‘AUDIT CHECKLIST 150 9001:2015 [ Objective evidence may represent documented information (procedures, manuals, records, drawings, standards, legislation, authorizations, licences, et), but also information obtained during interviews or aspects observed by auditors. 4, Context of the organization Y TN 4.1. The organization has determined external and intemal issues relevant to its purpose and strategic direction that affect its ability to achieve the intended results of its QMS? 4.2.Interested parties relevant for the QMS and their requirements have been identified? ‘Objective evidence (eg. relevant authorizations and licenses, business plans, market research and studies, SWOT analysis, diagrams, quality manuals, examples ofinterested parties etc) 4.3.4.4 Scope of the OMS. The OMS processes Y[N Ts the scope available as documented information? Requirements determined as not being applicable irany)are justified and do not affect the capability of the QMS to ensure conformity of products and services and the enhancement of ‘customer satisfaction? ‘The organization has determined the processes needed for the OMS and their application? ‘Objective evidence (eg. quality manual, process maps/ diagrams, ete) 5. Leadership Y[N 5.1. Top management demonstrates leadership and commitment with respect to the OMS and ‘customer focus? 5.2. Quality policy Y[W ‘A quality policyis established and maintained as documented information? The quality policy fulfils applicable requirements: itis appropriate to the purpose and context of the organization, provides a framework for setting quality objectives, includes a commitment to satisfy applicable requirements and to continual improvement of the QMS? “The quality policy is:communicated and understood in the organization? Available to relevant interested parties as appropriate? ‘Objective evidence (eg. quality policy date, edition; how is it communicated: how is it made available) 5.3. Organizational roles, responsibilities and authorities Y[N Responsibilities and authorities for the QMS have been assigned? Objective evidence (e.g. person/persons having responsibilty or the QMS and associated documented information job description, decisions, organization chart et) 6.Planning 6.1. Actions to address risks and opportunities Y[N “The organization has determined the risks and opportunities relevant for its OMS? ‘The organization plans and implementsactions to address the risks and opportunities? ‘Objective evidence (eg. - registry of risks and opportunities, SWOT analysis, FMEA, risk assessments, examples of risks identified, etc) ‘6.2. Quality objectives and planning to achieve them. Y TN ‘Quality objectives are available as documented information at relevant functions, levels and processes within the QMS? Paget ofS‘AUDIT CHECKLIST 150 9001:2015 (Objective evidence (examples of objectives, management programs, plans, ett) 7, Support 7.1.2. People Y TN ‘The organization has therequired personnelto control its processes effectively? 7.1.3. Infrastructure Y [NW Neededinfrastructure (buildings and associated utilities, equipment, transportation resources, and communication) is availableand properly maintained? ‘Objective evidence (eg. documented procedures, maintenance contracts, maintenance plans; service records; responsibilities for infrastructure maintenance) 7.1.4. Environment for the operation of processes ¥ N [NA The environment needed for the operation of processes (eg. temperature, hygene, heat, humidity, noise, light, social and psychological factors) is determined, provided and properly maintained? 7.1.5, Monitoring and measuring resources Y NL NA ‘Adequate monitoring and measuring equipment is available in order to verify the conformity of products and services? ‘Appropriate documented information as evidence of fess for purpose of the monitoring and measuring resources is available? Objective evidence (e.g. documented procedures, examples of measuring and monitoring resourk calibration records, responsibilities, etc) ce, 7.1.6. Organizational knowledge The knowledge required to operate the processes and achieve conformity of products and services is available? Objective evidence (e.g. intellectual property, experienced employees, access to sources of information, subscriptions, etc) 7.2. Competence “The organization hasdetermined the competence requirements for its personnel? ‘Competent personnel (based on studies, training and experience) is available? ‘The organization takes actions to acquireneeded competence for its personnel (ex. raining, mentoring, re-assigning of responsibilities, ete? 7.3. Awareness The organization ensuresthe awareness of personnel doing work under its control? (awareness should refer to the quality policy, quality objectives, contribution to the effectiveness of the QMS, implications of not conforming with the QMS) Objective evidence (e.g. documented procedures, training records, competence records for key personnel, etc) 7.4. Communication Y[N Internal and externalcommunications relevant to the OMS have been determined? (including about what, when, with whom, and who communicates) 7.5. Documented information yY[N ‘The OMS includes the documented information required by the standard? Pagezors‘AUDIT CHECKLIST 150 9001:2015 Documented information is controlled (distribution, access, retrieval, storage and preservation, control of changes, retention and disposition)? ‘Objective evidence (e.g. procedure for control of documented information list of OMS documents, ete) 8. Operation ¥. '8.1. Operational planning and control The organization plans, implements and controls the processes needed to meet the requirements forts products and services? ‘Control of outsourced processes is maintained? ‘8.2. Requirements for products and