Compliancy audit - iso 9001:2008 quality management systems requirements
Iso 9001:2008 quality management systems - requirements
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Opening meeting notes:
4.1. General Requirements
- Did the organisation determine the processes needed for the QMS and their application throughout the organization?
- Did the organisation determine the sequence and interaction of these processes?
- Did the organisation determine criteria and methods needed to ensure that both the operation and control of these processes are effective?
- Did the organisation ensure the availability of resources and information necessary to support the operation and monitoring of these processes?
- Do the organisation monitor, measure where applicable, and analyse these processes?
- Do the organisation implement actions necessary to achieve planned results and continual improvement of these processes?
4.2.2. Quality Manual
- Did the organisation establish and maintain a documented Quality Manual?
Do the Quality Manual include:
4.2.3. Control of Documents
- A documented procedure for the control of documents is available.
The procedure defines the controls needed:
4.2.4. Control of Records
- A documented procedure for the control of records is avalable.
The procedure defines the controls needed for the:
Do top management show evidence of their commitment by:
5.1. Management commitment
- a) communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements.
- b) establishing the quality policy.
- c) ensuring that quality objectives are established.
- d) conducting management reviews.
- e) ensuring the availability of resources.
5.2. Customer Focus
- Is top management involved in determining customer requirements with the aim of enhancing customer satisfaction?
Note: see section 7.2.1 and 8.2.1 to determine top management involvement and compliancy.
5.3. Quality Policy
- a) Is the policy statement appropriate to the purpose of the organisation?
- b) Do the policy statement include a commitment to comply with requirements and continually improve the effectiveness of QMS?
- c) Do the policy statement provide a framework for establishing and reviewing quality objectives?
- d) Is the policy statement communicated and understood within the organization?
- e) is the policy statement reviewed for continuing suitability?
5.4.1. Quality Objectives
- Are quality objectives established at relevant functions and levels within the organization?
- Are the objectives measurable and consistent with the quality policy?
5.4.2. Quality Management system Planning
- a) Is planning of the QMS carried out in order to meet the requirements given. In 4.1 as well as the quality objectives?
- b) Is the integrity of the QMS maintained when changes to the system are planned and implemented?
5.5.1. Responsibility and Authority
- Are responsibilities and authorities defined and communicated within the organization?
5.5.2. Management Representative
- Is the management representative formally appointed?
- Is the management representative part of the organisations management?
Do the management representatives responsibilities include:
5.5.3. Internal Communication
- Are the appropriate communication processes established for internal communication?
- Do communication take place regarding the effectiveness of the QMS?
5.6.1. General
- Do management review the QMS at planned intervals?
- Do the review include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives?
Do the input to the review include information on:
5.6.2. Review Input
- a) results of audits?
- b) customer feedback?
- c) process performance and product conformity?
- d) status of preventive and corrective actions?
- e) follow-up actions from previous management reviews?
- f) changes that could affect the QMS?
- g) recommendations for improvement?
Do the output of the review include any decisions and actions related to:
5.6.3. Review Output
- a) improvement of the effectiveness of the QMS and its processes?
- b) improvement of product related to customer requirements?
- c) resource needs?
Did the organisation determine and provide the resources needed:
6.1. Provision of Resources
- a) to implement and maintain the QMS and continually improve its effectiveness?
- b) to enhance customer satisfaction by meeting customer requirements?
6.2.1. General
- Are personnel performing work affecting conformity to product requirements competent on the basis appropriate education, training, skills and experience?
Do the organisation:
6.2.2. Competence, Training and Awareness
- a) determine the necessary competence for personnel performing work affecting conformity to product requirements?
- b) where applicable, provide training or take other actions to achieve the necessary competence?
- c) evaluate the effectiveness of the actions taken?
- d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?
- e) maintain appropriate records of education, training, skills and experience?
6.3. Infrastructure
- Do the organisation determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?
Are the following infrastructure needs determined, provided and maintained:
6.4. Work Environment
- Do the organisation determine and manage the work environment needed to achieve conformity to product requirements?
7.1. Planning of Product Realisation
- Do the organisation plan and develop the processes needed for product realisation?
Do the organisation determine the following, as appropriate:
Do the organisation determine:
7.2.1. Determination of Requirements Related to the Product
- a) requirements specified by the customer, including the requirements for delivery and post-delivery activities?
- b) requirements not stated by the customer but necessary for specified or intended use, where known?
- c) statutory and regulatory requirements applicable to the product?
- d) any additional requirements considered necessary by the organisation?
Do the organisation review the requirement prior to commitment in order to ensure that:
7.2.2. Review of Requirements Related to the product
- a) product requirements are defined?
- b) contract or order requirements differing from those previously expressed are resolved?
- c) the organisation has the ability to meet the defined requirements?
- Do the organisation maintain records of the results of the review and actions arising from the review?
