• Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Audit Preparation

  • Review corrective actions for previous IA findings

  • Review corrective actions for previous EA findings

  • Review corrective actions for any customer complaints

  • Review corrective actions for any customer audit findings

7.3.1 Design and Development Planning

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

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

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

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

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

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

7.3.2 Design & Development Inputs

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

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

  • applicable statutory and regulatory requirements?<br>

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

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

  • Are these inputs reviewed for adequacy?<br>

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

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>

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

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

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

  • contain or reference product acceptance criteria?<br>

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

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>

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

  • to identify any problems and propose necessary actions?

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

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

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>

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

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>

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

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

7.3.7 Design & Development Changes

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

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

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

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

7.5.1 Control of Production & Service Provision

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

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

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

  • the use of suitable equipment?<br>

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

  • the implementation of monitoring and measurement?<br>

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

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>

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

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

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

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

  • use of specific methods and procedures?<br>

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

  • revalidation?<br>

7.5.3 Identification and traceability

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

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

  • 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>

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>

  • 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>

  • 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>

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

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

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

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

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

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

  • 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>

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

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

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

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

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>

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

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

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

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>

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

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

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>

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

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

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

  • 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>

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>

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

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

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

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

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

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

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

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>

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

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

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

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

  • suppliers (see 7.4)?<br>


  • Auditor

  • Name

  • Auditee

  • Name

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