Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference

ISO 4 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1 ISO 4.1.a ISO 4.1.a ISO 4.1.b ISO 4.1.b ISO 4.1.c ISO 4.1.c ISO 4.1.d ISO 4.1.d ISO 4.2 ISO 4.2.1 ISO 4.2.1.a ISO 4.2.1.a ISO 4.2.1.b ISO 4.2.1.c ISO 4.2.1.d ISO 4.2.1.d

ISO Text (Paraphrased)

Quality Management System QMS General Requirements The organization shall establish a quality management system (QMS) in accordance with the requirements of this International Standard The organization shall document a QMS IAW the requirements of this International Standard The organization shall implement a QMS IAW the requirements of this International Standard The organization shall maintain a QMS IAW the requirements of this International Standard The organization shall continually improve the QMSs effectiveness IAW the requirements of this International Standard Manage QMS processes IAW the requirements of this International Standard Ensure control over outsourced processes that affect product conformity Specify control of outsourced processes in the QMS Identify processes needed for the QMS Identify the QMS processes application throughout the organization Determine the sequence of the QMS processes Determine the interaction of the QMS processes Determine the criteria needed to ensure the operation and control of QMS processes Determine the methods needed to ensure the operation and control of QMS processes Ensure the availability of resources necessary to support the operation and monitoring of QMS processes Ensure the availability of information necessary to support the operation and monitoring of QMS processes Documentation Requirements General Documented Quality Policy Documented Quality Objectives Documented Quality Manual Documented procedures required by this International Standard Documents that ensure effective planning of QMS processes Documents that ensure effective operation of QMS processes

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 4.2.1.d ISO 4.2.1.e ISO 4.2.2 ISO 4.2.2.a ISO 4.2.2.a ISO 4.2.2.a ISO 4.2.2.b ISO 4.2.2.b ISO 4.2.3 ISO 4.2.3 ISO 4.2.3 ISO 4.2.3.a ISO 4.2.3.b ISO 4.2.3.b ISO 4.2.3.b ISO 4.2.3.c ISO 4.2.3.c ISO 4.2.3.d ISO 4.2.3.e ISO 4.2.3.e ISO 4.2.3.f ISO 4.2.3.f ISO 4.2.3.g ISO 4.2.3.g ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4

ISO Text (Paraphrased)

Documents that ensure effective control of QMS processes Records required by this International Standard (ref. 4.2.4). Quality Manual Quality Manual include scope of QMS Quality Manual include details of exclusions (ref 1.2) Quality Manual include justification for exclusions (ref 1.2) Quality Manual include documented procedures for QMS (or reference to them) Quality Manual include interaction between QMS processes Control of Documents Control QMS documents Control RECORDS IAW 4.2.4 Procedure for document approval for adequacy prior to use Procedure for document review Procedure for document update (as necessary) Procedure for document re-approval Procedure to ensure document changes are identified Procedure to ensure document current revision status is identified Procedure to ensure document relevant versions are available for use Procedure to ensure documents remain legible Procedure to ensure documents are readily identifiable Procedure to ensure external origin documents are identified Procedure to ensure external origin document distribution is controlled Procedure to prevent unintended use of obsolete documents Procedure to apply suitable identification to retained obsolete documents Control of Records Establish RECORDS to provide evidence of conformance to the QMS requirements Establish RECORDS to provide evidence of the effective operation of the QMS Maintain RECORDS to provide evidence of conformance to QMS requirements Maintain RECORDS to provide evidence of the effective operation of the QMS RECORDS shall remain legible RECORDS shall be readily identifiable

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 4.2.4 ISO 5 ISO 5.1 ISO 5.1 ISO 5.1 ISO 5.1 ISO 5.1.a ISO 5.1.a ISO 5.1.a ISO 5.1.b ISO 5.1.c ISO 5.1.d ISO 5.1.e ISO 5.2 ISO 5.2 ISO 5.2 ISO 5.3 ISO 5.3.a ISO 5.3.b ISO 5.3.b

ISO Text (Paraphrased)

RECORDS shall be retrievable Documented procedure controls needed for RECORD identification Documented procedure controls needed for RECORD storage Documented procedure controls needed for RECORD protection Documented procedure controls needed for RECORD retrieval Documented procedure controls needed for RECORD retention time Documented procedure controls needed for RECORD disposition Management Responsibility Management Commitment Provide evidence of top managements commitment to the development of the quality management system Provide evidence of top managements commitment to the implementation of the quality management system Provide evidence of top managements commitment to the continuous improvement of the quality management system Top management communicates to the organization the importance of meeting customer requirements Top management communicates to the organization the importance of meeting statutory requirements Top management communicate to the organization the importance of meeting regulatory requirements Top management establishes the quality policy Top management ensures quality objectives are established Top management conducts management reviews of the QMS Top management ensures resource availability Customer Focus Top management ensures customer requirements are determined Top management ensures customer requirements are met (with an aim to enhance customer satisfaction) Quality Policy Top management ensures the quality policy is appropriate to the organizations purpose Top management ensures the quality policy includes a commitment to comply with requirements Top management ensures the quality policy includes a commitment to continually improve the QMS effectiveness

