Compliancy Audit - ISO 9001:2008 Quality Management Systems Requirements

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Opening meeting notes:

4. Quality Management system

4.1. General Requirements

• Did the organisation determine the processes needed for the QMS and their application throughout the organization?

  Yes

  No

  N/A

• Did the organisation determine the sequence and interaction of these processes?

  Yes

  No

  N/A

• Did the organisation determine criteria and methods needed to ensure that both the operation and control of these processes are effective?

  Yes

  No

  N/A

• Did the organisation ensure the availability of resources and information necessary to support the operation and monitoring of these processes?

  Yes

  No

  N/A

• Do the organisation monitor, measure where applicable, and analyse these processes?

  Yes

  No

  N/A

• Do the organisation implement actions necessary to achieve planned results and continual improvement of these processes?

  Yes

  No

  N/A

4.2. Documentation Requirements

4.2.2. Quality Manual

• Did the organisation establish and maintain a documented Quality Manual?

• Do the Quality Manual include:

• a) The scope of the Quality Management System, including details of and justification for any exclusions?

  Yes

  No

  N/A

• b) The documented procedures established for the QMS, or reference to them?

  Yes

  No

  N/A

• c) A description of the interaction between the processes of the QMS?

  Yes

  No

  N/A

4.2.3. Control of Documents

• A documented procedure for the control of documents is available.

• The procedure defines the controls needed:

• a) to approve documents for adequacy prior to use.

  Yes

  No

  N/A

• b) to review and update as necessary and re-approve documents.

  Yes

  No

  N/A

• c) to ensure that changes and current revision status of documents are identified.

  Yes

  No

  N/A

• d) to ensure that relevant versions of applicable documents are available at points of use.

  Yes

  No

  N/A

• e) to ensure that documents remain legible and readily identifiable.

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

  Yes

  No

  N/A

4.2.4. Control of Records

• A documented procedure for the control of records is avalable.

• The procedure defines the controls needed for the:

• a) identification of records.

  Yes

  No

  N/A

• b) storage of records.

  Yes

  No

  N/A

• c) protection of records.

  Yes

  No

  N/A

• d) retrieval of records.

  Yes

  No

  N/A

• e) retention of records.

  Yes

  No

  N/A

• f) disposition of records.

  Yes

  No

  N/A

• All records are legible, readily identifiable and retrievable?

  Yes

  No

  N/A

5. Management Responsibility

5.1. Management commitment

• Do top management show evidence of their commitment by:

• a) communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements.

  Yes

  No

  N/A

• b) establishing the quality policy.

  Yes

  No

  N/A

• c) ensuring that quality objectives are established.

  Yes

  No

  N/A

• d) conducting management reviews.

  Yes

  No

  N/A

• e) ensuring the availability of resources.

  Yes

  No

  N/A

5.2. Customer Focus

• Is top management involved in determining customer requirements with the aim of enhancing customer satisfaction?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• b) Do the policy statement include a commitment to comply with requirements and continually improve the effectiveness of QMS?

  Yes

  No

  N/A

• c) Do the policy statement provide a framework for establishing and reviewing quality objectives?

  Yes

  No

  N/A

• d) Is the policy statement communicated and understood within the organization?

  Yes

  No

  N/A

• e) is the policy statement reviewed for continuing suitability?

  Yes

  No

  N/A

5.4. Planning

5.4.1. Quality Objectives

• Are quality objectives established at relevant functions and levels within the organization?

  Yes

  No

  N/A

• Are the objectives measurable and consistent with the quality policy?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• b) Is the integrity of the QMS maintained when changes to the system are planned and implemented?

  Yes

  No

  N/A

5.5. Responsibility, Authority and Communication

5.5.1. Responsibility and Authority

• Are responsibilities and authorities defined and communicated within the organization?

  Yes

  No

  N/A

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:

• a) ensuring that processes needed for the QMS are established, implemented and maintained?

  Yes

  No

  N/A

• b) reporting to top management on the performance of the QMS and any need for improvement?

  Yes

  No

  N/A

• c) ensuring the promotion of awareness of customer requirements throughout the organisation?

  Yes

  No

  N/A

5.5.3. Internal Communication

• Are the appropriate communication processes established for internal communication?

  Yes

  No

  N/A

• Do communication take place regarding the effectiveness of the QMS?

  Yes

  No

  N/A

5.6. Management Review

5.6.1. General

• Do management review the QMS at planned intervals?

  Yes

  No

  N/A

• Do the review include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives?

  Yes

  No

  N/A

5.6.2. Review Input

• Do the input to the review include information on:

• a) results of audits?

