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www.iso-9001-checklist.co.ukInsert your company’s name or logo, and address.ISO 9001:2015Quality Manual TemplateThis quality manual is the property of Your Company. It must not be reproduced in whole or in part or otherwisedisclosed without prior written consent.The official controlled copy of this quality manual is the digitally signed PDF document held within our networkserver and visible to all authorised users. All printed copies, and all electronic copies and versions, except the onesdescribed above, are considered uncontrolled copies which should be used for reference only.
Insert your company’s name or logo.ISO 9001:2015Quality Manual TemplateContents1Introduction 52References 53Definitions 54About Our Organisation 654.1Organizational Context 64.2Relevant Interested Parties 74.3Quality Management System 74.3.1Management System Scope 74.3.2Management System Processes 74.3.3Outsourced Processes 84.3.4Documented Information 8Leadership & Governance 105.167Quality Management 105.1.2Customer Focus 115.1.3Quality Policy 115.2Role, Responsibilities & Authorities 125.3Communication 135.3.1Internal Communication 135.3.2External Communication 14Management System Planning 156.1Addressing Risks & Opportunities 156.2Quality Objectives 166.3Planning for Change 16Support 187.18Leadership & Commitment 105.1.1Resources 187.1.1General 187.1.2People 187.1.3Infrastructure 197.1.4Operational Environment 197.1.5Monitoring & Measurement Tools 197.1.6Organisational Knowledge 20Product & Service Development 218.1Operational Planning & Control 21www.iso-9001-checklist.co.ukPage 2 of 37
Insert your company’s name or logo.ISO 9001:2015Quality Manual Template8.2Customer Requirements 218.2.1Customer Communication 218.2.2Determining Requirements 218.2.3Review of Requirements 228.2.4Changes in Requirements 228.3Design & Development 228.3.1General 228.3.2Planning 238.3.3Inputs 238.3.4Controls 238.3.5Outputs 248.3.6Changes 248.4Control of Suppliers & External Processes 248.4.1General 248.4.2Purchasing Controls 258.4.3Purchasing Information 258.5Production & Service Provision 268.5.1Control of Production & Service Provision 268.5.2Identification & Traceability 268.5.33rd Party Property 268.5.4Preservation 268.5.5Post-delivery Activities 278.5.6Control of Changes 278.6Release of Products & Services 278.7Control of Non-conforming Outputs 289Performance Evaluation 299.1Monitoring, Measurement, Analysis & Evaluation 299.1.1General 299.1.2Customer Satisfaction 299.1.3Analysis and Evaluation 309.2Internal Audit 309.3Management Review 31109.3.1General 319.3.2Inputs 319.3.3Outputs 31Improvement 3210.1General 3210.2Non-conformity & Corrective Action 32www.iso-9001-checklist.co.ukPage 3 of 37
Insert your company’s name or logo.ISO 9001:2015Quality Manual Template10.3Improvement 33Appendices 34A.1Correlation Matrix 34A.2Sequence & Interaction of Processes 36A.3Organization Chart 37www.iso-9001-checklist.co.ukPage 4 of 37
ISO 9001:2015Insert your company’s name or logo.Quality Manual Template1 IntroductionYour organization has developed and implemented a quality management system (QMS), which uses ISO9001:2015 as a framework that allows our organization to document and improve our practices in order tobetter satisfy the needs and expectations of our customers, stakeholders and interested parties.This manual describes the quality management system, delineates authorities, inter relationships andresponsibilities of personnel operating within the management system. The manual also provides referencesto procedures and activities that also comprise our quality management system.The manual is used to familiarise customers and other external organizations or individuals with the controlsthat have been implemented and to assure them that the integrity of our quality management system ismaintained and is focused on customer satisfaction and continual improvement.Our quality management system meets the requirements of ISO 9001:2015 and uses the Plan, Do, Check andAct approach to process planning. Our QMS addresses and supports our strategies for the design,development, manufacturing, installation and servicing of our products . insert your scope statement here.This should succinctly summarize your products and/or services. A single sentence is all that is required, asthis will be shown your ISO 9001:2015 certificate . Also insert the registered address of your organization here The following table identifies any ISO 9001:2015 requirements, from Section 8.0, that are not applicable toour organization as well as providing a brief narrative to justify their omission from the scope of our QMS:ClauseJustification for Exclusion8.3We exclude design and development from our QMS, as we do not design or modify components2 ReferencesIn addition to ISO 9001:2015 we also make reference to other relevant British and/or international standardsas well as customer specifications appropriate to our products and market.StandardTitleDescriptionBS EN ISO 9000:2015Quality management systemsFundamentals and vocabularyBS EN ISO 9004:2000Quality management systemsGuidelines for performance improvementsBS EN ISO 19011:2011Auditing management systemsGuidelines for auditing3 DefinitionsThis document does not introduce any new definitions but rather relies on the following:1.Definitions typically used by our customers, stakeholders or marketplace;2.Terms typically used in standards and regulations as they relate to our QMS or products;3.Standard business terminology;4.Terms and vocabulary commonly used in quality and engineering practices.www.iso-9001-checklist.co.ukPage 5 of 37
ISO 9001:2015Insert your company’s name or logo.Quality Manual Template4 About Our Organisation4.1 Organizational ContextYour organization is committed to definingourpositioninthe marketplaceFigure 1: Typical QMS Input Hierarchyandunderstanding how relevant factors arisingLocal Factorsfrom legal, political, economic, social andInternalIssuestechnological issues influence our strategicMacro n and our organizational context.Yourorganizationidentifies,SWOT Analysisanalyzes,monitors and reviews factors that mayPESTLE AnalysisOrganizational Strategyaffect our ability to satisfy our customersand stakeholders, as well as; factors thatmay adversely affect the stability of ourBusiness Planningprocess, or our management system’sResourcesintegrity.To ensure that our QMS is aligned with ourstrategy, whilst taking account of relevantinternal and external factors; we initiallyQuality PolicyObjectivesKPIs/MetricsBudgetsManagment SystemContextScopecollate and analyze pertinent information inorder to determine potential impact on ourcontext and subsequent business strategy.Your organization then monitors and reviews this information to ensure that a continual understanding ofeach group’s requirements is derived and maintained. To facilitate the understanding of our context, weregularly consider issues that influence our context during management review meetings and are conveyedvia minutes and business planning documents.Internal IssuesExternal IssuesThe output from this activity is evident as an input toMarket shareCustomers & suppliersthe consideration of risks and opportunities, and theEmployeesMarkets & competitionactions that we take to address them. Refer to SectionPerformanceRegulatory & statutory6.1 for more information about our risk andValues & cultureTechnologicalopportunity management framework.Innovation & knowledgeCultural & socialAlthough we acknowledge that ISO 9001:2015 doesnot require our organizational context to be maintained as documented information, we maintain and retain;in addition to this document, the following documented information to describe our organizational context:1.Analysis of business plans, strategies, and statutory and regulatory commitments;2.Analysis of technology and comp
ISO 9001:2015 Quality Manual Template www.iso-9001-checklist.co.uk Page 8 of 37 1. Leadership and planning processes; 2. Customer and stakeholder processes; 3. Product/service development processes; 4. Evaluation and improvement processes. These
