Your ISO 9001 Certification Checklist Compliance Areas by Clause

What are internal issues?

Have you considered the internal issues relevant to your purpose and strategic direction that affect your organization’s ability to achieve the intended results of your Quality Management System (QMS)? Consider issues relating to values, culture, knowledge and performance of the organization?

Does your organization have a monitoring system in place for reviewing information related to external and internal issues?

Does your organization regularly review the information related to the external and internal issues that is obtained from that monitoring system?

How do I identify interested parties?

Clause 4.2 Compliance Score

4.2 Understanding the needs and expectations of interested parties

Considering the impact or potential impact on your organization’s ability to consistently provide products and services that meet consumer and relevant statutory and regulatory requirements, does your organization determine interested parties relevant to the QMS?

How do I identify interested parties?

Does your organization monitor the information about the interested parties you’ve identified and their relevant requirements?

Does your organization regularly review the information obtained from your monitoring system about the determined interested parties and their relevant requirements?

How do I determine my QMS scope?

Clause 4.3 Compliance Score

4.3 Determining the scope of the quality management system

“The organization shall determine the boundaries and applicability of the quality management system to establish its scope.”

Has your organization created a QMS scope document that is available and maintained as documented information?

When determining the scope of the QMS, did your organization consider the external and internal issues (4.1)?

When determining the scope of the QMS, did your organization consider the needs and requirements of relevant interested parties (4.2)?

When determining the scope of the QMS, did your organization consider the products and services of your organization?

Does your organization apply all of the ISO 9001:2015 requirements that can be implemented?

Does your organization provide justification for any situation where an ISO 9001:2015 requirement cannot be applied?

What is the difference between a “process” and a “procedure”?

4.4 Quality management system and its processes

Clause 4.4 Compliance Score

4.4.1

“The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.”

Have you determined the processes needed for your QMS, their interactions and applications throughout your organization?

Has your organization determined the inputs required and the outputs expected from the processes?

Has your organization determined the sequence and interaction of the processes?

Has your organization 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?

Has your organization determined the resources needed for these processes and ensure their availability?

Has your organization assigned the responsibilities and authorities for these processes?

Has your organization addressed the risks and opportunities as determined in accordance with the requirements of 6.1?

Has your organization monitored, measured, and evaluated these processes and implemented any necessary changes to ensure the processes will achieve their intended results?

Has your organization improved the processes and quality management system?

What are all the different types of documented information required by this standard?

Clause 4.4.2

Does your company maintain the necessary documented information to support the operation of its processes?

Does your company retain documented information to have confidence that the processes are being executed as planned?

How is leadership defined in ISO 9001:2015?

Clause 5: Leadership

Clause 5.1 Compliance Score

5.1 Leadership and commitment

5.1.1 General

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

What are quality objectives?

Does your top management ensure the quality policy and quality objectives of the QMS are established and compatible with the strategic direction and the context of the organization?

Does your top management ensure that the quality policy is communicated, understood, and implemented throughout the company?

Does your top management ensure the QMS requirements are integrated into the organization’s business processes?

Does your top management promote an awareness and understanding of the process approach?

Does your top management ensure that all resources needed for proper QMS implementation are available?

Does your top management communicate the importance of effective quality management and QMS requirement conformity?

Does your top management ensure that the QMS achieves its intended results?

Is your top management engaging, directing and supporting individuals to contribute to the effectiveness of the QMS?

What is continual improvement?

Does your top management promote continual improvement?

Does your top management support other relevant management roles to demonstrate their leadership in their particular areas of responsibility?

5.1.2 Customer Focus

Does your top management demonstrate leadership and commitment by ensuring that customer requirements are determined and met?

Does your top management demonstrate leadership and commitment by ensuring that all applicable statutory and regulatory requirements are determined and met?

Does your top management demonstrate a commitment to address the risks and opportunities that can affect conformity of products and services and the ability to improve customer satisfaction?

Does your leadership team focus on consistently offering products and services that meet customer requirements?

Does your leadership team focus on consistently offering products and services that meet applicable statutory and regulatory requirements?

Does your leadership team focus on enhancing customer satisfaction?

5.2 Policy

5.2 Compliance Score

Your organization is 5.5% compliant with Clause 5.2.

5.2.1 Developing the quality policy

Has your top management established, implemented and maintained a quality policy?

Does your company’s quality policy match the purpose and context of the organization and support its strategic direction?