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 5.3.c ISO 5.3.c ISO 5.3.d ISO 5.3.d ISO 5.3.e ISO 5.4 ISO 5.4.1 ISO 5.4.1 ISO 5.4.1 ISO 5.4.1 ISO 5.4.1 ISO 5.4.2 ISO 5.4.2.a ISO 5.4.2.a ISO 5.4.2.b ISO 5.4.2.b ISO 5.5 ISO 5.5.1 ISO 5.5.1 ISO 5.5.1 ISO 5.5.1 ISO 5.5.1 ISO 5.5.2 ISO 5.5.2.a

ISO Text (Paraphrased)

Top management ensure the quality policy provides a framework for establishing quality objectives Top management ensures the quality policy provides a framework for reviewing quality objectives Top management ensures the quality policy is communicated within the organization Top management ensures the quality policy is understood within the organization Top management ensures the quality policy is reviewed for continuing suitability Planning Quality Objectives Top management ensures quality objectives are established for relevant functions Top management ensures quality objectives are established for relevant levels Top management ensures quality objectives are measurable Top management ensures quality objectives are consistent with quality policy Quality Management System Planning Top management ensures QMS planning occurs to meet section 4.1 requirements Top management ensures QMS planning occurs to meet quality objectives Top management ensures QMS integrity is maintained when changes are planned Top management ensures QMS integrity is maintained when changes are implemented Responsibility, Authority, and Communications Responsibility and Authority Top management ensures organization responsibilities are defined Top management ensures organization responsibilities are communicated Top management ensures organization authorities are defined Top management ensures organization authorities are communicated Management Representative Top management appoints a management member with responsibility and authority to ensure QMS process are established

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 5.5.2.a ISO 5.5.2.a ISO 5.5.2.b ISO 5.5.2.b ISO 5.5.2.c ISO 5.5.3 ISO 5.5.3 ISO 5.5.3 ISO 5.6 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.1 ISO 5.6.2 ISO 5.6.2.a ISO 5.6.2.b ISO 5.6.2.c ISO 5.6.2.c ISO 5.6.2.d ISO 5.6.2.d

ISO Text (Paraphrased)

Top management appoints a management member with responsibility and authority to ensure QMS process are implemented Top management appoints a management member with responsibility and authority to ensure QMS process are maintained Top management appoints a management member with responsibility and authority to report QMS performance to top management Top management appoints a management member with responsibility and authority to report QMS improvement needs to top management Top management appoints a management member with responsibility and authority to promote awareness of customer requirements throughout the organization Internal Communication Top management ensures communication processes are established to communicate the effectiveness of the QMS Top management ensures the QMS effectiveness is communicated Management Review General Top management shall review the QMS at planned intervals to ensure its continued suitability Top management shall review the QMS at planned intervals to ensure its continued adequacy Top management shall review the QMS at planned intervals to ensure its continued effectiveness Top management planned reviews assess improvement opportunities Top management planned reviews assess need for QMS change Top management planned reviews assess need for Quality Policy changes Top management planned reviews assess need for Quality Objective changes Records of planned Top Management reviews are maintained Review Input Planned reviews address audit results Planned reviews address customer feedback Planned reviews address process performance Planned reviews address product conformity Planned reviews status preventive actions Planned reviews status corrective actions

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 5.6.2.e ISO 5.6.2.f ISO 5.6.2.g ISO 5.6.3 ISO 5.6.3.a ISO 5.6.3.a ISO 5.6.3.a ISO 5.6.3.a ISO 5.6.3.b ISO 5.6.3.b ISO 5.6.3.c ISO 5.6.3.c ISO 6 ISO 6.1 ISO 6.1.a ISO 6.1.a ISO 6.1.a ISO 6.1.a ISO 6.1.a ISO 6.1.a ISO 6.1.b ISO 6.1.b ISO 6.2 ISO 6.2.1 ISO 6.2.1 ISO 6.2.2 ISO 6.2.2.a

ISO Text (Paraphrased)

Planned reviews status follow-up actions from previous reviews Planned reviews assess changes to the QMS (potential or actual) Planned reviews assess improvement recommendations Review Output Planned reviews document decisions related to effectiveness improvement of the QMS itself Planned reviews document actions related to effectiveness improvement of the QMS itself Planned reviews document decisions related to effectiveness improvement of QMS processes Planned reviews document actions related to effectiveness improvements of QMS processes Planned reviews document decisions related to improvement of product related to customer requirements Planned reviews document actions related to improvements of product related to customer requirements Planned reviews document decisions related to resource needs Planned reviews document actions related to resource needs Resource Management Provision of Resources Determine resources needed to implement the QMS Provide resources needed to implement the QMS Determine resources needed to maintain the QMS Provide resources needed to maintain the QMS Determine resources needed to continually improve QMS effectiveness Provide resources needed to continually improve QMS effectiveness Determine resources needed to enhance customer satisfaction by meeting customer requirements Provide resources needed to enhance customer satisfaction by meeting customer requirements Human Resources General Personnel performing work effecting product quality are competent based on appropriate education, training, skills, and experience Competence, Awareness, and Training Determine the necessary competence level for personnel performing

