Scope of Audit

  • Comments:

Opening meeting

  • List attendees and roles:

  • Signatures of attendees:

  • Complete attendance register

  • Objectives of the audit. -Not to reject the system -re-currence may point to system failure - cant cover all aspects. -where no non-conformance detected does not mean non exist sample of activities

  • Review of audit programme:

  • Company representative :

  • Name of company representative:

  • Function of company representative

  • Time of closing meeting

  • Confidentiality:

  • Reasons for aborting audit:

  • Scoring

  • Audit scoring legend: 0 = Not addressed at all 1 = No evidence of effective application ( even if implemented) 2 = Implemented / partly implemented 3 = implemented -partly implemented 4 = fully implemented and effectively applied

  • Clarification of findings: 0 = Red (No) - System deficiency - action plan approved and monitored by SHEQ department 1 = Red (No) - Finding - (<5 requires action plan) 2 = Red (No) - Finding 3 = Red (No) - Observation 4 = Green (yes) - conforming - No finding

  • Invite questions

  • Comments:

Overview of organisation:

  • Comments:

Results of previous audits

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

4.1 General Requirements

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • determined the sequence and interaction of these processes?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • monitored, measured where applicable, and analysed these processes?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

4.2.1 Documentation Requirements - General

  • Has the organization documented their quality management system?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • a quality manual?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • documented procedures and records required by this International Standard?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Control of documents?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Control of quality records?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Internal audits?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Control of non-conformity?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Corrective action?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Preventive action?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

4.2.2 Quality Manual

  • Has the quality manual been established?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Is the quality manual maintained?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Does the quality manual include the scope of the quality management system?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

4.2.3 Control of Documents

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • to ensure that documents remain legible and readily identifiable?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are they controlled?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Storage of records?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Protection of records?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Retrieval of records?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • retention time of records?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • disposition of records?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are records legible?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are records readily identifiable?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are records readily retrievable?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.1 Management Commitment

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • establishing the quality policy?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • ensuring that quality objectives are established?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • conducting management reviews?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • ensuring the availability of resources?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.2 Customer Focus

  • Does top management ensure that customer requirements are determined?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Does top management ensure that customer requirements are met?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.3 Quality Policy

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • includes a commitment to comply with requirements

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • and continually improve the effectiveness of the quality management system?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • provides a framework for establishing and reviewing quality objectives?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • is communicated and understood within the organization?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • is reviewed for continuing suitability?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Comments:

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.

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are the quality objectives measurable?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are the quality objectives consistent with the quality policy?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.5.1 Responsibility and Authority

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.5.2 Management Representative

  • Has top management appointed a member of its management

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • ensuring the promotion of awareness of customer requirements throughout the organization?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.5.3 Internal Communication

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

5.6.2 Review Input

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • customer feedback?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • process performance and product conformity?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • status of preventive and corrective actions?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • follow-up actions from previous management reviews?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • changes that could affect the quality management system?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • recommendations for improvement?






  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • improvement of product related to customer requirements?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • resource needs?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • to enhance customer satisfaction by meeting customer requirements?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

6.2.2 Competence, Awareness & Training

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • evaluated the effectiveness of the actions taken?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Comments:

6.3 Infrastructure

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • process equipment (both hardware and software)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments:

6.4 Work Environment

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.1 Planning of Product Realization

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • statutory and regulatory requirements related to the product?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • any additional requirements considered necessary by the organization?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.2.2 Review of Requirements Related to the Product

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Does this review ensure that product requirements are defined?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • the organization has the ability to meet the defined requirements?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General Comments

7.2.3 Customer Communication

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • enquiries, contracts or order handling, including amendments?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • customer feedback, including customer complaints?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.3.1 Design and Development Planning

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • the responsibilities and authorities for design and development?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

7.3.2 Design & Development Inputs

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Do these inputs include functional and performance requirements?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • applicable statutory and regulatory requirements?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • where applicable, information derived from previous similar designs?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • other requirements essential for design and development?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • Are these inputs reviewed for adequacy?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • contain or reference product acceptance criteria?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • to identify any problems and propose necessary actions?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.3.7 Design & Development Changes

  • Are design and development changes identified and records maintained?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.4.1 Purchasing Process

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • requirements for qualification of personnel?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • quality management system requirements?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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



  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.5.1 Control of Production & Service Provision

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • the availability of work instructions, as necessary?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • the use of suitable equipment?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • the availability and use of monitoring and measuring equipment?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • the implementation of monitoring and measurement?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • approval of equipment and qualification of personnel?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • use of specific methods and procedures?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • requirements for records (see 4.2.4)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • revalidation?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

7.5.3 Identification and traceability

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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,

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • against measurement standards traceable to international or national measurement standards?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • be adjusted or re-adjusted as necessary?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • have identification in order to determine its calibration status?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

8.1 Measurement, analysis and improvement - General

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • to ensure conformity of the quality management system?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • to continually improve the effectiveness of the quality management system?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

8.2.2 Internal Audit

  • Does the organization conduct internal audits at planned intervals

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • is effectively implemented and maintained?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • as well as the results of previous audits?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • 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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • conformity to product requirements (see 7.2.1)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • suppliers (see 7.4)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

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?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

8.5.2 Corrective action

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • determining the causes of nonconformities?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • determining and implementing action needed?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • reviewing the effectiveness of the corrective action taken?





  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

8.5.3 Preventive action

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

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

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • determining and implementing action needed?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • records of results of action taken (see 4.2.4)?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • reviewing the effectiveness of the preventive action taken?

  • 4 - fully implemented and apply 3 - implemented partly elective 2 - implemented / partly implemented -not satisfactory 1 - no evidence of effective application (even if implemented) 0 - not addressed at all

  • General comments

Closing meeting

  • Attendance register

  • Signatures

  • Signatures

  • Audit only sample, where no non conformance reported, does not mean on exist

  • Summarise good practices if any

  • Comments

  • Copy of feedback report

  • Invite questions

  • Comments

Summary of audit report

  • Summary of total score

  • Scoring: high / low:

  • List non-conformances:

  • List points / areas / clauses for improvement/s:

  • List observations:

Purposed corrective action dates:

  • Purposed corrective action dates

Signatures

  • Auditor's signature

  • Auditee signature

  • Management representative signature

  • Lead Auditor signatures

  • Lead Auditor signatures

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