ISO 9001:2015 Audit Checklist

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• Conducted on

  Date

• Prepared by

• Location
  Address

4.1 Understanding the organisation and its context

• Has the organisation determined internal &external issues relevant to its purpose and strategic direction?<br>Note: Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation determined internal issues relevant to its purpose and strategic direction?<br>Note: Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.

  Compliant

  Minor N/C

  Major N/C

  N/A

• Do these issues affect the ability to achieve the intended result of the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation monitor and review information about these internal and external issues?

  Compliant

  Minor N/C

  Major N/C

  N/A

4.2 Understanding the needs and expectations of interested parties

• Has the organisation determined what interested parties are relevant to the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation determined what requirements those parties have that are relevant to the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has impact or potential impact been determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation monitor and review the information about interested parties and their relevant requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

4.3 Determining the scope of the quality management system

• Have the boundaries and applicability of the QMS been used to establish the scope of the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation considered the external and internal issues when determining the scope of the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation considered the requirements of relevant interested parties <br>when determining the scope of the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation considered the products and services when determining the scope of the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the application of the International Standard within the scope been determined, and has it been applied by the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have any requirements of the International Standard been determined as not applicable?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the scope available and maintained as documented information?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the document state what products and services are covered by the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• If applicable, does the document justify how instances of requirements of the QMS cannot be applied?

  Compliant

  Minor N/C

  Major N/C

  N/A

4.4 Quality management system and its processes

• Has the QMS been established and implemented?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the QMS maintained and continually improved?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have the processes been determined for the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have the inputs required and the outputs expected from these processes been determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have the sequence and interaction of these processes been determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have the criteria and methods (including monitoring and measurements and related performance indicators) needed to ensure the effective operation and control of these processes been determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have the resources needed for these processes been determined and their availability ensured?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have the responsibilities and authorities for these processes been assigned?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have risks and opportunities been considered and are plans in place to implement actions to address them?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have methods been used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve the intended results?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Have opportunities to improve the processes and the QMS been determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does documented information exists to support the operation of processes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How is this documented information retained?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How is confidence that the processes are being carried out as planned determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

5.1 Leadership and commitment

5.1.1 General

• Does top management demonstrate leadership and commitment to the QMS by taking accountability of the effectiveness of the QMS?

  Compliant

  Non-Compliant

  N/A

• Have the quality policy and objectives been established for the QMS?

  Compliant

  Non-Compliant

  N/A

• Are the quality policy and objectives compatible with the context and strategic direction of the organisation?

  Compliant

  Non-Compliant

  N/A

• Is the quality policy communicated within the organisation?

  Compliant

  Non-Compliant

  N/A

• Are the requirements of the QMS integrated into the business processes?

  Compliant

  Non-Compliant

  N/A

• Does the organisation promote awareness of the process approach?

  Compliant

  Non-Compliant

  N/A

• Does the organisation ensure that resources needed for the QMS area available?

  Compliant

  Non-Compliant

  N/A

• Is the importance of effective quality management communicated?

  Compliant

  Non-Compliant

  N/A

• Does the organisation communicate the importance of conforming to the QMS requirements?

  Compliant

  Non-Compliant

  N/A

• Does the organisation ensure that the QMS achieves its intended results?

  Compliant

  Non-Compliant

  N/A

• Does the organisation engage, direct and support people to contribute to the effectiveness of the QMS?

  Compliant

  Non-Compliant

  N/A

• Is continual improvement promoted?

  Compliant

  Non-Compliant

  N/A

• Does the organisation support other relevant management roles to demonstrate leadership in their areas of responsibility?

  Compliant

  Non-Compliant

  N/A

5.1.2 Customer focus

• Do top management demonstrate leadership and commitment to customer focus, ensuring requirements and applicable statutory & regulatory requirements are determined and met?

  Compliant

  Non-Compliant

  N/A

• Are risks and opportunities that can affect conformity of products and services determined?

  Compliant

  Non-Compliant

  N/A

• Has the ability to enhance customer satisfaction been determined and addressed?

