iso 9001 audit checklist

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ISO 9001:2008 Audit Checklist

Clause Detail Comments

1.2 Are there any exclusions to the Standard

Are exclusions limited to clause 7

4.1 a) b) c) d) e) f)

Have the processes required for the QMS been determined Has the sequence and interaction of processes been determined Has a criteria been determined for the processes Has a method been determined to ensure that both operation and control of the processes are effective (6) (6.2.2) Have sufficient resources been made available to support the monitoring of these processes Has sufficient information been made available to support the monitoring of these processes Have these processes been monitored Have these processes been measured Has this information been analysed Have the processes been fully implemented Have the implemented processes been improved or is an improvement plan in place

4.1 Does the organisation outsource any of its processes that could affect product conformity

Are outsourced processes controlled

5.4.2 a)

Where the above requirements are not met is there evidence of top management planning to comply

4.2.1 a) b) c)

(5.3) (5.4.1) Does the organisation have a quality manual Does the quality manual contain procedures for the control of records (4.2.4)

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d)

Does the quality manual contain procedures for the control of documents (4.2.3) Does the quality manual contain procedures for the control of internal audits (8.2.2) Does the quality manual contain procedures for the control of the control of non conforming products (8.3) Does the quality manual contain procedures for the control of corrective actions (8.5.2) Does the quality manual contain procedures for the control of preventive actions (8.5.3) Does the quality manual contain procedures that have been identified as being required to maintain the QMS Has the organisation determined what documentation and records are required to ensure the effective planning, operation and control of its processes Are these documents and records maintained

4.2.1 Are all procedures appropriately established, documented, implemented and maintained Is the QMS documentation appropriate to the size of the organisation, its activities, the complexity of its processes and their interactions and the competence of its personnel

4.2.2 a) b) c)

Has the scope of the quality manual been defined Have exclusions identified at 1.2 been justified Are the procedures established for the QMS contained in the quality manual or referred to in it Has the interaction of procedures been described

4.2.3 a) b) c) d) e) f)

Does the document control procedure define the means of Document approval Document review and re-approval Identification of revision status Identification of changes made to documentation Ensuring that only current and relevant versions of documentation are available at the point of use Ensuring that documents remain legible

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g) h) i) j) k)

Ensuring that documents remain readily identifiable Ensuring that appropriate external documentation is identified Ensuring that the distribution of external documents is controlled Removing obsolete document from use Ensuring that obsolete documents remain out of use

5.4.2 b)

Are the above procedures implemented and maintained

4.2.4 Does the procedure for the control of records define the controls for Identification of records Storage of records Protection of records Retrieval of records Retention of records The disposition of records

4.2.4 Are the above procedures implemented and maintained

5.1 Has top management Communicated the importance of meeting customer requirements Communicated the importance of statutory and regulatory requirements (5.3) (5.6) (6)

5.2 Have customer requirements been determined

Are customer requirements met with

5.3 a)

Does the organisation have a quality policy Is the policy appropriate to the purpose of the organisation

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b) c) d) e)

Does the policy include a commitment to comply with the requirements of the QMS Does the policy include commitment to continually improving the QMS Does the policy provide a framework for establishing and reviewing quality objectives Has the policy been communicated within the organisation Is the policy understood by the organisation Is the policy subject to review to ensure continued suitability

5.6 Has this review been undertaken by top management

5.4.1 Have quality objectives been set

Are quality objectives measurable

Are quality objectives consistent with the quality policy

Are the quality objectives set at relevant functions and levels

5.6 Have the quality objectives been reviewed by top management

5.4.2 a) b)

Where the above objectives have not been established is there evidence of top management planning to comply Have all changes to the QMS been managed effectively

5.5.1 Are responsibilities and authorities throughout the organisation defined Are responsibilities and authorities communicated throughout the organisation

5.5.2 a) b) c)

Has a QMR been appointed Does the QMR understand his/her responsibilities to: Ensure that the processes required for the QMS are established, implemented and maintained Report to top management on the performance of the QMS Report to top management on the need for improvements Promote the awareness of customer requirements Where agreed, to liaise with external parties on matters relating to the QMS

