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4 Context of the organization
4.1 Understanding the organization and its context
Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction. Meets requirement Non-conformance Improvement Opportunity N/A Verify how these issues affect the ability to achieve the intended result of the QMS. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization monitors and reviews information about these internal and external issues. Meets requirement Non-conformance Improvement Opportunity N/A
4.2 Understanding the needs and expectations of interested parties
Verify how organization determined relevant interested parties to QMS. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization has determined the relevant needs and expectations of interested parties. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization has determined the impact or potential impact of the interested parties. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization monitors and reviews information about interested parties and their relevant requirements. Meets requirement Non-conformance Improvement Opportunity N/A
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4.3 Determining the scope of the quality management system
Verify the QMS scope considers the following: Meets requirement Non-conformance Improvement Opportunity N/A External and internal issues. The requirements of relevant interested parties. The products and services of the organization. Verify how the organization has determined how the ISO 9001:2015 standard is applied within the organization. Meets requirement Non-conformance Improvement Opportunity N/A If the organization has determined any of the requirements of the ISO 9001:2015 standard not to be applicable, show me how conformity of products and services are not affected by this. Meets requirement Non-conformance Improvement Opportunity N/A Verify QMS scope is documented. Meets requirement Non-conformance Improvement Opportunity N/A Verify scope states what products and services are covered by the QMS and how it justi es instances where requirements cannot be applied. Meets requirement Non-conformance Improvement Opportunity N/A
4.3.1 Determining the scope of the quality management system - supplemental
Verify support functions included in scope Meets requirement Non-conformance Improvement Opportunity N/A If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design. Meets requirement Non-conformance Improvement Opportunity N/A
4.3.2 Customer-speci c requirements
Verify conformance to all applicable customer, statutory and regulatory requirements Meets requirement Non-conformance Improvement Opportunity N/A
4.4.1.2 Product Safety
Verify documented process Meets requirement Non-conformance Improvement Opportunity N/A Where applicable, shall include: Meets requirement Non-conformance Improvement Opportunity N/A identi cation of statutory and regulatory product-safety requirements and customer noti cation special approvals for design FMEA, process FMEAs and control plans identi cation and controls of product safety-related characteristics (including at the point of manufacture) reaction plans de nition of responsibilities, escalation process and ow of information, including top management and customer noti cation training required changes of product or process shall be approved prior to implementation transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources product traceability by manufactured lot (at a minimum) throughout the supply chain lessons learned for new product introductions
5 Leadership
5.1 Leadership and commitment
Top management is identi ed Meets requirement Non-conformance Improvement Opportunity N/A Verify top management demonstrates leadership and commitment by Meets requirement Non-conformance Improvement Opportunity N/A Taking accountability for QMS effectiveness Ensuring the QMS policy and objectives are established and are compatible with strategic direction and context of organization Ensuring the QMS is integrated into organization's business processes Promoting the use of the process approach and risk-based thinking Ensuring resources are available Communicating the importance of effective QMS and of conforming to its requirements Ensuring intended outcomes Engaging, directing and supporting persons to contribute to the effectiveness of the QMS Promoting continuous improvement Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of respsonsibility
provides a framework for setting quality objectives. includes a commitment to satisfy applicable requirements. includes a commitment to continual improvement of the QMS. Verify QMS Policy is maintained as documented information. Meets requirement Non-conformance Improvement Opportunity N/A Verify QMS Policy is communicated, understood and applied within the organization. Meets requirement Non-conformance Improvement Opportunity N/A Verify QMS Policy is available to relevant interested parties. Meets requirement Non-conformance Improvement Opportunity N/A
5.3 Organizational roles, responsibilities and authorities
Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization Meets requirement Non-conformance Improvement Opportunity N/A Verify top management assigns responsibility and authority for.. Meets requirement Non-conformance Improvement Opportunity N/A ensuring the QMS conforms to the ISO 9001:2015 and IATF 16949:2016 standards. ensuring that processes are delivering their intended outputs. reporting on the performance of the QMS and on opportunities for improvement, in particular to top management. ensuring the promotion of customer focus throughout the organization. ensuring the integrity of the QMS is maintained when changes to the QMS are planned and implemented.
