Iso2008 Qms

Document originator Document title Document number
Management Representative Quality Management System Manual QMS-M-001-00 Name
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REVISION HISTORY Revision number 00 DCF # DCF date Revision description Initial issue
More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com
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Management Representative Quality Management System Manual QMS-M-001-00
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Table of contents ISO 9001:2008 Clause 1 2 3 4 5 6 7 8 Manual Clause 1 2 3 4 5 6 7 8 Title Page
Front cover Table of Contents Scope References Terms and definitions Quality Management System Management responsibility Resource management Product realization Measurement, analysis and improvement
1 2 3 4 5 6 10 14 16 25
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 1 Scope 1.1 1.2 This manual describes the organizations quality management system in terms of The purpose of the quality management system is to 1.2.1 1.2.2 demonstrate its ability to consistently provide product that meets enhance customer satisfaction through the effective application of customer and applicable statutory and regulatory requirements, and the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. 1.3 The quality management system applies to the following products of the 1.3.1 1.3.2 1.4 Exclusions 1.4.1 1.4.2 1.4.3 State which clauses of the ISO 9001:2008 that do not apply to Exclusions are limited to sections within Clause 7 only. Delete the sections of the manual that are excluded from the Example, if your organization does not your quality management system. Describe your products here. Attach or insert your products process map here and describe it organization:
its policies, objectives and processes.
textually.
quality management system. Clause 7.3 from the manual.
design your products, Clause 7.3 is not applicable. Therefore, delete
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 2 References 2.1 These documents serve as references in the quality management system: 2.1.1 2.1.2 2.1.3 ISO 9001:2008 Quality management systems Requirements ISO 9000:2005 Quality management systems- Fundamentals and ISO 19011:2002 Guidelines for quality and/or environmental (Document ID #QMS-XX-XX-XX) vocabulary (Document ID #QMS-XX-XX-XX) management systems auditing (Document ID #QMS-XX-XX-XX)
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 3 Terms and definitions 3.1 For the purposes of this quality management system, the terms and definitions given in ISO 9000 apply. 3.2 Throughout the text of this manual, wherever the term "product" occurs, it also means "service". 3.3 Local terms that are unique to the organization and are used within this manual: 3.3.1 List unique acronyms, titles, references which are used within your QMS.
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 4 Quality Management System 4.1 General requirements 4.1.1 This quality management system has been established and documented in accordance with the requirements of ISO 9001:2008, which is an international standard for a quality management system. 4.1.2 The quality management system is made up of the processes for 4.1.2.1 Management activities (reference Clause 5), 4.1.2.2 Provision of resources(reference Clause 6), 4.1.2.3 Product realization (reference Clause 7),, and 4.1.2.4 Measurement, analysis and improvement (reference Clause 8). 4.1.3 4.1.4 The Quality Management System Flow Diagram (Figure 1) describes the sequence and interaction of these processes. The quality management system defines the 4.1.4.1 criteria and methods needed to ensure that both the operation and control of processes are effective; 4.1.4.2 necessary resources that are required in order to support the operation of the quality management system; and 4.1.4.3 monitoring, measurement (where applicable) and analysis of the processes.. 4.1.5 4.2 4.2.1 4.2.1.1 In operating the quality management system, the organization is committed to continually improve its effectiveness in meeting its objectives. Documentation requirements The quality management system documentation is made up of 4.2.1.1.1 statements of policies and objectives, General
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4.2.1.1.2
a quality manual, 4.2.1.1.3 documented procedures and records required by the ISO 9001:2008, and 4.2.1.1.4 other documents, including records, which are necessary to ensure the effective planning, operation and control of the quality management systems processes.
4.2.2
Quality Manual (Document ID #QMS-M-001-00) 4.2.2.1.1 describes the scope of the quality management system, including details of and justification for any exclusions, 4.2.2.1.2 includes references to the documented procedures established for the quality management system, and 4.2.2.1.3 describes the interactions of the process of the quality management system.
4.2.2.1 This quality management system manual
4.2.3
Control of documents (Document ID #QMS-XX-XX-XX) 4.2.3.1 A documented procedure has been established to define the controls needed to 4.2.3.1.1 approve documents for adequacy prior to issue, 4.2.3.1.2 review and update as necessary and re-approve documents, 4.2.3.1.3 ensure that the changes and the current revision status of documents are identified, 4.2.3.1.4 ensure that relevant versions of applicable documents are available at points of use, 4.2.3.1.5 ensure that documents of external origin are identified and their distribution controlled, and 4.2.3.1.6 prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com 4.2.4 Control of records (Document ID #QMS-XX-XX-XX) 4.2.4.1 4.2.4.2 Records are established to provide evidence of conformity to requirements and of the effective operation of the quality management system. A documented procedure has been established to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. 4.2.4.3 Records are maintained in order to ensure that they remain legible and are readily identifiable and retrievable.
