ongoing improvement through objective measurement.

ISO/TS 16949:2009(E) © ISO 2009 – All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp – All rights reserved â PSA Peugeot Citroởn, â Renault – All rights reserved xi

The process-based quality management system model depicted in Figure 1 highlights the connections outlined in Clauses 4 to 8, emphasizing the crucial role of customers in defining input requirements To ensure customer satisfaction, it is essential to assess information regarding customer perceptions of whether the organization has fulfilled their needs While the model encompasses all requirements of the International Standard, it does not delve into detailed process levels.

NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes PDCA can be briefly described as follows

Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results

Act: take actions to continually improve process performance

Figure 1 — Model of a process-based quality management system

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Relationship with ISO 9004

ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently

ISO 9001 outlines the essential requirements for a quality management system applicable for internal use, certification, or contractual obligations, emphasizing the system's effectiveness in fulfilling customer needs.

The revised edition of ISO 9004, currently under revision, will offer management guidance for achieving sustained success in a complex and ever-changing environment Unlike ISO 9001, ISO 9004 emphasizes a broader approach to quality management, focusing on the needs and expectations of all stakeholders and enhancing overall organizational performance through systematic and continuous improvement It is important to note that ISO 9004 is not designed for certification, regulatory, or contractual purposes.

NOTE The knowledge and use of the eight quality management principles referred to in ISO 9000:2005 and ISO 9004:—should be demonstrated and cascaded through the organization by top management.

Compatibility with other management systems

0.4 Compatibility with other management systems

In developing this International Standard, careful attention was paid to the provisions of ISO 14001:2004 to improve compatibility between the two standards, ultimately benefiting the user community.

A shows the correspondence between ISO 9001:2008 and ISO 14001:2004

This International Standard focuses solely on quality management systems and does not address specific requirements for other management systems, including environmental, occupational health and safety, financial, or risk management However, it allows organizations to align or integrate their quality management systems with related management system requirements Organizations can adapt their existing management systems to establish a quality management system that meets the criteria set forth by this International Standard.

Goal of this Technical Specification

This Technical Specification aims to establish a quality management system focused on continuous improvement, prioritizing defect prevention and minimizing variation and waste throughout the supply chain.

This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this Technical Specification

This Technical Specification is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production, and relevant service part organizations

TECHNICAL SPECIFICATION ISO/TS 16949:2009(E) © ISO 2009 – All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp – All rights reserved â PSA Peugeot Citroởn, â Renault – All rights reserved 1

Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

General

This International Standard outlines the requirements for a quality management system that enables organizations to consistently deliver products meeting customer and regulatory standards It emphasizes the importance of enhancing customer satisfaction through effective system application, continual improvement processes, and ensuring compliance with relevant statutory and regulatory requirements.

NOTE 1 In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) any intended output resulting from the product realization processes

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements

This Technical Specification, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products

This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured

Supporting functions, including on-site and remote locations like design centers, corporate headquarters, and distribution centers, are integral to the site audit process However, these functions cannot achieve independent certification under this Technical Specification.

This Technical Specification can be applied throughout the automotive supply chain.

Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion

Claims of conformity to this International Standard are only acceptable when exclusions are confined to the requirements outlined in Clause 7 These exclusions must not compromise the organization's ability or responsibility to deliver products that meet customer expectations and comply with relevant statutory and regulatory requirements.

The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development

Permitted exclusions do not include manufacturing process design

The referenced documents are essential for the application of this document For dated references, only the specified edition is applicable, while for undated references, the most recent edition, including any amendments, is relevant.

ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

For the purposes of this document, the terms and definitions given in ISO 9000 apply

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean

Terms and definitions for the automotive industry

For the purposes of this document, the terms and definitions given in ISO 9000:2005 and the following apply

3.1.1 control plan documented description of the systems and processes required for controlling product

3.1.2 design responsible organization organization with authority to establish a new, or change an existing, product specification

NOTE This responsibility includes testing and verification of design performance within the customer's specified application

3.1.3 error proofing product and manufacturing process design and development to prevent manufacture of nonconforming products

3.1.4 laboratory facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing

ISO/TS 16949:2009(E) © ISO 2009 – All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp – All rights reserved â PSA Peugeot Citroởn, â Renault – All rights reserved 3

