Source: https://www.scribd.com/presentation/27890193/Ts16949-2002-Awareness
Timestamp: 2016-10-21 16:41:06
Document Index: 591589078

Matched Legal Cases: ['art 9', 'art 1', 'art 5', 'art 2', 'art 3', 'art 4', 'art 6']

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General Requirements (4.1) • Establish, document, implement, maintain, and continually improve a QMS • Identify the processes needed for QMS • Determine sequence and interaction of processes • Determine criteria and methods to ensure operation and control of processes • Ensure availability of information to support operation and monitoring of processes • Measure, monitor, analyze and implement action to achieve results and continual improvement
General Documentation Requirements (4.2) • QMS shall include • Documented Procedures* required by the standard • Documents required by us to ensure the effective operation and control of processes *Requires the procedure to be established, documented, implemented and maintained
Management Commitment (5.1) • Top management shall provide evidence of its commitment to the development and improvement of the QMS by: • Communicating importance of meeting customer, regulatory and legal requirements • Establishing quality policy and quality objectives • Conducting management reviews • Ensuring availability of resources Customer Focus (5.2) • Top management shall ensure that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction.
Quality Policy (5.3) • Top management ensures that the quality policy: • is appropriate to the organization’s purpose • includes a commitment to meeting requirements and continual improvement • provides a framework for establishing and reviewing quality objectives • is communicated and understood in the organization • is reviewed for continuing suitability • The quality policy shall be controlled
Planning (5.4) • Quality Objectives (5.4.1) • Top management ensures quality objectives are established at relevant functions and levels within the organization. • Quality objectives shall be measurable and consistent with the quality policy including the commitment to continual improvement. • Quality objectives shall include those need to meet requirements for product • Quality Planning (5.4.2) • Top management ensures that resources needed to achieve quality objectives are identified and planned • Out put of the planning shall be documented)
Planning (5.4) • Quality Planning (5.4.2) • Top management ensures that resources needed to achieve quality objectives are identified and planned • Out put of the planning shall be documented • Quality planning includes: • Processes of the QMS, considering permissible exclusions • The resources needed • Continual improvement of the QMS • Planning ensures that change is conducted in a controlled manner and the integrity of the QMS is maintained during change.
Administration (5.5) • Responsibility and authority (5.5.2) • Functions and interrelations within the organization, including responsibilities and authorities, shall be defined and communicated to facilitate effective quality managment • Management representative (5.5.3) • Top management appoints member(s) of the management who have responsibility and authority that includes: • Ensuring that processes of the QMS are established and maintained • Reporting to top management on the performance of the QMS, including needs for improvement • Promoting awareness of customer requirements throughout the organization
Administration (5.5) • Management representative (5.5.3) • Top management appoints member(s) of the management who have responsibility and authority that includes: • Ensuring that processes of the QMS are established and maintained • Reporting to top management on the performance of the QMS, including needs for improvement • Promoting awareness of customer requirements throughout the organization • May include liaison with external parties on matters relating to the QMS
Administration (5.5) • Internal communication (5.5.4) • The organization ensures communication between its various levels and functions regarding the processes of the QMS and their effectiveness.
Administration (5.5) • Quality Manual (5.5.5) • A quality manual must be established and maintained that includes: • scope of the QMS • documented procedures or reference to them • description of the sequence and interaction of the processes in the QMS • The quality manual must be controlled
Administration (5.5) • Control of documents (5.5.6) • Documents required for the QMS must be controlled. A documented procedure must be established to:
• approve documents for adequacy prior to issue • review, update and re-approve documents • identify current revision of documents • ensure relevant versions of documents are available at points of use • ensure documents remain legible, identifiable and retrievable • ensure externally originated documents are identified and controlled • prevent unintended use of obsolete documents and apply identification if they are retained for any purpose
• Documents defined as quality records must be controlled
Administration (5.5) • Control of quality records (5.5.7) • Required records for the QMS must be controlled • Records must be maintained to provide evidence of conformance to requirements and of effective operation of the QMS • Documented procedure must be established for the identification, storage, retrieval, protection, retention time and disposition of quality records
Management review (5.6) • General (5.6.1) • Top management must review the QMS at planned intervals to ensure continuing suitability, adequacy, and effectiveness • Review must evaluate need for changes to the QMS, including quality policy and quality objectives
Management review (5.6) • Review input (5.6.2) • Inputs to management review must include current performance and improvement opportunities related to: • Results of audits • Customer feedback • Process performance and product conformance • Status of preventive and corrective actions • Follow-up actions from earlier management reviews • Changes that could affect the QMS
Management review (5.6) • Review Output (5.6.3) • Output from the management review must include actions related to: • Improvement of the QMS and its processes • Improvement of product related to customer requirements • Resource needs
Provision of resources (6.1) • The organization must determine and provide, in a timely manner, the resources needed to: • Implement and improve the processes of the QMS • Address customer satisfaction
Human resources (6.2) • Assignment of personnel (6.2.1) • Personnel assigned responsibilities defined in the QMS must be competent on the basis of applicable education, training, skills and experience