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 6.2.2.b ISO 6.2.2.c ISO 6.2.2.d ISO 6.2.2.d ISO 6.2.2.d ISO 6.2.2.d ISO 6.2.2.e ISO 6.2.2.e ISO 6.2.2.e ISO 6.2.2.e ISO 6.3 ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.a ISO 6.3.b

ISO Text (Paraphrased)

work affecting product quality Provide training (or other actions) to satisfy the competency needs Evaluate effectiveness of actions taken (note: ISO does not indicate a requirement to evaluate effectiveness of training, but this shall be evaluated as an action taken) Ensure personnel are aware of the relevance of their activities as related to quality objective contribution Ensure personnel are aware of the importance of their activities as related to quality objective contribution Ensure personnel are aware of the relevance of their activities as related to quality objective achievement Ensure personnel are aware of the relevance of their activities as related to quality objective achievement Maintain education records Maintain training records Maintain skills records Maintain experience records Infrastructure Determine building infrastructure needed to achieve product conformity requirements Provide building infrastructure to achieve product conformity requirements Maintain building infrastructure needed to achieve product conformity requirements Determine workspace infrastructure needed to achieve product conformity requirements Provide workspace infrastructure to achieve product conformity requirements Maintain workspace infrastructure needed to achieve product conformity requirements Determine utilities infrastructure needed to achieve product conformity requirements Provide utilities infrastructure to achieve product conformity requirements Maintain utilities infrastructure needed to achieve product conformity requirements Determine process equipment (hardware and software) infrastructure

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 6.3.b ISO 6.3.b ISO 6.3.c ISO 6.3.c ISO 6.3.c ISO 6.4 ISO 6.4 ISO 6.4 ISO 7 ISO 7.1 ISO 7.1 ISO 7.1 ISO 7.1 ISO 7.1 ISO 7.1.a ISO 7.1.a ISO 7.1.b ISO 7.1.b ISO 7.1.b ISO 7.1.c ISO 7.1.c ISO 7.1.c ISO 7.1.c

ISO Text (Paraphrased)

needed to achieve product conformity requirements Provide process equipment (hardware and software) infrastructure to achieve product conformity requirements Maintain process equipment (hardware and software) infrastructure needed to achieve product conformity requirements Determine supporting services (e.g., transportation, communications) infrastructure needed to achieve product conformity requirements Provide supporting services (e.g., transportation, communications) infrastructure to achieve product conformity requirements Maintain supporting services (e.g., transportation, communications) infrastructure needed to achieve product conformity requirements Work Environment Determine work environment needed to achieve product conformity requirements Manage work environment needed to achieve product conformity requirements Product Realization Planning of Product Realization Plan processes needed for product realization Develop processes needed for product realization Ensure planning of product realization is consistent with other QMS processes Ensure product realization planning outputs are suitable for method of operation Determine product quality objectives, as appropriate Determines product requirements, as appropriate Determine need to establish product specific processes, as appropriate Determine need to establish product specific documents, as appropriate Determine need to provide product specific resources (as appropriate) Determine product verification criteria (as appropriate) based on specific the product Determine product verification criteria (as appropriate) based on specific product acceptance criteria Determine product validation criteria (as appropriate) based on specific the product Determine product validation criteria (as appropriate) based on specific product acceptance criteria

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.1.c ISO 7.1.c ISO 7.1.c ISO 7.1.c ISO 7.1.c ISO 7.1.c ISO 7.1.d ISO 7.2 ISO 7.2.1 ISO 7.2.1.a ISO 7.2.1.a ISO 7.2.1.a ISO 7.2.1.b ISO 7.2.1.b ISO 7.2.1.c ISO 7.2.1.c ISO 7.2.1.d ISO 7.2.2 ISO 7.2.2 ISO 7.2.2 ISO 7.2.2 ISO 7.2.2 ISO 7.2.2 ISO 7.2.2 ISO 7.2.2

ISO Text (Paraphrased)

Determine product monitoring criteria (as appropriate) based on specific the product Determine product monitoring criteria (as appropriate) based on specific product acceptance criteria Determine product inspection criteria (as appropriate) based on specific the product Determine product inspections criteria (as appropriate) based on specific product acceptance criteria Determine product test activities criteria (as appropriate) based on specific the product Determine product test activities criteria (as appropriate) based on specific product acceptance criteria Determine records needed to provide evidence that realization processes and resulting products meet requirements Customer-Related Processes Determination of Requirements Related to Product Determine customer specified product requirements Determine product delivery requirements Determine product post-delivery activities Determine product requirements, where known, not stated by customer, but necessary for specified use Determine product requirements, where known, not stated by customer, but necessary for intended use Determine product statutory requirements Determine product regulatory requirements Determine any additional product requirements Review of Requirements Related to the Product Review product requirements Ensure product requirements review occurs before commitment to supply product Review result records are maintained Review action records are maintained Ensure confirmation of customer requirements, when customer provides no documented statement of requirements, before acceptance (of contract) Ensure relevant documents are updated when requirements change Ensure relevant personnel are made aware of requirements changes