3.1.5 laboratory scope controlled document containing

⎯ specific tests, evaluations and calibrations that a laboratory is qualified to perform,

⎯ a list of the equipment which it uses to perform the above, and

⎯ a list of methods and standards to which it performs the above

3.1.6 manufacturing process of making or fabricating

⎯ heat treating, welding, painting, plating or other finishing services

3.1.7 predictive maintenance activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes

3.1.8 preventive maintenance planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design

3.1.9 premium freight extra costs or charges incurred additional to contracted delivery

NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc

3.1.10 remote location location that supports sites and at which non-production processes occur

3.1.11 site location at which value-added manufacturing processes occur

3.1.12 special characteristic product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product

General requirements

General requirements — Supplemental

Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements

Documentation requirements

General

A quality management system must encompass several key components: a documented quality policy and objectives, a quality manual, necessary documented procedures and records as specified by the International Standard, and any additional documents or records deemed essential by the organization for effective planning, operation, and control of its processes.

NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained A single document may address the requirements for one or more procedures A requirement for a documented procedure may be covered by more than one document

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel

NOTE 3 The documentation can be in any form or type of medium.

Quality manual

The organization must create and uphold a quality manual that outlines the quality management system's scope, justifying any exclusions It should also document the procedures for the quality management system or provide references to them, along with a description of how the processes within the quality management system interact.

Control of documents

Documents required by the quality management system shall be controlled Records are a special type of document and shall be controlled according to the requirements given in 4.2.4

A documented procedure must be established to ensure effective document control, including the approval of documents for adequacy before issuance, regular reviews and updates, and re-approval as necessary It is essential to identify changes and the current revision status of documents, ensuring that relevant versions are accessible at points of use Additionally, documents must remain legible and easily identifiable, while external documents deemed necessary for the quality management system should be identified and their distribution controlled Finally, measures must be taken to prevent the unintended use of obsolete documents, including appropriate identification if they are retained for any purpose.

The organization must establish a process to ensure the prompt review, distribution, and implementation of all customer engineering standards and specifications, as well as any changes, in accordance with the customer's required schedule Reviews should be conducted as quickly as possible, with a maximum timeframe of two working weeks.

The organization shall maintain a record of the date on which each change is implemented in production Implementation shall include updated documents.

Any modifications to these standards or specifications necessitate an updated record of customer production part approval, particularly when these specifications are cited in the design record or impact documents related to the production part approval process, including control plans and FMEAs.

Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled

The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records

Records shall remain legible, readily identifiable and retrievable

NOTE 2 “Records” also include customer-specified records

The control of records shall satisfy statutory, regulatory and customer requirements

Management commitment

Process efficiency

Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.

Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

Quality policy

Top management must ensure that the quality policy aligns with the organization's purpose, demonstrates a commitment to compliance and continuous improvement of the quality management system, establishes a framework for setting and reviewing quality objectives, is effectively communicated and understood throughout the organization, and is regularly reviewed for ongoing relevance.

Planning

Quality objectives

Top management must establish measurable quality objectives at all relevant functions and levels within the organization to meet product requirements These objectives should align with the overall quality policy.

Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy

NOTE Quality objectives should address customer expectations and be achievable within a defined time period.

Quality management system planning

Top management must ensure that the planning of the quality management system aligns with the requirements outlined in section 4.1 and meets established quality objectives Additionally, they are responsible for maintaining the integrity of the quality management system during any planned and implemented changes.

Responsibility, authority and communication

Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization

Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements

Personnel responsible for conformity to product requirements shall have the authority to stop production to correct quality problems

Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements

Management representative

Top management must designate a member of the organization's management to oversee the quality management system This individual is responsible for establishing, implementing, and maintaining necessary processes, reporting on the system's performance and areas for improvement, and promoting awareness of customer requirements across the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system

Top management must appoint individuals with the responsibility and authority to address customer requirements effectively This encompasses the selection of specific characteristics, the establishment of quality objectives, the provision of relevant training, and the implementation of corrective and preventive actions, as well as overseeing product design and development.

