A. Verification of Previous Findings

  • 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. Context of the Organization

4.1 Understanding the organization and its context

  • Has the organization determined the external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system?

  • Has the organization monitored and reviewed information about these external and internal issues?

  • NOTE 1: Issues can include positive and negative factors or conditions for consideration.

  • NOTE 2: 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.

  • NOTE 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

4.2 Understanding the needs and expectations of interested parties

  • Has the organization:
    a) determined the interested parties that are relevant to the quality management system?

  • b) determined the relevant requirements of these interested parties?

  • Has the organization monitored and reviewed information about these interested parties and their relevant requirements?

4.3 Determining the scope of the quality management system

  • Has the organization determined the boundaries and applicability of the quality management system to establish its scope?

  • When determining scope, has the organization considered:
    a) the external and internal issues referred to in 4.1?

  • b) the requirements of relevant interested parties referred to in 4.2?

  • c) the products and services of the organization?

  • Has the organization applied all the requirements of this International Standard if they are applicable within the determined scope of its quality management system?

  • Has the scope of the organization’s quality management system been made available and maintained as documented information?

  • Does the scope state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system?

  • Is it clear that conformity to the ISO9001:2015 standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction?

4.4 Quality management system and its processes

4.4.1

  • Has the organization established, implemented, maintained and continually improved a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard?

  • Has the organization determined the processes needed for the quality management system and their application throughout the organization?

  • In relation to these processes, has the organization:
    a) determined the inputs required and the outputs expected from these processes?

  • b) determined the sequence and interaction of these processes?

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

  • d) determined the resources needed for these processes and ensure their availability?

  • e) assigned the responsibilities and authorities for these processes?

  • f) addressed the risks and opportunities as determined in accordance with the requirements of 6.1?

  • g) evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results?

  • h) improved the processes and the quality management system?

4.4.2

  • To the extent necessary, has the organization:
    a) maintained documented information to support the operation of its processes?

  • b) retained documented information to have confidence that the processes are being carried out as planned?

5. Leadership

5.1 Leadership Committment

5.1.1 General

  • Has top management demonstrated leadership and commitment with respect to the quality management system by:
    a) taking accountability for the effectiveness of the quality management system?

  • b) ensuring that the quality policy and quality objectives are established and are compatible with the strategic direction and the context of the organization?

  • c) ensuring the integration of the quality management system requirements into the organization’s business processes?

  • d) promoting the use of the process approach and risk-based thinking?

  • e) ensuring that the resources needed for the quality management system are available?

  • f) communicating the importance of effective quality management and of conforming to the quality management system requirements?

  • g) ensuring that the quality management system achieves its intended results?

  • h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system?

  • i) promoting improvement?

  • j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?

  • NOTE: Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

5.1.2 Customer Focus

  • Has top management demonstrated leadership and commitment with respect to customer focus by:
    a) ensuring that customer and applicable statutory and regulatory requirements are determined, understood and consistently met?

  • b) ensuring that the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?

  • c) ensuring that the focus on enhancing customer satisfaction is maintained?

5.2 Policy

5.2.1 Establishing the quality policy

  • Has top management established, implemented and maintained a quality policy that:
    a) is appropriate to the purpose and context of the organization and supports its strategic direction?

  • b) provides a framework for setting quality objectives?

  • c) includes a commitment to satisfy applicable requirements?

  • d) includes a commitment to continual improvement of the quality management system?

5.2.2 Communicating the quality policy

  • Has the quality policy been:
    a) made available and maintained as documented information?

  • b) communicated, understood, and applied within the organization?

  • c) made available to relevant interested parties, as appropriate?

5.3 Organizational roles, responsibilities and authorities

  • Has top management ensured the responsibilities and authorities for roles relevant to quality are assigned, communicated and understood within the organization?

  • Has top management assigned responsibility and authority for:
    a) ensuring that the quality management system conforms to the requirements of the ISO9001:2015 International Standard?