  Yes

  No

  N/A

• b) customer feedback?

  Yes

  No

  N/A

• c) process performance and product conformity?

  Yes

  No

  N/A

• d) status of preventive and corrective actions?

  Yes

  No

  N/A

• e) follow-up actions from previous management reviews?

  Yes

  No

  N/A

• f) changes that could affect the QMS?

  Yes

  No

  N/A

• g) recommendations for improvement?

  Yes

  No

  N/A

5.6.3. Review Output

• Do the output of the review include any decisions and actions related to:

• a) improvement of the effectiveness of the QMS and its processes?

  Yes

  No

  N/A

• b) improvement of product related to customer requirements?

  Yes

  No

  N/A

• c) resource needs?

  Yes

  No

  N/A

6. Resource Management

6.1. Provision of Resources

• Did the organisation determine and provide the resources needed:

• a) to implement and maintain the QMS and continually improve its effectiveness?

  Yes

  No

  N/A

• b) to enhance customer satisfaction by meeting customer requirements?

  Yes

  No

  N/A

6.2. Human Resources

6.2.1. General

• 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

• Do the organisation:

• a) determine the necessary competence for personnel performing work affecting conformity to product requirements?

  Yes

  No

  N/A

• b) where applicable, provide training or take other actions to achieve the necessary competence?

  Yes

  No

  N/A

• c) evaluate the effectiveness of the actions taken?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• e) maintain appropriate records of education, training, skills and experience?

  Yes

  No

  N/A

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:

• a) buildings, workspace and associated utilities?

  Yes

  No

  N/A

• b) process equipment (both hardware and software)?

  Yes

  No

  N/A

• c) supporting services ( such as transport, communication and information systems)?

  Yes

  No

  N/A

6.4. Work Environment

• Do the organisation determine and manage the work environment needed to achieve conformity to product requirements?

  Yes

  No

  N/A

7. Product Realization

7.1. Planning of Product Realisation

• Do the organisation plan and develop the processes needed for product realisation?

  Yes

  No

  N/A

• Do the organisation determine the following, as appropriate:

• a) quality objectives and requirements for the product?

  Yes

  No

  N/A

• b) the need to establish processes and documents, and to provide resources specific to the product?

  Yes

  No

  N/A

• c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance?

  Yes

  No

  N/A

• d) records needed to provide evidence that the realisation processes and resulting product meet requirements?

  Yes

  No

  N/A

7.2. Customer Related Processes

7.2.1. Determination of Requirements Related to the Product

• Do the organisation determine:

• a) requirements specified by the customer, including the requirements for delivery and post-delivery activities?

  Yes

  No

  N/A

• b) requirements not stated by the customer but necessary for specified or intended use, where known?

  Yes

  No

  N/A

• c) statutory and regulatory requirements applicable to the product?

  Yes

  No

  N/A

• d) any additional requirements considered necessary by the organisation?

  Yes

  No

  N/A

7.2.2. Review of Requirements Related to the product

• Do the organisation review the requirement prior to commitment in order to ensure that:

• a) product requirements are defined?

  Yes

  No

  N/A

• b) contract or order requirements differing from those previously expressed are resolved?

  Yes

  No

  N/A

• c) the organisation has the ability to meet the defined requirements?

  Yes

  No

  N/A

• Do the organisation maintain records of the results of the review and actions arising from the review?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

7.2.3. Customer Communication

• Do the organisation determine and implement effective arrangements for communicating with customers in relation to:

• a) product information?

  Yes

  No

  N/A

• b) enquiries, contracts or order handling, including amendements?

  Yes

  No

  N/A

• c) customer feedback, including customer complaints?

  Yes

  No

  N/A

7.3. Design and Development

7.3.1. Design and Development Planning

• During design and development planning, do the organisation determine:

• a) the design and development stages?

  Yes

  No

  N/A

• b) the review, verification and validation that are appropriate to each design and development stage?

  Yes

  No

  N/A

• c) the responsibilities and authorities for design and development?

  Yes

  No

  N/A

7.3.2. Design and Development Inputs

• Do the design and development inputs include:

• a) functional and performance requirements?

  Yes

  No

  N/A

• b) applicable statutory and regulatory requirements?

  Yes

  No

  N/A

• c) where applicable, information derived from previous similar designs?

  Yes

  No

  N/A

• d) other requirements essential for design and development?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Do the design and development outputs:

• a) meet the input requirements for design and development

  Yes

  No

  N/A

• b) provide appropriate information for purchasing, production and service provision?

  Yes

  No

  N/A

• c) contain or reference product acceptance criteria?