Internal communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

Management review

General

Top management must regularly evaluate the organization's quality management system to ensure its ongoing relevance, adequacy, and effectiveness This evaluation should involve identifying opportunities for improvement and determining necessary changes to the quality management system, including the quality policy and objectives.

Records from management reviews shall be maintained (see 4.2.4)

These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process

Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1)

These results shall be recorded to provide, as a minimum, evidence of the achievement of

⎯ the quality objectives specified in the business plan, and

⎯ customer satisfaction with product supplied.

Review input

The management review input must encompass several key elements: the outcomes of audits, customer feedback, process performance and product conformity, the status of preventive and corrective actions, follow-up actions from prior management reviews, any changes that may impact the quality management system, and suggestions for improvement.

Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment.

Review output

The management review will encompass decisions and actions aimed at enhancing the effectiveness of the quality management system and its processes, improving products to meet customer requirements, and identifying resource needs.

Provision of resources

The organization will identify and allocate the necessary resources to establish and sustain an effective quality management system while continuously improving its performance Additionally, it aims to boost customer satisfaction by fulfilling customer requirements.

Human resources

General

Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience

NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

Competence, training and awareness

The organization must identify the required competencies for personnel involved in ensuring product conformity, provide necessary training or alternative measures to achieve these competencies, and assess the effectiveness of these actions Additionally, it is essential for personnel to understand the significance of their roles in meeting quality objectives, while maintaining accurate records of their education, training, skills, and experience.

The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques

Applicable tools and techniques shall be identified by the organization

The organization must implement and uphold documented procedures to identify training needs and ensure the competence of all personnel involved in activities that impact product conformity It is essential that personnel assigned to specific tasks are qualified, with a strong focus on meeting customer requirements.

NOTE 1 This applies to all employees having an effect on quality at all levels of the organization

NOTE 2 An example of the customer-specific requirements is the application of digitized mathematically based data

The organization will offer on-the-job training for employees in new or modified roles that impact product conformity, including contract and agency staff It is essential that personnel whose work influences quality are made aware of the potential consequences of failing to meet quality requirements for the customer.

The organization must implement a process that inspires employees to meet quality objectives, fosters continuous improvement, and cultivates an innovative environment This process should emphasize the importance of quality and technological awareness across the entire organization.

The organization must implement a process to assess the awareness of its personnel regarding the significance of their roles and how these roles contribute to achieving quality objectives.

Infrastructure

Plant, facility and equipment planning

The organization will adopt a multidisciplinary approach to create effective plans for plants, facilities, and equipment Optimizing plant layouts will enhance material travel, handling, and the efficient use of floor space while promoting synchronous material flow Additionally, methods will be established to assess and monitor the effectiveness of current operations.

NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.

Contingency plans

The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns

Work environment

Personnel safety to achieve conformity to product requirements

Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities.

Cleanliness of premises

The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs

Planning of product realization

Planning of product realization — Supplemental

Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.

Acceptance criteria

Acceptance criteria shall be defined by the organization and, where required, approved by the customer

For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1).

Confidentiality

The organization shall ensure the confidentiality of customer-contracted products and projects under development, and related product information.

Change control

The organization must establish a process to manage and respond to changes affecting product realization It is essential to assess the impact of any changes, including those from suppliers, and to define verification and validation activities to ensure adherence to customer requirements Furthermore, all changes must be validated prior to implementation.

For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated

When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met

NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer

NOTE 2 The above requirement applies to product and manufacturing process changes.

Customer-related processes

Determination of requirements related to the product

7.2.1 Determination of requirements related to the product

The organization will identify the following requirements: a) customer-specified needs, including those related to delivery and post-delivery activities, b) necessary requirements not explicitly stated by the customer but essential for intended use, c) applicable statutory and regulatory requirements for the product, and d) any additional requirements deemed necessary by the organization.

NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

NOTE 1 Post-delivery activities include any after-sales product service provided as part of the customer contract or purchase order

NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes (see 7.3.2.3)

NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials

The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

Review of requirements related to the product

7.2.2 Review of requirements related to the product

The organization will assess product requirements before committing to supply, such as during tender submissions or contract acceptances This review ensures that product requirements are clearly defined, any discrepancies in contract or order requirements are addressed, and the organization is capable of fulfilling the specified requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4)

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements

NOTE In some situations, such as internet sales, a formal review is impractical for each order Instead the review can cover relevant product information such as catalogues or advertising material

7.2.2.1 Review of requirements related to the product — Supplemental

Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization

The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.