Does your company’s quality policy offer a framework for establishing and reviewing quality objectives?

Does your company’s quality policy include a commitment to continually improving the QMS?

5.2.2 Communicating the quality policy

Is your company’s quality policy communicated within your company?

Is your company’s quality policy understood within your company?

Is your company’s quality policy applied within your company?

Is your company’s quality policy available as documented information?

Is your company’s quality policy available to all relevant interested parties?

Clause 5.3 Compliance Score

5.3 Organizational roles, responsibilities and authorities

Does your company’s top management assign responsibility and authority for ensuring the QMS conforms to ISO 9001:2015 requirements?

Does your company’s top management assign responsibility and authority for ensuring processes are delivering their intended outputs?

Does your company’s top management assign responsibility and authority for reporting on the performance of the QMS on improvement opportunities and for reporting back to top management?

Does your company’s top management assign responsibility and authority for ensuring a prioritization of customer focus throughout your entire company?

Does your company’s top management assign responsibility and authority for ensuring the integrity of the QMS is maintained after changes have been planned and implemented?

Clause 6: Planning

Clause 6.1 Compliance Score

6.1 Actions to address risks and opportunities

6.1.1

During QMS planning, does your organization consider the issues of 4.1 and 4.2?

Does your company determine the risks and opportunities that need to be addressed to assure the QMS can achieve its intended result(s)?

Does your company determine the risks and opportunities that need to be addressed to enhance desirable effects?

Does your company determine the risks and opportunities that need to be addressed to prevent, or reduce, undesired effects?

Does your company determine the risks and opportunities that need to be addressed in order to improve?

6.1.2

Does your organization plan actions to address risks and opportunities named in 6.1.1?

Does your organization have a plan for how to integrate and implement the actions into its QMS processes? (4.4)

Does your organization have a plan for how to evaluate the effectiveness of these actions?

Are your actions taken to address the risks and opportunities proportionate to the potential impact on the conformity of products and services?

What is a quality objective?

Clause 6.2 Compliance Score

6.2 Quality objectives and planning to achieve them

6.2.1

Does your organization establish quality objectives at relevant functions, levels and processes needed for the quality management system?

Are your quality objectives consistent with the quality policy?

Are your quality objectives measurable?

Do your quality objectives take into account applicable requirements?

Are your quality objectives relevant to the conformity of products and services and to the improvement of customer satisfaction?

Are your quality objectives monitored?

Are your quality objectives communicated?

Are your quality objectives updated when appropriate?

6.2.2

Does your organization determine what exactly will be done when planning how to achieve its quality objectives?

Does your organization determine what resources will be required when planning how to achieve its quality objectives?

Does your organization determine responsible parties when planning how to achieve its quality objectives?

Does your organization determine completion times when planning how to achieve its quality objectives?

Does your organization determine how the results will be evaluated when planning how to achieve its quality objectives?

Clause 6.3 Compliance Score

6.3 Planning of changes

When your organization determines the need for changes to the QMS, are the changes carried out in a planned manner (refer to 4.4)?

When determining the need for QMS changes, does your organization consider the purpose of the changes and their possible consequences?

When determining the need for QMS changes, does your organization consider the integrity of the QMS?

When determining the need for QMS changes, does your organization consider resource availability?

When determining the need for QMS changes, does your organization consider the allocation or reallocation of responsibilities and authorities?

Clause 7: Support

7.1 Resources

Clause 7.1 Compliance Score

7.1.1 General

Does your organization identify and provide resources needed to establish, maintain and continually improve the QMS?

Does your organization consider the capabilities of and constraints on existing internal resources when establishing, maintaining, and improving the QMS?

Does your organization consider what needs to be obtained from external providers when establishing, maintaining, and improving the QMS?

7.1.2 People

Does your organization determine and provide the responsible persons to effectively implement the QMS and for the operation and control of its processes?

7.1.3 Infrastructure

Does your organization determine, provide and maintain the necessary infrastructure for the operation of processes and in order to achieve product and service conformity?

Have you considered the buildings and associated utilities?

Have you considered equipment, including hardware?

Have you considered equipment, including software?

Have you considered transportation resources?

Have you considered information and communication technology?

7.1.4 Environment for the operation of processes

Does your organization determine, provide and maintain the environment necessary infrastructure for the operation of processes and in order to achieve product and service conformity?