  Compliant

  Non-Compliant

  N/A

• Has top management ensured that the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements are maintained?

  Compliant

  Non-Compliant

  N/A

• Is customer satisfaction maintained?

  Compliant

  Non-Compliant

  N/A

5.2 Policy

5.2.1 Establishing the quality policy

• Does top management establish, review and maintain the quality policy?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the policy determined to be appropriate to the purpose and context of the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the policy provide a framework for setting and reviewing quality objectives?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the policy contain a commitment to satisfy applicable requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the policy include a commitment to continual improvement of the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

5.2.2 Communicating the quality policy

• Is the policy available and maintained as documented information?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the policy communicated?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the policy understood and applied within the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the policy available to relevant interested parties, as appropriate?

  Compliant

  Minor N/C

  Major N/C

  N/A

5.3 Organisational roles, responsibilities and authorities

• Do top management ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood within the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Do top management assign the responsibility and authority for ensuring that the QMS conforms to the requirements of the International Standard?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Do top management assign the responsibility and authority for ensuring that the processes are delivering their intended outputs

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the performance of the QMS, opportunities for improvement and the need for change or innovation reported to top management?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is customer focus promoted within the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the integrity of the QMS maintained when changes to the QMS are planned and implemented?

  Compliant

  Minor N/C

  Major N/C

  N/A

6.1 Actions to address risks and opportunities

• Are the internal and external issues and interested parties considered when planning for the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are risks and opportunities determined and addressed so that the QMS can achieve its intended results?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are risks and opportunities determined and addressed so that the QMS can prevent or reduce undesired effects?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are risks and opportunities determined and addressed so that the QMS can achieve continual improvement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation planned actions to address these risks and opportunities?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation integrated and implemented the actions into its QMS processes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation evaluate the effectiveness of these actions?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are actions taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

6.2 Quality objectives and planning to achieve them

• Are the quality objectives consistent with the quality policy?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the quality objectives measurable?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Do the quality objectives take into account applicable requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the quality objectives relevant to conformity of products and services and do they enhance of customer satisfaction?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the quality objectives monitored and recorded?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the quality objectives communicated?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the quality objectives updated as appropriate?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine what will be done, with what resources, when completed and how will results be evaluated for quality objectives?

  Compliant

  Minor N/C

  Major N/C

  N/A

6.3 Planning of changes

• Are changes to the QMS planned systematically?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider the purpose of the changes and their potential consequences?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider the integrity of the quality management system?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider the availability of resources?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider the allocation or reallocation of responsibilities and authorities?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.1 Resources

7.1.1 General

• Can the organisation demonstrate how resources are determined for the establishment, implementation, maintenance and continual improvement of the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider the capabilities of, and constraints on, existing internal resources?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider what needs to be obtained from external providers?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.1.2 People

• Does the organisation provide persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.1.3 Infrastructure

• Does the organisation determine, provide and maintain the infrastructure for the operation of processes to achieve products and service conformity?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.1.4 Environment for the operation of processes

• Does the organisation determine, provide and maintain the environment for the operation of processes to achieve products and service conformity?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.1.5 Monitoring and measuring resources

• Are the resources determined for ensuring valid and reliable monitoring and measuring results, where used?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that resources provided are suitable for the specific monitoring and measurement activities and are maintained to ensure continued fitness for purpose?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Where applicable, are the measurement instruments verified of calibrated as specified intervals against national or international measurement standards? (When no such standards exist, is the basis used for calibration or verification retained as documented information.)<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are measurement instruments identified to determine their calibration status?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are they safeguarded from adjustments that would invalidate the calibration status and subsequent measurement results?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are safeguarded from damage and deterioration that would invalidate the calibration status and subsequent measurement results?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the validity of previous measurements if you find an instrument to be defective during verification or calibration?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the appropriate action taken as necessary?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.1.6 Organizational knowledge