  • b) ensuring that the processes are delivering their intended outputs?

  • c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management?

  • d) ensuring the promotion of customer focus throughout the organization?

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

6. Planning

6.1 Actions to address risk and opportunities

6.1.1

  • When planning for the quality management system, has the organization considered:
    a) the issues referred to in 4.1?

  • b) the requirements referred to in 4.2?

  • Has the organization determined the risks and opportunities that need to be addressed to:
    a) give assurance that the quality management system can achieve its intended result(s)?

  • b) enhance desirable effects?

  • c) prevent, or reduce, undesired effects?

  • d) achieve improvement?

6.1.2

  • Has the organization planned:
    a) actions to address these risks and opportunities?

  • b) how to:
    1) integrate and implement the actions into its quality management system processes (see 4.4)?

  • 2) evaluate the effectiveness of these actions?

  • Have actions taken to address risks and opportunities been proportionate to the potential impact on the conformity of products and services?

  • NOTE 1: Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

  • NOTE 2: Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

6.2 Quality objectives and planning to achieve them

6.2.1

  • Has the organization established quality objectives at relevant functions, levels and processes needed for the quality management system?

  • Are the quality objectives:
    a) consistent with the quality policy?

  • b) measurable?

  • c) taking into account applicable requirements?

  • d) relevant to conformity of products and services and to enhancement of customer satisfaction?

  • e) monitored?

  • f) communicated?

  • g) updated as appropriate?

  • Has the organization maintained documented information on the quality objectives?

6.2.2

  • When planning how to achieve its quality objectives, has the organization determined:
    a) what will be done?

  • b) what resources will be required?

  • c) who will be responsible?

  • d) when it will be completed?

  • e) how the results will be evaluated?

6.3 Planning of changes

  • When the organization determines the need for changes to the quality management system, have the changes been carried out in a planned manner (see 4.4)?

  • Has the organization considered:
    a) the purpose of the changes and their potential consequences?

  • b) the integrity of the quality management system?

  • c) the availability of resources?

  • d) the allocation or reallocation of responsibilities and authorities?

7. Support

7.1 Resources

7.1.1 General

  • Has the organization determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system?

  • Has the organization considered:
    a) the capabilities of, and constraints on, existing internal resources?

  • b) what needs to be obtained from external providers?

7.1.2 People

  • Has the organization determined and provided the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes?

7.1.3 Infrastructure

  • Has the organization determined, provided and maintained the infrastructure necessary for the operation of its processes and to achieve conformity of products and services?

  • NOTE: Infrastructure can include: a) buildings and associated utilities; b) equipment, including hardware and software; c) transportation resources; d) information and communication technology.

7.1.4 Environment for the operation of processes

  • Has the organization determined, provided and maintained the environment necessary for the operation of its processes and to achieve conformity of products and services?

  • NOTE: A suitable environment can be a combination of human and physical factors, such as: a) social (e.g. non-discriminatory, calm, non-confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ substantially depending on the products and services provided.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

  • Has the organization determined and provided the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements?

  • Has the organization ensured that the resources provided:
    a) are suitable for the specific type of monitoring and measurement activities being undertaken?

  • b) are maintained to ensure their continuing fitness for their purpose?

  • Has the organization retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources?

7.1.5.2 Measurement traceability

  • When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, has measuring equipment been:
    a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist is the basis used for calibration or verification retained as documented information?

  • b) identified in order to determine their status?

  • c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results?

  • Has the organization determined if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and taken appropriate action as necessary?

7.1.6 Organizational knowledge

  • Has the organization determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services?

  • Has this knowledge been maintained and been made available to the extent necessary?

  • When addressing changing needs and trends, has the organization considered its current knowledge and determined how to acquire or access any necessary additional knowledge and required updates?

  • NOTE 1: Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

  • NOTE 2: Organizational knowledge can be based on: a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services); b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

7.2 Competence

  • Has the organization:
    a) determined the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system?