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Figure 1: Quality Management System Flow Diagram
(Note: You may need to expand this flow diagram to reflect the actual processes of your organization. And to facilitate better document change management, you can create this flow diagram as a separate document and as an attachment to the QMS Manual.)
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 5 Management responsibility 5.1 Management commitment 5.1.1 The top management of the organization is committed to continually improve the quality management system and this is demonstrated by 5.1.1.1 communicating to the organization of the importance of meeting customer as well as statutory and regulatory requirements, 5.1.1.2 establishing the quality policy, 5.1.1.3 ensuring that quality objectives are established, 5.1.1.4 conducting management reviews, and 5.1.1.5 ensuring the availability of resources. 5.2 Customer focus 5.2.1 Top management ensures that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 5.3 Quality Policy (Document ID #QMS-XX-XX-XX) 5.3.1 5.3.2 Top management has established a quality policy that states the organizations position with regard to product quality. It is appropriate to the purpose of the organization and includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system. 5.3.3 5.3.4 The quality policy also provides a framework for establishing and reviewing quality objectives. Top management ensures that the quality policy is communicated and understood within the organization, and is reviewed for continuing suitability. 5.4 Planning 5.4.1 Quality objectives (Document ID #QMS-XX-XX-XX) More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com
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5.4.1.1 Quality objectives, including those to meet requirements for products, are established at relevant functions and levels within the organization. 5.4.1.2 The quality objectives are measurable and consistent with the quality policy. 5.4.1.3 Quality objectives are used as the primary tool of controlling a given process in terms of its performance and effectiveness. 5.4.2 Quality management system planning 5.4.2.1 Top management ensures that the planning of the quality management system is carried out in order to meet all requirements as well as the quality objectives, and the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority (Document ID #QMS-XX-XX-XX) 5.5.1.1 Top management ensures that responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management Representative 5.5.2.1 Top management has appointed a member of the organization's management who, irrespective of other responsibilities, is responsible and has the authority in 5.5.2.1.1 ensuring that processes needed for the quality management system are established, implemented and maintained, 5.5.2.1.2 reporting to top management on the performance of the quality management system and any need for improvement, and
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5.5.2.1.3
ensuring the promotion of awareness of
customer requirements throughout the organization. 5.5.2.2 The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system. 5.5.2.3 The Management Representative is assisted at the departmental level by Quality Representatives. 5.5.2.3.1 Manager. 5.5.2.3.2 The Quality Representative is responsible for the quality processes which are applicable to his/her department. 5.5.2.3.3 The Quality Representative heads the Quality Improvement Team which is established for the purpose of identifying opportunities for improvements within each department. 5.5.2.4 Collectively, the Management Representative and the Quality Representatives Committee. represent the Quality Management System This committee meets regularly to ensure that This position is assumed by the Department
communications and subsequent resolutions about the effectiveness of the quality management system take place. 5.5.3 Internal communication 5.5.3.1 Top management ensures that appropriate communication processes are established within the organization. 5.5.3.2 The Quality Management System Committee and the Quality Improvement Teams meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place.
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5.5.3.3 Meeting minutes are maintained in order to ensure the effectiveness of the communications. More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com 5.6 Management review 5.6.1 General 5.6.1.1 Top management reviews the quality management system at planned intervals in order to ensure its continuing suitability, adequacy and effectiveness. 5.6.1.2 This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. 5.6.1.3 Records such as meeting minutes and supplemental documents from management reviews are maintained. 5.6.2 Review input 5.6.2.1 The inputs to a management review include information on 5.6.2.1.1 results of audit, 5.6.2.1.2 customer feedback, 5.6.2.1.3 process performance and product conformity, 5.6.2.1.4 status of preventive and corrective actions, 5.6.2.1.5 follow-up actions from previous management reviews, 5.6.2.1.6 changes that could affect the quality management system, and 5.6.2.1.7 recommendations for improvement. 5.6.2 Review output 5.6.2.1 The outputs from the management review include decisions and actions related to the 5.6.2.1.1 improvement of the effectiveness of the quality management system and its processes,
