ISO 9001 Standards Requirement – Product Realization
Planning of Product RealizationPlan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the:Quality objectives and product requirementsNeed for processes, documents, and resourcesVerification, validation, monitoring, measurement, inspection, and test activitiesCriteria for product acceptanceRecords as evidence the processes and resulting product meet requirements
Customer-Related Processes
Determination of Requirements Related to the ProductDetermine customer requirements:Specified for the product (including delivery and post-delivery activities)Not specified for the product (but needed for specified or intended use, where known)Determine:Statutory and regulatory requirements applicable to the productAny additional requirements considered necessary by the organization
Review of Requirements Related to the ProductReview the product requirements before committing to supply the product to the customer in order to:Ensure product requirements are definedResolve any requirements differing from those previously expressedEnsure its ability to meet the requirementsMaintain the results of the review, and any subsequent follow-up actions. When the requirements are not documented, they must be confirmed before acceptance.If product requirements are changed, ensure relevant documents are amended and 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 catalogs or advertising material.
Customer CommunicationDetermine and implement effective arrangements for communicating with customers on:Product informationInquiries, contracts, or order handling (including amendments)Customer feedback (including customer complaints)
Friday, October 9, 2009
ISO 9001 Standards Requirements – Design and Development
ISO 9001 Standards Requirements – Design and Development
Design and Development PlanningPlan and control the product design and development. This planning must determine the:Stages of design and developmentAppropriate review, verification, and validation activities for each stageResponsibility and authority for design and developmentThe interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Design and Development InputsDetermine product requirement inputs and maintain records. The inputs must include:Functional and performance requirementsApplicable statutory and regulatory requirementsApplicable information derived from similar designsRequirements essential for design and developmentReview these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Design and Development OutputsDocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:Meet design and development input requirementsProvide information for purchasing, production, and serviceContain or reference product acceptance criteriaDefine essential characteristics for safe and proper useBe approved before their release
Design and Development ReviewPerform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:Evaluate the ability of the results to meet requirementsIdentify problems and propose any necessary actionsThe reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Design and Development VerificationPerform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.
Design and Development ValidationPerform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.
Control of Design and Development ChangesIdentify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.
Design and Development PlanningPlan and control the product design and development. This planning must determine the:Stages of design and developmentAppropriate review, verification, and validation activities for each stageResponsibility and authority for design and developmentThe interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Design and Development InputsDetermine product requirement inputs and maintain records. The inputs must include:Functional and performance requirementsApplicable statutory and regulatory requirementsApplicable information derived from similar designsRequirements essential for design and developmentReview these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Design and Development OutputsDocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:Meet design and development input requirementsProvide information for purchasing, production, and serviceContain or reference product acceptance criteriaDefine essential characteristics for safe and proper useBe approved before their release
Design and Development ReviewPerform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:Evaluate the ability of the results to meet requirementsIdentify problems and propose any necessary actionsThe reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Design and Development VerificationPerform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.
Design and Development ValidationPerform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.
Control of Design and Development ChangesIdentify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.
What is a “document” In ISO 9001 Standard?
What is a “document” In ISO 9001 Standard?
The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;a) Communication of Information as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.b) Evidence of conformity provision of evidence that what was planned, has actually been done.c) Knowledge sharing to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:papermagneticelectronic or optical computer discphotographmaster sample
The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;a) Communication of Information as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.b) Evidence of conformity provision of evidence that what was planned, has actually been done.c) Knowledge sharing to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:papermagneticelectronic or optical computer discphotographmaster sample
Organizations preparing to implement a QMS For ISO 9001
Organizations preparing to implement a QMS For ISO 9001
For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:- Identifying the processes necessary for the effective implementation of the quality management system- understanding the interactions between these processes.- documenting the processes to the extent necessary to assure their effective operation and control. (It may beappropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)These processes include the management, resource, product realization and measurement processes that are relevantto the effective operation of the QMS.Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.
For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:- Identifying the processes necessary for the effective implementation of the quality management system- understanding the interactions between these processes.- documenting the processes to the extent necessary to assure their effective operation and control. (It may beappropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)These processes include the management, resource, product realization and measurement processes that are relevantto the effective operation of the QMS.Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.
Outsourced Processes In ISO 9001 Standards
Outsourced Processes In ISO 9001 Standards
One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).• The organization does not have the competence to carry out the process itself, and chooses to outsource it.
One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).• The organization does not have the competence to carry out the process itself, and chooses to outsource it.
Demonstrating conformity with ISO 9001:2008
Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.Organizations may be able to demonstrate conformity without the need for extensive documentation.To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)Planning of product realization, and clause 8.2.4
Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.Organizations may be able to demonstrate conformity without the need for extensive documentation.To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)Planning of product realization, and clause 8.2.4
Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.
Records required by ISO 9001:2008
Records required by ISO 9001:2008
Clause Record required5.6.1 Management reviews6.2.2 e) Education, training, skills and experience7.1 d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained8.5.2 e) Results of corrective action8.5.3 d) Results of preventive action
Clause Record required5.6.1 Management reviews6.2.2 e) Education, training, skills and experience7.1 d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained8.5.2 e) Results of corrective action8.5.3 d) Results of preventive action
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