1. Internal & External Factors (4.1)
Has the organization evaluated the internal and external factors that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended outcomes of its QMS, including factors related to customer expectations, regulatory obligations, and competitive environment?
2. Interested Parties' Needs (4.2)
Has the organization determined the needs and expectations of relevant interested parties – including customers, regulatory bodies, and suppliers – that are relevant to the QMS and the products and services it provides?
3. Scope of QMS & Exclusions (4.3)
Has the organization clearly established and documented the scope of its QMS, including the boundaries and applicability of the standard, the products and services covered, and any justification for exclusions from the requirements of ISO 9001:2015?
4. QMS Processes & Ownership (4.4)
Has the organization defined, implemented, and maintained the QMS processes necessary to meet requirements, including determining the sequence and interaction of these processes, assigning ownership, and ensuring continual improvement mechanisms are in place?
5. Leadership & Commitment (5.1)
Has top management demonstrated leadership and commitment to the QMS by ensuring that quality policy and objectives are established, that the QMS is integrated into business processes, and that a culture of continual improvement and customer focus is actively promoted throughout the organization?
6. Quality Policy (5.2)
Has the organization established a quality policy that is appropriate to its context, provides a framework for setting quality objectives, includes a commitment to satisfying applicable requirements and to continual improvement, and has been communicated and is understood by relevant personnel?
7. Roles, Responsibilities & Authorities (5.3)
Have organizational roles, responsibilities, and authorities been clearly defined and communicated to ensure the QMS conforms to the requirements of ISO 9001:2015, that processes are delivering their intended outputs, and that customer focus and requirements are maintained at all levels?
8. Risks and Opportunities (6.1)
Has the organization identified the risks and opportunities relevant to the QMS that need to be addressed to give assurance that the QMS can achieve its intended results, prevent or reduce undesired effects, and achieve continual improvement, and has it planned actions to address them?
9. Quality Objectives (6.2)
Have measurable quality objectives been established at relevant functions, levels, and processes within the organization, and are they consistent with the quality policy, relevant to the conformity of products and services, and monitored and updated as appropriate?
10. Planning to Achieve Objectives (6.2)
Has the organization determined what needs to be done to achieve quality objectives, including the resources required, who is responsible, the timeline for completion, and how results will be evaluated?
11. Planning of Changes (6.3)
When the organization determines the need for changes to the QMS, are those changes carried out in a planned and systematic manner, with consideration given to the purpose of the change, potential consequences, resource availability, and allocation of responsibilities?
12. Resources & Infrastructure (7.1)
Has the organization determined and provided the resources – including personnel, infrastructure, process environment, monitoring and measurement equipment, and organizational knowledge – needed to establish, implement, maintain, and continually improve the QMS?
13. Competency & Records (7.2)
Are persons performing work under the organization’s control who affect the performance and effectiveness of the QMS competent on the basis of appropriate education, training, or experience, and are records of competence maintained?
14. Awareness of Policy & Contribution (7.3)
Are all persons doing work under the organization’s control aware of the quality policy and relevant quality objectives, their contribution to the effectiveness of the QMS (including the benefits of improved quality performance), and the implications of not conforming with QMS requirements?
15. Communication & Documented Information (7.4 & 7.5)
Has the organization determined the need for internal and external communications relevant to the QMS, and is documented information required by the standard and necessary for the operation of QMS processes properly created, controlled, maintained, and retained?
16. Operational Processes & Criteria (8.1)
Has the organization planned, implemented, controlled, and maintained the processes needed to meet the requirements for the provision of products and services, including establishing criteria for processes and acceptance of products and services, and retaining documented information to demonstrate conformity?
17. Review & Control of Operational Changes (8.1)
When organizational or process changes are required, are they reviewed and controlled to prevent unintended consequences, and are actions taken to mitigate any adverse effects of unplanned changes on product and service conformity?
18. Customer Communication (8.2)
Does the organization have a defined process for communicating with customers about product and service information, enquiries, contracts, order handling, and customer feedback – including complaints – and for managing customer property?
19. Requirements Review & Confirmation (8.2)
Has the organization established a process to determine, review, and confirm the requirements related to the products and services it offers, including statutory and regulatory requirements, and to resolve any differences between contract and tender requirements before acceptance?
20. Design & Development Process (8.3)
Has the organization established, implemented, and maintained a design and development process that includes defined stages and controls for design and development activities, review, verification, and validation activities at appropriate stages, assignment of responsibilities for design and development, and documented information to demonstrate that requirements have been met?
21. External Provider Criteria (Design Stage) (8.3)
Has the organization established criteria for the evaluation, selection, monitoring, and re-evaluation of external providers, and does it ensure that externally provided processes, products, and services conform to specified requirements before incorporation into its own products and services?
22. Communication of External Requirements (Design Stage) (8.3)
Has the organization communicated to external providers all relevant requirements including processes to be performed, products and services to be provided, quality requirements, competence requirements, and the right to verify conformity at the provider’s premises?
23. Control of External Provision (8.4)
Has the organization established criteria for the evaluation, selection, monitoring, and re-evaluation of external providers, and does it ensure that externally provided processes, products, and services conform to specified requirements before incorporation into its own products and services?
24. External Provision Communication (8.4)
Has the organization communicated to external providers all relevant requirements including processes to be performed, products and services to be provided, quality requirements, competence requirements, and the right to verify conformity at the provider’s premises?
25. Production & Service Control (8.5)
Has the organization implemented production and service provision under controlled conditions, including the availability of documented information, monitoring and measurement activities at appropriate stages, suitable infrastructure, and the use of competent persons where required?
26. Identification & Traceability (8.5)
Does the organization identify the outputs of processes, products, and services by suitable means throughout production and service provision, and control the unique identification of outputs where traceability is a requirement, retaining the relevant documented information?
27. Nonconforming Outputs Control (8.6)
Does the organization identify and control outputs that do not conform to requirements to prevent their unintended use or delivery, and are appropriate actions taken – such as correction, segregation, or customer notification – with documented information retained as evidence of nonconformity and actions taken?
28. Monitoring & QMS Evaluation (9.1)
Has the organization determined what needs to be monitored and measured in relation to customer satisfaction, QMS performance, and product and service conformity, including the methods, timing, frequency, and responsibilities for analysis and evaluation, and is documented information retained as evidence of the results?
29. Customer Perception & Feedback (9.1)
Does the organization monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled, using appropriate methods such as surveys, feedback, warranty claims, or compliment and complaint analysis, and are the results used to drive improvement?
30. Internal Audits (9.2)
Are internal QMS audits conducted at planned intervals by objective and impartial auditors to determine whether the QMS conforms to the organization’s own requirements and the requirements of ISO 9001:2015, and are audit findings documented and communicated to relevant management?
31. Management Review (9.3)
Does top management review the QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization, with documented outputs including decisions on improvement opportunities and any changes needed to the QMS?
32. Improvement Selection & Action (10.1)
Has the organization determined and selected opportunities for improvement, and implemented any necessary actions to meet customer requirements and enhance customer satisfaction, including improvement of products and services, correction of undesired effects, and improvement of QMS performance?
33. Nonconformity & Corrective Action (10.2)
When a nonconformity occurs, including any arising from complaints, does the organization take action to control and correct it, evaluate the need to eliminate the causes to prevent recurrence, implement necessary corrective actions, review their effectiveness, and retain documented information as evidence?
34. Continual Improvement (10.3)
Does the organization continually improve the suitability, adequacy, and effectiveness of the QMS by considering the results of analysis and evaluation, management review outputs, and by identifying opportunities to enhance quality performance and customer satisfaction?