Information
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Organisation Audited
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Document No.
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Office / Site
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Conducted on
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Prepared by
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Location
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Personnel
Opening Meeting
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Opening meeting notes:
4. Quality Management system
4.1. General Requirements
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Did the organisation determine the processes needed for the QMS and their application throughout the organization?
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Did the organisation determine the sequence and interaction of these processes?
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Did the organisation determine criteria and methods needed to ensure that both the operation and control of these processes are effective?
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Did the organisation ensure the availability of resources and information necessary to support the operation and monitoring of these processes?
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Do the organisation monitor, measure where applicable, and analyse these processes?
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Do the organisation implement actions necessary to achieve planned results and continual improvement of these processes?
4.2. Documentation Requirements
4.2.2. Quality Manual
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Did the organisation establish and maintain a documented Quality Manual?
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Do the Quality Manual include:
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a) The scope of the Quality Management System, including details of and justification for any exclusions?
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b) The documented procedures established for the QMS, or reference to them?
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c) A description of the interaction between the processes of the QMS?
4.2.3. Control of Documents
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A documented procedure for the control of documents is available?
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The procedure defines the controls needed:
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a) to approve documents for adequacy prior to use.
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b) to review and update as necessary and re-approve documents.
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c) to ensure that changes and current revision status of documents are identified.
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d) to ensure that relevant versions of applicable documents are available at points of use.
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e) to ensure that documents remain legible and readily identifiable.
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f) to ensure that documents of external origin determined by the organisation to be necessary for the planning and operation of the QMS are identified and their distribution controlled.
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g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4.2.4. Control of Records
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A documented procedure for the control of records is available?
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The procedure defines the controls needed for the:
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a) identification of records.
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b) storage of records.
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c) protection of records.
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d) retrieval of records.
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e) retention of records.
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f) disposition of records.
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All records are legible, readily identifiable and retrievable?
5. Management Responsibility
5.1. Management commitment
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Do top management show evidence of their commitment by:
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a) communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements.
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b) establishing the quality policy.
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c) ensuring that quality objectives are established.
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d) conducting management reviews.
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e) ensuring the availability of resources.
5.2. Customer Focus
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Is top management involved in determining customer requirements with the aim of enhancing customer satisfaction?
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Note: see section 7.2.1 and 8.2.1 to determine top management involvement and compliancy.
5.3. Quality Policy
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a) Is the policy statement appropriate to the purpose of the organisation?
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b) Do the policy statement include a commitment to comply with requirements and continually improve the effectiveness of QMS?
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c) Do the policy statement provide a framework for establishing and reviewing quality objectives?
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d) Is the policy statement communicated and understood within the organization?
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e) is the policy statement reviewed for continuing suitability?
5.4. Planning
5.4.1. Quality Objectives
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Are quality objectives established at relevant functions and levels within the organization?
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Are the objectives measurable and consistent with the quality policy?
5.4.2. Quality Management system Planning
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a) Is planning of the QMS carried out in order to meet the requirements given. In 4.1 as well as the quality objectives?
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b) Is the integrity of the QMS maintained when changes to the system are planned and implemented?
5.5. Responsibility, Authority and Communication
5.5.1. Responsibility and Authority
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Are responsibilities and authorities defined and communicated within the organization?
5.5.2. Management Representative
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Is the management representative formally appointed?
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Is the management representative part of the organisations management?
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Do the management representatives responsibilities include:
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a) ensuring that processes needed for the QMS are established, implemented and maintained?
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b) reporting to top management on the performance of the QMS and any need for improvement?
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c) ensuring the promotion of awareness of customer requirements throughout the organisation?
5.5.3. Internal Communication
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Are the appropriate communication processes established for internal communication?
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Do communication take place regarding the effectiveness of the QMS?
5.6. Management Review
5.6.1. General
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Do management review the QMS at planned intervals?
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Do the review include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives?
5.6.2. Review Input
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Do the input to the review include information on:
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a) results of audits?
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b) customer feedback?
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c) process performance and product conformity?
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d) status of preventive and corrective actions?
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e) follow-up actions from previous management reviews?
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f) changes that could affect the QMS?
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g) recommendations for improvement?
5.6.3. Review Output
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Do the output of the review include any decisions and actions related to:
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a) improvement of the effectiveness of the QMS and its processes?
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b) improvement of product related to customer requirements?
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c) resource needs?
6. Resource Management
6.1. Provision of Resources
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Did the organisation determine and provide the resources needed:
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a) to implement and maintain the QMS and continually improve its effectiveness?
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b) to enhance customer satisfaction by meeting customer requirements?
6.2. Human Resources
6.2.1. General
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Are personnel performing work affecting conformity to product requirements competent on the basis appropriate education, training, skills and experience?
6.2.2. Competence, Training and Awareness
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Do the organisation:
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a) determine the necessary competence for personnel performing work affecting conformity to product requirements?
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b) where applicable, provide training or take other actions to achieve the necessary competence?
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c) evaluate the effectiveness of the actions taken?
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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?
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e) maintain appropriate records of education, training, skills and experience?
6.3. Infrastructure
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Do the organisation determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?