Customer communication

The organization will establish and execute efficient communication strategies with customers regarding a) product details, b) handling inquiries, contracts, or orders, including any modifications, and c) gathering customer feedback, which encompasses complaints.

The organization shall have the ability to communicate necessary information, including data, in a customer- specified language and format (e.g computer-aided design data, electronic data exchange).

Design and development

Design and development planning

The organization shall plan and control the design and development of product

In the design and development planning phase, the organization must identify the stages of design and development, establish the necessary review, verification, and validation processes for each stage, and define the responsibilities and authorities involved in the design and development process.

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility

Planning output shall be updated, as appropriate, as the design and development progresses

Design and development review, verification, and validation serve unique purposes and can be performed and documented independently or in various combinations, depending on the needs of the product and the organization.

The organization shall use a multidisciplinary approach to prepare for product realization, including

⎯ development/finalization and monitoring of special characteristics,

⎯ development and review of FMEAs, including actions to reduce potential risks, and

⎯ development and review of control plans

NOTE A multidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, production and other appropriate personnel

Design and development inputs

Product requirements must be clearly defined and documented, including functional and performance criteria, relevant statutory and regulatory obligations, insights from previous similar designs, and any other essential requirements for effective design and development.

The inputs shall be reviewed for adequacy Requirements shall be complete, unambiguous and not in conflict with each other

NOTE Special characteristics (see 7.2.1.1) are included in this requirement

The organization shall identify, document and review the product design input requirements, including the following:

⎯ customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability and packaging;

The organization must implement a systematic approach to utilize insights from past design projects, competitor evaluations, supplier feedback, internal contributions, field data, and other pertinent sources to enhance current and future projects of a similar nature.

⎯ targets for conformity to product requirements, life, reliability, durability, maintainability, timing and cost

The organization shall identify, document and review the manufacturing process design input requirements, including

⎯ targets for productivity, process capability and cost,

⎯ customers requirements, if any, and

NOTE The manufacturing process design includes the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered

The organization shall identify special characteristics [see 7.3.3 d)] and

⎯ include all special characteristics in the control plan,

⎯ comply with customer-specified definitions and symbols, and

Identify process control documents such as drawings, FMEAs, control plans, and operator instructions that incorporate the customer's special characteristic symbol or the organization's equivalent notation, ensuring that all process steps impacting special characteristics are included.

NOTE Special characteristics can include product characteristics and process parameters

Design and development outputs

The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release

Design and development outputs must fulfill the input requirements, offer relevant information for purchasing, production, and service delivery, include or reference product acceptance criteria, and define the essential characteristics necessary for the product's safe and proper use.

NOTE Information for production and service provision can include details for the preservation of product.

The product design output shall be expressed in terms that can be verified and validated against product design input requirements The product design output shall include

⎯ product special characteristics and specifications,

⎯ product error-proofing, as appropriate,

⎯ product definition including drawings or mathematically based data,

⎯ product design reviews results, and

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated The manufacturing process design output shall include

⎯ manufacturing process flow chart/layout,

⎯ data for quality, reliability, maintainability and measurability,

⎯ results of error-proofing activities, as appropriate, and

⎯ methods of rapid detection and feedback of product/manufacturing process nonconformities

Design and development review

Systematic reviews of design and development will be conducted at appropriate stages, following planned arrangements, to assess whether the design outcomes meet the specified requirements and to identify any issues, along with proposing necessary corrective actions.

Participants in the reviews will consist of representatives from relevant functions involved in the design and development stages being evaluated Records of the review outcomes and any required actions will be kept for reference.

NOTE These reviews are normally coordinated with the design phases and include manufacturing process design and development

Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review

NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.

Design and development verification

Verification will be conducted as per the established plans to confirm that the design and development outputs align with the input requirements Additionally, records of the verification results and any required actions will be preserved.

Design and development validation

Design and development validation must be conducted according to established plans to ensure the product meets the requirements for its intended application Whenever possible, validation should be finalized before the product's delivery or implementation Additionally, records of validation results and any required actions must be maintained.