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5.6.2.1.2 improvement of product related to customer requirements, and 5.6.2.1.3 resource needs. More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 6 Resource management 6.1 Provision of resources 6.1.1 The organization is committed to continually improve the To achieve this, effectiveness of the quality management system in order to meet customer requirements and to enhance customer satisfaction. 6.1.2 6.1.3 6.1.3.1 required resources are determined and provided for as necessary. Records of resource planning are maintained. (Document ID #QMS-XX-XX-XX) Human resources General 6.1.3.2 The organization ensures that personnel performing work affecting conformity to product quality requirements are competent on the basis of appropriate education, training, skills and experience. 6.1.3.3 Competence, training and awareness (Document ID #QMS-XX-XX-XX) 6.1.3.3.1 The Employee Induction program ensures that all personnel are made aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. 6.1.3.3.2 In order to ensure the competency of personnel within the quality management system, the organization 6.1.3.3.2.1 determines the necessary competency requirements, 6.1.3.3.2.2 provides training or take other actions to achieve the necessary competence, and
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6.1.3.3.2.3 evaluates the effectiveness of the actions taken. 6.1.3.3.3 6.2 Infrastructure 6.2.1 Requirements for necessary infrastructure such as buildings, workspace and associated utilities, process equipment (both hardware and software), and supporting services such as transport, or communication, or information systems are determined, provided for and maintained in order to ensure conformity to product requirements. 6.3 Work environment 6.3.1 A conducive working environment which relates to conditions under which work is performed including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather is maintained and improved upon in order to ensure conformity to product requirements Appropriate records of education, training, skills and experience are maintained.
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Clause 7 Product realization 7.1 General 7.1.1 The organization defines the processes needed for product realization in order to ensure that all customer and applicable legal requirements are met and complied with. 7.1.2 The product quality planning includes: 7.1.2.1 Determination of quality objectives and requirements for the product; 7.1.2.2 Description of the necessary processes, 7.1.2.3 7.1.2.4 Required documentation, Provision of resources specific to the product; 7.1.2.5 Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; and 7.1.2.6 Records needed to provide evidence that the realization processes and resulting product meet all specified requirements. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product (Document ID #QMSXX-XX-XX) 7.2.1.1 In determining the requirements related to the product, these requirements are considered: 7.2.1.1.1 requirements specified by the customer, including the requirements for delivery and post-delivery activities, 7.2.1.1.2 requirements not stated by the customer but necessary for specified or intended use, where known, 7.2.1.1.3 applicable statutory and regulatory requirements related to the product, and
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7.2.1.1.4 More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com 7.2.1.1.5 additional requirements considered necessary by the organization. 7.2.2 Review of requirements related to the product (DOCUMENT ID # QMSXX-XX-XX) 7.2.2.1 The organization conducts reviews of the requirements related to the product prior to the organization's commitment to supply any product to the customer. These reviews ensure that 7.2.2.1.1 product requirements are defined, 7.2.2.1.2 contract or order requirements differing from those previously expressed are resolved, and 7.2.2.1.3 the organization has the ability to meet the defined requirements. 7.2.2.2 Where the customer provides no documented statement of requirement, the customer requirements are confirmed by the organization before acceptance. 7.2.2.3 Where product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements. 7.2.2.4 Records of the results of the review and actions arising from the review are maintained. 7.2.3 Customer communication 7.2.3.1 The organization implements effective arrangements for communicating with customers in relation to product information, enquiries, contracts or order handling, including amendments, and customer feedback, including customer complaints. 7.3 7.3.1 Design and development (Document ID # QMS XX-XX-XX) Design and development planning
