Information

  • 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 any customer complaints

4.1 General Requirements

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

  • Do those in the department now where it is kept?<br>

  • Has the organization determined the process under the quality management system and the application required for Tenders, Enquiries and quotations (see 1.2)?

  • Has the organization determined criteria and methods needed to ensure that both the operation and control of these process is effective?<br>

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

  • Has the organization monitored, measured where applicable, and analysed this process?<br>

  • Has the organization implemented actions necessary to achieve planned results and continual improvement of these process?

4.2.1 Documentation Requirements - General

  • Has the organization documented procedures and records required by this International Standard?<br>

  • Has the organization a system for Control of documents?

  • Has the organization a system for Control of quality records?

  • Has the organization a system for Control of non-conformity?

  • Has the organization a system for Corrective action?

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

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

  • Has the organization a system to review and update as necessary and re-approve documents?

  • Has the organization a system to ensure that changes and the current revision status of documents are identified?

  • Has the organization a system to ensure that relevant versions of applicable documents are available at points of use?

  • Has the organization a system to ensure that documents remain legible and readily identifiable?

  • Has the organization a system to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the process are identified and their distribution controlled?

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

4.2.4 Control of Records

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

  • Are they controlled?

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

  • Has a documented procedure been established to define the controls needed for the Storage of records?<br>

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

  • Has a documented procedure been established to define the controls needed for the Retrieval of records?<br>

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

  • Has a documented procedure been established to define the controls needed for the destruction of records?<br>

  • Are records readily retrievable?<br>

  • Are records legible?

  • Are records readily identifiable?<br>

5.2 Customer Focus

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

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

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

5.3 Quality Policy

  • Does top management ensure that the quality policy is communicated and understood within the organization?<br>

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.

5.5.1 Responsibility and Authority

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

5.5.3 Internal Communication

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

  • Has top management ensured that communication takes place regarding the effectiveness of the process within the quality management system?

6.1 Provision of Resources

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

  • Has the organization determined and provided the resources needed to enhance customer satisfaction by meeting customer requirements?

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>

6.2.2 Competence, Awareness & Training

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

  • Has the organization determined the necessary competence where applicable, provided training or taken other actions to achieve the necessary competence?

  • Has the organization evaluated the effectiveness of the actions taken?

  • Has the organization 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?

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

6.3 Infrastructure

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

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

  • Does this infrastructure include process equipment (both hardware and software)?<br>

  • Does this infrastructure include supporting services (such as transport, communication or information systems)?

6.4 Work Environment

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

7.2.1 Determination of Requirements Related to the Product/process

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

  • Has the organization determined requirements not stated by the customer but necessary for specified or intended use, where known?

  • Has the organization determined statutory and regulatory requirements related to the product?

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

7.2.2 Review of Requirements Related to the Product/process

  • Does the organization review the requirements related to the process?

  • 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)?

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

  • Does this review ensure that contract or order requirements differing from those previously expressed are resolved?<br>

  • Does this review ensure that the organization has the ability to meet the defined requirements?

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

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

  • 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?

7.2.3 Customer Communication

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

  • Does the organization determine and implement effective arrangements for communicating with customers in relation to enquiries, contracts or order handling, including amendments?

  • Does the organization determine and implement effective arrangements for communicating with customers in relation to customer feedback, including customer complaints?

7.5.3 Identification and traceability

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

  • 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>

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?

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

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 process<br>

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

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

8.2.4 Monitoring and measurement of product

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

  • 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)?

  • 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?

8.5.2 Corrective action

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

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

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

  • Has a documented procedure been established to define requirements for determining the causes of nonconformities?<br>

  • Has a documented procedure been established to define requirements for evaluating the need for action to ensure that nonconformities do not recur?

  • Has a documented procedure been established to define requirements for determining and implementing action needed?

  • Has a documented procedure been established to define requirements for records of the results of action taken (see 4.2.4)?

  • Has a documented procedure been established to define requirements for reviewing the effectiveness of the corrective action taken?

8.5.3 Preventive action

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

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

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

  • Has a documented procedure been established to define requirements for evaluating the need for action to prevent occurrence of nonconformities?

  • Has a documented procedure been established to define requirements for determining and implementing action needed?

  • Has a documented procedure been established to define requirements for records of results of action taken (see 4.2.4)?

  • Has a documented procedure been established to define requirements for reviewing the effectiveness of the preventive action taken?

  • Assessor

  • Process Owner

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