• Does the organisation determine necessary knowledge for the operation of processes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine necessary knowledge to achieve conformity of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation maintain this knowledge and how do you make it available to the extent necessary?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation consider current knowledge and how do you acquire additional knowledge when addressing changing needs and trends?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.2 Competence

• Has the organisation determined the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that these persons are competent on the basis of appropriate education, training, or experience?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Where applicable, does the organisation take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain appropriate documented information as evidence of competence?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.3 Awareness

• Does the organisation ensure that persons doing work under the organisation’s control are aware of the quality policy?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that persons doing work under the organisation’s control are aware of the relevant quality objectives?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that persons doing work under the organisation’s control are aware of their contribution to the effectiveness of the quality management system, including the benefits of improved performance?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that persons doing work under the organisation’s control are aware of the implications of not conforming with the quality management system requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.4 Communication

• Does the organisation determine internal and external communications relevant to the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine on what it will communicate?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine when to communicate?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine with whom to communicate?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine how to communicate?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine who communicates?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.5 Documented information

7.5.1 General

• Does the organisation’s QMS include documented information required by this International Standard?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation's QMS include documented information determined by the organisation as being necessary for the effectiveness of the quality management system?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.5.2 Creating and updating

• When creating and updating documented information, does the organisation ensure appropriate identification and description (e.g. a title, date, author, or reference number)?

  Compliant

  Minor N/C

  Major N/C

  N/A

• When creating and updating documented information, does the organisation consider the format (e.g. language, software version, graphics) and media (e.g. paper, electronic)?

  Compliant

  Minor N/C

  Major N/C

  N/A

• When creating and updating documented information, does the organisation review and approve for suitability and adequacy?

  Compliant

  Minor N/C

  Major N/C

  N/A

7.5.3 Control of documented information

• Is the documented information required by the QMS and by this International Standard controlled to ensure it is available and suitable for use, where and when it is needed?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the documented information required by the QMS and by this International Standard controlled to ensure it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)?

  Compliant

  Minor N/C

  Major N/C

  N/A

• For the control of documented information, does the organisation consider the distribution, access, retrieval and use?

  Compliant

  Minor N/C

  Major N/C

  N/A

• For the control of documented information, does the organisation consider the storage and preservation, including preservation of legibility?

  Compliant

  Minor N/C

  Major N/C

  N/A

• For the control of documented information, does the organisation consider the control of changes (e.g. version control)?

  Compliant

  Minor N/C

  Major N/C

  N/A

• For the control of documented information, does the organisation consider the retention and disposition?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation identify as appropriate and control documented information of external origin which you have determined as necessary for the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.1 Operational planning and control

• Are processes needed to meet requirements for provision of products and services planned, implemented and controlled?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the requirements for products and services determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is criteria for processes and acceptance for products and services determined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the resources needed to achieve conformity to the product and service requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement control of the processes in accordance with the criteria?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation have documented information that shows confidence in that the processes have been carried out as planned?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation have documented information that can demonstrate conformity of products and service?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation determined that the output from the planning process is suitable for your operations?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation control planned changes and review the consequences of unintended changes?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.2 Requirements for products and services

8.2.1 Customer communication

• Does communication with customers include providing information relating to products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does communication with customers include handling enquiries, contracts or orders, including changes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does communication with customers include obtaining customer feedback relating to products and services, including customer complaints?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does communication with customers include handling or controlling customer property?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does communication with customers include establishing specific requirements for contingency actions, when relevant?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.2.2 Determining the requirements for products and services

• Is there a process to determine the requirements for products and services to be offered to potential customers?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation establish, implement and maintain this process?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation define product and service requirements including statutory and regulatory requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that you have the ability to meet the defined requirements and substantiate any claims for your products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.2.3 Review of requirements related to products and services