Verify personnel are assigned responsibility and authority to ensure that customer requirements are met and these assignments are documented. Meets requirement Non-conformance Improvement Opportunity N/A Verify personnel responsible for conformity have the authority to stop shipment and stop production to correct quality problems. Meets requirement Non-conformance Improvement Opportunity N/A Verify personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform Meets requirement Non-conformance Improvement Opportunity N/A Verify that personnel across all shifts have responsibility for ensuring conformity to product requirements. Meets requirement Non-conformance Improvement Opportunity N/A
6 Planning
6.1 Actions to address risks and opportunities
Verify how the internal and external issues and interested parties are considered when planning for the QMS? Meets requirement Non-conformance Improvement Opportunity N/A Verify how risks and opportunities are determined and addressed so the QMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement Meets requirement Non-conformance Improvement Opportunity N/A Verify how actions are planned to address risks and opportunities. Meets requirement Non-conformance Improvement Opportunity N/A Verify how actions are integrated and implemented into the QMS processes. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization evaluates the effectiveness of the actions. Meets requirement Non-conformance Improvement Opportunity N/A Verify how actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services. Meets requirement Non-conformance Improvement Opportunity N/A
Verify top management ensures that quality objectives are de ned, established and maintained at relevant functions, levels and processes. Meets requirement Non-conformance Improvement Opportunity N/A Verify the quality objectives are.. Meets requirement Non-conformance Improvement Opportunity N/A consistent with the quality policy. measurable. taking into account applicable requirements. relevant to the conformity of products and services and to the enhancement of customer satisfaction. moinitored. communicated. updated as appropriate. Verify objectives are documented. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives. Meets requirement Non-conformance Improvement Opportunity N/A Verify annual quality objectives and related performance targets (internal and external) are established Meets requirement Non-conformance Improvement Opportunity N/A
6.3 Planning of changes
Verify how QMS changes are planned systematically. Meets requirement Non-conformance Improvement Opportunity N/A
Verify how the organization demonstrates the purpose and potential consequences of changes. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization considers the integrity of the QMS. Meets requirement Non-conformance Improvement Opportunity N/A Verify how resources are made available. Meets requirement Non-conformance Improvement Opportunity N/A Verify how responsibility and authority is allocated and reallocated. Meets requirement Non-conformance Improvement Opportunity N/A
7 Support
7.1 Resources
7.1.1 General - 7.1.3 Infrastructure
Verify how resources are determined for the organization. Meets requirement Non-conformance Improvement Opportunity N/A Show me how the capabilities and constraints on internal resources are considered. Meets requirement Non-conformance Improvement Opportunity N/A Show me how needs from external providers are considered. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity. Meets requirement Non-conformance Improvement Opportunity N/A Verify design layout optimizes material ow, material handling and value-added use of oor space Meets requirement Non-conformance Improvement Opportunity N/A
Verify MSA Meets requirement Non-conformance Improvement Opportunity N/A Verify criteria used conforms to those in reference manuals on MSA Meets requirement Non-conformance Improvement Opportunity N/A Verify documented process for managing calibration/veri cation records Meets requirement Non-conformance Improvement Opportunity N/A Verify calibration/veri cation activities and records shall include: Meets requirement Non-conformance Improvement Opportunity N/A revisions following engineering changes that impact measurement systems any out-of-spec readings as received for calibration/veri cation risk assessment caused by out-of-spec condition documented information on the validity of previous measurement results when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned veri cation or calibration or during its use customer noti cation if product or material has been shipped statements of conformity to spec after calibration/veri cation veri cation of software version records of the calibration and maintenance activities for all gauging, including employee-owned, customer-owned or on-site supplier-owned equipment production-related software veri cation used for product and process control
Verify de ned scope for internal laboratory is documented Meets requirement Non-conformance Improvement Opportunity N/A Verify laboratory requirements for: Meets requirement Non-conformance Improvement Opportunity N/A adequacy of the laboratory technical procedures competency of laboratory personnel testing of the product traceability to relevant process standard (such as ASTM, EN, etc.) or when no national standard(s) is available, the organization shall de ne and implement a methodology to verify measurement system capability customer requirements, if any review of related records Verify external laboratories are accredited to ISO/IEC 17025 or national equivalent and or is acceptable to the customer Meets requirement Non-conformance Improvement Opportunity N/A Verify scope incudes relevant inspection, test or calibration service and the certi cate of calibration or test report includes the mark of a national accreditation body Meets requirement Non-conformance Improvement Opportunity N/A
