Document originator Document title Document number

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

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Prepared by

Reviewed and approved by

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REVISION HISTORY Revision number 00 DCF # DCF date Revision description Initial issue

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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 organization’s 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 product’s 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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1 2.iso9001documents.blogspot.3 ISO 9001:2008 Quality management systems – Requirements ISO 9000:2005 Quality management systems.blogspot.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 4 of 30 00 More ISO 9001:2008 documents at http://www.2 2.com Distribution control status Master copy .1.com Clause 2 References 2.1 These documents serve as references in the quality management system: 2.1.1.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) More ISO 9001:2008 documents at http://www.iso9001documents.

blogspot. 3.1 List unique acronyms.com Clause 3 Terms and definitions 3.3. wherever the term "product" occurs. references which are used within your QMS. More ISO 9001:2008 documents at http://www.1 For the purposes of this quality management system. it also means "service". the terms and definitions given in ISO 9000 apply. 3.2 Throughout the text of this manual.iso9001documents.blogspot.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 5 of 30 00 More ISO 9001:2008 documents at http://www.com Distribution control status Master copy .3 Local terms that are unique to the organization and are used within this manual: 3.iso9001documents. titles.

The quality management system defines the 4..3 monitoring.1. analysis and improvement (reference Clause 8). 4.1.2.1 4. and 4.1.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 6 of 30 00 More ISO 9001:2008 documents at http://www.1..1.1.com Clause 4 Quality Management System 4.2.1.1 statements of policies and objectives. 4.1 General requirements 4.2 The quality management system is made up of the processes for 4.2.2.2 4. the organization is committed to continually improve its effectiveness in meeting its objectives.1.1. 4. measurement (where applicable) and analysis of the processes.1.5 4.2.2.2 necessary resources that are required in order to support the operation of the quality management system.2. Documentation requirements The quality management system documentation is made up of 4.4.1. 4.1 criteria and methods needed to ensure that both the operation and control of processes are effective. General Distribution control status Master copy .iso9001documents.2 Provision of resources(reference Clause 6).1.4. 4.1. 4.1 This quality management system has been established and documented in accordance with the requirements of ISO 9001:2008.4 The Quality Management System Flow Diagram (Figure 1) describes the sequence and interaction of these processes.3 Product realization (reference Clause 7).4.1 Management activities (reference Clause 5). and 4.4 Measurement.blogspot.1.3 4.1. which is an international standard for a quality management system.1 In operating the quality management system.

4.2.3 ensure that the changes and the current revision status of documents are identified.2. 4.1.2 includes references to the documented procedures established for the quality management system.3.2. Distribution control status Master copy . and to apply suitable identification to them if they are retained for any purpose.2.2 a quality manual.2.2.1.6 prevent the unintended use of obsolete documents.1.2.1.1 approve documents for adequacy prior to issue.1.2. and 4.1.1. operation and control of the quality management system’s processes.2.3 Control of documents (Document ID #QMS-XX-XX-XX) 4. including details of and justification for any exclusions.1.3 describes the interactions of the process of the quality management system.2.1. 4.2. which are necessary to ensure the effective planning.2.1 This quality management system manual 4.3.1 A documented procedure has been established to define the controls needed to 4. including records.1.3.3. and 4.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 7 of 30 00 4. 4.2.1.2.3 documented procedures and records required by the ISO 9001:2008.3.1.2.2.4 other documents. 4.4 ensure that relevant versions of applicable documents are available at points of use.2.2.2. 4.5 ensure that documents of external origin are identified and their distribution controlled.3.1.2 Quality Manual (Document ID #QMS-M-001-00) 4.1 describes the scope of the quality management system. and 4.3. 4. 4.1.2 review and update as necessary and re-approve documents.2.1.

2.com Distribution control status Master copy .4. More ISO 9001:2008 documents at http://www.4.blogspot.com 4. 4. A documented procedure has been established to define the controls needed for the identification.3 Records are maintained in order to ensure that they remain legible and are readily identifiable and retrievable.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 8 of 30 00 More ISO 9001:2008 documents at http://www.iso9001documents. and disposition of records.1 4.2.2. protection.iso9001documents.4.4 Control of records (Document ID #QMS-XX-XX-XX) 4. retention.2.blogspot.2 Records are established to provide evidence of conformity to requirements and of the effective operation of the quality management system. storage. retrieval.

com Distribution control status Master copy .Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 9 of 30 00 More ISO 9001:2008 documents at http://www. And to facilitate better document change management.) More ISO 9001:2008 documents at http://www.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.iso9001documents. you can create this flow diagram as a separate document and as an attachment to the QMS Manual.blogspot.iso9001documents.

