ISO 9001:2008 System Audit Checklist

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Audit Preparation

• Review corrective actions for previous IA findings

  Yes

  No

  N/A

• Review corrective actions for previous EA findings

  Yes

  No

  N/A

• Review corrective actions for any customer complaints

  Yes

  No

  N/A

• Which Cotta QMS documents are relevant to this audit?

  Yes

  No

  N/A

4.1 General Requirements

• Has the organization established, documented, implemented and maintained a quality management system?<br>

  Yes

  No

  N/A

• Does the organization continually improve the effectiveness of its quality management system in accordance with the requirements of this International Standard?<br>

  Yes

  No

  N/A

• Has the organization:<br>determined the processes needed for the quality management system and their application throughout the organization (see 1.2)?

  Yes

  No

  N/A

• determined the sequence and interaction of these processes?<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• ensured the availability of resources and information necessary to support the operation and monitoring of these processes?<br>

  Yes

  No

  N/A

• monitored, measured where applicable, and analysed these processes?<br>

  Yes

  No

  N/A

• implemented actions necessary to achieve planned results and continual improvement of these processes?

  Yes

  No

  N/A

• Are these processes managed by the organization in accordance with the requirements of this International Standard?<br>

  Yes

  No

  N/A

• Where the organization chooses to outsource any process that affects product conformity to requirements, has the organization ensured control over such processes?<br>

  Yes

  No

  N/A

• Is the type and extent of control of such outsourced processes defined within the quality management system?<br>

  Yes

  No

  N/A

• Are the relevant Cotta QMS procedures being followed?

  Yes

  No

  N/A

4.2.1 Documentation Requirements - General

• Has the organization documented their quality management system?<br>

  Yes

  No

  N/A

• Does the documentation include documented statements of a quality policy and quality objectives?<br>

  Yes

  No

  N/A

• a quality manual?<br>

  Yes

  No

  N/A

• documented procedures and records required by this International Standard?

  Yes

  No

  N/A

• Control of documents?<br>

  Yes

  No

  N/A

• Control of quality records?<br>

  Yes

  No

  N/A

• Internal audits?<br>

  Yes

  No

  N/A

• Control of non-conformity?<br>

  Yes

  No

  N/A

• Corrective action?<br>

  Yes

  No

  N/A

• Preventive action?<br>

  Yes

  No

  N/A

• Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes?<br>

  Yes

  No

  N/A

4.2.2 Quality Manual

• Has the quality manual been established?<br>

  Yes

  No

  N/A

• Is the quality manual maintained?<br>

  Yes

  No

  N/A

• Does the quality manual include the scope of the quality management system? <br>

  Yes

  No

  N/A

• Details of and justification for any exclusions (see 1.2)?

  Yes

  No

  N/A

• the documented procedures established for the quality management system, or reference to them?<br>

  Yes

  No

  N/A

• a description of the interaction between the processes of the quality management system?<br>

  Yes

  No

  N/A

4.2.3 Control of Documents

• Are all documents required by the quality management system controlled?<br>

  Yes

  No

  N/A

• Are records considered to be a special type of document?<br>

  Yes

  No

  N/A

• Are records controlled according to the requirements given in 4.2.4?<br>

  Yes

  No

  N/A

• Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue?<br>

  Yes

  No

  N/A

• to review and update as necessary and re-approve documents?<br>

  Yes

  No

  N/A

• to ensure that changes and the current revision status of documents are identified?<br>

  Yes

  No

  N/A

• to ensure that relevant versions of applicable documents are available at points of use?<br>

  Yes

  No

  N/A

• to ensure that documents remain legible and readily identifiable?<br>

  Yes

  No

  N/A

• to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled?<br>

  Yes

  No

  N/A

• to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?<br>

  Yes

  No

  N/A

4.2.4 Control of Records

• Have records been established to provide evidence of conformity to requirements and of the effective operation of the quality management system?<br>

  Yes

  No

  N/A

• Are they controlled?<br>

  Yes

  No

  N/A

• Has a documented procedure been established to define the controls needed for the identification of records?