• Does the organisation ensure that it has the ability to meet the requirements for products and services to be offered to customers?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct a review of the requirements specified by the customer, including the requirements for delivery and postdelivery activities?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct a review of the requirements not stated by the customer, but necessary for the specified or intended use, when<br>known?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct a review of the requirements specified by the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct a review of the statutory and regulatory requirements applicable to the products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct a review of the contract or order requirements differing from those previously expressed?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information on the results of the review?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information on any new requirements for the products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organization have documented information which describes results of the review including any new or changed requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation have documented information containing changes to products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that relevant personnel are made aware of those changes?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.3 Design and development of products and services

8.3.1 General

• Does the organisation establish, implement and maintain a design and development process (where detailed requirements of your products and services are not already established or defined by the customer or other parties)?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.3.2 Design and development planning

• In determining the stages and controls for design and development, does the organisation consider the nature, duration and complexity of the design and development activities?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the required process stages, including applicable design and development reviews?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the required design and development verification and validation activities?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the responsibilities and authorities involved in the design and development process?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the internal and external resource needs for the design and development of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the need to control interfaces between persons involved in the design and development process?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the need for involvement of customers and users in the design and development process?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the requirements for subsequent provision of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the level of control expected for the design and development process by customers and other relevant interested parties?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the stages and controls for design and development, does the organisation consider the documented information needed to demonstrate that design and development requirements have been met?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.3.3 Design and development inputs

• Does the organisation determine the requirements essential for the type of products and services being designed and developed, including as applicable?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the functional & performance requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the statutory and regulatory requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the standards or codes of practice where there is a commitment to implement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the internal and external resources needed for the design and development of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the potential consequences of failure?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the level of control expected of the design and development process by customers and other relevant parties?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine that inputs are adequate, complete and unambiguous for design and development?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation resolve conflicts among inputs?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.3.4 Design and development controls

• Does the organisation apply controls to the design and development process to ensure that the results to be achieved are defined?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply controls to the design and development process to ensure that reviews are conducted to evaluate the ability of the results of design and development to meet requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply controls to the design and development process to ensure that verification activities are conducted to ensure that the design and development outputs meet the input requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply controls to the design and development process to ensure that validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply controls to the design and development process to ensure that any necessary actions are taken on problems determined during the reviews, or verification and validation activities?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply controls to the design and development process to ensure that documented information of these activities is retained?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.3.5 Design and development outputs

• Does the organisation ensure that design and development outputs meet the input requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that design and development outputs are adequate for the subsequent processes for the provision of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that design and development outputs include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation ensure that design and development outputs specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information on design and development outputs?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.3.6 Design and development changes

• Does the organisation retain documented information on design and development changes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information on the results of reviews?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information on the authorisation of the changes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information on the actions taken to prevent adverse impacts?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.4 Control of externally provided processes, products and services

8.4.1 General

• Does the organisation ensure externally provided processes, products and services conform to specified requirements?

  Yes

  No

  N/A

• Does the organisation apply specified requirements for the control of externally provided products and services when products and services are provided by external providers for incorporation into your own products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply specified requirements for the control of externally provided products and services when you provide products and services directly to customers by external providers on your behalf?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation apply specified requirements for the control of externally provided products and services when a process or part-process is provided by an external provider as a result of a decision to outsource a process or function.

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers.

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation assess their ability to provide processes or products and services in accordance with specified requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation have documented information of the results of evaluations, monitoring of performance and re-evaluations of external providers?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.4.2 Type and extent of control

• Does the organisation determine the controls applied to the external provision of processes, products and services and take into consideration the potential impact of the externally provided processes, products and services on the ability to consistently meet customer and applicable statutory and regulatory requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the controls applied to the external provision of processes, products and services and take into consideration the perceived effectiveness of the controls applied by the external provider?

  Compliant

  Minor N/C

  Major N/C

  N/A

• What verification or other activities do the organisation have to ensure externally provided processes, products and services do not adversely affect your ability to consistently deliver conforming products and services to your customers?