  Yes

  No

  N/A

• d) specify the characteristics of the product that are essential for its safe and proper use?

  Yes

  No

  N/A

7.3.4. Design and Development Review

• Do the organisation systematically review the design and development in accordance with planned arrangements to:

• a) evaluate the ability of the results of design and development to meet requirements?

  Yes

  No

  N/A

• b) identify any problems and propose necessary actions?

  Yes

  No

  N/A

• Are records maintained of the results of the review and any necessary actions taken?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Are records of the results of the verification and any necessary actions maintained?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Are records of the results of validation and any necessary actions maintained?

  Yes

  No

  N/A

7.3.7. Control of Design and Development Changes

• Are design and development changes identified and records maintained?

  Yes

  No

  N/A

• Do the organisation review, verify, validate, as appropriate, and approve changes before implementation?

  Yes

  No

  N/A

• Are records of the results of the review of changes and any necessary actions maintained?

  Yes

  No

  N/A

7.4. Purchasing

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?

  Yes

  No

  N/A

• Do the organisation have an approved supplier list?

  Yes

  No

  N/A

• Do the organisation have criteria for the selection of suppliers?

  Yes

  No

  N/A

• What is the selection criteria for suppliers?

• Do the organisation have evaluation criteria for suppliers?

  Yes

  No

  N/A

• What is the evaluation criteria for suppliers?

• Do the organisation have re-evaluation criteria for suppliers?

  Yes

  No

  N/A

• What is the re-evaluation criteria for suppliers?

• Are records of the results of evaluations and any necessary actions arising from the evaluation maintained?

  Yes

  No

  N/A

7.4.2. Purchasing Information

• Do the purchasing information describe the product to be purchased?

  Yes

  No

  N/A

• Do the information include, where appropriate:

• a) requirements for approval of product, procedures, processes and equipment?

  Yes

  No

  N/A

• b) requirements of qualification of personnel?

  Yes

  No

  N/A

• c) QMS requirements?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

7.5. Production and Service Provision

7.5.1. Control of Production and Service Provision

• Do the organisation plan and carry out production and service provision under controlled conditions including, as appropriate:

• a) the availability of information that describes the characteristics of the product?

  Yes

  No

  N/A

• b) the availability of work instructions, as necessary?

  Yes

  No

  N/A

• c) the use of suitable equipment?

  Yes

  No

  N/A

• d) the availability and use of monitoring and measuring equipment?

  Yes

  No

  N/A

• e) the implementation of monitoring and measurement?

  Yes

  No

  N/A

• f) the implementation of product release, delivery and post-delivery activities?

  Yes

  No

  N/A

7.5.2. Validation of Processes for Production and Service Provision

• Do validation demonstrate the ability of processes to achieve planned results?

  Yes

  No

  N/A

• Do the organisations arrangements for these processes include, as appropriate:

• a) defined criteria for review and approval of the processes?

  Yes

  No

  N/A

• b) approval of equipment and qualification of personnel?

  Yes

  No

  N/A

• c) use of specific methods and procedures?

  Yes

  No

  N/A

• d) requirements for records?

  Yes

  No

  N/A

• e) revalidation?

  Yes

  No

  N/A

7.5.3. Identification and Traceability

• Do the organisation identify the product by suitable means throughout product realisation?

  Yes

  No

  N/A

• Do the organisation identify the product status with respect to monitoring and measurement requirements throughout product realisation?

  Yes

  No

  N/A

• Do the organisation control unique identification of the product and maintain records, where traceability is a requirement?

  Yes

  No

  N/A

7.5.4. Customer Property

• Do the organisation make use of product provided by the customer for use or incorporation into the product?

  Yes

  No

• Do the organisation identify customer property?

  Yes

  No

  N/A

• Do the organisation verify customer property?

  Yes

  No

  N/A

• Do the organisation protect and safeguard customer property?

  Yes

  No

  N/A

• Do the organisation report to the customer any customer property that is lost, damaged or otherwise found to be unsuitable for use?

  Yes

  No

  N/A

7.5.5. Preservation of Product

• Do the organisation deal with product?

  Yes

  No

• Is product preserved trough identification?

  Yes

  No

  N/A

• Is product preserved through handling?

  Yes

  No

  N/A

• Is product preserved trough packaging?

  Yes

  No

  N/A

• Is product preserved trough storage?

  Yes

  No

  N/A

• Is product preserved trough protection?

  Yes

  No

  N/A

7.6. Control of Monitoring and Measuring Equipment

• Do the organisation make use monitoring and measuring equipment?

  Yes

  No

• Do the organisation determine the monitoring and measuring equipment needed to provide evidence of conformity of the product to determined requirements?