5.1 5.1 communicating to the organization of the importance of meeting customer as well as statutory and regulatory requirements.1.3 5. 5.1.1.1. and is reviewed for continuing suitability.1 Quality objectives (Document ID #QMS-XX-XX-XX) More ISO 9001:2008 documents at http://www. and 5.2 Customer focus 5.1 The top management of the organization is committed to continually improve the quality management system and this is demonstrated by 5. Top management ensures that the quality policy is communicated and understood within the organization.1.2.blogspot.com Distribution control status Master copy .5 ensuring the availability of resources.1. 5.3 ensuring that quality objectives are established. 5.1.4 conducting management reviews.1.3 Quality Policy (Document ID #QMS-XX-XX-XX) 5.1. 5.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 10 of 30 00 More ISO 9001:2008 documents at http://www.3.3.iso9001documents.1 Top management ensures that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 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.blogspot.4 The quality policy also provides a framework for establishing and reviewing quality objectives.1.4.4 Planning 5.3.1.com Clause 5 Management responsibility 5.1 Management commitment 5.iso9001documents.3.2 establishing the quality policy.2 Top management has established a quality policy that states the organization’s position with regard to product quality. 5.

2.3 Quality objectives are used as the primary tool of controlling a given process in terms of its performance and effectiveness.2 The quality objectives are measurable and consistent with the quality policy.1.2.1. 5. authority and communication 5.1 Quality objectives. are established at relevant functions and levels within the organization.5.1. and Distribution control status Master copy .1 ensuring that processes needed for the quality management system are established.5.5. 5.5 Responsibility. 5.4.1. including those to meet requirements for products. and the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.2. 5. implemented and maintained.2.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 11 of 30 00 5.2 reporting to top management on the performance of the quality management system and any need for improvement. is responsible and has the authority in 5.1 Top management ensures that responsibilities and authorities are defined and communicated within the organization.2 Quality management system planning 5. 5. irrespective of other responsibilities.2 Management Representative 5.5.1 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.4. 5.4.4.5.1.1 Top management has appointed a member of the organization's management who.1 Responsibility and authority (Document ID #QMS-XX-XX-XX) 5.1.5.4.

5.3.5.1 Top management ensures that appropriate communication processes are established within the organization.5.5.3 The Management Representative is assisted at the departmental level by Quality Representatives. 5.5. 5.2.3.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 12 of 30 00 5.3.3 Internal communication 5. 5.5. 5. 5.5.5.2.2.3 ensuring the promotion of awareness of customer requirements throughout the organization.2. 5. 5.4 Collectively.1.1 Manager.2.2 The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.2.3 The Quality Representative heads the Quality Improvement Team which is established for the purpose of identifying opportunities for improvements within each department. Distribution control status Master copy .5. the Management Representative and the Quality Representatives Committee.2 The Quality Representative is responsible for the quality processes which are applicable to his/her department.2.5.3. 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.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. 5.3.

blogspot.1.1. 5.1.5 follow-up actions from previous management reviews.1 The inputs to a management review include information on 5.3 process performance and product conformity.1.6.7 recommendations for improvement.6.4 status of preventive and corrective actions.6.1. including the quality policy and quality objectives. 5.6 Management review 5.1 General 5.3 Records such as meeting minutes and supplemental documents from management reviews are maintained.2.6. 5. 5.2.iso9001documents. 5.1. Distribution control status Master copy . 5.1. 5.2.1.com 5.2.6.6.1 The outputs from the management review include decisions and actions related to the 5.1 results of audit.1.1 Top management reviews the quality management system at planned intervals in order to ensure its continuing suitability.3 Meeting minutes are maintained in order to ensure the effectiveness of the communications.6.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 13 of 30 00 5.6. adequacy and effectiveness.1.1.6.2.1 improvement of the effectiveness of the quality management system and its processes.6.6. More ISO 9001:2008 documents at http://www.3.2.6.6 changes that could affect the quality management system.6.2 customer feedback.2.2 Review output 5.5.6.6.2 Review input 5. 5. 5.2 This review includes assessing opportunities for improvement and the need for changes to the quality management system.2.2. and 5.2.6.