  • b) ensured that these persons are competent on the basis of appropriate education, training or experience?

  • c) where applicable, taken actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken?

  • d) retain appropriate documented information as evidence of competence?

  • NOTE: Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons

7.3 Awareness

  • Has the organization ensured that persons doing work under the organization’s control are aware of:
    a) the quality policy?

  • b) relevant quality objectives?

  • c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance?

  • d) the implications of not conforming with the quality management system requirements?

7.4 Communication

  • Has the organization determined the internal and external communications relevant to the quality management system, including:
    a) on what it will communicate?

  • b) when to communicate?

  • c) with whom to communicate?

  • d) how to communicate?

  • e) who communicates?

7.5 Documented Information

7.5.1 General

  • Does the organization’s quality management system include:
    a) documented information required by this International Standard?

  • b) documented information determined by the organization as being necessary for the effectiveness of the quality management system?

  • NOTE: The extent of documented information for a quality management system can differ from one organization to another due to: 1) the size of organization and its type of activities, processes, products and services; 2) the complexity of processes and their interactions; 3) the competence of persons.

7.5.2 Creating and updating

  • When creating and updating documented information has the organization ensured appropriate:
    a) identification and description (e.g. a title, date, author, or reference number)?

  • b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic)?

  • c) review and approval for suitability and adequacy?

7.5.3 Control of documented information

7.5.3.1

  • Has documented information required by the quality management system and by this International Standard been controlled to ensure:
    a) it is available and suitable for use, where and when it is needed?

  • b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)?

7.5.3.2

  • For the control of documented information, has the organization addressed the following activities, as applicable:
    a) distribution, access, retrieval and use?

  • b) storage and preservation, including the preservation of legibility?

  • c) control of changes (e.g. version control)?

  • d) retention and disposition?

  • Has documented information of external origin been determined by the organization to be necessary for the planning and operation of the quality management system identified as appropriate, and controlled?

  • Has documented information retained as evidence of conformity been protected from unintended alterations?

  • NOTE: Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

8. Operation

8.1 Operational planning and control

  • Has the organization planned, implemented, and controlled the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions identified in Clause 6, by:
    a) determining the requirements for the products and services?

  • b) establishing criteria for:
    1) the processes?

  • 2) the acceptance of products and services?

  • c) determining the resources needed to achieve conformity to the product and service requirements?

  • d) implementing control of the processes in accordance with the criteria?

  • e) determining, maintaining and retaining documented information to the extent necessary:
    1) to have confidence that the processes have been carried out as planned?

  • 2) to demonstrate the conformity of products and services to their requirements?

  • Is the output of this planning suitable for the organization’s operations?

  • Has the organization controlled planned changes and reviewed the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?

  • Has the organization ensured that outsourced processes are controlled (see 8.4)?

8.2 Requirements for products and services

8.2.1 Customer communication

  • Has communication with customers included:
    a) providing information relating to products and services?

  • b) handling enquiries, contracts or orders, including changes?

  • c) obtaining customer feedback relating to products and services, including customer complaints?

  • d) handling or controlling customer property?

  • e) establishing specific requirements for contingency actions, when relevant?

8.2.2 Determining the requirements for products and services

  • When determining the requirements for the products and services to be offered to customers, has the organization ensured that:
    a) the requirements for the products and services are defined, including:
    1) any applicable statutory and regulatory requirements?

  • 2) those considered necessary by the organization?

  • b) the organization can meet the claims for the products and services it offers?

8.2.3 Review of the requirements for products and services

8.2.3.1

  • Has the organization ensured that it has the ability to meet the requirements for products and services to be offered to customers?

  • Has the organization conducted a review before committing to supply products and services to a customer, including:
    a) requirements specified by the customer, including the requirements for delivery and post-delivery activities?

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

  • c) requirements specified by the organization?

  • d) statutory and regulatory requirements applicable to the products and services?