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.2.2.a ISO 7.2.2b ISO 7.2.2.c ISO 7.2.3 ISO 7.2.3.a ISO 7.2.3.a ISO 7.2.3.b ISO 7.2.3.b ISO 7.2.3.b ISO 7.2.3.b ISO 7.2.3.c ISO 7.2.3.c ISO 7.3 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1 ISO 7.3.1

ISO Text (Paraphrased)

Ensure product requirements are defined by review Ensure that contract/order requirements differing from previously expressed requirements are resolved Ensures organizations ability to meet defined requirements. Customer Communication Determine effective arrangements for communicating with customers product information Implement effective arrangements for communicating with customers product information Determine effective arrangements for communicating with customers enquires Implement effective arrangements for communicating with customers product information enquires Determine effective arrangements for communicating with customers contracts/order handing, including amendments Implement effective arrangements for communicating with customers contracts/order handling, including amendments Determine effective arrangements for communicating with customers customer feedback, including complaints Implement effective arrangements for communicating with customers customer feedback, including complaints Design and Development Design and Development Planning Plan product design Control product design Plan product development Control product development Manage interfaces between design groups to ensure effective communication Manage interfaces between design groups to ensure clear responsibility assignment Manage interfaces between development groups to ensure effective communication Manage interfaces between development groups to ensure clear responsibility assignment Update planning outputs, as appropriate, as the design progresses Update planning outputs, as appropriate, as the development progresses

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.3.1.a ISO 7.3.1.a ISO 7.3.1.b ISO 7.3.1.b ISO 7.3.1.b ISO 7.3.1.b ISO 7.3.1.b ISO 7.3.1.b ISO 7.3.1.c ISO 7.3.1.c ISO 7.3.1.c ISO 7.3.1.c ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2 ISO 7.3.2.a ISO 7.3.2.a

ISO Text (Paraphrased)

Determine design stages during design and development planning Determine development stages during design and development planning Determine appropriate design reviews for each design stage during design and development planning Determine appropriate development reviews for each development stage during design and development planning Determine appropriate design verification for each design stage during design and development planning Determine appropriate development verification for each development stage during design and development planning Determine appropriate design validation for each design stage during design and development planning Determine appropriate development validation for each development stage during design and development planning Determine design responsibilities during design and development planning Determine development responsibilities during design and development planning Determine design authorities during design and development planning Determine development authorities during design and development planning Design and Development Inputs Determine product requirements as design inputs Maintain records of product requirements as design inputs Determine product requirements as development inputs Maintain records of product requirements as development inputs Review design inputs for adequacy Review development inputs for adequacy Verify design requirements are complete Verify development requirements are complete Verify design requirements are unambiguous Verify development requirements are unambiguous Verify design requirements do not conflict with other requirements Verify development requirements do not conflict with other requirements Consider product functional requirements as design inputs Consider product functional requirements as development inputs

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.3.2.a ISO 7.3.2.a ISO 7.3.2.b ISO 7.3.2.b ISO 7.3.2.b ISO 7.3.2.b ISO 7.3.2.c ISO 7.3.2.c ISO 7.3.2.d ISO 7.3.2.d ISO 7.3.3 ISO 7.3.3 ISO 7.3.3 ISO 7.3.3 ISO 7.3.3 ISO 7.3.3.a ISO 7.3.3.a ISO 7.3.3.b ISO 7.3.3.b ISO 7.3.3.b ISO 7.3.3.b ISO 7.3.3.b ISO 7.3.3.b ISO 7.3.3.c ISO 7.3.3.c

ISO Text (Paraphrased)

Consider product performance requirements as design inputs Consider product performance requirements as development inputs Consider applicable statutory requirements as design inputs Consider applicable statutory requirements as development inputs Consider applicable regulatory requirements as design inputs Consider applicable regulatory requirements as development inputs Consider information from previous similar designs, where applicable, as design inputs Consider information from previous similar deigns, where applicable, as development inputs Consider other requirements essential for design and development as design inputs Consider other requirements essential for design and development as development inputs Design and Development Outputs Ensure design outputs format enables verification against design and development inputs Ensure development outputs format enables verification against design and development inputs Ensure design outputs are approved prior to release Ensure development outputs are approved prior to release Ensure design outputs meet input requirements for design and development Ensure development outputs meet input requirements for design and development Ensure design outputs provide appropriate information for purchasing Ensure development outputs provide appropriate information for purchasing Ensure design outputs provide appropriate information for production Ensure development outputs provide appropriate information for production Ensure design outputs provide appropriate information for service provisions Ensure development outputs provide appropriate information fore service provisions Ensure design outputs contain/reference product acceptance criteria Ensure development outputs contain/reference product acceptance