  Yes

  No

  N/A

• Storage of records?<br>

  Yes

  No

  N/A

• Protection of records?<br>

  Yes

  No

  N/A

• Retrieval of records?<br>

  Yes

  No

  N/A

• retention time of records?<br>

  Yes

  No

  N/A

• disposition of records?<br>

  Yes

  No

  N/A

• Are records legible?<br>

  Yes

  No

  N/A

• Are records readily identifiable?<br>

  Yes

  No

  N/A

• Are records readily retrievable?<br>

  Yes

  No

  N/A

5.1 Management Commitment

• Does top management provide evidence of its commitment to the development and implementation of the quality management system?<br>

  Yes

  No

  N/A

• Does top management provide evidence of its commitment to continually improving the effectiveness of the quality management system by<br>communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements?<br>

  Yes

  No

  N/A

• establishing the quality policy?<br>

  Yes

  No

  N/A

• ensuring that quality objectives are established?<br>

  Yes

  No

  N/A

• conducting management reviews?<br>

  Yes

  No

  N/A

• ensuring the availability of resources?<br>

  Yes

  No

  N/A

5.2 Customer Focus

• Does top management ensure that customer requirements are determined?<br>

  Yes

  No

  N/A

• Does top management ensure that customer requirements are met?<br>

  Yes

  No

  N/A

• Is this with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?<br>

  Yes

  No

  N/A

5.3 Quality Policy

• Does top management ensure that the quality policy is appropriate to the purpose of the organization?<br>

  Yes

  No

  N/A

• includes a commitment to comply with requirements <br>

  Yes

  No

  N/A

• and continually improve the effectiveness of the quality management system?<br>

  Yes

  No

  N/A

• provides a framework for establishing and reviewing quality objectives?<br>

  Yes

  No

  N/A

• is communicated and understood within the organization?<br>

  Yes

  No

  N/A

• is reviewed for continuing suitability?<br>

  Yes

  No

  N/A

5.4.1 Quality Objectives

• Does top management ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. <br>

  Yes

  No

  N/A

• Are the quality objectives measurable?<br>

  Yes

  No

  N/A

• Are the quality objectives consistent with the quality policy?<br>

  Yes

  No

  N/A

5.4.2 Quality Management System Planning

• Does top management ensure that the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?<br>

  Yes

  No

  N/A

• the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?<br>

  Yes

  No

  N/A

5.5.1 Responsibility and Authority

• Does top management ensure that responsibilities and authorities are defined and communicated within the organization?<br>

  Yes

  No

  N/A

5.5.2 Management Representative

• Has top management appointed a member of its management

  Yes

  No

  N/A

• who, irrespective of other responsibilities, has responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained?<br>

  Yes

  No

  N/A

• reporting to top management on the performance of the quality management system and any need for improvement?<br>

  Yes

  No

  N/A

• ensuring the promotion of awareness of customer requirements throughout the organization?<br>

  Yes

  No

  N/A

5.5.3 Internal Communication

• Has top management ensured that appropriate communication processes are established within the organization?<br>

  Yes

  No

  N/A

• Has top management ensured that communication takes place regarding the effectiveness of the quality management system?<br>

  Yes

  No

  N/A

5.6.1 Management Review - General

• Does top management review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?<br>

  Yes

  No

  N/A

• Does this review include assessing opportunities for improvement and the need for changes to the quality management system?<br>

  Yes

  No

  N/A

• Does this review include assessing opportunities for improvement and the need for changes to the quality policy and quality objectives?<br>

  Yes

  No

  N/A

• Have records from management reviews been maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

5.6.2 Review Input

• Does the input to management review include information on results of audits?<br>

  Yes

  No

  N/A

• customer feedback?<br>

  Yes

  No

  N/A

• process performance and product conformity?<br>

  Yes

  No

  N/A

• status of preventive and corrective actions?<br>

  Yes

  No

  N/A

• follow-up actions from previous management reviews?<br>

  Yes

  No

  N/A

• changes that could affect the quality management system?<br>

  Yes

  No

  N/A

• recommendations for improvement?<br><br><br><br><br><br><br>

  Yes

  No

  N/A

5.6.3 Review Output

• Does the output from the management review include any decisions and actions related to improvement of the effectiveness of the quality management system and its processes?<br>

  Yes

  No

  N/A

• improvement of product related to customer requirements?<br>

  Yes

  No

  N/A

• resource needs?<br>

  Yes

  No

  N/A

6.1 Provision of Resources

• Has the organization determined and provided the resources needed to implement and maintain the quality management system and continually improve its effectiveness?<br>