  Compliant

  Minor N/C

  Major N/C

  N/A

• When processes or functions have been outsourced to external providers, how does the organisation consider the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory<br>requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• When processes or functions have been outsourced to external providers, how does the organisation consider the effectiveness of the controls applied by the external provider?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.4.3 Information for external providers

• Does the organisation communicate to external providers its requirements for the processes, products and services to be provided?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation communicate to external providers its requirements for the approval of products and services, methods, processes and equipment and the release of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation communicate to external providers its requirements for competence, including any required qualification of persons?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation communicate to external providers its requirements for the external providers’ interactions with the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation communicate to external providers its requirements for control and monitoring of the external providers’ performance to be applied by the organisation?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation communicate to external providers its requirements for verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.5 Production and service provision

8.5.1 Control of production and service provision

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the characteristics of the products to be produced, the services to be provided, or the activities to be performed?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include the results to be achieved?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the availability and use of suitable monitoring and measuring resources?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the implementation of monitoring and measurement activities at appropriate stages to verify that<br>criteria for control of processes or outputs, and acceptance criteria for products and services, have been met?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the use of suitable infrastructure and environment for the operation of processes?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the appointment of competent persons, including any required qualification?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the implementation of actions to prevent human error?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation implement production and service provision under controlled conditions which include, the availability of documented information that defines the implementation of release, delivery and post-delivery activities?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.5.2 Identification and traceability

• Does the organisation use suitable means to identify outputs when it is necessary to ensure the conformity of products and services?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organization identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation control the unique identification of the outputs when traceability is a requirement, and retain the documented information necessary to enable traceability?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.5.3 Property belonging to customers or external providers

• Does the organistion exercise care with property belonging to customers or external providers while it is under the organisation’s control or being used by the organisation?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, does the organisation report this to the customer or external provider and retain documented information on what has occurred?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.5.4 Preservation

• Does the organisation preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.5.5 Post-delivery activities

• In determining the extent of post-delivery activities that are required, does the organisation consider the statutory and regulatory requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the extent of post-delivery activities that are required, does the organisation consider the potential undesired consequences associated with its products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the extent of post-delivery activities that are required, does the organisation consider the the nature, use and intended lifetime of its products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the extent of post-delivery activities that are required, does the organisation consider the customer requirements?

  Compliant

  Minor N/C

  Major N/C

  N/A

• In determining the extent of post-delivery activities that are required, does the organisation consider any customer feedback?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.5.6 Control of changes

• Does the organisation review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation retain documented information describing the results of the review of changes, the person(s) authorising the change, and any necessary actions arising from the review?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.6 Release of products and services

• Has the organisation implemented planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation ensure the release of products and services is held until planned arrangements for verification of conformity have been satisfactorily completed, unless approved by a relevant authority, or the customer if applicable?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation have documented information which shows traceability to the person authorising release of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

8.7 Control of nonconforming outputs

• How does the organisation identify and control process outputs, products and services that do not conform to requirements and prevent their unintended use or delivery?

  Compliant

  Minor N/C

  Major N/C

  N/A

• What appropriate corrective actions are taken based on the nature of the nonconformity and its impact on the conformity of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How do you apply this to nonconformity detected after delivery?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation deal with nonconforming process outputs, products and services in terms of correction?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation deal with nonconforming process outputs, products and services in terms of segregation, containment, return or suspension of provision of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation deal with nonconforming process outputs, products and services in terms of informing the customer?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation deal with nonconforming process outputs, products and services in terms of obtaining authorisation for use as-is?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation deal with nonconforming process outputs, products and services in terms of release, continuation or re-provision of the products and service?<br>

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation deal with nonconforming process outputs, products and services in terms of acceptance under concession?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How does the organisation verify conformance where process outputs, products and services are corrected following nonconformance?

  Compliant

  Minor N/C

  Major N/C

  N/A

• What documented information does the organisation keep following actions taken to address nonconformities, including any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformance?

  Compliant

  Minor N/C

  Major N/C

  N/A

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

• Has the organisation determined what needs to be monitored and measured?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation determined the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation determined when the monitoring and measuring shall be performed?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation determined when the results from monitoring and measurement shall be analysed and evaluated?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation retained appropriate documented information as evidence of the results?