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.3.3.d ISO 7.3.3.d ISO 7.3.3.d ISO 7.3.3.d ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4 ISO 7.3.4.a ISO 7.3.4.a ISO 7.3.4.a ISO 7.3.4.a ISO 7.3.4.b ISO 7.3.4.b ISO 7.3.4.b ISO 7.3.4.b

ISO Text (Paraphrased)

criteria Ensure design outputs specify product characteristics essential for safe use Ensure development outputs specify product characteristics essential for safe use Ensure design outputs specify product characteristics essential for proper use Ensure development outputs specify product characteristics essential for proper use Design and Development Review Ensure systematic design reviews are performed in accordance with plan Ensure systemic development reviews are performed in accordance with plan Ensure system design reviews include participants concerned with the design at that stage Ensure systemic development reviews in participants concerned with the development at that stage Ensure results records from systemic design reviews are maintained Ensure results records from systemic development reviews are maintained Ensure necessary actions records from systemic design reviews are maintained Ensure necessary actions records from systemic development reviews are maintained Ensure the design results to meet design requirements at systemic design reviews Ensure the design results meet development requirements at system development reviews Ensure the development results to meet design requirements at systemic design reviews Ensure the development results meet development requirements at system development reviews Ensure design problems are identified during systemic design reviews Ensure development problems are identified during systemic development reviews Ensure necessary actions are proposed at systemic design reviews Ensure necessary actions are proposed at systemic development reviews

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.3.5 ISO 7.3.5 ISO 7.3.5 ISO 7.3.5 ISO 7.3.5 ISO 7.3.5 ISO 7.3.5 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.6 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7

ISO Text (Paraphrased)

Design and Development Verification Ensure design verifications (i.e., outputs met input requirements) are performed per plan Ensure development (i.e., outputs met input requirements) verifications are performed per plan Ensure design verification results records are maintained Ensure development verifications results records are maintained Ensure design verification necessary actions records are maintained Ensure development verification necessary actions records are maintained Design and Development Validation Ensure design validations (i.e., resulting products are capable of meeting requirements for intended/specified use) are performed per plan Ensure development (i.e., resulting products are capable of meeting requirements for intended/specified use) validations are performed per plan Perform design validations prior to product delivery or product implementation, where practical Perform development validations prior to product delivery or product implementation, where practical Ensure design validations results records are maintained Ensure development validations results records are maintained Ensure design validations necessary actions records are maintained Ensure development validations necessary actions records are maintained Control of Design and Development Changes Ensure design changes are identified Ensure development changes are identified Ensure design change records are maintained Ensure development change records are maintained Ensure design changes are reviewed Ensure development changes are reviewed Ensure design changes are verified, as appropriate Ensure development changes are verified, as appropriate Ensure design changes are validated, as appropriate Ensure development changes are validated, as appropriate Ensure design changes are approved before implementation

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.3.7 ISO 7.4 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.1 ISO 7.4.2 ISO 7.4.2 ISO 7.4.2 ISO 7.4.2.a ISO 7.4.2.a ISO 7.4.2.a

ISO Text (Paraphrased)

Ensure development changes are approved before implementation Ensure design change reviews evaluate the effect of the changes on constituent parts Ensure development change reviews evaluate the effect of the changes on constituent parts Ensure design change reviews evaluate the effect of the changes of delivered product Ensure development change reviews evaluate the effect of the changes of delivered products Ensure design change review results records are maintained Ensure development change review results records are maintained Ensure design change review necessary actions are maintained Ensure development change review necessary actions are maintained Purchasing Purchasing Process Ensure purchased product conforms to specified purchase requirements Ensure type of supplier control depends of effect of purchased product on subsequent product realization or final product Ensure extent of supplier control depends of effect of purchased product on subsequent product realization or final product Evaluate suppliers based on ability to supply products per requirements Select suppliers based on ability to supply products per requirements Ensure selection criteria is established Ensure evaluation criteria is established Ensure re-evaluation criteria is established Ensure supplier evaluation results records are maintained Ensure supplier evaluation necessary actions records are maintained Purchasing Information Ensure purchasing information describes the product being purchased Ensure adequacy of specified purchase requirements prior to their communication to the supplier Ensure purchasing information describes product approval requirements, where appropriate Ensure purchasing information describes procedure approval requirements, where appropriate Ensure purchasing information describes process approval requirements,

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.4.2.a ISO 7.4.2.b ISO 7.4.2.c ISO 7.4.3 ISO 7.4.3 ISO 7.4.3 ISO 7.4.3 ISO 7.4.3 ISO 7.4.3 ISO 7.5 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1 ISO 7.5.1