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7.3.1.1 More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com 7.3.1.2 7.3.1.2.1 In planning and controlling the design and development of a product, the organization determines the design and development stages, 7.3.1.2.2 7.3.1.2.3 7.3.1.3 review, verification and validation that are appropriate to each design and development stage, and responsibilities and authorities for design and development. Design and development review, verification and validation are conducted and recorded separately or in any combination, as suitable for the product and the organization. 7.3.1.4 The interfaces between different groups involved in design and development are controlled appropriately in order to ensure effective communication and clear assignment of responsibility and the planning output are updated, as appropriate, as the design and development progresses. 7.3.2 Design and development inputs. 7.3.2.1 Inputs relating to product requirements are determined and records maintained. The inputs include 7.3.2.1.1 functional and performance requirements, 7.3.2.1.2 applicable statutory and regulatory requirements, 7.3.2.1.3 7.3.2.1.4 7.3.2.2 7.3.3 where applicable, information derived from previous similar designs, and other requirements essential for design and development. These inputs are reviewed for adequacy to ensure that they are complete, unambiguous and not in conflict with each other. Design and development outputs
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7.3.3.1
The outputs of design and development enable suitable verification to be performed against the design and development inputs and are approved prior to release.
7.3.3.2
The organization ensures that all design and development outputs 7.3.3.2.1 7.3.3.2.2 meet the input requirements for design and development, provide appropriate information for purchasing, production, service provision and details for the preservation of product. 7.3.3.2.3 7.3.3.2.4 contain or reference product acceptance criteria, and specify the characteristics of the product that are essential for its safe and proper use.
7.3.4
Design and development review 7.3.4.1 7.3.4.2 Systematic reviews of design and development are performed in accordance with planned arrangements at suitable stages. These reviews are conducted for the purposes of evaluating the ability of the results of design and development to meet requirements, and identifying any problems and propose necessary actions. 7.3.4.3 Participants in such reviews include representatives of functions concerned with the design and development stages being reviewed. 7.3.4.4 Records of the results of the reviews and any necessary actions are maintained.
7.3.5
Design and development verification 7.3.5.1 Verification is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com
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7.3.5.2 7.3.6
Records of the result of the verification and any necessary actions are maintained.
Design and development validation 7.3.6.1 Design and development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, when known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. 7.3.6.2 Records of the results of validations and any necessary actions are maintained.
7.3.7
Control of design and development changes 7.3.7.1 Design and development changes are identified and records maintained. The changes are reviewed, verified and validated, as appropriate, and approved before implementation. 7.3.7.2 The review of design and development changes includes evaluation of the effect of changes on constituent parts and product already delivered. 7.3.7.3 Records of the results of the review of changes and any necessary actions are maintained.
7.4 7.4.1
Purchasing (Document ID # QMS XX-XX-XX) General 7.4.1.1 The organization ensures that purchased products conform to specified requirements. The type and extent of control applied to the suppliers and the purchased products are dependent upon the effect of the purchased product on subsequent product realization or the final products. 7.4.1.2 The criteria for selection, evaluation and re-evaluation of suppliers are maintained.
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7.4.1.3
The organization evaluates and selects suppliers based on their ability to supply product in accordance with the organizations requirements.
7.4.1.4 7.4.2
Records of the results of evaluations and any necessary actions arising from the evaluation are maintained.
Purchasing information 7.4.2.1 Purchasing information that is generated from the design and development process describes the product to be purchased, including where appropriate 7.4.2.1.1 7.4.2.1.2 personnel, and 7.4.2.1.3 requirements. 7.4.2.2 The organization ensures the adequacy of purchase requirements prior to their communication to the suppliers. quality management system requirements for approval of product, requirements for qualification of procedures and equipment,
7.4.3
Verification of purchased product 7.4.3.1 The organization inspects and tests all purchased products, where appropriate, in order to ensure that they meet specified purchase requirements. 7.4.3.2 Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
7.5
Production and service operations (Document ID # QMS XX-XX-XX) 7.5.1 General
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7.5.1.1
The organization plans and carries out production and service provisions under controlled conditions. include 7.5.1.1.1 the availability of information that describes the characteristics of the product, 7.5.1.1.2 the availability of work instructions, as necessary, 7.5.1.1.3 the use of suitable equipments, 7.5.1.1.4 the availability and use of monitoring and measuring equipments, 7.5.1.1.5 the implementation of monitoring and measurement, and 7.5.1.1.6 the implementation of product release, delivery and postdelivery activities. Controlled conditions
7.5.2
Validation of processes for production and service provision 7.5.2.1 The organization validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. 7.5.2.2 Where applicable, the validation process includes 7.5.2.2.1defined 7.5.2.2.2approval 7.5.2.2.3use procedures, 7.5.2.2.4requirements for records, and of criteria of specific for review and and and approval of the processes, equipment methods qualification of personnel,