Has your organization considered the social factors that affect the suitability of the environment? (e.g. non-discriminatory, calm, non-confrontational)

Has your organization considered the psychological factors that affect the suitability of the environment? (e.g. stress-reducing, emotionally supportive and protective)

Has your organization considered the physical factors that affect the suitability of the environment? (e.g. temperature, light, airflow, humidity, noise, seating)

7.1.5 Monitoring and measuring resources

7.1.5.1 General

Does your organization determine and provide the necessary resources to ensure valid and reliable results whenever monitoring or measuring is used to verify product and service conformity to requirements?

Does your organization ensure that the resources provided are suitable for the specific type of monitoring and measurement activities being performed?

Does your organization ensure that the resources provided are maintained to ensure their continued suitability for their purpose?

Does your organization retain relevant documented information as evidence of suitabilty for purpose of the monitoring and measurement resources?

7.1.5.2 Measurement traceability

When measurement traceability is a requirement or important for determining the validity of results, is your measuring equipment calibrated or verified (or both) at specified intervals, or prior to use?

Does your organization retain documented information for calibration or verification when no standards exist for specified interval testing or testing prior to use?

When measurement traceability is a requirement or important for determining the validity of results, is your measuring equipment identified in order to determine their status?

When measurement traceability is a requirement or important for determining the validity of results, is your measuring equipment safeguarded from adjustments, damage or deterioriation that would invalidate the calibration status and measurements?

Does your organization determine if the validity of previous measurements has been adversely affected when measuring equipment is discovered to be unfit for its intended purpose?

Does your organization take appropriate action if you determine the validity of previous measurements has been adversely affected when measuring equipment was discovered to be unfit for its intended purpose?

7.1.6 Organizational knowledge

Does your organization determine the knowledge necessary for the operation of its processes and to achieve product and service conformity?

Does your organization maintain and make this knowledge available as necessary?

When addressing changing needs and trends, does your organization consider its current knowledge and determine how to acquire or access any additional knowledge and required updates?

When obtaining organizational knowledge, does your organization consider internal sources (e.g. any sharing of undocumented knowledge, experience or expertise; lessons learned from the organization's successes and failures; process improvement results; intellectual property)?

When obtaining organizational knowledge, does your organization consider external sources (e.g. regulations; standards; conferences or other professional development events; knowlege gained from customers, suppliers, or other external providers)?

Clause 7.2 Compliance Score

7.2 Competence

Does your organization determine the necessary competence of responsible persons doing work under its control that affect the performance and overall effectiveness of the QMS?

Does your organization ensure that these persons have competent education, training or experience?

Does your organization take actions, where applicable, to acquire the necessary competence and evaluate the effectiveness of their actions?

Has your organization considered, for example, applicable actions including training, mentoring or reassignment of existing employees or the hiring or contracting of competent persons?

Does your organization retain appropriate documented information as evidence of employee competence?

Clause 7.3 Compliance Score

7.3 Awareness

Does your organization ensure that all persons working under its control are aware of the quality policy?

Does your organization ensure that all persons working under its control are aware of relevant quality objectives?

Does your organization ensure that all persons working under its control are aware of their contribution to QMS effectiveness, including the benefits of improved performance?

Does your organization ensure that all persons working under its control are aware of the implications of not conforming with the QMS requirements?

What is internal communication?

7.4 Compliance Score

7.4 Communication

Does your organization determine the internal and external communications relevant to the QMS, including what to communicate on?

What is external communication?

Does your organization determine the internal and external communications relevant to the QMS, including when to communicate?

Does your organization determine the internal and external communications relevant to the QMS, including who to communicate with?

Does your organization determine the internal and external communications relevant to the QMS, including how to communicate?

Does your organization determine the internal and external communications relevant to the QMS, including who communicates?

What is documented information?

Clause 7.5 Compliance Score

7.5 Documented information

7.5.1 General

Does your organization's QMS include all documents required by this International Standard?

Required documentation includes the scope of the QMS, Quality Policy, Quality Objectives, and criteria for selecting and assessing suppliers.

Does your organization's QMS include all documented records you've identified as being necessary for the effectiveness of the QMS?

7.5.2 Creating and updating

When creating and updating documented information, does your organization use appropriate identification and description (e.g. title, author, date, or reference number)

When creating and updating documented information, does your organization use appropriate format (language, software, images) and media (e.g. paper, electronic forms)?