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5.5.3 Have top management established appropriate communication processes for the purposes of the QMS Is there evidence of effective communication via the established means

5.6 Have top management established a plan for reviews of the QMS Are reviews undertaken in accordance with the management plan

5.6.2 a) b) c) d) e) f) g)

Has the top management review included: Results of audits Customer feedback Process performance Product conformity Status of preventive action Status of corrective action Follow-up action from previous reviews Changes that could affect the QMS Recommendations for improvement

5.6.3 Do top management review outputs include the decisions made or actions taken related to: Improving the QMS Improving the product related to customer requirements Improving the need for resources

6.1 Has the organisation determined the resources required to maintain the QMS

6.2.2 a) b) c) d)

Has the organisation: Determined the necessary competencies required by personnel performing work affecting conformity to product requirements Provided training or taken other measures to ensure competency where applicable Evaluated the effectiveness of these actions Do personnel understand the relevance and importance of

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E)

their activities Do workers understand how they contribute to the quality objectives Are training records maintained

6.3 a) b) c)

Has the organisation determined: The building, workspace and associated utilities needed to achieve conformity to product requirements The process equipment (both hardware and software) needed to achieve conformity to product requirements Supporting services (such as transport, communication or information systems) needed to achieve conformity to product requirements

6.3 Have the above resources been provided Have the above resources been maintained

6.4 Has the organisation determined the work environment needed to achieve conformity to product requirements

7.1 a) b) c) d)

Has the organisation determined: The quality objectives and requirements for the product The processes specific to the product The documentation specific to the product The resources specific to the product The required verification activities and acceptance criteria for the specific product The required validation activities and acceptance criteria for the specific product The required monitoring activities and acceptance criteria for the specific product The required measuring activities and acceptance criteria for the specific product The required inspection activities and acceptance criteria for the specific product The required test activities and acceptance criteria for the specific product The records needed to provide evidence of product

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7.1

conformity Is the product realisation planning consistent with the other QMS processes Is the product realisation planning consistent with the organisations method of operation

7.2.1 a) b) c) d)

Has the organisation determined: Product requirements determined by the customer The delivery and post delivery requirements of the customer Requirements necessary for the products intended use Statutory or regulatory requirements of the product The requirements considered necessary by the organisation

7.2.2 a) b) c) 7.2.2

Has the organisation, prior to submission of tenders, acceptance of contracts or orders ensured: That product requirements are defined That contract or order requirements differing from previous contracts or orders have been resolved That the organisation can meet the defined requirements Have actions under this clause been recorded Has clause 4.2.4 been applied to these records If customer requirements have not been stated in writing have they been confirmed by other means Have changes to requirements been communicated

7.2.3 a) b) c) 7.2.3

Has the organisation determined effective arrangements for communications with customers in relation to: Product information Enquiries, contracts or order handling Enquiry, contracts or order amendments Customer feedback and customer complaints Have these arrangements been implemented

7.3.1 Has the organisation determined: The design and development stages

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A review that is appropriate to each design and development stage A means of verification that is appropriate to each design and development stage A means of validation that is appropriate to each design and development stage The responsibilities and authorities for design and development Is there effective communication and assignment of responsibility between different groups involved in the design and development stages

7.3.2 a) b) c) d) 7.3.2

Are functional and performance requirements determined at the design stage Are functional and performance requirements recorded at the design stage Are statutory and regulatory requirements determined at the design stage Are statutory and regulatory requirements recorded at the design stage Where information from previous similar designs has been used has this information been determined and recorded Has the organisation determined other requirements essential for design and development Has the organisation recorded other requirements essential for design and development Have these inputs been subject to review for adequacy Are the identified requirements complete, unambiguous and free of conflict with each other

7.3.3 a) b)

Can the design outputs be verified against the design and development inputs Are the design and development outputs approved prior to release Do the design and development outputs: Meet the input requirements for design and development Provide appropriate information for purchasing

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c) d)