  Compliant

  Minor N/C

  Major N/C

  N/A

9.1.2 Customer satisfaction

• Does the organisation monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation determine the methods for obtaining,<br>monitoring and reviewing this information?

  Compliant

  Minor N/C

  Major N/C

  N/A

9.1.3 Analysis and evaluation

• Does the organisation analyse and evaluate appropriate data and information arising from monitoring and measurement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate conformity of products and services?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate the degree of customer satisfaction?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate the performance and effectiveness of the quality management system?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate if planning has been implemented effectively?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate the effectiveness of actions taken to address risks and opportunities?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate the performance of external providers?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Are the results of analysis used to evaluate the need for improvements to the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

9.2 Internal audit

• Does the organisation conduct internal audits at planned intervals to provide information on whether the QMS conforms to the organization’s own requirements for its QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct internal audits at planned intervals to provide information on whether the QMS conforms to the requirements of this International Standard?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Does the organisation conduct internal audits at planned intervals to provide information on whether the QMS is effectively implemented and maintained?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is there an audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization and the results of previous audits?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is the audit criteria and scope defined for each audit?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t audit their own work?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How are audit results reported to relevant management?

  Select Compliant Minor N/C Major N/C N/A

  • Compliant
  • Minor N/C
  • Major N/C
  • N/A

• Can you demonstrate that necessary correction and corrective actions are taken without undue delay?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is there documented information of the audit programme and the audit results?

  Compliant

  Minor N/C

  Major N/C

  N/A

9.3 Management Review

• What is the frequency that top management reviews the organization's QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• How is the QMS deemed suitable, adequate and effective?

  Select Compliant Minor N/C Major N/C N/A

  • Compliant
  • Minor N/C
  • Major N/C
  • N/A

• Are the following included in the management reviews: actions status of previous reviews; changes to internal/external issues relevant to the QMS;<br>issues that affect strategy; KPIs for nonconformities and corrective actions;<br>monitor and measurement of results; audit results; customer satisfaction;<br>issues concerning external providers; issues concerning other relevant parties;<br>adequacy of resources and effectiveness of QMS; process performance;<br>conformity of products and services; actions taken to address risks and opportunities and their effectiveness; new potential opportunities for continual improvement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is there evidence that management reviews include decisions and actions relating to, continual improvement opportunities and the need for changes to the QMS including resource needs?

  Compliant

  Minor N/C

  Major N/C

  N/A

10 Improvement

• How does the organisation determine and select opportunities for improvement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• What necessary actions have you implemented so that you have met customer requirements and enhanced customer satisfaction?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Has the organisation improved processes to prevent nonconformities; Improved products and services to meet known and predicted requirements; Improved QMS results?

  Compliant

  Minor N/C

  Major N/C

  N/A

• When nonconformities occur, is there evidence of how the organisation react;<br>Take action to control and correct it; Deal with the consequences; Evaluate the need for action to eliminate the cause so that it does not recur or occur elsewhere by: Reviewing the nonconformity; Determining the cause of the nonconformity; Determining if similar nonconformities exist or could potentially occur; Actions needed are implemented; Review the effectiveness of corrective actions taken, if any; Make necessary changes to the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Is there evidence on how correction actions were appropriate to the effects of the nonconformities encountered?

  Compliant

  Minor N/C

  Major N/C

  N/A

• What documented information can you show as evidence of:<br>The nature of the nonconformities and subsequent actions taken; The results of any corrective action

  Compliant

  Minor N/C

  Major N/C

  N/A

• Can the organisation demonstrate that you continually improve the suitability, adequacy and effectiveness of the QMS?

  Compliant

  Minor N/C

  Major N/C

  N/A

• Can the organisation demonstrate that outputs of analysis and evaluation and the outputs from management review are considered to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement?

  Compliant

  Minor N/C

  Major N/C

  N/A

• What applicable tools and methodologies for investigation of the causes of underperformance and to support continual improvement are selected?

  Compliant

  Minor N/C

  Major N/C

  N/A