  Yes

  No

  N/A

• Where necessary to ensure valid results, are measuring equipment:

• 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?)

  Yes

  No

  N/A

• b) adjusted or re-adjusted as necessary?

  Yes

  No

  N/A

• c) identified in order to determine its calibration status?

  Yes

  No

  N/A

• d) safeguarded from adjustments that would invalidate the measurement result?

  Yes

  No

  N/A

• e) protected from damage and deterioration during handling, maintenance and storage?

  Yes

  No

  N/A

• Do the organisation assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements?

  Yes

  No

  N/A

• Do the organisation take appropriate action on the equipment and any product affected?

  Yes

  No

  N/A

• Do the organisation maintain records of the results of calibration and verification?

  Yes

  No

  N/A

8. Measurement, Analysis and Improvement

8.2. Monitoring and Measurement

8.2.1. Customer Satisfaction

• Do the organisation monitor information relating to customer perception as to whether the organisation has met customer requirements?

  Yes

  No

  N/A

• 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:

• a) conforms to planned arrangements, to the requirements of the ISO 9001 standard and to the QMS requirements established by the organisation?

  Yes

  No

  N/A

• b) is effectively implemented and maintained?

  Yes

  No

  N/A

• Do the organisation have a planned audit programme?

  Yes

  No

  N/A

• Is the audit criteria, scope, frequency and methods defined?

  Yes

  No

  N/A

• Is the selection of auditors and conduct of audits objective and impartial to the audit process?

  Yes

  No

  N/A

• Do the organisation maintain records of the audits and their results?

  Yes

  No

  N/A

• Do the responsible management ensure that any necessary corrections and corrective actions are taken to eliminate detected nonconformities and their causes?

  Yes

  No

  N/A

8.2.3. Monitoring and Measurement of Processes

• Do the organisation apply methods for monitoring and, where applicable, measurement of the QMS processes?

  Yes

  No

  N/A

• Do these methods demonstrate the ability of the processes to achieve planned results?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Do records indicate the person(s) authorising release of product for delivery to the customer?

  Yes

  No

  N/A

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:

• a) by taking action to eliminate the detected nonconformity?

  Yes

  No

  N/A

• b) by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?

  Yes

  No

  N/A

• c) by taking action to preclude its original intended use or application?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Do the organisation subject corrected nonconforming product to re-verification to demonstrate conformity to the requirements?

  Yes

  No

  N/A

• Do the organisation maintain records of the nature of nonconformities and any subsequent actions taken, including concessions obtained?

  Yes

  No

  N/A

8.4. Analysis of Data

• Do the organisation analyse data generated as a result of monitoring and measurement and from other relevant sources?

  Yes

  No

  N/A

• Do the analysis of data provide information relating to:

• a) customer satisfaction?

  Yes

  No

  N/A

• b) conformity to product requirements?

  Yes

  No

  N/A

• c) characteristics and trends of processes and product, including opportunities for preventive action?

  Yes

  No

  N/A

• d) suppliers?

  Yes

  No

  N/A

8.5. Improvement

8.5.2. Corrective Action

• Do the organisation have a documented procedure defining the requirements for corrective action?

• Do the organisation take action to eliminate the cause of nonconformities in order to prevent recurrence?

  Yes

  No

  N/A

• Do the documented procedure define requirements for:

• a) reviewing nonconformities (including customer complaints)?

  Yes

  No

  N/A

• b) determining the cause of nonconformities?

  Yes

  No

  N/A

• c) evaluating the need for action to ensure that nonconformities do not recur?

  Yes

  No

  N/A

• d) determining and implementing action needed?

  Yes

  No

  N/A

• e) records of the results of actions taken?

  Yes

  No

  N/A

• f) reviewing the effectiveness of the corrective action taken?

  Yes

  No

  N/A

8.5.3. Preventive Action

• Do the organisation have a documented procedure defining the requirements for preventive action?

• Do the organisation determine action to eliminate the causes of potential nonconformities in order to prevent their occurance?

  Yes

  No

  N/A

• Do the documented procedure define requirements for:

• a) determining potential nonconformities and their causes?

  Yes

  No

  N/A

• b) evaluating the need for action to prevent occurrence of nonconformities?

  Yes

  No

  N/A

• c) determining and implementing action needed?

  Yes

  No

  N/A

• d) records of results of action taken?

  Yes

  No

  N/A

• e) reviewing the effectiveness of the preventive action taken?

  Yes

  No

  N/A

• Closing meeting notes:

• Client Management Representative

  Sign

• Auditor

  Sign