NOTE 1 The validation process normally includes an analysis of field reports for similar products

NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes

7.3.6.1 Design and development validation — Supplemental

Design and development validation shall be performed in accordance with customer requirements, including programme timing

The organization must implement a prototype program and control plan as requested by the customer, utilizing the same suppliers, tooling, and manufacturing processes that will be employed in production whenever feasible.

All performance-testing activities shall be monitored for timely completion and conformity to requirements

While services may be outsourced, the organization shall be responsible for the outsourced services, including technical leadership

The organization shall conform to a product and manufacturing process approval procedure recognized by the customer

NOTE Product approval should be subsequent to the verification of the manufacturing process

This product and manufacturing process approval procedure shall also be applied to suppliers.

Control of design and development changes

7.3.7 Control of design and development changes

Design and development changes must be documented and maintained These changes should be reviewed, verified, validated, and approved prior to implementation The review process must assess the impact of changes on existing components and products already delivered Additionally, records of the review outcomes and any required actions must be kept.

NOTE Design and development changes include all changes during the product programme life (see 7.1.4).

Purchasing

Purchasing process

The organization must guarantee that all purchased products meet the specified requirements The level of control exercised over the supplier and the purchased products will vary based on the impact these products have on the realization of subsequent products or the final product.

The organization will assess and choose suppliers based on their capability to meet product requirements Established criteria will guide the selection, evaluation, and re-evaluation processes Additionally, records of evaluation outcomes and any required follow-up actions will be kept.

NOTE 1 Purchased products above include all products and services that affect customer requirements such as sub- assembly, sequencing, sorting, rework and calibration services

NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier's quality management system and its effectiveness

All purchased products or materials used in product shall conform to applicable statutory and regulatory requirements

7.4.1.2 Supplier quality management system development

The organization aims to develop a supplier quality management system to ensure compliance with this Technical Specification, with ISO 9001:2008 conformity being the initial step towards achieving this objective.

NOTE The prioritization of suppliers for development depends upon, for example, the supplier's quality performance and the importance of the product supplied

Unless otherwise specified by the customer, suppliers to the organization shall be third party, registered to ISO 9001:2008 by an accredited third-party certification body.

Where specified by the contract (e.g customer engineering drawing, specification), the organization shall purchase products, materials or services from approved sources

The use of customer-designated sources, including tool/gauge suppliers, does not relieve the organization of the responsibility for ensuring the quality of purchased products.

Purchasing information

The purchasing information must detail the product being acquired, including necessary approval requirements for the product, relevant procedures, processes, and equipment It should also outline the qualifications needed for personnel and specify the quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements

When an organization or its customer plans to conduct verification at the supplier's location, it must clearly outline the verification arrangements and product release methods in the purchasing information.

7.4.3.1 Incoming product conformity to requirements

The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:

⎯ receipt of, and evaluation of, statistical data by the organization;

⎯ receiving inspection and/or testing, such as sampling based on performance;

⎯ second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product conformity to requirements;

⎯ part evaluation by a designated laboratory;

⎯ another method agreed with the customer

Supplier performance shall be monitored through the following indicators:

⎯ delivered product conformity to requirements;

⎯ customer disruptions, including field returns;

⎯ delivery schedule performance (including incidents of premium freight);

⎯ special status customer notifications related to quality or delivery issues

The organization shall promote supplier monitoring of the performance of their manufacturing processes.

Production and service provision

Control of production and service provision

7.5.1 Control of production and service provision

The organization must ensure that production and service delivery occur under controlled conditions, which encompass the availability of product characteristic information, necessary work instructions, appropriate equipment, and monitoring and measuring tools Additionally, it is essential to implement effective monitoring and measurement processes, as well as to manage product release, delivery, and post-delivery activities.

Develop comprehensive control plans at various levels—system, subsystem, component, and material—for the supplied product This includes plans for processes that produce both bulk materials and individual parts.

⎯ have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs

⎯ list the controls used for the manufacturing process control,

⎯ include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organization,

⎯ include the customer-required information, if any, and

⎯ initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable

Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA (see 7.1.4)

NOTE Customer approval may be required after review or update of the control plan

The organization will create documented work instructions for all employees responsible for operating processes that affect product conformity These instructions will be readily available at each work station for easy access.