ISO Text (Paraphrased)

where appropriate Ensure purchasing information describes equipment approval requirements, where appropriate Ensure purchasing information describes personnel qualification requirements, where appropriate Ensure purchasing information describes quality management system requirements, where appropriate Verification of Purchased Product Established inspection (or other) activities to ensure purchased product meets specified purchase criteria Implement inspection (or other) activities to ensure purchased product meets specified purchase criteria State organization or customer intent to perform product verification at supplier premises in purchasing information State verification arrangements, for organization or customer verification at supplier premises, in purchasing information State method of product release, for organization or customer verification at supplier premises, in purchasing information Production and Service Provision Control of Production and Service Provision Plan production under controlled conditions Plan service under controlled conditions Carry out production under controlled conditions Carry out service under controlled conditions Controlled conditions include information that describes product characteristics Controlled conditions include availability of work instructions, as necessary Controlled conditions include use of suitable equipment Controlled conditions include availability of monitoring devices Controlled conditions include availability of measuring devices Controlled conditions include use of monitoring devices Controlled conditions include use of measuring devices Controlled conditions include implementation of monitoring Controlled conditions include implementation of measuring Controlled conditions include implementation of release activities

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.5.1 ISO 7.5.1 ISO 7.5.2 ISO 7.5.2 ISO 7.5.2 ISO 7.5.2.a ISO 7.5.2.a ISO 7.5.2.b ISO 7.5.2.b ISO 7.5.2.c ISO 7.5.2.c ISO 7.5.2.d ISO 7.5.2.e ISO 7.5.3 ISO 7.5.3 ISO 7.5.3 ISO 7.5.3 ISO 7.5.3 ISO 7.5.3 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4 ISO 7.5.4

ISO Text (Paraphrased)

Controlled conditions include implementation of delivery activities Controlled conditions include implementation of post-delivery activities Validation of Processes for Production and Service Provision Validate production processes where resulting output cannot be verified by monitoring/measuring, including any process where deficiencies are apparent only after the product is in use or the service has been delivered Validation demonstrates processes ability to achieve planned results Establish defined criteria for review of these processes Establish defined criteria for approval of these processes Establish arrangements for equipment approval Establish arrangements for personnel qualifications Establish arrangements for use of specific methods Establish arrangements for use of specific procedures Establish arrangements for records requirements Establish arrangements for process revalidation Identification and Traceability Ensure product identification by suitable means, throughout product realization, when appropriate Identify product status with respect to monitoring requirements Identify product status with respect to measurement requirements Where traceability is required, control unique product identification Where traceability is required, record unique product identification Customer Property Exercise care with customer property under organization control Exercise care with customer property being used by the organization Identify customer property provided for use Identify customer property to be incorporated in product Verify customer property provided for use Verify customer property to be incorporated in product Protect customer property provided for use Protect customer property to be incorporated in product Safeguard customer property provided for use Safeguard customer property to be incorporated in product Report lost customer property to the customer Report damaged customer property to the customer Report customer property found to be unsuitable for use to the customer

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.5.4 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.5.5 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6 ISO 7.6

ISO Text (Paraphrased)

Maintain records of customer property
(Note: ISO wording indicates records are required for lost, damaged, unsuitable reporting only this may not meet FAR requirements)

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Preservation of Product Preserve product conformity during internal processing Preserve product conformity during delivery to intended destination Preservation includes identification Preservation includes handling Preservation includes packaging Preservation includes storage Preservation includes protection Preservation also applies to constituent parts Control of Monitoring and Measuring Devices Determine monitoring to be undertaken Determine measurement to be undertaken Determine monitoring devices needed to provide evidence of product conformity to determine requirements Determine measuring devices needed to provide evidence of product conformity to determine requirements Establish processes to ensure monitoring can be carried out consistent with monitoring requirements Establish processes to ensure measurement can be carried out consistent with monitoring requirements Assess validity of previous measuring results when equipment is found to not conform to requirements (i.e., out-of-specification) Record previous measurement validity assessments Take appropriate action to repair/replace out-of-specification measuring equipment Take appropriate action for product affected by measuring equipment found to be out-of-specification Ensure measuring equipment calibration results records are maintained Ensure measuring equipments verification results records are maintained Prior to initial use, confirm computer softwares ability to satisfy requirements when used in monitoring or measurement to specified requirements Reconfirm, as necessary, computer softwares ability to satisfy requirements when used in monitoring or measurement to specified

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 7.6.a ISO 7.6.a ISO 7.6.b ISO 7.6.c ISO 7.6.d ISO 7.6.e ISO 7.6.e ISO 7.6.e ISO 7.6.e ISO 7.6.e ISO 7.6.e ISO 8 ISO 8.1 ISO 8.1 ISO 8.1 ISO 8.1.a ISO 8.1.a ISO 8.1.a ISO 8.1.a ISO 8.1.a ISO 8.1.a