When creating and updating documented information, does your organization use appropriate reviewing and approval processes for suitability and adequacy?

7.5.3 Control of documented information

7.5.3.1

Does your organization control documented information required by the QMS and this International Standard to ensure its availability and suitability for use whenever and wherever it is needed?

Does your organization control documented information required by the QMS and this International Standard to ensure it is adequately protected (e.g. from confidentiality loss, integrity loss or improper use)?

7.5.3.2

Does your organization address the distribution, access, retrieval and use of documented information?

Does your organization address the storage and preservation, including preservation of legibility of documented information?

Does your organization address the control of changes (e.g. version control) of documented information?

Does your organization address the retention and disposition of documented information?

Does your company control and identify appropriate documented information of external origin you've determined necessary for the planning and operation of the QMS?

Does your organization protect documented information retained as evidence from unintended alterations?

Clause 8: Operations

Clause 8.1 Compliance Score

8.1 Operational planning and control

Does your organization plan, implement and control the processes (see 4.4) necessary to meet the requirements for the provision of products and services, and to implement the determined actions of Clause 6 by determining product and service requirements?

Is your organization achieving the above by establishing criteria for the processes?

Is your organization achieving the above by establishing criteria for the acceptance of products and services?

Is your organization achieving the above by determining the resources necessary to achieve conformity to product and service requirements?

Is your organization achieving the above by implementing process control that meets the criteria?

Is your organization achieving the above by identifying, maintaining and retaining documented information to the proper extent to have confidence that the processes have been executed as intended?

Is your organization achieving the above by identifying, maintaining and retaining documented information to the proper extent to demonstrate conformity of products and services?

Is the output of this planning suitable for your organization's operations?

Does your organization control planned changes and review the potential consequences of unintended changes, and take action to mitigate any adverse effects?

Does your organization ensure your outsourced processes are controlled (see 8.4)?

8.2 Requirements for products and services

Clause 8.2 Compliance Score

8.2.1 Customer communication

Do you communicate to customers information relating to products and services?

Do you handle enquiries, contracts, orders (and changes) with customers?

Does your organization obtain customer feedback relating to products and services?

Does your organization communicate with customers regarding the handling or controlling of customer property?

Does your organization communicate with customers when establishing specific requirements for contingency actions?

8.2.2 Determining the requirements related to products and services

Does your organization ensure those product and service requirements considered necessary are defined?

When determining product and service requirements for customers, does your organization ensure the requirements are defined including any applicable statutory and regulatory requirements?

Does your organization ensure the organization can meet the claims for your products and services?

8.2.3 Review of requirements related to products and services

8.2.3.1

Does your organization ensure it can meet the requirements for products and services by conducting a review before committing to supply them to customers?

Does your organization include in its review customer-specified requirements, including those for delivery and post-delivery activities?

Does your organization include in its review the requirements unstated by customers, but necessary for the specific or intended use?

Does your organization include in its review the requirements specified by the organization?

Does your organization include in its review the statutory and regulatory requirements applicable to its products and services?

Does your organization include in its review the contract or order requirements that may differ from those previously defined?

Does your organization ensure the contract or order requirements differing from those previously defined are addressed/resolved?

If a customer does not offer a documented statement of requirements, does your organization confirm customer requirements before acceptance?

8.2.3.2

Does your organization retain documented information where necessary on the results of the review?

Does your organization retain documented information on any new requirements for products and services?

8.2.4 Changes to requirements for products and services

Does your organization enusre that relevant documented information is revised, and that appropriate persons are made aware of new requirements when the product and service requirements have changed?

8.3 Design and development of products and services

Clause 8.3 Compliance Score

8.3.1 General

Does your organization establish, implement and maintain an appropriate design and developmental process for ensuring the provision of products and services?

What is the Design and Development Process?

8.3.2 Design and development planning

When determining the stages and controls for design and development, does your organization consider the nature, duration and complexity of the design and development activities?

Does your organization consider the necessary process stages, including relevant design and development reviews?

Does your organization consider the required design and development verification and validation activities?

Does your organization consider the responsibilities and authorities involved in the design and development process?

Does your organization consider the needs of all internal and external resources for the design and development process?

Does your organization consider the need to control interfaces between persons involved in the design and development process?

Does your organization consider the need for customer and user involvement in the design and development process?