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Are the following infrastructure needs determined, provided and maintained:
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a) buildings, workspace and associated utilities?
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b) process equipment (both hardware and software)?
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c) supporting services ( such as transport, communication and information systems)?
6.4. Work Environment
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Do the organisation determine and manage the work environment needed to achieve conformity to product requirements?
7. Product Realization
7.1. Planning of Product Realisation
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Do Planning of Product Realisation form part of the QMS?
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Do the organisation plan and develop the processes needed for product realisation?
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Do the organisation determine the following, as appropriate:
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a) quality objectives and requirements for the product?
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b) the need to establish processes and documents, and to provide resources specific to the product?
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c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance?
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d) records needed to provide evidence that the realisation processes and resulting product meet requirements?
7.2. Customer Related Processes
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Do Customer Related processes form part of the QMS?
7.2.1. Determination of Requirements Related to the Product
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Do the organisation determine:
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a) requirements specified by the customer, including the requirements for delivery and post-delivery activities?
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b) requirements not stated by the customer but necessary for specified or intended use, where known?
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c) statutory and regulatory requirements applicable to the product?
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d) any additional requirements considered necessary by the organisation?
7.2.2. Review of Requirements Related to the product
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Do the organisation review the requirement prior to commitment in order to ensure that:
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a) product requirements are defined?
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b) contract or order requirements differing from those previously expressed are resolved?
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c) the organisation has the ability to meet the defined requirements?
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Do the organisation maintain records of the results of the review and actions arising from the review?
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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?
7.2.3. Customer Communication
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Do the organisation determine and implement effective arrangements for communicating with customers in relation to:
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a) product information?
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b) enquiries, contracts or order handling, including amendements?
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c) customer feedback, including customer complaints?
7.3. Design and Development
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Does Design and Development form part of the QMS?
7.3.1. Design and Development Planning
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During design and development planning, do the organisation determine:
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a) the design and development stages?
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b) the review, verification and validation that are appropriate to each design and development stage?
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c) the responsibilities and authorities for design and development?
7.3.2. Design and Development Inputs
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Do the design and development inputs include:
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a) functional and performance requirements?
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b) applicable statutory and regulatory requirements?
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c) where applicable, information derived from previous similar designs?
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d) other requirements essential for design and development?
7.3.3. Design and Development Outputs
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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?
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Do the design and development outputs:
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a) meet the input requirements for design and development
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b) provide appropriate information for purchasing, production and service provision?
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c) contain or reference product acceptance criteria?
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d) specify the characteristics of the product that are essential for its safe and proper use?
7.3.4. Design and Development Review
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Do the organisation systematically review the design and development in accordance with planned arrangements to:
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a) evaluate the ability of the results of design and development to meet requirements?
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b) identify any problems and propose necessary actions?
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Are records maintained of the results of the review and any necessary actions taken?
7.3.5. Design and Development Verification
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Do the organisation perform verification to ensure that the design and development outputs have met the design and development input requirements?
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Are records of the results of the verification and any necessary actions maintained?
7.3.6. Design and Development Validation
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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?
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Are records of the results of validation and any necessary actions maintained?
7.3.7. Control of Design and Development Changes
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Are design and development changes identified and records maintained?
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Do the organisation review, verify, validate, as appropriate, and approve changes before implementation?
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Are records of the results of the review of changes and any necessary actions maintained?
7.4. Purchasing
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Do Purchasing form part of the QMS?
7.4.1. Purchasing Process
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Do the organisation evaluate and select suppliers based on their ability to supply product in accordance with the organisations requirements?
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Do the organisation have an approved supplier list?
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Do the organisation have criteria for the selection of suppliers?
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What is the selection criteria for suppliers?
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Do the organisation have evaluation criteria for suppliers?
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What is the evaluation criteria for suppliers?
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Do the organisation have re-evaluation criteria for suppliers?
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What is the re-evaluation criteria for suppliers?
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Are records of the results of evaluations and any necessary actions arising from the evaluation maintained?
7.4.2. Purchasing Information
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Do the purchasing information describe the product to be purchased?
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Do the information include, where appropriate:
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a) requirements for approval of product, procedures, processes and equipment?
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b) requirements of qualification of personnel?
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c) QMS requirements?
7.4.3. Verification of Purchased Product
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Do the organisation do the necessary inspections and other activities for ensuring that purchased product meets specified purchase requirements?
7.5. Production and Service Provision
7.5.1. Control of Production and Service Provision
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Do Control of Production and Service Provision form part of the QMS?
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Do the organisation plan and carry out production and service provision under controlled conditions including, as appropriate:
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a) the availability of information that describes the characteristics of the product?
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b) the availability of work instructions, as necessary?
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c) the use of suitable equipment?
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d) the availability and use of monitoring and measuring equipment?
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e) the implementation of monitoring and measurement?
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f) the implementation of product release, delivery and post-delivery activities?
7.5.2. Validation of Processes for Production and Service Provision
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Do Validation of Processes for Production and Service Provision form part of the QMS?
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Do validation demonstrate the ability of processes to achieve planned results?