  • e) contract or order requirements differing from those previously expressed?

  • Has the organization ensured that contract or order requirements differing from those previously defined are resolved?

  • Have the customer’s requirements been confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements?

  • NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.

8.2.3.2

  • Has the organization retained documented information, as applicable:
    a) on the results of the review?

  • b) on any new requirements for the products and services?

8.2.4 Changes to requirements for products and services

  • Has the organization ensured that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed?

8.3 Design and development of products and services

8.3.1 General

  • Has the organization established, implemented and maintained a design and development process that is appropriate to ensure the subsequent provision of products and services?

8.3.2 Design and development planning

  • In determining the stages and controls for design and development, has the organization considered:
    a) the nature, duration and complexity of the design and development activities?

  • b) the required process stages, including applicable design and development reviews?

  • c) the required design and development verification and validation activities?

  • d) the responsibilities and authorities involved in the design and development process?

  • e) the internal and external resource needs for the design and development of products and services;?

  • f) the need to control interfaces between persons involved in the design and development process?

  • g) the need for involvement of customers and users in the design and development process?

  • h) the requirements for subsequent provision of products and services?

  • i) the level of control expected for the design and development process by customers and other relevant interested parties?

  • j) the documented information needed to demonstrate that design and development requirements have been met?

8.3.3 Design and development inputs

  • Has the organization determined the requirements essential for the specific types of products and services to be designed and developed?

  • In determining these requirements, has the organization considered:
    a) functional and performance requirements?

  • b) information derived from previous similar design and development activities?

  • c) statutory and regulatory requirements?

  • d) standards or codes of practice that the organization has committed to implement?

  • e) potential consequences of failure due to the nature of the products and services?

  • Are inputs for design and development purposes adequate, complete and unambiguous?

  • Have conflicting design and development inputs been resolved?

  • Has the organization retained documented information on design and development inputs?

8.3.4 Design and development controls

  • Has the organization applied controls to the design and development process to ensure that:
    a) the results to be achieved are defined?

  • b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements?

  • c) verification activities are conducted to ensure that the design and development outputs meet the input requirements?

  • d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use?

  • e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities?

  • f) documented information of these activities is retained?

  • NOTE: Design and development reviews, verification and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

8.3.5 Design and development outputs

  • Has the organization ensured that design and development outputs:
    a) meet the input requirements?

  • b) are adequate for the subsequent processes for the provision of products and services?

  • c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria?

  • d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision?

  • Has the organization retained documented information on design and development outputs?

8.3.6 Design and development changes

  • Has the organization identified, reviewed and controlled changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements?

  • Has the organization retained documented information on:
    a) design and development changes?

  • b) the results of reviews?

  • c) the authorization of the changes?

  • d) the actions taken to prevent adverse impacts?

8.4 Control of externally provided processes, products and services

8.4.1 General

  • Has organization ensured that externally provided processes, products and services conform to requirements?

  • Has the organization determined the controls to be applied to externally provided processes, products and services when:
    a) products and services from external providers are intended for incorporation into the organization’s own products and services?

  • b) products and services are provided directly to the customer(s) by external providers on behalf of the organization?

  • c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization?

  • Has the organization determined and applied criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements?

  • Has the organization retained documented information of these activities and any necessary actions arising from the evaluations?

8.4.2 Type and extent of control

  • Has the organization ensured that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers?

  • Has the organization:
    a) ensured that externally provided processes remain within the control of its quality management system?

  • b) defined both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output?

  • c) taken into consideration:
    1) 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 requirements?

  • 2) the effectiveness of the controls applied by the external provider?

  • d) determined the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?

8.4.3 Information for external providers

  • Has the organization ensured the adequacy of requirements prior to their communication to the external provider?

  • Has the organization communicated to external providers its requirements for:
    a) the processes, products and services to be provided?

  • b) the approval of:
    1) products and services?

  • 2) methods, processes and equipment?