  Yes

  No

  N/A

• to enhance customer satisfaction by meeting customer requirements?<br>

  Yes

  No

  N/A

6.2.1 Human Resources - General

• Are personnel performing work affecting conformity to product requirements competent on the basis of appropriate education, training, skills and experience?<br>

  Yes

  No

  N/A

6.2.2 Competence, Awareness & Training

• Has the organization determined the necessary competence for personnel performing work affecting conformity to product requirements?<br>

  Yes

  No

  N/A

• where applicable, provided training or taken other actions to achieve the necessary competence?<br>

  Yes

  No

  N/A

• evaluated the effectiveness of the actions taken?<br>

  Yes

  No

  N/A

• ensured that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?<br>

  Yes

  No

  N/A

• maintained appropriate records of education, training, skills and experience (see 4.2.4)?<br>

  Yes

  No

  N/A

6.3 Infrastructure

• Has the organization determined, provided and maintained the infrastructure needed to achieve conformity to product requirements?<br>

  Yes

  No

  N/A

• Does this infrastructure include, as applicable buildings, workspace and associated utilities?<br>

  Yes

  No

  N/A

• process equipment (both hardware and software)?<br>

  Yes

  No

  N/A

• supporting services (such as transport, communication or information systems)?<br>

  Yes

  No

  N/A

6.4 Work Environment

• Has the organization determined and managed the work environment needed to achieve conformity to product requirements?<br>

  Yes

  No

  N/A

7.1 Planning of Product Realization

• Has the organization planned and developed the processes needed for product realization?<br>

  Yes

  No

  N/A

• Is planning of product realization consistent with the requirements of the other processes of the quality management system (see 4.1)?<br>

  Yes

  No

  N/A

• In planning product realization, has the organization determined the following, as appropriate: quality objectives and requirements for the product?<br>

  Yes

  No

  N/A

• the need to establish processes, documents, and provide resources specific to the product?<br>

  Yes

  No

  N/A

• required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance?<br>

  Yes

  No

  N/A

• records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)?<br>

  Yes

  No

  N/A

• Is the output of this planning in a form suitable for the organization's method of operations?<br>

  Yes

  No

  N/A

7.2.1 Determination of Requirements Related to the Product

• Has the organization determined requirements specified by the customer, including the requirements for delivery and post-delivery activities?<br>

  Yes

  No

  N/A

• requirements not stated by the customer but necessary for specified or intended use, where known?<br>

  Yes

  No

  N/A

• statutory and regulatory requirements related to the product?<br>

  Yes

  No

  N/A

• any additional requirements considered necessary by the organization?<br>

  Yes

  No

  N/A

7.2.2 Review of Requirements Related to the Product

• Does the organization review the requirements related to the product?<br>

  Yes

  No

  N/A

• Is this review conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders)?<br>

  Yes

  No

  N/A

• Does this review ensure that product requirements are defined?<br>

  Yes

  No

  N/A

• contract or order requirements differing from those previously expressed are resolved?<br>

  Yes

  No

  N/A

• the organization has the ability to meet the defined requirements?<br>

  Yes

  No

  N/A

• Have records of the results of the review and actions arising from the review been maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Where the customer provides no documented statement of requirement, have the customer requirements been confirmed by the organization before acceptance?<br>

  Yes

  No

  N/A

• Where product requirements are changed, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?<br>

  Yes

  No

  N/A

7.2.3 Customer Communication

• Does the organization determine and implement effective arrangements for communicating with customers in relation to product information?<br>

  Yes

  No

  N/A

• enquiries, contracts or order handling, including amendments?<br>

  Yes

  No

  N/A

• customer feedback, including customer complaints?<br>

  Yes

  No

  N/A

7.3.1 Design and Development Planning

• Does the organization plan and control the design and development of product?<br>

  Yes

  No

  N/A

• During the design and development planning, does the organization determine the design and development stages?<br>

  Yes

  No

  N/A

• the review, verification and validation that are appropriate to each design and development stage?<br>

  Yes

  No

  N/A

• the responsibilities and authorities for design and development?<br>

  Yes

  No

  N/A

• Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility?<br>

  Yes

  No

  N/A

• Is planning output updated, as appropriate, as the design and development progresses?<br>

  Yes

  No

  N/A

7.3.2 Design & Development Inputs

• Are inputs relating to product requirements determined and records maintained (see 4.2.4)? <br>