1 required resources are determined and provided for as necessary.1.1.6.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 14 of 30 00 5.2. and 5.com Clause 6 Resource management 6.2 provides training or take other actions to achieve the necessary competence.2 improvement of product related to customer requirements.2.3.1.3.1.3.3. 6.1.3 Competence.blogspot.3.2 The organization ensures that personnel performing work affecting conformity to product quality requirements are competent on the basis of appropriate education.3.3 6.1 Provision of resources 6.2.1.2.1.3. training and awareness (Document ID #QMS-XX-XX-XX) 6.6. More ISO 9001:2008 documents at http://www.iso9001documents.1. effectiveness of the quality management system in order to meet customer requirements and to enhance customer satisfaction.3.2 In order to ensure the competency of personnel within the quality management system. training.1. 6. the organization 6.3 resource needs. skills and experience.3. 6. 6. Records of resource planning are maintained.1 determines the necessary competency requirements.2 6.1.1 The organization is committed to continually improve the To achieve this. (Document ID #QMS-XX-XX-XX) Human resources General 6.3.1. and Distribution control status Master copy .1.3.1 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.

3.com Distribution control status Master copy .3 evaluates the effectiveness of the actions taken. process equipment (both hardware and software).3 6.2 Infrastructure 6. temperature.1 A conducive working environment which relates to conditions under which work is performed including physical. provided for and maintained in order to ensure conformity to product requirements. 6. or communication. environmental.3.1 Requirements for necessary infrastructure such as buildings.1. lighting.iso9001documents. More ISO 9001:2008 documents at http://www. skills and experience are maintained.2.3.3 Work environment 6. or information systems are determined.3. and other factors such as noise.2. or weather is maintained and improved upon in order to ensure conformity to product requirements Appropriate records of education. humidity.3. workspace and associated utilities. and supporting services such as transport.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 15 of 30 00 6. training.1.blogspot. 6.

and Distribution control status Master copy .1.2 The product quality planning includes: 7.1.1 General 7.4 Required documentation. 7.1.2 requirements not stated by the customer but necessary for specified or intended use. these requirements are considered: 7.3 applicable statutory and regulatory requirements related to the product.2.1.1 In determining the requirements related to the product.6 Records needed to provide evidence that the realization processes and resulting product meet all specified requirements.2.1 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.1. 7.1.1.1 requirements specified by the customer.1. including the requirements for delivery and post-delivery activities. 7.3 7.1. 7.1.1.2. 7. validation.1.2 Customer-related processes 7.1 Determination of quality objectives and requirements for the product. measurement.2. 7. inspection and test activities specific to the product and the criteria for product acceptance. and 7.5 Required verification.2. Provision of resources specific to the product.2.2.2 Description of the necessary processes.2.1.1.2.1.2. 7. monitoring.2.1 Determination of requirements related to the product (Document ID #QMSXX-XX-XX) 7.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 16 of 30 00 Clause 7 Product realization 7. where known.

5 additional requirements considered necessary by the organization. 7. contracts or order handling.3 Where product requirements are changed.2.2. 7.2.1 Design and development (Document ID # QMS –XX-XX-XX) Design and development planning Distribution control status Master copy .3 the organization has the ability to meet the defined requirements.2.3.1. the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.2.3 7.3 Customer communication 7.2.blogspot.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 17 of 30 00 7.2 Where the customer provides no documented statement of requirement. including customer complaints.iso9001documents. and customer feedback.1.1.2.1 The organization implements effective arrangements for communicating with customers in relation to product information.2.1.1. the customer requirements are confirmed by the organization before acceptance. and 7.com 7.2 Review of requirements related to the product (DOCUMENT ID # QMSXX-XX-XX) 7.1. enquiries. 7.1 The organization conducts reviews of the requirements related to the product prior to the organization's commitment to supply any product to the customer.2.2.2. 7.2.4 Records of the results of the review and actions arising from the review are maintained. 7.2.2 contract or order requirements differing from those previously expressed are resolved. 7.1 product requirements are defined. 7.3.2.2.1. These reviews ensure that 7.2. including amendments.2.2.2.4 More ISO 9001:2008 documents at http://www.