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7.5.2.2.5re-validation. 7.5.3 Identification and traceability 7.5.3.1 All product status is identified throughout product realization with respect to monitoring and measurement requirements. 7.5.3.2 Where traceability is a requirement, the organization controls and records the unique identification of the product and maintains appropriate records. 7.5.4 Customer property 7.5.4.1 The organization reports any customer property that is lost, damaged, or otherwise found to be unsuitable for use, to the customer and maintains appropriate records. personal data. 7.5.5 Preservation of product 7.5.5.1 All products including their constituents are preserved during internal processing and delivery to the intended destination in order to maintain conformity to requirements. Preservation activities include identification, handling, packaging, storage and protection. 7.6 Control of monitoring and measuring equipment QMS-XX-XX-XX) 7.6.1 The organization maintains necessary monitoring and measurement processes that are to be undertaken in order to provide evidence of conformity of product requirements. 7.6.2 7.6.2.1 In order to ensure valid results, measuring equipments are calibrated or verified, or both, at specified interval, or prior to use, against measurement standards traceable to international or national measurement standards; where no (DOCUMENT ID # These customer properties may include intellectual property and
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such standards exist, the basis used for calibration or verification are recorded; 7.6.2.2 7.6.2.3 7.6.2.4 7.6.2.5 7.6.3 adjusted or re-adjusted as necessary; identified in order to determine its calibration status; safeguarded from adjustment that would invalidate the measurement result; and protected from damage and deterioration during handling, maintenance and storage. Records of the previous measuring results are assessed to ensure validity when the equipment is found not to conform to requirements and appropriate actions shall be taken on the equipment and any product affected. 7.6.4 Records of the results of calibration and verification are maintained.
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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com Clause 8 Measurement, analysis and improvement 8.1 General 8.1.1 8.1.1.1 8.1.1.2 The organization plans and implements necessary monitoring, measurement, analysis and improvement processes needed in order to demonstrate conformity to product requirements, ensure conformity of the quality management system, and 8.1.1.3 continually improve the effectiveness of the quality management system. 8.1.2 8.2 8.2.1 These processes include determination of applicable methods, including statistical techniques, and the extent of their use. Monitoring and measurement Customer satisfaction (DOCUMENT ID # QMS-XX-XX-XX) 8.2.1.1 Information relating to customer perception is monitored and measured in order to quantify customer satisfaction levels. 8.2.1.2 Monitoring customer perception may include obtaining input from sources such as 8.2.1.2.1 customer satisfaction surveys, 8.2.1.2.2 user opinion surveys, 8.2.1.2.3 lost business analysis, 8.2.1.2.4 compliments, 8.2.1.2.5 warranty claims, etc.
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8.2.2
Internal audit (DOCUMENT ID # QMS-XX-XX-XX) 8.2.2.1 Internal audits are conducted at planned interval to determine whether the quality management system 8.2.2.1.1 conforms to the quality management system requirements, 8.2.2.1.2 conforms to the requirements of the ISO 9001:2008 International Standard, and 8.2.2.1.3 is effectively implemented and maintained. 8.2.2.2 The audit programme is planned accordingly, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. 8.2.2.3 The audit criteria, scope, frequency and methods are defined. 8.2.2.4 Auditors are ensured to be objective, impartial and independent of the area being audited. 8.2.2.5 A documented procedure is established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. 8.2.2.6 Records of the audits and their results are maintained. 8.2.2.7 The management responsible for the area being audited ensures that any necessary corrections and corrective are taken without undue delay to eliminate detected nonconformities and their causes. 8.2.2.8 Follow-up activities include the verification of the actions taken and the reporting of verification results. 8.2.3Monitoring and measurement of processes (DOCUMENT ID # QMS-XXXX-XX) 8.2.3.1 Suitable methods for monitoring and, where applicable, measurement of the quality management system processes are applied in order to demonstrate the ability of the processes to achieve planned results.