  Yes

  No

  N/A

• Do these inputs include functional and performance requirements?<br>

  Yes

  No

  N/A

• applicable statutory and regulatory requirements?<br>

  Yes

  No

  N/A

• where applicable, information derived from previous similar designs?<br>

  Yes

  No

  N/A

• other requirements essential for design and development?<br>

  Yes

  No

  N/A

• Are these inputs reviewed for adequacy?<br>

  Yes

  No

  N/A

• Are requirements complete, unambiguous and not in conflict with each other?<br>

  Yes

  No

  N/A

7.3.3 Design & Development Outputs

• Are the outputs of design and development provided in a form suitable for verification against the design and development input?<br>

  Yes

  No

  N/A

• Are the outputs of design and development approved prior to release?<br>

  Yes

  No

  N/A

• Do design and development outputs meet the input requirements for design and development?<br>

  Yes

  No

  N/A

• provide appropriate information for purchasing, production and for service provision?<br>

  Yes

  No

  N/A

• contain or reference product acceptance criteria?<br>

  Yes

  No

  N/A

• specify the characteristics of the product that are essential for its safe and proper use?<br>

  Yes

  No

  N/A

7.3.4 Design & Development Review

• At suitable stages, are systematic reviews of design and development performed in accordance with planned arrangements (see 7.3.1)?<br>

  Yes

  No

  N/A

• to evaluate the ability of the results of design and development to meet requirements?<br>

  Yes

  No

  N/A

• to identify any problems and propose necessary actions?

  Yes

  No

  N/A

• Do participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed?<br>

  Yes

  No

  N/A

• Are records of the results of the reviews and any necessary actions maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

7.3.5 Design & Development Verification

• Is verification performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements?<br>

  Yes

  No

  N/A

• Are records of the results of the verification and any necessary actions maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

7.3.6 Design & Development Validation

• Is design and development validation performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?<br>

  Yes

  No

  N/A

• Wherever practicable, is validation completed prior to the delivery or implementation of the product?<br>

  Yes

  No

  N/A

• Are records of the results of validation and any necessary actions maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

7.3.7 Design & Development Changes

• Are design and development changes identified and records maintained?<br>

  Yes

  No

  N/A

• Are the changes reviewed, verified and validated, as appropriate, and approved before implementation?<br>

  Yes

  No

  N/A

• Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered?

  Yes

  No

  N/A

• Are records of the results of the review of changes and any necessary actions maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

7.4.1 Purchasing Process

• Does the organization ensure that purchased product conforms to specified purchase requirements?<br>

  Yes

  No

  N/A

• Is the type and extent of control applied to the supplier and the purchased product dependent upon the effect of the purchased product on subsequent product realization or the final product?<br>

  Yes

  No

  N/A

• Does the organization evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements?<br>

  Yes

  No

  N/A

• Have criteria for selection, evaluation and re-evaluation been established?<br>

  Yes

  No

  N/A

• Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

7.4.2 Purchasing Information

• Does purchasing information describe the product to be purchased, including where appropriate requirements for approval of product, procedures, processes and equipment?<br>

  Yes

  No

  N/A

• requirements for qualification of personnel?<br>

  Yes

  No

  N/A

• quality management system requirements?<br>

  Yes

  No

  N/A

• Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?<br><br><br><br>

  Yes

  No

  N/A

7.4.3 Verification of Purchased Product

• Has the organization established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?<br>

  Yes

  No

  N/A

• Where the organization or its customer intends to perform verification at the supplier's premises, has the organization stated the intended verification arrangements and method of product release in the purchasing information?<br>

  Yes

  No

  N/A

7.5.1 Control of Production & Service Provision

• Has the organization planned and carried out production and service provision under controlled conditions?<br>

  Yes

  No

  N/A

• Do controlled conditions include, as applicable the availability of information that describes the characteristics of the product?<br>

  Yes

  No

  N/A

• the availability of work instructions, as necessary?<br>

  Yes

  No

  N/A

• the use of suitable equipment?<br>

  Yes

  No

  N/A

• the availability and use of monitoring and measuring equipment?<br>

  Yes

  No

  N/A

• the implementation of monitoring and measurement?<br>

  Yes

  No

  N/A

• the implementation of product release, delivery and post-delivery activities?<br>