2.3.3.3.1.2. 7.2 7.2. as appropriate. unambiguous and not in conflict with each other.2. 7.2 7.2. information derived from previous similar designs.3.2 Design and development inputs.1 functional and performance requirements.3. 7.3.1.1.3.4 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. These inputs are reviewed for adequacy to ensure that they are complete.iso9001documents.1. as suitable for the product and the organization.com 7. and other requirements essential for design and development. 7. and responsibilities and authorities for design and development.1 More ISO 9001:2008 documents at http://www.2 7.3.3 where applicable.1.1 In planning and controlling the design and development of a product. verification and validation are conducted and recorded separately or in any combination.3 7.3.1. Design and development review. as the design and development progresses.3.2.3.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 18 of 30 00 7.2 applicable statutory and regulatory requirements.3.3.1.2. verification and validation that are appropriate to each design and development stage.1. Design and development outputs Distribution control status Master copy .blogspot. 7.1.3 7. The inputs include 7.3 review.2.3.1. 7.1.2.4 7.3.1 Inputs relating to product requirements are determined and records maintained. the organization determines the design and development stages.

production.4. 7.4 contain or reference product acceptance criteria.3. More ISO 9001:2008 documents at http://www.4 Records of the results of the reviews and any necessary actions are maintained. 7.3.com Distribution control status Master copy .3.3.2.2.4. 7.3.3.1 7.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 19 of 30 00 7.2. and identifying any problems and propose necessary actions.3. and specify the characteristics of the product that are essential for its safe and proper use.blogspot.2.3 Participants in such reviews include representatives of functions concerned with the design and development stages being reviewed. 7.5. provide appropriate information for purchasing.3. 7.2 meet the input requirements for design and development.4.3.1 Verification is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements.2 Systematic reviews of design and development are performed in accordance with planned arrangements at suitable stages.3.iso9001documents.3.3. service provision and details for the preservation of product.5 Design and development verification 7. 7.1 7.3.4 Design and development review 7.4.3.3.3.3.2 The organization ensures that all design and development outputs 7.3 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. These reviews are conducted for the purposes of evaluating the ability of the results of design and development to meet requirements.

7.7.2 The criteria for selection.4 7. Design and development validation 7.1 Purchasing (Document ID # QMS –XX-XX-XX) General 7.4.6. 7. 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.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.4.1 The organization ensures that purchased products conform to specified requirements.6. as appropriate.6 Records of the result of the verification and any necessary actions are maintained.7.3. The changes are reviewed.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 20 of 30 00 7.3.2 7. 7.3 Records of the results of the review of changes and any necessary actions are maintained.3.1. verified and validated. 7.3. Distribution control status Master copy .3.2 Records of the results of validations and any necessary actions are maintained.3.7 Control of design and development changes 7.1 Design and development changes are identified and records maintained. evaluation and re-evaluation of suppliers are maintained. validation shall be completed prior to the delivery or implementation of the product. 7. when known. 7.1. Wherever practicable.4.3. 7. and approved before implementation.5.3.2 The review of design and development changes includes evaluation of the effect of changes on constituent parts and product already delivered.

4.4.4.3.2.1 General Distribution control status Master copy . in order to ensure that they meet specified purchase requirements.1 7.3 The organization evaluates and selects suppliers based on their ability to supply product in accordance with the organization’s requirements.1.4.2 personnel. Purchasing information 7.4 7.3. 7.2.1 The organization inspects and tests all purchased products.4.4.1.5.4.2 Records of the results of evaluations and any necessary actions arising from the evaluation are maintained.5 Production and service operations (Document ID # QMS –XX-XX-XX) 7.4.2 Where the organization or its customer intends to perform verification at the supplier's premises.2.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 21 of 30 00 7.1 Purchasing information that is generated from the design and development process describes the product to be purchased.4. requirements for qualification of procedures and equipment. quality management system requirements for approval of product.2. where appropriate.4. 7.2 The organization ensures the adequacy of purchase requirements prior to their communication to the suppliers.3 requirements. 7.1.4.2. including where appropriate 7. and 7.3 Verification of purchased product 7. the organization shall state the intended verification arrangements and method of product release in the purchasing information. 7.1.1. 7.

5.1. the validation process includes 7.2.1.5.5.2. delivery and postdelivery activities.1.1.1 The organization validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and.5 the implementation of monitoring and measurement.2.2 Validation of processes for production and service provision 7.2.5.6 the implementation of product release.4 the availability and use of monitoring and measuring equipments.5. 7. as a consequence.2.1.5.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 22 of 30 00 7.2.1.1. Distribution control status Master copy . and of criteria of specific for review and and and approval of the processes. 7.1. 7.5.4requirements for records.2 Where applicable.2approval 7.1 the availability of information that describes the characteristics of the product.1.2 the availability of work instructions. 7. 7.5. deficiencies become apparent only after the product is use or the service has been delivered.2. Controlled conditions 7.1.5.2.1.3use procedures.5.5.5. Validation demonstrates the ability of these processes to achieve planned results.1.1. as necessary.5. equipment methods qualification of personnel. and 7.2. include 7.2. 7.3 the use of suitable equipments.1 The organization plans and carries out production and service provisions under controlled conditions.1defined 7.5.

