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ISO 9001:2015 Assessment ChecklistType:Clause4. Context d its contextAssessors:RequirementThe organization shall determine external andinternal issues that are relevant to its purposeand its strategic direction and that affect its abilityto achieve the intended result(s) of its qualitymanagement system.The organization shall monitor and reviewinformation about these external and internalissues.NOTE 1 Issues can include positive and negativefactors or conditions for consideration.NOTE 2 Understanding the external context can befacilitated by considering issues arising from legal,technological, competitive, market, cultural, socialand economic environments, whether international,national, regional or local.NOTE 3 Understanding the internal context can befacilitated by considering issues related to values,culture, knowledge and performance of theorganization.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment tandingthe needs andexpectations ofinterestedpartiesDue to their effect or potential effect on theorganization’s ability to consistently provideproducts andservices that meet customer and applicablestatutory and regulatory requirements, theorganizationshall determine:a) the interested parties that are relevant to thequality management system;b) the requirements of these interested parties thatare relevant to the quality management system.The organization shall monitor and reviewinformation about these interested parties and theirrelevant requirements.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Assessors:ClauseRequirement4.3 Determiningthe scope ofthe qualitymanagementsystemThe organization shall determine the boundariesand applicability of the quality management systemto establish its scope.When determining this scope, the organizationshall consider:a) the external and internal issues referred to in4.1;b) the requirements of relevant interested partiesreferred to in 4.2;c) the products and services of the organization.The organization shall apply all the requirements ofthis International Standard if they are applicablewithin the determined scope of its qualitymanagement system.The scope of the organization’s qualitymanagement system shall be available and bemaintained asdocumented information. The scope shall state thetypes of products and services covered, andprovidejustification for any requirement of this InternationalStandard that the organization determines is notapplicable to the scope of its quality managementsystem.Conformity to this International Standard may onlybe claimed if the requirements determined as notbeing applicable do not affect the organization’sability or responsibility to ensure the conformity ofitsproducts and services and the enhancement ofcustomer satisfaction.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Documented information requiredCompliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Clause4. Qualitymanagementsystem and itsprocesses4.4.1 Theorganizationshall establish,implement,maintain andcontinuallyimprove a qualitymanagementsystem,including theprocessesneeded and theirinteractions, inaccordance withtherequirements ofthis InternationalStandard.Assessors:RequirementThe organization shall determine the processesneeded for the quality management system andtheirapplication throughout the organization, and shall:a) determine the inputs required and the outputsexpected from these processes;b) determine the sequence and interaction of theseprocesses;c) determine and apply the criteria and methods(including monitoring, measurements and relatedperformance indicators) needed to ensure theeffective operation and control of these processes;d) determine the resources needed for theseprocesses and ensure their availability;e) assign the responsibilities and authorities forthese processes;f) address the risks and opportunities asdetermined in accordance with the requirements of6.1;g) evaluate these processes and implement anychanges needed to ensure that these processesachievetheir intended results;h) improve the processes and the qualitymanagement system.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Clause4.4.2Assessors:RequirementTo the extent necessary, the organization shall:a) maintain documented information to support theoperation of its processes;b) retain documented information to haveconfidence that the processes are being carried outas planned.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Documented information requiredCompliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Clause5 Leadership5.1 LeadershipandcommitmentAssessors:RequirementDate (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Clause5.1.1 GeneralAssessors:RequirementTop management shall demonstrate leadership andcommitment with respect to the qualitymanagement system by:a) taking accountability for the effectiveness of thequality management system;b) ensuring that the quality policy and qualityobjectives are established for the qualitymanagement system and are compatible with thecontext and strategic direction of the organization;c) ensuring the integration of the qualitymanagement system requirements into theorganization’s business processes;d) promoting the use of the process approach andrisk-based thinking;e) ensuring that the resources needed for thequality management system are available;f) communicating the importance of effective qualitymanagement and of conforming to the qualitymanagement system requirements;g) ensuring that the quality management systemachieves its intended results;h) engaging, directing and supporting persons tocontribute to the effectiveness of the qualitymanagement system;i) promoting improvement;j) supporting other relevant management roles todemonstrate their leadership as it applies to theirareas of responsibility.NOTE Reference to “business” in this InternationalStandard can be interpreted broadly to mean thoseactivities that are core to the purposes of theorganization’s existence, whether the organizationis public, private, for profit or not for profit.