  Yes

  No

  N/A

7.5.2 Validation of processes for production and service provision

• Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?<br>

  Yes

  No

  N/A

• Does this include any processes where deficiencies become apparent only after the product is in use or the service has been delivered?<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Has the organization established arrangements for these processes including, as applicable defined criteria for review and approval of the processes?<br>

  Yes

  No

  N/A

• approval of equipment and qualification of personnel?<br>

  Yes

  No

  N/A

• use of specific methods and procedures?<br>

  Yes

  No

  N/A

• requirements for records (see 4.2.4)?<br>

  Yes

  No

  N/A

• revalidation?<br>

  Yes

  No

  N/A

7.5.3 Identification and traceability

• Where appropriate, does the organization identify the product by suitable means throughout product realization?<br>

  Yes

  No

  N/A

• Does the organization identify the product status with respect to monitoring and measurement requirements throughout product realization?<br>

  Yes

  No

  N/A

• Where traceability is a requirement, does the organization control and record the unique identification of the product and maintain records (see 4.2.4)?<br>

  Yes

  No

  N/A

7.5.4 Customer property

• Does the organization exercise care with customer property while it is under the organization's control or being used by the organization?<br>

  Yes

  No

  N/A

• Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product?<br>

  Yes

  No

  N/A

• If any customer property is lost, damaged or otherwise found to be unsuitable for use, is this reported to the customer by the organization?<br>

  Yes

  No

  N/A

• If any customer property is lost, damaged or otherwise found to be unsuitable for use, are records maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

7.5.5 Preservation of product

• Does the organization preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements?<br>

  Yes

  No

  N/A

• As applicable, does this preservation include identification, handling, packaging, storage and protection?<br>

  Yes

  No

  N/A

• Does preservation also apply to the constituent parts of a product?<br>

  Yes

  No

  N/A

7.6 Control of monitoring and measuring equipment

• Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements (see 7.2.1)?<br>

  Yes

  No

  N/A

• Has the organization established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements?<br>

  Yes

  No

  N/A

• Where necessary to ensure valid results, has the organization ensured that measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use, <br>

  Yes

  No

  N/A

• against measurement standards traceable to international or national measurement standards?<br>

  Yes

  No

  N/A

• Where no such standards exist, is the basis used for calibration or verification recorded?<br>

  Yes

  No

  N/A

• be adjusted or re-adjusted as necessary?<br>

  Yes

  No

  N/A

• have identification in order to determine its calibration status?<br>

  Yes

  No

  N/A

• be safeguarded from adjustments that would invalidate the measurement result?<br>

  Yes

  No

  N/A

• be protected from damage and deterioration during handling, maintenance and storage?<br>

  Yes

  No

  N/A

• In addition, does the organization assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements?<br>

  Yes

  No

  N/A

• Does the organization take appropriate action on the equipment and any product affected?<br>

  Yes

  No

  N/A

• Have records of the results of calibration and verification been maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• When used in the monitoring and measurement of specified requirements, is the ability of computer software to satisfy the intended application confirmed?<br>

  Yes

  No

  N/A

• Is this undertaken prior to initial use and reconfirmed as necessary?<br>

  Yes

  No

  N/A

8.1 Measurement, analysis and improvement - General

• Has the organization planned and implemented the monitoring, measurement, analysis and improvement processes needed<br>to demonstrate conformity to product requirements?<br>

  Yes

  No

  N/A

• to ensure conformity of the quality management system?<br>

  Yes

  No

  N/A

• to continually improve the effectiveness of the quality management system?<br>

  Yes

  No

  N/A

• Does this include determination of applicable methods, including statistical techniques, and the extent of their use?<br>

  Yes

  No

  N/A

8.2.1 Customer satisfaction

• As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements?<br>

  Yes

  No

  N/A

• Have the methods for obtaining and using this information been determined?<br>

  Yes

  No

  N/A

8.2.2 Internal Audit

• Does the organization conduct internal audits at planned intervals<br>

  Yes

  No

  N/A

• to determine whether the quality management system conforms to the planned arrangements (see 7.1)? to the requirements of this International Standard? and to the quality management system requirements established by the organization?<br>

  Yes

  No

  N/A

• is effectively implemented and maintained?<br>

  Yes

  No

  N/A

• Has an audit programme been planned, taking into consideration the status and importance of the processes and areas to be audited,<br>

  Yes

  No

  N/A

• as well as the results of previous audits?<br>

  Yes

  No

  N/A

• Have the audit criteria, scope, frequency and methods been be defined?<br>

  Yes

  No

  N/A

• Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?<br>

  Yes

  No

  N/A

• Does the audit programme ensure that auditors shall not audit their own work?<br>

  Yes

  No

  N/A

• Have the responsibilities and requirements for planning and conducting audits, establishing records and reporting results been defined in a documented procedure?<br>

  Yes

  No

  N/A

• Are records of the audits and their results maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Does the management responsible for the area being audited ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes?