5. packaging.2. or both.5. where no (DOCUMENT ID # These customer properties may include intellectual property and Distribution control status Master copy .1 The organization maintains necessary monitoring and measurement processes that are to be undertaken in order to provide evidence of conformity of product requirements.5.2 7. 7. or otherwise found to be unsuitable for use.5re-validation.6 Control of monitoring and measuring equipment QMS-XX-XX-XX) 7.1 All products including their constituents are preserved during internal processing and delivery to the intended destination in order to maintain conformity to requirements. 7. 7.3 Identification and traceability 7. 7. personal data.1 All product status is identified throughout product realization with respect to monitoring and measurement requirements.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 23 of 30 00 7.5. handling.5.4 Customer property 7. to the customer and maintains appropriate records.2. 7.6.3.5. storage and protection.5.5.4.1 In order to ensure valid results.1 The organization reports any customer property that is lost.6.5 Preservation of product 7. at specified interval. Preservation activities include identification.6. measuring equipments are calibrated or verified. damaged.3.2.5. against measurement standards traceable to international or national measurement standards. 7. or prior to use.2 Where traceability is a requirement. the organization controls and records the unique identification of the product and maintains appropriate records.

4 7.2.6.6. identified in order to determine its calibration status.4 Records of the results of calibration and verification are maintained. Distribution control status Master copy . and protected from damage and deterioration during handling. safeguarded from adjustment that would invalidate the measurement result.2. 7.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 24 of 30 00 such standards exist. 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.6.3 adjusted or re-adjusted as necessary. 7.2.2 7.6. the basis used for calibration or verification are recorded.3 7.6.6.5 7. maintenance and storage.2.

2.4 compliments.1.2 8. Distribution control status Master copy .2.2.1 General 8.com More ISO 9001:2008 documents at http://www.2.iso9001documents. analysis and improvement 8.1 Information relating to customer perception is monitored and measured in order to quantify customer satisfaction levels.5 warranty claims.1.2.2.2 8.2. Monitoring and measurement Customer satisfaction (DOCUMENT ID # QMS-XX-XX-XX) 8.1 These processes include determination of applicable methods.2.2 user opinion surveys. measurement.2. including statistical techniques.1.1.2 Monitoring customer perception may include obtaining input from sources such as 8. 8. 8.2.iso9001documents.2 The organization plans and implements necessary monitoring.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 25 of 30 00 More ISO 9001:2008 documents at http://www. 8.blogspot.2. 8.1.3 lost business analysis.2. and 8. analysis and improvement processes needed in order to demonstrate conformity to product requirements.1.2. and the extent of their use.1.1. 8.com Clause 8 Measurement.1 8.1 customer satisfaction surveys.3 continually improve the effectiveness of the quality management system.1.1.1.1.1. etc.1. ensure conformity of the quality management system.1 8. 8.1.blogspot.

2.3 is effectively implemented and maintained.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 26 of 30 00 8. taking into consideration the status and importance of the processes and areas to be audited. establishing records and reporting results. 8.2. Distribution control status Master copy . where applicable.6 Records of the audits and their results are maintained.2. as well as the results of previous audits. 8.5 A documented procedure is established to define the responsibilities and requirements for planning and conducting audits.2 The audit programme is planned accordingly.2. 8.2. scope.1 conforms to the quality management system requirements.1 Internal audits are conducted at planned interval to determine whether the quality management system 8.2.3. and 8.2.2.3Monitoring and measurement of processes (DOCUMENT ID # QMS-XXXX-XX) 8.2.2.2.2.2.2.2.1.2.1.2. 8. impartial and independent of the area being audited. 8.8 Follow-up activities include the verification of the actions taken and the reporting of verification results.2 conforms to the requirements of the ISO 9001:2008 International Standard. 8.2.2.2.3 The audit criteria.4 Auditors are ensured to be objective.1 Suitable methods for monitoring and. 8.2 Internal audit (DOCUMENT ID # QMS-XX-XX-XX) 8.2.2.2.7 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. 8.1.2. measurement of the quality management system processes are applied in order to demonstrate the ability of the processes to achieve planned results. frequency and methods are defined. 8.2.