Human resources (6.2) • Training, awareness and competency (6.2.2) • The organization must: • Identify competency needs for personnel performing activities affecting quality • Provide training to satisfy these needs • Evaluate the effectiveness of the training provided • Ensure employees are aware of relevance and importance of their activities and how they contribute to achievement of quality objectives • Maintain records of education, experience, training and qualifications
Facilities (6.3) • The organization must identify, provide and maintain the facilities needed to achieve product conformity including: • Workspace and associated facilities • Equipment, hardware and software • Supporting services
Work environment (6.4) • The organization must identify and manage the human and physical factors of the work environment needed to achieve product conformity
Planning of realization processes (7.1) • Sequence of processes required to achieve product • Consistent with other requirements of QMS • Documented • Planning must determine, as appropriate: • Quality objectives for the product, project or contract • Need to establish processes and documentation, provide resources, facilities specific to the product • Verification and validation and criteria for acceptability • Records necessary to provide confidence of conformity of the processes and resulting product
Customer-related processes (7.2) • Identification of customer requirements (7.2.1) • The organization must determine customer requirements including • Customer specified product requirements including availability, delivery and support • Requirements not specified but necessary for intended or specified use • Product obligations including regulatory and legal requirements
Customer-related processes (7.2) • Review of product requirements (7.2.2) • Organization must review customer and other determined requirements • The review must be prior to commitment to supply a product to the customer and ensure that: • Product requirements are defined • In the absence of customer provided requirements, customer requirements are confirmed • Differences from requirements previously expressed are resolved • Organization has the ability to meet requirements • Results must be recorded • Changes must be documented and communicated
Customer-related processes (7.2) • Customer communication (7.2.3) • Organization must identify and implement arrangements for communication with customers relating to: • Product information • Enquiries, contracts or order handling including amendments • Customer feedback, including customer complaints
Design and/or development (7.3) • Design and/or development planning (7.3.1) • Plan and control design/development of product • Planning must determine: • Stages of design/development processes • Review, verification, and validation activities appropriate to each stage • Responsibilities and authorities for design/development activities • Interfaces between involved groups must be managed to ensure effective communication and clarity of responsibilities • Planning output must be updated as design/development progresses
Design and/or development (7.3) • Design and/or development inputs (7.3.2) • Inputs relating to product requirements must be defined and documented, including: • Functional and performance requirements • Regulatory and legal requirements • Information derived from previous similar designs • Other requirements essential for design/development • Inputs must be reviewed for adequacy • Incomplete, ambiguous or conflicting requirements must be resolved
Design and/or development (7.3) • Design and/or development outputs (7.3.3) • Outputs must be documented in a manner that enables verification against the inputs • Output must: • Meet the input requirements • Provide information for production and service operations • Contain or reference acceptance criteria • Define the characteristics of the product essential to its safe and proper use • Output documents must be approved prior to release
Design and/or development (7.3) • Design and/or development review (7.3.4) • At suitable stages, systematic reviews must be conducted to: • Evaluate the ability to fulfill requirements • Identify problems and propose follow-up actions • Participants in reviews must include representatives of functions concerned with design/development stages reviewed • Results of reviews and subsequent follow-up actions must be recorded
Design and/or development (7.3) • Design and/or development verification (7.3.5) • Must be performed to ensure output meets inputs • Results of verification and follow-up actions must be recorded (see 5.5.7) ISO 10007 for guidance
Design and/or development (7.3) • Design and/or development validation (7.3.6) • Must be performed to confirm that product is capable of meeting requirements for intended use. • Must be completed prior to delivery or implementation of product • If full validation is impractical, partial validation must be performed to the extent applicable • Results of the validation and follow-up actions must be recorded (see 5.5.7) ISO 10007 for guidance
Design and/or development (7.3) • Design and/or development changes (7.3.7) • Must be identified, documented and controlled. • Includes evaluation of effect of changes on constituent parts and delivered products • Must be verified and validated, as appropriate • Approved before implementation • Results of review of changes and follow-up actions must be documented (see 5.5.7) ISO 10007 for guidance
Purchasing (7.4) • Purchasing Control (7.4.1) • Must control purchasing processes to ensure purchased product conforms to requirements • Type and extent dependent on realization processes and their output
Purchasing (7.4) • Purchasing Information (7.4.2) • Purchasing documents must contain information describing the product to be purchased including, where appropriate: • Requirements for approval or qualification of • Product • Procedures • Processes • Equipment • Personnel • QMS requirements • Must ensure adequacy of specified requirements contained in purchasing documents prior to release
Purchasing (7.4) • Verification of purchased product (7.4.3) • Must identify and implement activities necessary for verification of purchased product • If organization or customer proposes to perform verification at supplier, organization must specify intended verification arrangements and method of product release in purchasing information