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Do the organisations arrangements for these processes include, as appropriate:
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a) defined criteria for review and approval of the processes?
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b) approval of equipment and qualification of personnel?
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c) use of specific methods and procedures?
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d) requirements for records?
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e) revalidation?
7.5.3. Identification and Traceability
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Do Identification and Traceability form part of the QMS?
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Do the organisation identify the product by suitable means throughout product realisation?
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Do the organisation identify the product status with respect to monitoring and measurement requirements throughout product realisation?
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Do the organisation control unique identification of the product and maintain records, where traceability is a requirement?
7.5.4. Customer Property
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Do the organisation make use of product provided by the customer for use or incorporation into the product?
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Do the organisation identify customer property?
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Do the organisation verify customer property?
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Do the organisation protect and safeguard customer property?
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Do the organisation report to the customer any customer property that is lost, damaged or otherwise found to be unsuitable for use?
7.5.5. Preservation of Product
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Do the organisation deal with product?
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Is product preserved trough identification?
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Is product preserved through handling?
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Is product preserved trough packaging?
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Is product preserved trough storage?
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Is product preserved trough protection?
7.6. Control of Monitoring and Measuring Equipment
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Do the organisation make use monitoring and measuring equipment?
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Do the organisation determine the monitoring and measuring equipment needed to provide evidence of conformity of the product to determined requirements?
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Where necessary to ensure valid results, are measuring equipment:
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a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? ( where no such standards exist do the organisation record the basis used for calibration or verification?)
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b) adjusted or re-adjusted as necessary?
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c) identified in order to determine its calibration status?
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d) safeguarded from adjustments that would invalidate the measurement result?
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e) protected from damage and deterioration during handling, maintenance and storage?
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Do the organisation assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements?
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Do the organisation take appropriate action on the equipment and any product affected?
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Do the organisation maintain records of the results of calibration and verification?
8. Measurement, Analysis and Improvement
8.2. Monitoring and Measurement
8.2.1. Customer Satisfaction
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Do the organisation monitor information relating to customer perception as to whether the organisation has met customer requirements?
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What method is used?
8.2.2. Internal Audit
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Do the organisation have a documented procedure that defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting results?
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Do the organisation conduct internal audits at planned intervals to determine whether the QMS:
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a) conforms to planned arrangements, to the requirements of the ISO 9001 standard and to the QMS requirements established by the organisation?
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b) is effectively implemented and maintained?
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Do the organisation have a planned audit programme?
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Is the audit criteria, scope, frequency and methods defined?
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Is the selection of auditors and conduct of audits objective and impartial to the audit process?
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Do the organisation maintain records of the audits and their results?
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Do the responsible management ensure that any necessary corrections and corrective actions are taken to eliminate detected nonconformities and their causes?
8.2.3. Monitoring and Measurement of Processes
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Do the organisation apply methods for monitoring and, where applicable, measurement of the QMS processes?
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Do these methods demonstrate the ability of the processes to achieve planned results?
8.2.4. Monitoring and Measurement of Product
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Do the organisation monitor and measure the characteristics of the product to verify that product requirements have been met?
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Do records indicate the person(s) authorising release of product for delivery to the customer?
8.3. Control of Nonconforming Product
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Do the organisation have a documented procedure that defines the controls and related responsibilities and authorities for dealing with nonconforming product?
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Do the organisation deal with nonconforming product by one or more of the following ways:
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a) by taking action to eliminate the detected nonconformity?
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b) by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?
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c) by taking action to preclude its original intended use or application?
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d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?
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Do the organisation subject corrected nonconforming product to re-verification to demonstrate conformity to the requirements?
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Do the organisation maintain records of the nature of nonconformities and any subsequent actions taken, including concessions obtained?
8.4. Analysis of Data
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Do the organisation analyse data generated as a result of monitoring and measurement and from other relevant sources?
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Do the analysis of data provide information relating to:
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a) customer satisfaction?
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b) conformity to product requirements?
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c) characteristics and trends of processes and product, including opportunities for preventive action?
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d) suppliers?
8.5. Improvement
8.5.2. Corrective Action
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Do the organisation have a documented procedure defining the requirements for corrective action?
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Do the organisation take action to eliminate the cause of nonconformities in order to prevent recurrence?
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Do the documented procedure define requirements for:
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a) reviewing nonconformities (including customer complaints)?
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b) determining the cause of nonconformities?
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c) evaluating the need for action to ensure that nonconformities do not recur?
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d) determining and implementing action needed?
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e) records of the results of actions taken?
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f) reviewing the effectiveness of the corrective action taken?
8.5.3. Preventive Action
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Do the organisation have a documented procedure defining the requirements for preventive action?
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Do the organisation determine action to eliminate the causes of potential nonconformities in order to prevent their occurance?
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Do the documented procedure define requirements for:
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a) determining potential nonconformities and their causes?
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b) evaluating the need for action to prevent occurrence of nonconformities?
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c) determining and implementing action needed?
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d) records of results of action taken?
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e) reviewing the effectiveness of the preventive action taken?
Closing Meeting
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Closing meeting notes:
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Organisations' Management Representative
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Auditor