Provide appropriate information for production Provide appropriate information for service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for its safe and proper use

7.3.4 a) b) 7.3.4

Have suitable stages been determined for the systematic review of design and development in accordance with clause 7.3.1 Have the determined reviews been performed Have these reviews been adequate to: Evaluate the ability of the results of design and development to meet the requirements Identify any problems Propose necessary actions Have representatives of functions concerned with design and development stages been involved in the review Have records of reviews and necessary actions been maintained in accordance with 4.2.4

7.3.5 Has verification been performed in accordance with 7.3.1 Have records of verification results and associated necessary actions been maintained in accordance with 4.2.4

7.3.6 Has validation been performed in accordance with 7.3.1 Was validation undertaken prior to delivery / implementation (should be where practicable) Have records of validation results and associated necessary actions been maintained in accordance with 4.2.4

7.3.7 Have any design and development changes taken place Have any design and development changes been identified and recorded Have changes been subject to review, verified, validated and approved before implementation

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Does the review of design and development changes include the evaluation of the effect of the changes on constituent parts Does the review of design and development changes include the evaluation of the effect of the changes on product already delivered Have records of these reviews and associated actions been maintained in accordance with 4.2.4

7.4.1 Has the organisation established controls over purchased product that is appropriate to the purchased products effect on subsequent product realisation or the final product Has the organisation set criteria for the selection of approved suppliers Are records of approved suppliers and actions resulting from evaluation maintained in accordance with 4.2.4

7.4.2 a) b) c)

Does purchasing information describe the product to be purchased Does this description include: The requirements for approval of product, procedures, processes and equipment The requirements for qualification of personnel Any requirements of the QMS

7.4.3 Has the organisation established and implemented appropriate measures to ensure that purchased product meets specified purchase requirements Where verification is to be performed at the suppliers premises has the organisation stated the intended arrangements and method of product release in the purchasing information

7.5.1 a) b) c) d)

Has the organisation planned production Does this planning include: The availability of the description of the characteristics of the product The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring equipment (7.6)

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e) f)

The implementation of monitoring and measurement Product release Product delivery Post delivery activities

7.5.2 a) b) c) d) e)

If production and service provision output cannot be verified by subsequent monitoring and measuring has the organisation defined arrangements for (as applicable): Defining the criteria for review and approval of the processes The approval of equipment The approval of qualification of personnel The use of specific methods and procedures The requirements of records in accordance with 4.2.4 Revalidation

7.5.3 Where appropriate has the organisation identified the product by suitable means throughout product realisation Has the organisation identified the status of the product with respect to monitoring and measurement requirements throughout product realisation Where traceability is a requirement, has the organisation controlled the unique identification of the product and maintained records in accordance with 4.2.4

7.5.4 Where the organisation is in possession of customer property, which has been provided for use or incorporation into the product, has the organisation: Identified the property Verified the property Taken measures to protect and safeguard the customers property

7.5.4 If customer property has been lost, damaged or otherwise found to be unsuitable for use, has the customer reported such to the customer Have records been maintained for such reports in accordance with 4.2.4

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7.5.5 Has the organisation taken appropriate measures to preserve the product, including its constituent parts, during internal processing and delivery including, as applicable: Identification Handling Packaging Storage and protection

7.6 a) b) c) d) e)

Has the organisation determined the monitoring and measurement to be undertaken to provide evidence of conformity of product to determined requirements Has the organisation identified the measuring equipment needed to achieve the determined monitoring and measurement Has the organisation established processes to ensure that monitoring and measurement can be carried out in a manner that is consistent with the monitoring and measurement requirements Where necessary to ensure valid results has the organisation ensured that the measuring equipment is: 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 standard exist, has the basis used for calibration or verification been recorded and records maintained in accordance with 4.2.4 Adjusted or re-adjusted as necessary Marked with an identification number in order to determine its calibration status Safeguarded from adjustments that would invalidate the measurement result Protected from damage and deterioration during handling, maintenance and storage