- Do the organisation ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements where product requirements are changed?
Do the organisation determine and implement effective arrangements for communicating with customers i
7.2.3. Customer Communication
- a) product information?
- b) enquiries, contracts or order handling, including amendements?
- c) customer feedback, including customer complaints?
During design and development planning, do the organisation determine:
7.3.1. Design and Development Planning
- a) the design and development stages?
- b) the review, verification and validation that are appropriate to each design and development stage?
- c) the responsibilities and authorities for design and development?
Do the design and development inputs include:
7.3.2. Design and Development Inputs
- a) functional and performance requirements?
- b) applicable statutory and regulatory requirements?
- c) where applicable, information derived from previous similar designs?
- d) other requirements essential for design and development?
7.3.3. Design and Development Outputs
- Are the outputs of the design and development in a form suitable for verification against the design and development input and approved prior to release?
Do the design and development outputs:
Do the organisation systematically review the design and development in accordance with planned arran
7.3.4. Design and Development Review
- a) evaluate the ability of the results of design and development to meet requirements?
- b) identify any problems and propose necessary actions?
- Are records maintained of the results of the review and any necessary actions taken?
7.3.5. Design and Development Verification
- Do the organisation perform verification to ensure that the design and development outputs have met the design and development input requirements?
- Are records of the results of the verification and any necessary actions maintained?
7.3.6. Design and Development Validation
- Do the organisation perform design and development validation to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?
- Are records of the results of validation and any necessary actions maintained?
7.3.7. Control of Design and Development Changes
- Are design and development changes identified and records maintained?
- Do the organisation review, verify, validate, as appropriate, and approve changes before implementation?
- Are records of the results of the review of changes and any necessary actions maintained?
7.4.1. Purchasing Process
- Do the organisation evaluate and select suppliers based on their ability to supply product in accordance with the organisations requirements?
- Do the organisation have an approved supplier list?
- Do the organisation have criteria for the selection of suppliers?
What is the selection criteria for suppliers?
What is the evaluation criteria for suppliers?
What is the re-evaluation criteria for suppliers?
7.4.2. Purchasing Information
- Do the purchasing information describe the product to be purchased?
Do the information include, where appropriate:
7.4.3. Verification of Purchased Product
- Do the organisation do the necessary inspections and other activities for ensuring that purchased product meets specified purchase requirements?
Do the organisation plan and carry out production and service provision under controlled conditions i
7.5.1. Control of Production and Service Provision
- a) the availability of information that describes the characteristics of the product?
- b) the availability of work instructions, as necessary?
- c) the use of suitable equipment?
- d) the availability and use of monitoring and measuring equipment?
- e) the implementation of monitoring and measurement?
- f) the implementation of product release, delivery and post-delivery activities?
7.5.2. Validation of Processes for Production and Service Provision
- Do validation demonstrate the ability of processes to achieve planned results?
Do the organisations arrangements for these processes include, as appropriate:
7.5.3. Identification and Traceability
- Do the organisation identify the product by suitable means throughout product realisation?
- Do the organisation identify the product status with respect to monitoring and measurement requirements throughout product realisation?
- Do the organisation control unique identification of the product and maintain records, where traceability is a requirement?
7.5.4. Customer Property
- Do the organisation make use of product provided by the customer for use or incorporation into the product?
7.5.5. Preservation of Product
- Do the organisation deal with product?
7.6. Control of Monitoring and Measuring Equipment
- Do the organisation make use monitoring and measuring equipment?
8.2.1. Customer Satisfaction
- Do the organisation monitor information relating to customer perception as to whether the organisation has met customer requirements?
What method is used?
8.2.2. Internal Audit
- Do the organisation have a documented procedure that defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting results?
Do the organisation conduct internal audits at planned intervals to determine whether the QMS:
8.2.3. Monitoring and Measurement of Processes
- Do the organisation apply methods for monitoring and, where applicable, measurement of the QMS processes?
- Do these methods demonstrate the ability of the processes to achieve planned results?
8.2.4. Monitoring and Measurement of Product
- Do the organisation monitor and measure the characteristics of the product to verify that product requirements have been met?
- Do records indicate the person(s) authorising release of product for delivery to the customer?
8.3. Control of Nonconforming Product
- Do the organisation have a documented procedure that defines the controls and related responsibilities and authorities for dealing with nonconforming product?
Do the organisation deal with nonconforming product by one or more of the following ways:
8.4. Analysis of Data
- Do the organisation analyse data generated as a result of monitoring and measurement and from other relevant sources?
Do the analysis of data provide information relating to:
8.5.2. Corrective Action
- Do the organisation have a documented procedure defining the requirements for corrective action?
Do the documented procedure define requirements for:
8.5.3. Preventive Action
- Do the organisation have a documented procedure defining the requirements for preventive action?
Closing meeting notes:
Client Management Representative
Auditor
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