  Yes

  No

  N/A

• Do follow-up activities include the verification of the actions taken and the reporting of verification results (see 8.5.2)?<br>

  Yes

  No

  N/A

8.2.3 Monitoring and measurement of processes

• Does the organization apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes?<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• When planned results are not achieved, is correction and corrective action taken, as appropriate?<br>

  Yes

  No

  N/A

8.2.4 Monitoring and measurement of product

• Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met?<br>

  Yes

  No

  N/A

• Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1)?<br>

  Yes

  No

  N/A

• Has evidence of conformity with the acceptance criteria been maintained?<br>

  Yes

  No

  N/A

• Do records indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4)?<br>

  Yes

  No

  N/A

• Does the organization ensure that the release of product and delivery of service shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer?<br>

  Yes

  No

  N/A

8.3 Control of nonconforming product

• Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery?<br>

  Yes

  No

  N/A

• Have the controls and related responsibilities and authorities for dealing with nonconforming product been defined in a documented procedure?<br>

  Yes

  No

  N/A

• Does the organization deal with nonconforming product by one or more of the following ways: by taking action to eliminate the detected nonconformity?<br>

  Yes

  No

  N/A

• by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?<br>

  Yes

  No

  N/A

• by taking action to preclude its original intended use or application?<br>

  Yes

  No

  N/A

• 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

• When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements?<br>

  Yes

  No

  N/A

• Are records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, maintained (see 4.2.4)?<br><br>

  Yes

  No

  N/A

8.4 Analysis of data

• Does the organization determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made?<br>

  Yes

  No

  N/A

• Does this include data generated as a result of monitoring and measurement and from other relevant sources?<br>

  Yes

  No

  N/A

• Does the analysis of data provide information relating to customer satisfaction (see 8.2.1)?<br>

  Yes

  No

  N/A

• conformity to product requirements (see 7.2.1)?<br>

  Yes

  No

  N/A

• characteristics and trends of processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4)?<br>

  Yes

  No

  N/A

• suppliers (see 7.4)?<br>

  Yes

  No

  N/A

8.5.1 Continual improvement

• Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review?<br>

  Yes

  No

  N/A

8.5.2 Corrective action

• Does the organization take action to eliminate the causes of nonconformities in order to prevent recurrence?<br>

  Yes

  No

  N/A

• Are corrective actions appropriate to the effects of the nonconformities encountered?<br>

  Yes

  No

  N/A

• Has a documented procedure been established to define requirements for reviewing nonconformities (including customer complaints)?<br>

  Yes

  No

  N/A

• determining the causes of nonconformities?<br>

  Yes

  No

  N/A

• evaluating the need for action to ensure that nonconformities do not recur?<br>

  Yes

  No

  N/A

• determining and implementing action needed?<br>

  Yes

  No

  N/A

• records of the results of action taken (see 4.2.4)?<br>

  Yes

  No

  N/A

• reviewing the effectiveness of the corrective action taken?<br><br><br><br><br><br>

  Yes

  No

  N/A

8.5.3 Preventive action

• Has the organization determined action to eliminate the causes of potential nonconformities in order to prevent their occurrence?<br>

  Yes

  No

  N/A

• Are preventive actions appropriate to the effects of the potential problems?<br>

  Yes

  No

  N/A

• Has a documented procedure been established to define requirements for determining potential nonconformities and their causes?<br>

  Yes

  No

  N/A

• evaluating the need for action to prevent occurrence of nonconformities?<br>

  Yes

  No

  N/A

• determining and implementing action needed?<br>

  Yes

  No

  N/A

• records of results of action taken (see 4.2.4)?<br>

  Yes

  No

  N/A

• reviewing the effectiveness of the preventive action taken?<br>

  Yes

  No

  N/A