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8.2.3.2 When determining suitable methods, the organization considers the type and extent of monitoring or measurement appropriate to each of the processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. 8.2.3.3 When planned results are not achieved, correction and corrective action are taken, as appropriate. 8.2.4 Monitoring and measurement of product 8.2.4.1 Product characteristics are monitored and measured in order to verify that requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements for the product. 8.2.4.2 Evidence of conformity with the acceptance criteria are maintained and appropriate records indicate the person(s) authorizing release of product for delivery to the customer. 8.2.4.3 The release of product and delivery of service to the customer does not proceed until the planned arrangements for the product have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. 8.3 Control of nonconforming product (DOCUMENT ID # QMS-XX-XXX-XX) 8.3.1 The organization ensures that products which do not conform to product requirements are identified and controlled to prevent unintended use or delivery. 8.3.2 A documented procedure is established to define the controls and related responsibilities and authorities for dealing with nonconforming product. 8.3.3 8.3.3.1 Where applicable, the organization deals with nonconforming product by one of the following ways: taking action to eliminate the detected nonconformity;
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8.3.3.2 authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; 8.3.3.3 taking action to preclude its original intended use or application; More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com 8.3.3.4 taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. 8.3.4 8.3.5 8.4 When nonconforming product is corrected, it is subjected to re-verification to Records of the nature of nonconformities and any subsequent actions taken, demonstrate conformity to requirements. including concessions obtained, are maintained. Analysis of data (DOCUMENT ID # QMS-XX-XX-XX) 8.4.1 Data from monitoring and measurement activities are collected and analyzed in order to demonstrate the suitability and effectiveness of the quality management system and evaluate where continual improvement of the effectiveness of the quality management system can be made. These data include data generated as a result of monitoring and measurement and from other relevant sources, as applicable. 8.4.2 8.4.2.1 8.4.2.2 The analysis of data provides information relating to customer satisfaction, conformity to product requirements, 8.4.2.3 characteristics and trends of processes and products, including opportunities for preventive action, and 8.4.2.4 suppliers. 8.4.3 the 8.4.3.1 8.4.3.2 8.4.3.3 8.4.3.4 Data to be analyzed; Methods of analysis; Intervals between the analyses; and Allocation of responsibilities. A table has been drawn up to define the analysis process. The table defines
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8.5
Improvement 8.5.1 Continual improvement More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com 8.5.1.1 The organization is committed to continually improve the effectiveness of the quality manage system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 8.5.1.2 Improvement efforts are carried out by the Quality Management System Committee at the quality management system level while at the process level, the Quality Improvement Teams meet regularly to identify ways and means to enhance the effectiveness of their respective processes. 8.5.2 The organization takes appropriate action to eliminate the causes of nonconformities in order to prevent recurrence. (DOCUMENT ID # QMSXX-XX-XX) 8.5.2.1 The organization ensures that the corrective actions are appropriate to the effects of the nonconformities encountered. 8.5.2.2 A documented procedure is established to define requirements for 8.5.2.2.1 reviewing nonconformities including customer complaints, 8.5.2.2.2 determining the causes of nonconformities, 8.5.2.2.3 evaluating the need for action to ensure that nonconformities do not recur, 8.5.2.2.4 determining and implementing action needed, 8.5.2.2.5 records of the results of action taken, and 8.5.2.2.6 reviewing the effectiveness of the corrective action taken. 8.5.3 Preventive action (DOCUMENT ID # QMS-XX-XX-XX) 8.5.3.1 The organization determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence.
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8.5.3.2 The organization ensures that preventive actions are appropriate to the effects of the potential problems. 8.5.3.3 A documented procedure is established to define requirements for 8.5.3.3.1 determining potential nonconformities and their causes, 8.5.3.3.2 8.5.3.3.3 8.5.3.3.4 8.5.3.3.5 evaluating the need foe action to prevent determining and implementing action needed, records of results of action taken, and reviewing the effectiveness of the preventive occurrence of nonconformities,
action taken.
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Iso2008 Qms

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00 Name

Page number Effective date Revision number Title Management Representative

Reviewed and approved by

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

Table of contents ISO 9001:2008 Clause 1 2 3 4 5 6 7 8 Manual Clause 1 2 3 4 5 6 7 8 Title Page

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

its policies, objectives and processes.

quality management system. Clause 7.3 from the manual.

design your products, Clause 7.3 is not applicable. Therefore, delete

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

4.2.2.1 This quality management system manual

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

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More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

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Document originator Document title Document number

Management Representative Quality Management System Manual QMS-M-001-00

Page number Effective date Revision number

ensuring the promotion of awareness of

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