  • 3) the release of products and services?

  • c) competence, including any required qualification of persons?

  • d) the external providers’ interactions with the organization?

  • e) control and monitoring of the external providers’ performance to be applied by the organization?

  • f) verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises?

8.5 Production and service provision

8.5.1 Control of production and service provision

  • Has the organization implemented production and service provision under controlled conditions?

  • Have controlled conditions included, as applicable:
    a) the availability of documented information that defines:
    1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed?

  • 2) the results to be achieved?

  • b) the availability and use of suitable monitoring and measuring resources?

  • c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met?

  • d) the use of suitable infrastructure and environment for the operation of processes?

  • e) the appointment of competent persons, including any required qualification?

  • f) 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?

  • g) the implementation of actions to prevent human error?

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

8.5.2 Identification and traceability

  • Has the organization used suitable means to identify outputs when it is necessary to ensure the conformity of products and services?

  • Has the organization identified the status of outputs with respect to monitoring and measurement requirements throughout production and service provision?

  • Has the organization controlled the unique identification of the outputs when traceability is a requirement, and retained the documented information necessary to enable traceability?

8.5.3 Property belonging to customers or external providers

  • Has the organization exercised care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization?

  • Has the organization identified, verified, protected and safeguarded customers’ or external providers’ property provided for use or incorporation into the products and services?

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

  • NOTE: A customer’s or external provider’s property can include materials, components, tools and equipment, premises, intellectual property and personal data.

8.5.4 Preservation

  • Has the organization preserved the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?

  • NOTE: Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

8.5.5 Post-delivery activities

  • Has the organization met requirements for post-delivery activities associated with the products and services?

  • In determining the extent of post-delivery activities that are required, has the organization considered:
    a) statutory and regulatory requirements?

  • b) the potential undesired consequences associated with its products and services?

  • c) the nature, use and intended lifetime of its products and services?

  • d) customer requirements?

  • e) customer feedback?

  • NOTE: Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

8.5.6 Control of changes

  • Has the organization reviewed and controlled changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?

  • Has the organization retained documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review?

8.6 Release of products and services

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

  • Has the release of products and services to the customer not proceeded until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer?

  • Has the organization retained documented information on the release of products and services?

  • Does the documented information include:
    a) evidence of conformity with the acceptance criteria?

  • b) traceability to the person(s) authorizing the release?

8.7 Control of nonconforming outputs

8.7.1

  • Has the organization ensured that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?

  • Has the organization taken appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services, including nonconforming products and services detected after delivery of products, during or after the provision of services?

  • Does the organization deal with nonconforming outputs in one or more of the following ways?
    a) correction;
    b) segregation, containment, return or suspension of provision of products and services;
    c) informing the customer;
    d) obtaining authorization for acceptance under concession.

  • Has conformity to the requirements been verified when nonconforming outputs are corrected?

8.7.2

  • Has the organization retained documented information that:
    a) describes the nonconformity?

  • b) describes the actions taken?

  • c) describes any concessions obtained?

  • d) identifies the authority deciding the action in respect of the nonconformity?

9. Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

  • Has the organization determined:
    a) what needs to be monitored and measured?

  • b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results?

  • d) when the monitoring and measuring shall be performed?

  • e) when the results from monitoring and measurement shall be analysed and evaluated?

  • Has the organization evaluated the performance and the effectiveness of the quality management system?

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

9.1.2 Customer satisfaction

  • Has the organization monitored customers’ perceptions of the degree to which their needs and expectations have been fulfilled?

  • Has the organization determined the methods for obtaining, monitoring and reviewing this information?

  • NOTE: Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.

9.1.3 Analysis and evaluation

  • Has the organization analyzed and evaluated appropriate data and information arising from monitoring and measurement?

  • Have the results of this analysis been used to evaluate:
    a) conformity of products and services?

  • b) the degree of customer satisfaction?

  • c) the performance and effectiveness of the quality management system?