These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process

7.5.1.3 Verification of job set-ups

Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or job change

Work instructions shall be available for set-up personnel The organization shall use statistical methods of verification, where applicable

NOTE Last-off-part comparisons are recommended

The organization will identify essential process equipment and allocate resources for maintenance, establishing a comprehensive planned total preventive maintenance system This system will, at a minimum, encompass key components necessary for effective upkeep.

⎯ packaging and preservation of equipment, tooling and gauging;

⎯ availability of replacement parts for key manufacturing equipment;

⎯ documenting, evaluating and improving maintenance objectives

The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment

The organization shall provide resources for tool and gauge design, fabrication and verification activities The organization shall establish and implement a system for production tooling management including:

⎯ maintenance and repair facilities and personnel;

⎯ tool-change programmes for perishable tools;

⎯ tool design modification documentation, including engineering change level;

⎯ tool modification and revision to documentation;

⎯ tool identification, defining the status, such as production, repair or disposal

The organization shall implement a system to monitor these activities if any work is outsourced

NOTE This requirement also applies to the availability of tools for vehicle service parts

Production scheduling must align with customer needs, utilizing a just-in-time approach supported by an information system that provides access to critical production data at key stages and is driven by orders.

7.5.1.7 Feedback of information from service

A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained

NOTE The intent of the addition of “service concerns” to this subclause is to ensure that the organization is aware of nonconformities that occur outside of its organization

When there is a service agreement with the customer, the organization shall verify the effectiveness of

⎯ any special-purpose tools or measurement equipment, and

⎯ the training of service personnel.

Validation of processes for production and service provision

7.5.2 Validation of processes for production and service provision

The organization must validate production and service processes when the output cannot be verified through monitoring or measurement, as deficiencies may only become evident after the product is in use or the service has been provided.

Validation shall demonstrate the ability of these processes to achieve planned results

The organization shall establish arrangements for these processes including, as applicable a) defined criteria for review and approval of the processes,

ISO/TS 16949:2009 outlines essential requirements for the automotive industry, including the approval of equipment and qualification of personnel, the implementation of specific methods and procedures, the necessity for maintaining records, and the process of revalidation.

7.5.2.1 Validation of processes for production and service provision — Supplemental

The requirements of 7.5.2 shall apply to all processes for production and service provision.

Identification and traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization

The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization

Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4)

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained

Inspection and test status should not be inferred from a product's position in the production flow, except in cases where it is clearly evident, like materials in an automated transfer process Alternative methods are acceptable as long as the status is clearly identified, documented, and fulfills the intended purpose.

The words “Where appropriate” in 7.5.3 shall not apply.

Customer property

The organization is committed to safeguarding customer property while it is in its possession or use It will identify, verify, and protect customer property intended for use or integration into products In the event of loss, damage, or unsuitability of any customer property, the organization will promptly inform the customer and keep detailed records.

NOTE Customer property can include intellectual property and personal data

NOTE Customer-owned returnable packaging is included in this subclause

Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined

Preservation of product

The organization is committed to preserving the product throughout internal processing and delivery to ensure it meets all requirements This preservation process includes essential activities such as identification, handling, packaging, storage, and protection Additionally, preservation measures extend to the individual components of the product.

In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals

The organization will implement an inventory management system to enhance inventory turnover and ensure effective stock rotation, utilizing methods like "first-in-first-out" (FIFO) Additionally, obsolete products will be managed similarly to nonconforming products.

Control of monitoring and measuring equipment

Measurement system analysis

Statistical analyses will be performed to evaluate the variability in results from different measuring and testing equipment systems, as outlined in the control plan The analytical methods and acceptance criteria must align with those specified in the customer reference manuals for measurement systems analysis Alternative analytical methods and acceptance criteria may be utilized, provided they receive customer approval.

Calibration/verification records

All calibration and verification activities for gauges, measuring, and test equipment must be documented to demonstrate product conformity to specified requirements This includes records for both employee-owned and customer-owned equipment.