Does your organization consider the requirements for the provision of products and services?

Does your organization consider the level of control expected for the design and development process by customers and any other relevant interested parties?

Does your organization consider the documented information necessary to demonstrate that all design and development requirements have been met?

8.3.3 Design and development inputs

Does your organization determine the requirements needed for the specific types of products and services to be designed and developed?

When determining these requirements, does your organization consider functional and performance requirements?

Does your organization consider information derived from previous similar design and development activities?

Does your organization consider statutory and regulatory requirements?

Does your organization consider standards or codes of practice you have committed to adopt/implement?

Does your organization consider the potential consequences of failure from the products and services?

Are your inputs complete and unambiguous for design and development purposes?

Does your organization resolve any conflicting design and development inputs?

Does your organization retain documented information on design and development inputs?

8.3.4 Design and development controls

Does your organization apply controls to the design and development process to ensure that expected results are defined?

Does your organization ensure that reviews are conducted to evaluate whether design and development results will meet requirements?

Does your organization conduct verification activities to ensure the design and development outputs meet the input requirements?

Does your organization conduct validation activities to ensure that the products and services meet requirements for their intended use?

Does your organization ensure necessary actions are taken to address problems during the reviews, verification and validation activities?

Does your organization retain documented information of these activities?

8.3.5 Design and development outputs

Does your organization ensure that design and development outputs meet the input requirements?

Does your organization ensure that design and development outputs are suitable for the subsequent processes for product and service provision?

Does your organization ensure that design and development outputs include or reference monitoring and measuring requirements and acceptable criteria?

Does your organization ensure that design and development outputs specify the product and service traits that are needed for their intended purpose and safe and proper provision?

Does your organization retain documented information on design and development outputs?

8.3.6 Design and development changes

Does your organization identify, review and control changes made during or subsequent to the product and service design and development in order to ensure there is no adverse impact on requirement conformity?

Does your organization retain documented information on design and development changes?

Does your organization retain documented information on the results of reviews?

Does your organization retain documented information on the authorization of the changes?

Does your organization retain documented information on the actions taken to prevent adverse impacts?

8.4 Compliance Score

8.4 Control of externally provided processes, products and services

8.4.1 General

Does your organization ensure that externally provided processes, products and services conform to requirements?

Does your organization determine the controls to be applied to externally provided processes, products and services when the products and services from external providers are intended for incorporation into your own products and services?

Does your organization determine these controls for when products and services are provided directly to the customer(s)by external providers on behalf of your company?

Does your organization determine these controls for when the company decides that a process, or part of a process, will be provided by an external provider?

Has your organization established and applied criteria for evaluating, selecting, monitoring performance, and re-evaluating external providers based on their ability to provide processes or products and services according to requirements?

Has your organization retained documented information of the results of external provider evaluations, re-evaluations or other performance monitoring?

8.4.2 Type and extent of control

Does your organization ensure that externally provided processes, products and services do not negatively impact its ability to consistently deliver products and services that conform to requirements?

Does your organization ensure that externally provided processes stay within QMS control?

Does your organization define the controls it wishes to apply to an external provider and those it wishes to apply to the resulting output?

Does your organization consider the potential impact of all externally provided processes, products and services on its ability to regularly meet customer and statutory and regulatory requirements?

Does your organization consider the effectiveness of control applied by external providers?

Does your organization determine 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

Does your organization ensure the suitability of requirements before communicating them to an external provider?

Does your organization communicate to external providers your requirements for the processes, products and services that will be provided?

Does your organization communicate to external providers your requirements for the approval of products and services?

Does your organization communicate to external providers your requirements for the approval of methods, processes and equipment?

Does your organization communicate to external providers your requirements for the approval of the release of products and services?

Does your organization communicate to external providers your requirements for competence and required qualification of individuals?

Does your organization communicate to external providers your requirements for the external providers' interactions with the organization?

Does your organization communicate to external providers your requirements for control and monitoring of external provider performance?

Does your organization communicate to external providers your requirements for verification or validation activities that your company or its customer plans to perform at the external providers' locations?

Clause 8.5 Compliance Score

8.5 Production and service provision

8.5.1 Control of production and service provision

Does the organization implement production and service provision under controlled conditions?

Have you considered controlled conditions such as the availability of documented information that defines product characteristics, services to be provided or activities to be performed?

Have you considered controlled conditions such as the availability of documented information that defines the results to be achieved?