  • d) if planning has been implemented effectively?

  • e) the effectiveness of actions taken to address risks and opportunities?

  • f) the performance of external providers?

  • g) the need for improvements to the quality management system?

  • NOTE: Methods to analyze data can include statistical techniques.

9.2 Internal Audit

9.2.1

  • Has the organization conducted internal audits at planned intervals to provide information on whether
    the quality management system:
    a) conforms to
    1) the organization’s own requirements for its quality management system?

  • 2) the requirements of this International Standard?

  • b) is effectively implemented and maintained?

9.2.2

  • Has the organization:
    a) planned, established, implemented and maintained an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits?

  • b) defined the audit criteria and scope for each audit?

  • c) selected auditors and conducted audits to ensure objectivity and the impartiality of the audit process?

  • d) ensured that the results of the audits are reported to relevant management?

  • e) taken appropriate correction and corrective actions without undue delay?

  • f) retained documented information as evidence of the implementation of the audit programme and the audit results?

  • NOTE: See ISO 19011 for guidance.

9.3 Management Review

9.3.1 General

  • Has top management reviewed the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization?

9.3.2 Management review inputs

  • Has the management review been planned and carried out taking into consideration:
    a) the status of actions from previous management reviews?

  • b) changes in external and internal issues that are relevant to the quality management system?

  • c) information on the performance and effectiveness of the quality management system, including trends in:
    1) customer satisfaction and feedback from relevant interested parties?

  • 2) the extent to which quality objectives have been met?

  • 3) process performance and conformity of products and services?

  • 4) nonconformities and corrective actions?

  • 5) monitoring and measurement results?

  • 6) audit results?

  • 7) the performance of external providers?

  • d) the adequacy of resources?

  • e) the effectiveness of actions taken to address risks and opportunities (see 6.1)?

  • f) opportunities for improvement?

9.3.3 Management review outputs

  • Has the output of the management included decisions and actions related to:
    a) opportunities for improvement?

  • b) any need for changes to the quality management system?

  • c) resource needs?

  • Has the organization retained documented information as evidence of the results of management reviews?

10. Improvement

10.1 General

  • Has the organization determined opportunities for improvement and implemented any necessary actions to meet customer requirements and enhance customer satisfaction?

  • Have these actions included:
    a) improving products and services to meet requirements as well as to address future needs and expectations?

  • b) correcting, preventing or reducing undesired effects?

  • c) improving the performance and effectiveness of the quality management system?

  • NOTE: Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.

10.2 Nonconformity and corrective action

10.2.1

  • When a nonconformity occurs, including any arising from complaints, has the organization:
    a) reacted to the nonconformity, and as applicable:

  • 1) taken action to control and correct it?

  • 2) dealt with the consequences?

  • b) evaluated the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by:
    1) reviewing and analyzing the nonconformity?

  • 2) determining the causes of the nonconformity?

  • 3) determining if similar nonconformities exist, or could potentially occur?

  • c) implemented any action needed?

  • d) reviewed the effectiveness of any corrective action taken?

  • e) updated risks and opportunities determined during planning, if necessary?

  • f) made changes to the quality management system, if necessary?

  • Have corrective actions been appropriate to the effects of the nonconformities encountered?

10.2.2

  • Has the organization retained documented information as evidence of:
    a) the nature of the nonconformities and any subsequent actions taken?

  • b) the results of any corrective action?

10.3 Continual Improvement

  • Has the organization continually improved the suitability, adequacy and effectiveness of the quality management system?

  • Has the organization considered the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement?

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. Any ratings or scores displayed in our Public Library have not been verified by SafetyCulture for accuracy. Users of our platform may provide a rating or score that is incorrect or misleading. You should independently determine whether the template is suitable for your circumstances. You can use our Public Library to search based on criteria such as industry and subject matter. Search results are based on their relevance to your search and other criteria. We may feature checklists based on subject matters we think may be of interest to our customers.