services ¥ The organization ensures efficient communication with its customers? (providing information about products and services, handling contracts and orders, obtaining customer feedback including complaints, handling customer property, etc) The organization determines the requirements for its products and services to be offered to ‘customers? The organization conducts a review before committing to supply products and services to the customer? (this review includes: requirements specified by the customer; requirements not stated by the customer but necessary for theintended use; requirements of the organization; statutory and regulatory ‘requirements; requirements difering from ones previously expressed) ‘When the requirements for products and services are changed relevant information isamended and persons are made aware? Objective evidence (e.g. offers; catalogues of products/ services; websites; contracts; etc) 8.3. Design and development of products and services YIN NIA The design and development process is appropriate to ensure the subsequent provision of products and services? The organization ensures an appropriate planning for the design and development process? Essential requirements for the products and services to be designed and developed are determined? Controls to the design and development process are applied? (including review, verification, validation and actions on problems identified) ‘Changes to design and development are identified, reviewed and controlled? Documented information relevant to the design and development process is maintained? Objective evidence (e.g. documented procedures, projects, responsibilities for design and development design and development records, etd ‘8.4, Control of externally provided processes, products and services ¥ The organization determines and applies criteria for the evaluation, selection, monitoring and re-evaluation ofits external providers? ‘The organization takes into consideration the potential impact of extemallyprovided processes, products and services on its ability to meet customer and other requirements? Information communicated to external providers is adequate? Objective evidence (e.g. documented procedures for purchasing; persons/ structure responsible for purchasing; ists of suppliers; supplier evaluation recor records/conformity documents etc) Pages ors‘AUDIT CHECKLIST 150 9001:2015 '8.5, Production and service provision Y DN The organization ensures controlled conditions for itsproduction and service provision processes? In cases where the resulting output cannot be verified through measuring and monitoring, the ‘organization performs validation and periodic revalidation? The organization ensures adequate identification andtraceability of outputs from production and service provision? Property belonging to customers or suppliers that is under the control of the organization is, identified and adequately protected? The organization ensures adequate preservation of outputs from production and service provision? (preservation can include identification, handling, contamination control, packaging, storage, transportation, protection, etc) The organization meets the requirements forpost-delivery activities associated to its products and services? (e.g. warranty, maintenance, recycling, final disposal, customer feedback, etc) ‘Changesto the production and service provision processes are controlled to ensure continuing conformity to requirements? The organization ensures that products and services are not released to the customer until all arrangements are satisfactory completed? Documented information on the release of products and services (evidence of conformity and person(s) authorizing the release) is retained? Nonconforming outputs are identified and controlled to prevent their unintended use or delivery? The organization takes actions on nonconforming products and services(eg, correction, segregation, containment, return, suspension of provision, informing customers, obtaining authorization, ete) Objective evidence (e.g. documented procedures for production/ service provision; instructions; specifications; quality plans; production/ service provision records; minutes; records of nonconforming products-etc) ‘9. Performance evaluation Y[N “The organization evaluates the performance and effectiveness of its QMS? Results of performance evaluation are retained as documented information? 9.1.2. Customer satisfaction Y[N The organization monitors customer satisfaction? (Objective evidence (documented procedure, surveys, questionnaires, examples of customers, recommendations, etc) ‘9.2. Internal audit Y[N ‘The organization performs internal audits of the OMS at planned intervals? The planning ofinternal audits takes into consideration the importance of the processes cconcermed, changes to the organization, risks? (Objective evidence (documented procedures, audit programs, plans, checKlsts, reports, competence of, auditors) ‘9.3. Management review Y[N ‘Top management reviews the QMS at planned intervals? ‘Objective evidence (documented procedures, minutes, plans, actions programs, etc) Pagea orsauoIT (CHECKLIST 150 9001:2015 10. Improvement. Nonconformity and corrective action. Continual improvement The organization reviews and treats nonconformities (including complaints) by implementing corrections and corrective actions? ‘The organization improves continually the suitability, adequacy and effectiveness ofits OMS? (Objective evidence (e.g. documented procedures, nonconformity reports, corrective actions, com action plans, etc) plaints, Use of certification mark andreference to certi n (if applicable) The organization follows the rules for the use of certification mark and reference to certification? Auditor. Pages ofS