⎯ equipment identification, including the measurement standard against which the equipment is calibrated,

⎯ any out-of-specification readings as received for calibration/verification,

⎯ an assessment of the impact of out-of-specification condition,

⎯ statements of conformity to specification after calibration/verification, and

⎯ notification to the customer if suspect product or material has been shipped.

Laboratory requirements

An organization's internal laboratory must have a clearly defined scope that outlines its ability to conduct necessary inspection, testing, or calibration services This scope should be documented within the quality management system Additionally, the laboratory is required to specify and implement essential technical requirements.

⎯ adequacy of the laboratory procedures,

⎯ competency of the laboratory personnel,

⎯ capability to perform these services correctly, traceable to the relevant process standard (such as ASTM,

⎯ review of the related records

NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory conformity to this requirement but is not mandatory

External, commercial, or independent laboratory facilities utilized by the organization for inspection, testing, or calibration services must possess a clearly defined laboratory scope that demonstrates their ability to conduct the necessary inspections, tests, or calibrations.

⎯ there shall be evidence that the external laboratory is acceptable to the customer, or

⎯ the laboratory shall be accredited to ISO/IEC 17025 or national equivalent

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second- party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met

General

Identification of statistical tools

Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.

Knowledge of basic statistical concepts

Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization.

Monitoring and measurement

Customer satisfaction

To assess the effectiveness of its quality management system, the organization must monitor customer perceptions regarding the fulfillment of their requirements It is essential to establish methods for collecting and utilizing this information effectively.

Monitoring customer perception involves gathering insights from various sources, including customer satisfaction surveys, data on product quality, user opinion surveys, analysis of lost business, customer compliments, warranty claims, and dealer reports.

NOTE Consideration should be given to both internal and external customers

Customer satisfaction will be assessed through ongoing evaluation of the organization's performance in realization processes Performance indicators will rely on objective data and will encompass a range of metrics.

⎯ customer disruptions, including field returns,

⎯ delivery schedule performance (including incidents of premium freight), and

⎯ customer notifications related to quality or delivery issues

The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.

Internal audit

The organization will perform internal audits at scheduled intervals to assess the conformity of the quality management system with planned arrangements, the requirements of the International Standard, and the organization's established quality management system requirements, while also ensuring that it is effectively implemented and maintained.

An effective audit program must be strategically planned, considering the significance of the processes and areas to be audited, along with insights from prior audits It is essential to clearly define the audit criteria, scope, frequency, and methods To maintain objectivity and impartiality, the selection of auditors and the execution of audits must be carefully managed, ensuring that auditors do not evaluate their own work.

A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results

Records of the audits and their results shall be maintained (see 4.2.4)

Management must promptly implement necessary corrections and corrective actions to address identified nonconformities and their root causes Follow-up activities should involve verifying the actions taken and reporting the results of these verifications.

NOTE See ISO 19011 for guidance

The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements

The organization shall audit each manufacturing process to determine its effectiveness

The organization will conduct audits of products during key stages of production and delivery to ensure they meet all specified requirements, including dimensions, functionality, packaging, and labeling, at a predetermined frequency.

Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan

When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased

NOTE Specific checklists should be used for each audit

The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification( see 6.2.2.2).

Monitoring and measurement of processes

8.2.3 Monitoring and measurement of processes

The organization will implement effective monitoring and measurement techniques for its quality management system processes to ensure they meet planned objectives In cases where these objectives are not met, appropriate corrective actions will be taken to address the issues.

When selecting appropriate methods, organizations should evaluate the type and level of monitoring or measurement needed for each process, considering their influence on product conformity and the overall effectiveness of the quality management system.

8.2.3.1 Monitoring and measurement of manufacturing processes

The organization will conduct process studies on all new manufacturing processes, including assembly and sequencing, to assess process capability and enhance process control The findings will be documented alongside relevant specifications for production means, measurement and testing, and maintenance instructions These documents will outline objectives for manufacturing process capability, reliability, maintainability, and availability, as well as establish acceptance criteria.

The organization must uphold the manufacturing process capability as outlined by the customer's part approval process requirements It is essential to implement the control plan and process flow diagram while ensuring compliance with the specified standards.