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Assessors:ClauseRequirement5.1.2 CustomerfocusTop management shall demonstrate leadership andcommitment with respect to customer focus byensuring that:a) customer and applicable statutory and regulatoryrequirements are determined, understood andconsistently met;b) the risks and opportunities that can affectconformity of products and services and the abilityto enhance customer satisfaction are determinedand addressed;c) the focus on enhancing customer satisfaction ismaintained.5.2 Policy5.2.1Establishingthe qualitypolicyTop management shall establish, implement andmaintain a quality policy that:a) is appropriate to the purpose and context of theorganization and supports its strategic direction;b) provides a framework for setting qualityobjectives;c) includes a commitment to satisfy applicablerequirements;d) includes a commitment to continual improvementof the quality management system.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment unicatingthe qualitypolicyThe quality policy shall:a) be available and be maintained as documentedinformation;b) be communicated, understood and appliedwithin the organization;c) be available to relevant interested parties, iesand authoritiesTop management shall ensure that theresponsibilities and authorities for relevant roles areassigned, communicated and understood within theorganization.Top management shall assign the responsibilityand authority for:a) ensuring that the quality management systemconforms to the requirements of thisInternational Standard;b) ensuring that the processes are delivering theirintended outputs;c) reporting on the performance of the qualitymanagement system and on opportunities forimprovement (see 10.1), in particular to topmanagement;d) ensuring the promotion of customer focusthroughout the organization;e) ensuring that the integrity of the qualitymanagement system is maintained when changesto the quality management system are planned andimplemented.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Documented information requiredCompliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:ClauseAssessors:Requirement6 Planning6.1 Actions toaddress risksandopportunities6.1.1When planning for the quality management system,the organization shall consider the issuesreferred to in 4.1 and the requirements referred toin 4.2 and determine the risks and opportunitiesthatneed to be addressed to:a) give assurance that the quality managementsystem can achieve its intended result(s);b) enhance desirable effects;c) prevent, or reduce, undesired effects;d) achieve improvement.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Clause6.1.2Assessors:RequirementThe organization shall plan:a) actions to address these risks and opportunities;b) how to:1) integrate and implement the actions into itsquality management system processes (see 4.4);2) evaluate the effectiveness of these actions.Actions taken to address risks and opportunitiesshall be proportionate to the potential impact on theconformity of products and services.NOTE 1 Options to address risks can includeavoiding risk, taking risk in order to pursue anopportunity, eliminating the risk source, changingthe likelihood or consequences, sharing the risk, orretaining risk byinformed decision.NOTE 2 Opportunities can lead to the adoption ofnew practices, launching new products, openingnew markets, addressing new customers, buildingpartnerships, using new technology and otherdesirable and viable possibilities to address theorganization’s or its customers’ needs.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Compliance(Y, N, Partial)

ISO 9001:2015 Assessment ChecklistType:Clause6.2 Qualityobjectives andplanning toachieve them6.2.16.2.2Assessors:Requirement6.2.1 The organization shall establish qualityobjectives at relevant functions, levels andprocessesneeded for the quality management system.The quality objectives shall:a) be consistent with the quality policy;b) be measurable;c) take into account applicable requirements;d) be relevant to conformity of products andservices and to enhancement of customersatisfaction;e) be monitored;f) be communicated;g) be updated as appropriate.The organization shall maintain documentedinformation on the quality objectives.When planning how to achieve its qualityobjectives, the organization shall determine: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.Date (s)Evidence Sighted(Identify documents or records, e.g.show title, date, author or referencenumber)Documented information requiredCompliance(Y, N, Partial)