7.1.6 Organizational knowledge
Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services. Meets requirement Non-conformance Improvement Opportunity N/A Verify how knowledge is maintained and made available to the extent necessary. Meets requirement Non-conformance Improvement Opportunity N/A
applicable manufacturing process(es) to be audited, including PFMEA and control plan (second-party auditor only) understanding of the applicable core tool requirements understanding how to plan, conduct, report and close out audit ndings Verify how manufacturing process auditors demonstrate technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (PFMEA) and control plan Meets requirement Non-conformance Improvement Opportunity N/A Verify product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity Meets requirement Non-conformance Improvement Opportunity N/A Verify maintenance of and improvement in internal auditor competence by Meets requirement Non-conformance Improvement Opportunity N/A executing minimum number of audits per year, as de ned by organization maintaining knowledge of relevant requirements based on internal or external changes
7.3 Awareness
Verify people doing work under the organization's control are aware of Meets requirement Non-conformance Improvement Opportunity N/A the quality policy. the relevant quality objectives. their contribution to the effectiveness of the QMS, including the bene ts of improved performance. the implications of not conforming with the QMS requirements.
7.4 Communication
Verify internal and external communication process (what, when, with whom and how to communicate). Meets requirement Non-conformance Improvement Opportunity N/A
7.5 Documented information
Verify documented information required by the ISO 9001:2015 standard. Meets requirement Non-conformance Improvement Opportunity N/A Verify documented information that shows the effectiveness of the QMS. Meets requirement Non-conformance Improvement Opportunity N/A Show me that your documented information contains appropriate identi cation, format (language, software version, graphics, ...) and media (paper, electronic, ...). Meets requirement Non-conformance Improvement Opportunity N/A Show me how the documented information is reviewed and approved for suitability and adequacy. Meets requirement Non-conformance Improvement Opportunity N/A Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information. Meets requirement Non-conformance Improvement Opportunity N/A Verify documented information of external origin is identi ed, as appropriate, and controlled. Meets requirement Non-conformance Improvement Opportunity N/A Verify quality manual and it includes, at a minimum: Meets requirement Non-conformance Improvement Opportunity N/A Scope of the QMS, including details of and justi cation for any exclusions documented processes established for the QMS or reference to them
Verify how resources are determined. Meets requirement Non-conformance Improvement Opportunity N/A Verify how process control is implemented. Meets requirement Non-conformance Improvement Opportunity N/A Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services. Meets requirement Non-conformance Improvement Opportunity N/A Determine how output from the planning process is suitable for operations. Meets requirement Non-conformance Improvement Opportunity N/A Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary. Meets requirement Non-conformance Improvement Opportunity N/A Verify how outsourced processes are controlled. Meets requirement Non-conformance Improvement Opportunity N/A Verify topics shall be included in planning for product realization: Meets requirement Non-conformance Improvement Opportunity N/A customer product requirements and technical speci cations logistics requirements manufacturing feasibility project planning acceptance criteria Verify organization ensures con dentiality Meets requirement Non-conformance Improvement Opportunity N/A
8.2 Determination of requirements for products and services
Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and speci c requirements for contingency actions. Meets requirement Non-conformance Improvement Opportunity N/A Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained. Meets requirement Non-conformance Improvement Opportunity N/A Verify how product and service requirements including statutory and regulatory requirements are de ned. Verify that the organization has the ability to meet the de ned requirements and substantiate any claims for its products and services. Meets requirement Non-conformance Improvement Opportunity N/A Verify how the organization reviews.. Meets requirement Non-conformance Improvement Opportunity N/A customer requirements for delivery and post-delivery. requirements necessary for customer's speci ed or intended use, where known. statutory and regulatory requirements applicable to the products and services. other contract or order requirements. Verify retained documented evidence of customer-authorized waiver of above requirements for a formal review Meets requirement Non-conformance Improvement Opportunity N/A Verify organization's manufacturing processes are capable (capability analysis, Cp, Cpk, Pp, Ppk) Meets requirement Non-conformance Improvement Opportunity N/A Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer. Meets requirement Non-conformance Improvement Opportunity N/A