Production and service operations (7.5) • Operations Control (7.5.1) • Must control production and service operations through: • Availability of information specifying characteristics of product • Availability of work instructions (where necessary) • Use and maintenance of suitable equipment for production and service operations • Availability and use of measuring and monitoring devices • Implementation of monitoring devices • Implementation of defined processes for release, delivery, and applicable post-delivery activities
Production and service operations (7.5) • Identification and traceability (7.5.2) • Must identify, where appropriate, product by suitable means throughout production and service operations • Must identify status of product with respect to measurement and monitoring activities • Must control and record unique identification of product, where traceability is a requirement (see 5.5.7) • Customer property (7.5.3) • Preservation of product (7.5.4)
Production and service operations (7.5) • Customer property (7.5.3) • Must exercise care with customer property while under organization’s control or being used by organization • Must identify, verify, protect and maintain customer property provided for use or incorporation into product • Customer property lost, damaged, or otherwise unsuitable must be recorded and reported to customer • Preservation of product (7.5.4)
Production and service operations (7.5) • Preservation of product (7.5.4) • Must preserve conformity of product with customer requirements during internal processing and delivery to intended destination • Must include identification, handling, packaging, storage, and protection • Also applies to constituent parts of a product
Production and service operations (7.5) • Validation of processes (7.5.5) • Must validate any production and service processes where the resulting output cannot be verified by measurement or monitoring • Includes processes where deficiencies may become apparent only after product is in use or service delivered • Must define arrangements for validation that must include, as applicable: • Qualification of processes • Qualification of equipment or personnel • Use of defined methodologies and procedures • Requirements for records • Re-validation
Control of measurement and monitoring devices (7.6) (See ISO 10012) • Must identify measurements to be made and measuring and monitoring devices required to assure conformity of product to requirements • Devices must be used and controlled to ensure measurement capability is consistent with measurement requirements • Devices must (where applicable) • Be calibrated • Be safeguarded from adjustments • Be protected from damage • Have calibration results recorded (see 5.5.7) • Have validity of previous results assessed if found out of calibration
Planning (8.1) • Must define, plan and implement measurement and monitoring activities to assure conformity and achieve improvement • Includes determination of need for, and use of, statistical techniques
Section 8 Measurement and monitoring (8.2) • Customer satisfaction (8.2.1) • Must monitor information on customer satisfaction as measurement of performance of QMS • Must determine methods for obtaining an using this information
Section 8 Measurement and monitoring (8.2)
• Internal audit (8.2.2) • Must conduct internal audits to determine whether QMS: • conforms to ISO • has been effectively implemented and maintained • Must plan audit program considering • Status and importance of activities and areas • Results of previous audits • Must define scope, frequency and methodologies • Documented procedure must include responsibilities and requirements for conducting audits, ensuring independence, recording results, and reporting to management • Management must take corrective action on deficiencies • Follow up actions must include verification of implementation of corrective action, and reporting of verification results See ISO 10011
Section 8 Measurement and monitoring (8.2) • Measurement and monitoring of processes (8.2.3) • Must apply methods of M&M of processes necessary to meet customer requirements • Must confirm continuing ability of process to satisfy its intended purpose
Section 8 Measurement and monitoring (8.2) • Measurement and monitoring of product (8.2.4) • Must M & M characteristics of product to verify that requirements are met • Must be carried out at appropriate stages of realization process • Evidence of conformity must be documented. • Records must indicate authority responsible for release of product (see 5.5.7) • Product release and service delivery must not proceed until all activities have been completed, unless approved by customer
Section 8 Control of nonconformity (8.3) • Must ensure that nonconforming product is identified and controlled to prevent unintended use or delivery • Activities must be defined in documented procedure • When nonconforming product is detected after delivery or use, must take action regarding consequences
Section 8 Analysis of data (8.4) • Must collect and analyze data to determine the suitability and effectiveness of QMS and to identify improvement opportunities • Includes data generated by measuring and monitoring activities and other relevant sources • Must analyze data to provide information on: • Customer satisfaction and/or dissatisfaction • Conformance to customer requirements • Characteristics or processes, product, and trends • Suppliers
Section 8 Improvement (8.5) • Planning for continual improvement (8.5.1) • Must plan and manage processes necessary for the continual improvement of QMS • Must facilitate the continual improvement of QMS through quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review
Section 8 Improvement (8.5)
• Corrective action (8.5.2) • Must take corrective action to eliminate the cause of nonconformities to prevent recurrence. • Must be appropriate to impact of problems encountered • Documented procedure must define requirements for: • Identifying nonconformities • Identifying customer complaints • Determining causes of nonconformity • Evaluating need for action to prevent recurrence of nonconformity • Determining and implementing corrective action • Recording results of actions taken • Reviewing corrective action taken
Section 8 Improvement (8.5) • Preventive action (8.5.3) • Must identify preventive action to eliminate causes of potential nonconformities to prevent occurrence • Must be appropriate to impact of potential problems
• Documented procedure must define requirements for:
• Identifying potential nonconformities and their causes • Determining and ensuring implementation of preventive action • Recording results of action taken • Reviewing preventive action taken
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