Have you considered controlled conditions such as the availability and use of acceptable monitoring and measuring resources?

Have you considered controlled conditions such as during the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for process or output control and acceptance criteria for products and services have been met?

Have you considered controlled conditions such as the use of suitable infrastructure environment for process operations?

Have you considered controlled conditions such as during the appointment of competent personnel?

Have you considered controlled conditions such as the validation and revalidation of the ability to achieve planned results of product and service provision when the resulting output cannot be verified by monitoring or measurement?

Have you considered controlled conditions such as the implementation of actions to prevent human error?

Have you considered controlled conditions such as the implementation of release, delivery and post-delivery activities?

8.5.2 Identification and traceability

Does your organization use adequate means to identify outputs when necessary to ensure product and service conformity?

Does your organization identify the status of outputs with regard to monitoring and measurement requirements throughout the provision of products and services?

Does your organization control the unique identification of outputs when traceability is required?

Does your organization retain the documented information necessary to enable traceability?

8.5.3 Property belonging to customers or external providers

Does your organization exercise care with customer or external provider property while it is under your control or while you are using it?

Does your organization identify, protect and safeguard customer' or external providers' property provided for your use or when incorporating in products and services?

Does your organization report to customers or external providers any time their property is lost, damaged, or found unsuitable for use?

Does your organization retain documented information whenever they report the loss, damage, or unsuitability of customer or external provider property?

8.5.4 Preservation

Does your organization preserve the outputs during production and service provision so they can ensure conformity to requirements?

What are Post-Delivery Activities?

8.5.5 Post-delivery activities

Does your organization meet requirements for post-delivery activities associated with products and services?

When determining the extent of post-delivery activities required, does your organization consider statutory and regulatory requirements?

When determining the extent of post-delivery activities required, does your organization consider potential negative consequences associated with products and services?

When determining the extent of post-delivery activities required, does your organization consider the nature, use and intended lifetime of products and services?

When determining the extent of post-delivery activities required, does your organization consider customer requirements?

When determining the extent of post-delivery activities required, does your organization consider customer feedback?

8.5.6 Control of changes

Does your organization review and control changes to the provision of products and services to ensure ongoing conformity to requirements?

Does your organization retain documented information detaiing the results of the review of changes, personnel authorizing the change, and any necessary actions as a result of the review?

Clause 8.6 Compliance Score

8.6 Release of products and services

Does your organization implement plans at appropriate stages to verify that product and service requirements have been met?

Does your organization ensure that the release of products and services does not proceed until planned arrangements have been satisfactorily completed, unless otherwise directed by a relevant authority or the customer (if applicable)?

Does your organization retain documented information on the release of products and services?

Does this documented information include evidence of conformity with acceptance criteria?

Does this documented information include traceability to the person(s) authorizing the release?

Clause 8.7 Compliance Score

8.7 Control of nonconforming outputs

8.7.1

Does your organization ensure that outputs that do not conform to requirements are identified and controlled to prevent their unintended use or delivery?

Does your organization take corrective action based on the nature of a nonconformity and its effect on the conformity of products and services?

Does your organization take corrective action on nonconforming products and services identified after or during their delivery?

Does your organization address nonconformities in at least one of the following ways: correction; segregation, containment, return or suspension of product and service provision; informing customers; obtaining authorization for acceptance under concession?

Does your organization verify conformity to requirements when nonconformities are corrected?

8.7.2

Does your organization retain documented information that describes the nonconformity?

Does your documented information describe the actions taken?

Does your documented information describe any concessions obtained?

Does your documented information identify the authority deciding how to address the nonconformity?

Clause 9: Performance Evaluation

Clause 9.1 Compliance Score

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

Does your organization identify what needs to be monitored and measured?

Does your organization identify the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results?

Does your organization identify when the monitoring and measuring should be conducted?

Does your organization idenfity when the results from monitoring and measuring should be analyzed and evaluated?

Does your organization evaluate the performance and the effectiveness of the QMS?

Does your organization retain appropriate documented information as evidence of monitoring and measuring results?

9.1.2 Customer satisfaction

Does your organization monitor customers' perceptions of the degree to which their needs and expectations have been met?

Has your organization determined the methods for obtaining, monitoring, or reviewing the above information?

9.1.3 Analysis and evaluation

Does your organization analyze and evaluate appropriate data and information resulting from monitoring and measurement?