ISO Text (Paraphrased)

requirements Calibrate or verify measuring equipment used for results validation at specified intervals (or prior to use) against standards traceable to national or international standards Where no national or international calibration measurement standard exists, record the basis used for calibration or verification Adjust/Re-adjust measuring equipment used for results validation as necessary Identify calibration status on measuring equipment used for results validation Safeguard measuring equipment used for results validation from adjustment that would invalidate measurement results Protect measuring equipment used for results validation from damage during handling Protect measuring equipment used for results validation from damage during maintenance Protect measuring equipment used for results validation from damage during storage Protect measuring equipment used for results validation from deterioration during handling Protect measuring equipment used for results validation from deterioration during maintenance Protect measuring equipment used for results validation from deterioration during storage Measurement, Analysis, and Improvement General Ensure determination of applicable methods, including statistical techniques Ensure determination of the extent of applicable method use Plan monitoring processes needed to demonstrate product conformity Implement monitoring processes needed to demonstrate product conformity Plan measurement processes needed to demonstrate product conformity Implement measurement processes needed to demonstrate product conformity Plan analysis processes needed to demonstrate product conformity Implement analysis processes needed to demonstrate product conformity

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 8.1.a ISO 8.1.a ISO 8.1.b ISO 8.1.b ISO 8.1.b ISO 8.1.b ISO 8.1.b ISO 8.1.b ISO 8.1.b ISO 8.1.b ISO 8.1.c ISO 8.1.c ISO 8.1.c ISO 8.1.c ISO 8.1.c ISO 8.1.c ISO 8.1.c ISO 8.1.c ISO 8.2 ISO 8.2.1 ISO 8.2.1 ISO 8.2.1 ISO 8.2.1 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2.a ISO 8.2.2.a ISO 8.2.2.b ISO 8.2.2.b ISO 8.2.2 ISO 8.2.2

ISO Text (Paraphrased)

Plan improvement processes needed to demonstrate product conformity Implement improvement processes needed to demonstrate product conformity Plan monitoring processes needed to ensure QMS conformity Implement monitoring processes needed to ensure QMS conformity Plan measurement processes needed to ensure QMS conformity Implement measurement processes needed to ensure QMS conformity Plan analysis processes needed to ensure QMS conformity Implement analysis processes needed to ensure QMS conformity Plan improvement processes needed to ensure QMS conformity Implement improvement processes needed to ensure QMS conformity Plan monitoring processes needed to improve QMS effectivity Implement monitoring processes needed to improve QMS effectivity Plan measurement processes needed to improve QMS effectivity Implement measurement processes needed to improve QMS effectivity Plan analysis processes needed to improve QMS effectivity Implement analysis processes needed to improve QMS effectivity Plan improvement processes needed to improve QMS effectivity Implement improvement processes needed to improve QMS effectivity Monitoring and Measurement Customer Satisfaction Monitor customer perception as to organizations meeting customer requirements Determine methods for obtaining customer perception data Determine methods for using customer perception data Internal Audit Conduct internal audits at planned intervals Internal audits determine QMS conformity to planned arrangements (reference 7.1) Internal audits determine QMS conformity to this ISO standard Internal audits determine QMS conformity to QMS established requirements Internal audits determine QMS implementation effectivity Internal audits determine QMS maintenance effectivity Plan the audit program Ensure audit program considers process status

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.2 ISO 8.2.3 ISO 8.2.3 ISO 8.2.3 ISO 8.2.3

ISO Text (Paraphrased)

Ensure audit program considers process importance Ensure audit program considers status of areas to be audited Ensure audit program considers importance of areas to be audited Ensure audit program considers results of previous audits Define audit criteria Define audit scope Define audit frequency Define audit methods Ensure auditor selection assures audit objectivity Ensure auditor selection assures audit impartiality Ensure auditor conduct assures audit objectivity Ensure auditor conduct assures audit impartiality Ensure auditors do not audit their own work Define, in a documented procedure, audit planning responsibilities Define, in a documented procedure, audit conducting responsibilities Define, in a documented procedure, audit planning requirements Define, in a documented procedure, audit conducting requirements Define, in a documented procedure, audit results reporting responsibilities Define, in a documented procedure, audit results reporting requirements Define, in a documented procedure, audit record maintenance responsibilities Define, in a documented procedure, audit record maintenance requirements Audited are management ensures actions are taken, without undue delay, to eliminate detected nonconformities Audited area management ensures actions are taken, without undue delay, to eliminate the causes of detected nonconformities Ensure audit follow-up activities verify actions taken associated with the conducted audit Ensure audit follow-up verification results activities are reported Monitoring and Measurement of Processes Apply suitable methods for monitoring QMS processes Apply suitable methods for measurement, where applicable, of QMS processes Methods ensure the ability of the processes to achieve planned results

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 8.2.3 ISO 8.2.3 ISO 8.2.4 ISO 8.2.4 ISO 8.2.4 ISO 8.2.4 ISO 8.2.4 ISO 8.2.4

ISO Text (Paraphrased)