7.6 If measuring equipment has been found not to conform to requirements has the organisation assessed and recorded the validity of previous measurement results If measuring equipment has been found not to conform to requirements has the organisation taken appropriate action on the measuring equipment

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If measuring equipment has been found not to conform to requirements has the organisation taken appropriate action on affected product Have all calibration and verification results been recorded and the records maintained in accordance with 4.2.4 If computer software is used in the monitoring and measurement of specified requirements, has the ability of the software to satisfy the intended application been confirmed prior to use and reconfirmed as necessary

8.1 a) b) c)

Has the organisation planned and implemented the monitoring, measurement, analysis and improvement processes needed to: Demonstrate conformity to product requirements Ensure conformity of the QMS Continually improve the QMS

8.2.1 Has the organisation determined means to monitor customer perception Has the determined means been implemented and maintained

8.2.2 a) b)

Are internal audits planned Are internal audits successful in determining whether or not the QMS: Conforms to the planned arrangements (7.1) Conforms to the requirements of the Standard Conforms to the QMS requirements established by the organisation Is effectively implemented and maintained

8.2.2 Does the audit programme take into account the status and importance of the processes and areas to be audited Does the audit programme take into account the results of previous audits Has the organisation defined the audit: Criteria Scope Frequency and methods

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8.2.2 Have audits been objective and impartial Have audits been conducted by personnel not involved in the audited activity Have records of audits been maintained in accordance with 4.2.4 Have actions and corrective actions been taken without undue delay(8.5.2)

8.2.3 Are the QMS processes monitored and, where applicable measured to Demonstrate the achievement of planned results Initiate corrective action Take appropriate corrective action to ensure product conformity

8.2.4 Has the organisation monitored and, where applicable measured the characteristics of the product to verify that product requirements have been met Has this been carried out at appropriate stages in accordance with planned arrangements (7.1) Has evidence of conformity, along with acceptance criteria been maintained Do records indicate the person(s) who authorised release of product for delivery to the customer Have planned arrangements (7.1) been satisfactorily completed prior to product release for delivery to the customer or have they been otherwise approved by a relevant authority and, where applicable, the customer

8.3 Is nonconforming product identifiable Where applicable, has the organisation dealt with non conforming product by one or more of the following ways: By taking action to eliminate the detected nonconformity By authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer By taking action to preclude its original intended use or application

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By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started

8.3 Where applicable, has nonconforming product, which has been corrected, been subject to re-verification to demonstrate conformity to requirements Have records of non-conformance and subsequent actions, including concessions obtained, been maintained in accordance with 4.2.4

8.4 a) b) c) d)

Has the organisation determined the data required to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made Does the data that has been determined include that data generated as a result of monitoring and measurement and other relevant sources Has the organisation collected and analysed the data determined Does the analysis of data provide information relating to: Customer satisfaction (8.2.1) Conformity of product requirements (8.2.4) Characteristics and trends of processes and products, including opportunities for preventive action (8.2.3 and 8.2.4) Suppliers

8.5.1 Has the organisation continually improved the effectiveness of the QMS through the use of: The quality policy Quality objectives Audit results Analysis of data Corrective actions Preventative actions Management review

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8.5.2 a) b) c) d) e) f)

Has the organisation taken action to eliminate the causes of nonconformities to prevent recurrence Has the corrective action bee appropriate to the effects of the nonconformities Has a documented procedure been established, which defines requirements for: Reviewing nonconformities (including customer complaints) Determining the causes of nonconformities Evaluating the need for action to ensure that nonconformities do not recur Determining and implementing action needed Records of the results of action taken (4.2.4) Reviewing the effectiveness of the corrective action taken

8.5.3 Has the organisation determined action to eliminate the causes of potential nonconformities in order to prevent their occurrence Are the preventive actions determined appropriate to the effects of the potential problems Has a documented procedure been established, which defines requirements for: Determining potential nonconformities and their causes Evaluating the need for action to prevent occurrence of nonconformities Determining and implementing action needed Records of results of action taken (4.2.4) Reviewing the effectiveness of the preventive action taken

Organisation name: Location: Audit Date: Auditor(s): Audit number:

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