⎯ reaction plans when acceptance criteria are not met

Significant process events, such as tool change or machine repair, shall be recorded

The organization will implement a reaction plan based on the control plan for characteristics that are statistically incapable or unstable This plan will involve product containment and 100% inspection as necessary Subsequently, a corrective action plan will be developed, detailing specific timelines and assigned responsibilities to ensure process stability and capability These plans will be reviewed and approved by the customer when required.

The organization shall maintain records of effective dates of process changes.

Monitoring and measurement of product

8.2.4 Monitoring and measurement of product

The organization will monitor and measure product characteristics to ensure compliance with requirements at key stages of the product realization process, as outlined in the planned arrangements Evidence of conformity with acceptance criteria will be documented and maintained.

Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4)

Product release and service delivery to customers will only occur after the successful completion of planned arrangements, as outlined in section 7.1, unless approved by the relevant authority and, if necessary, the customer.

NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determines the types of product characteristics, leading to

⎯ the capability and skills required

8.2.4.1 Layout inspection and functional testing

Each product will undergo a layout inspection and functional verification to ensure compliance with customer engineering material and performance standards as outlined in the control plans The results of these inspections will be made available for customer review.

NOTE Layout inspection is the complete measurement of all product dimensions shown on the design records

For organizations manufacturing parts designated by the customer as “appearance items”, the organization shall provide

⎯ appropriate resources, including lighting, for evaluation,

⎯ masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate,

⎯ maintenance and control of appearance masters and evaluation equipment, and

⎯ verification that personnel making appearance evaluations are competent and qualified to do so

Control of nonconforming product

Control of nonconforming product — Supplemental

Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3).

Control of reworked product

Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate personnel.

Customer information

Customers shall be informed promptly in the event that nonconforming product has been shipped.

Customer waiver

The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved

The organization must keep a record of the expiration date or authorized quantity and ensure adherence to the original or updated specifications upon expiration Additionally, all materials shipped under an authorization must be clearly identified on each shipping container.

This applies equally to purchased product The organization shall approve any requests from suppliers before submission to the customer

Analysis of data

Analysis and use of data

Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following:

⎯ development of priorities for prompt solutions to customer-related problems;

⎯ determination of key customer-related trends and correlation for status review, decision-making and longer term planning;

⎯ an information system for the timely reporting of product information arising from usage

NOTE Data should be compared with those of competitors and/or appropriate benchmarks.

Improvement

Continual improvement

The organization will enhance the effectiveness of its quality management system by utilizing the quality policy, setting quality objectives, analyzing audit results and data, implementing corrective and preventive actions, and conducting management reviews.

8.5.1.1 Continual improvement of the organization

The organization shall define a process for continual improvement

Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters

NOTE 1 Controlled characteristics are documented in the control plan

NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.

Corrective action

The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence Corrective actions shall be appropriate to the effects of the nonconformities encountered

A documented procedure must be established to outline the requirements for reviewing nonconformities, including customer complaints, identifying their causes, and evaluating necessary actions to prevent recurrence This includes determining and implementing the required actions, maintaining records of the results, and assessing the effectiveness of the corrective measures taken.

The organization shall have a defined process for problem solving leading to root cause identification and elimination

If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format

The organization shall use error-proofing methods in their corrective action process

The organization shall apply to other similar processes and products the corrective action, and controls implemented, in order to eliminate the cause of a nonconformity

The organization will analyze components rejected by customer manufacturing plants, engineering facilities, and dealerships, aiming to minimize the cycle time of this process Records of these analyses will be maintained and made available upon request Additionally, the organization will conduct thorough analyses and implement corrective actions to prevent future occurrences.

NOTE Cycle time related to rejected product analysis should be consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation

Preventive action

The organization will identify and implement measures to eliminate the root causes of potential nonconformities, thereby preventing their occurrence These preventive actions will be tailored to address the severity of the potential issues.

A documented procedure must be established to outline the requirements for identifying potential nonconformities and their causes, assessing the need for preventive actions, determining and implementing necessary actions, maintaining records of the results, and reviewing the effectiveness of the preventive measures taken.

Tiêu đề	Tiêu chuẩn iso ts 16949 2009
Trường học	International Organization for Standardization
Chuyên ngành	Quality Management Systems
Thể loại	Technical Specification
Năm xuất bản	2009
Thành phố	Geneva

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Số trang	52
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