Make QMS process correction, as appropriate, when planned results are not achieved to ensure product conformity Take QMS process corrective action, as appropriate, when planned results are not achieved to ensure product conformity Monitoring and Measurement of Product Monitor product characteristics to verify product requirements are met Measure product characteristics to verify product requirements are met Ensure evidence of conformity with acceptance criteria is maintained Ensure records indicate personnel authorizing product release Ensure product release does not occur unless planned arrangements (reference 7.1) are satisfactorily completed
(Note: Product release can occur if authorized by a relevant organization authority and, when applicable, by the customer an example would be delivery of a product on an approved waiver or deviation)

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ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3 ISO 8.3.a ISO 8.3.b

Control of Nonconforming Product Ensure nonconforming product is identified Ensure nonconforming product is controlled to prevent unintended use Ensure nonconforming material is controlled to prevent unintended delivery Have a documented procedure that defines the controls and related responsibilities and authorities for dealing with nonconforming product Maintain records of nonconformities including subsequent actions taken and concessions obtained (if applicable) Re-verify corrected nonconforming product to demonstrate conformity to requirements Take appropriate action regarding the effects or potential effects of nonconforming product detected after delivery Take appropriate action regarding the effects or potential effects of nonconforming product detected after the product has been put in use One method to deal with nonconforming product is to take action to eliminate the detected nonconformity (e.g., rework or standard repair)
(Note: use this or another defined method)

One method to deal with nonconforming product is to authorize its use, release, or acceptance by concession of a relevant authority and, where applicable, by the customer (e.g. material review board use-as-is or nonstandard repair)
(Note: use this or another defined method)

ISO 8.3.c

One method to deal with nonconforming product is to take action to

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4 ISO 8.4.a ISO 8.4.b ISO 8.4.c ISO 8.4.c ISO 8.4.c ISO 8.4.c ISO 8.4.c ISO 8.4.c ISO 8.5 ISO 8.5.1 ISO 8.5.1 ISO 8.5.1 ISO 8.5.1 ISO 8.5.1 ISO 8.5.1 ISO 8.5.1 ISO 8.5.1 ISO 8.5.2 ISO 8.5.2 ISO 8.5.2 ISO 8.5.2.a

ISO Text (Paraphrased)

preclude its original intended use or application (e.g., scrap)
(Note: use this or another defined method)

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Analysis of Data Determine appropriate data to demonstrate QMS suitability Determine appropriate data to determine QMS effectiveness Collect data to determine QMS suitability Collect data to determine QMS effectiveness Analyze data to determine QMS suitability Analyze data to determine QMS effectivity Evaluate continuous improvement opportunities related to QMS effectiveness Include data as a result of monitoring activities Include data as a result of measurement activities Include other relevant data Data analysis includes customer satisfaction information Data analysis includes product conformity information Data analysis includes process characteristic information Data analysis includes product characteristic information Data analysis includes process trend information Data analysis includes product trend information Data analysis includes opportunities for preventative actions Data analysis includes supplier information Improvement Continual Improvement Continually improve QMS effectiveness using quality policy Continually improve QMS effectiveness using quality objectives Continually improve QMS effectiveness using audit results Continually improve QMS effectiveness using data analysis Continually improve QMS effectiveness using corrective actions Continually improve QMS effectiveness using preventative actions Continually improve QMS effectiveness using management reviews Corrective Action Take action to eliminate causes of nonconformance to prevent recurrence Ensure corrective actions are appropriate to the nonconformance effects Establish a documented procedure that defines nonconformance review requirements

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Quality Management System ISO 9001-2000 Requirements and Status Matrix

ISO 9000 Reference
ISO 8.5.2.a ISO 8.5.2.b ISO 8.5.2.b ISO 8.5.2.c ISO 8.5.2.c ISO 8.5.2.d ISO 8.5.2.d ISO 8.5.2.e ISO 8.5.2.f ISO 8.5.3 ISO 8.5.3 ISO 8.5.3 ISO 8.5.3.a ISO 8.5.3.a ISO 8.5.3.b ISO 8.5.2.c ISO 8.5.3.c ISO 8.5.3.d ISO 8.5.3.e

ISO Text (Paraphrased)

Establish a documented procedure that defines customer complaint review requirements Establish a documented procedure that defines nonconformance cause determination Establish a documented procedure that defines customer complaint cause determination Establish a documented procedure that defines action evaluation to ensure nonconformances do not recur Establish a documented procedure that defines action evaluation to ensure customer complaints do not recur Establish a documented procedure that determines when action is needed Establish a documented procedure for implementing required action Establish a documented procedure that defines the records required as results of actions taken Establish a documented procedure for review corrective action taken Preventative Action Determine actions to eliminate potential nonconformance causes in order to prevent the nonconformance from occurring Ensure preventative action is appropriate to potential problems effects Establish a documented procedure that defines potential nonconformance determination Establish a documented procedure that defines potential nonconformance cause determination Establish a documented procedure that defines action to prevent nonconformance need evaluation Establish a documented procedure that defines action need determination Establish a documented procedure that defines action need implementation Establish a documented procedure that defines action taken results records requirements Establish a documented procedure that defines preventive action taken review requirements

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