Distribution control status Master copy .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.3 8.2.1 Product characteristics are monitored and measured in order to verify that requirements have been met.2. 8.3.2. 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.2 A documented procedure is established to define the controls and related responsibilities and authorities for dealing with nonconforming product.2. 8.1 The organization ensures that products which do not conform to product requirements are identified and controlled to prevent unintended use or delivery.4 Monitoring and measurement of product 8.3 When planned results are not achieved.2. where applicable. 8. 8.1 Where applicable.3.4.3. unless otherwise approved by a relevant authority and. correction and corrective action are taken.4.3.4.3. by the customer.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 27 of 30 00 8. 8.2 When determining suitable methods.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. as appropriate.3.2.3. 8. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements for the product. 8. the organization deals with nonconforming product by one of the following ways: taking action to eliminate the detected nonconformity.3 Control of nonconforming product (DOCUMENT ID # QMS-XX-XXX-XX) 8.

are maintained.3. Intervals between the analyses.3.blogspot.4.4 8.1 8.1 8. and Allocation of responsibilities.4. 8.3.3.5 8.4.3 8. including opportunities for preventive action.4.3.3. Methods of analysis. by the customer. 8.4. 8.4 Data to be analyzed.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 28 of 30 00 8.2.4.3 characteristics and trends of processes and products. and 8. as applicable.4 taking action appropriate to the effects. including concessions obtained.com 8.4.3 taking action to preclude its original intended use or application. conformity to product requirements.4. or potential effects. demonstrate conformity to requirements. Analysis of data (DOCUMENT ID # QMS-XX-XX-XX) 8.2 8. it is subjected to re-verification to Records of the nature of nonconformities and any subsequent actions taken. A table has been drawn up to define the analysis process. The table defines Distribution control status Master copy .4. release or acceptance under concession by a relevant authority and.2. 8. where applicable.3 the 8.3.4 When nonconforming product is corrected.2 The analysis of data provides information relating to customer satisfaction.4. These data include data generated as a result of monitoring and measurement and from other relevant sources.4.2 8.3.3.3.2 authorizing its use.3. More ISO 9001:2008 documents at http://www.iso9001documents.2. of the nonconformity when nonconforming product is detected after delivery or use has started.2.1 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.3.4 suppliers. 8.

1 The organization determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence. 8. and 8.5. corrective and preventive actions and management review. the Quality Improvement Teams meet regularly to identify ways and means to enhance the effectiveness of their respective processes. 8. 8. 8.2.2.5 Improvement 8.5. 8. quality objectives.5.5.2.5.3 Preventive action (DOCUMENT ID # QMS-XX-XX-XX) 8.com 8.5.1 reviewing nonconformities including customer complaints.2.1 The organization ensures that the corrective actions are appropriate to the effects of the nonconformities encountered.5. (DOCUMENT ID # QMSXX-XX-XX) 8.1 Continual improvement More ISO 9001:2008 documents at http://www.2.1.2.2 Improvement efforts are carried out by the Quality Management System Committee at the quality management system level while at the process level. Distribution control status Master copy .blogspot.3 evaluating the need for action to ensure that nonconformities do not recur. 8.1.4 determining and implementing action needed. analysis of data.2.iso9001documents.2.2 The organization takes appropriate action to eliminate the causes of nonconformities in order to prevent recurrence.2. 8.2 A documented procedure is established to define requirements for 8. 8.6 reviewing the effectiveness of the corrective action taken.2.5.2.3.5.5.5.5.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 29 of 30 00 8. audit results.2.2 determining the causes of nonconformities.2.1 The organization is committed to continually improve the effectiveness of the quality manage system through the use of the quality policy.5.2.5 records of the results of action taken.5.

blogspot. action taken.5.3.3.3.1 determining potential nonconformities and their causes. and reviewing the effectiveness of the preventive occurrence of nonconformities.5.3 8.Document originator Document title Document number Management Representative Quality Management System Manual QMS-M-001-00 Page number Effective date Revision number 30 of 30 00 8.3.3.4 8.2 The organization ensures that preventive actions are appropriate to the effects of the potential problems.3. More ISO 9001:2008 documents at http://www. records of results of action taken.3.5.3.3.5.5.5 evaluating the need foe action to prevent determining and implementing action needed. 8.3.iso9001documents.3.3 A documented procedure is established to define requirements for 8.5.3.5.2 8.com Distribution control status Master copy . 8.

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