Does your organization use the results of analysis to evaluate conformity of products and services?

Does your organization use the results of analysis to evaluate the degree of customer satisfaction?

Does your organization use the results of analysis to evaluate the performance and effectives of the QMS?

Does your organization use the results of analysis to evaluate if planning has been effectively implemented?

Does your organization use the results of analysis to evaluate the effectiveness of actions to address risks and opportunities?

Does your organization use the results of analysis to evaluate the performance of external providers?

Does your organization use the results of analysis to evaluate the necessity for QMS improvements?

Clause 9.2 Compliance Score

9.2 Internal audit

9.2.1

Does your organization conduct internal audits at planned intervals to demonstrate whether your QMS conforms to its own requirements?

Does your organization conduct internal audits at planned intervals to demonstrate whether your QMS conforms to SO 9001:2015 requirements?

Does your organization conduct internal audits at planned intervals to demonstrate whether your QMS is effectively implemented and maintained?

9.2.2

Does your organization plan, establish, implement and maintain an audit program that includes the frequency, methods, responsibilities, planning requirements and reporting?

Does this audit program take into consideration the importance of the processes concerned, changes impacting the organization, and the results of previous audits?

Does your organization define the audit criteria and scope?

Does your organization select auditors and conduct audits to ensure objectivity in the audit process?

Does your organization ensure audit results are reported to relevant management?

Does your organization take appropriate correction and corrective actions without unnecessary delay?

Does your organization retain documented information as evidence of audit program implementation and audit results?

Clause 9.3 Compliance Score

9.3 Management review

9.3.1 General

Does your top management review your QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness and alignment with your organization's strategic direction?

9.3.2 Management review inputs

Is your organization's management review planned and executed with consideration for the status of actions from earlier management reviews?

Is your organization's management review planned and executed with consideration for changes in external and internal issues relevant to the QMS?

Is your organization's management review planned and executed with consideration for information on the performance and effectiveness of the QMS, including trends in customer satisfaction and feedback from interested parties?

Does your management review consider trends in the extent to which quality objectives have been met?

Does your management review consider trends in process performance and conformity of products and services?

Does your management review consider trends in nonconformities and corrective actions?

Does your management review consider trends in monitoring and measurement results?

Does your management review consider trends in audit results?

Does your management review consider trends in the performance of external providers?

Is your organization's management review planned and executed with consideration for the adequacy of resources?

Is your organization's management review planned and executed with consideration for effectiveness of actions taken to address risks and opportunities (see 6.1)?

Is your organization's management review planned and executed with consideration for opportunities for improvement?

9.3.3 Management review outputs

Do your management review outputs include decisions and actions related to opportunities for improvement?

Do your management review outputs include decisions and actions related to a need for changes to the QMS?

Do your management review outputs include decisions and actions related to resource needs?

Does your organization retain documented information as evidence of management review results?

Clause 10: Improvements

Clause 10.1 Compliance Score

10.1 General

Does your organization determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and satisfaction?

In order to meet customer requirements, has your organization improved products and services and addressed future needs and expectations?

In order to meet customer requirements, has your organization corrected, prevented or reduced undesired effects?

In order to meet customer requirements, has your organization improved the performance and effectiveness of the QMS?

Clause 10.2 Compliance Score

10.2 Nonconformity and corrective action

10.2.1

When a nonconformity occurs, does your organization react to the nonconformity and, as applicable take action to control and correct it?

What is a nonconformity?

When a nonconformity occurs, does your organization react to the nonconformity and, as applicable deal with the consequences?

When a nonconformity occurs does your organization evaluate the need for action to eliminate the nonconformity's cause so it won't reoccur?

Does your organization review and analyze the nonconformity?

Does your organization determine the cause of the nonconformity?

Does your organization determine if similar nonconformities exist or could potentially occur in the future?

When a nonconformity occurs does your organization implement any action needed?

When a nonconformity occurs does your organization review the effectiveness of whatever corrective action is taken?

When a nonconformity occurs does your organization update risks and opportunities identified during the planning stage?

When a nonconformity occurs does your organization make QMS changes, if necessary?

Are your corrective actions appropriate to the effects of your nonconformities?

10.2.2

Does your organization retain documented information as evidence of the nature of any nonconformities and all subsequent actions taken?

Does your organization retain documented information as evidence of the results of any corrective action that is taken?