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Quality Management System Guidance - ISO 9001 Help

Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation 2017 Page 1 of 75 Table of Contents 1 INTRODUCTION .. 4 IMPLEMENTATION & DEVELOPMENT .. 5 MANAGING THE CHANGE .. 5 TOP Management COMMITMENT .. 6 SENIOR Management ENGAGEMENT .. 6 IMPLEMENTATION 7 GAP ANALYSIS .. 7 TEAM MEETINGS .. 8 CHOOSING YOUR REGISTRAR .. 8 2 DOCUMENTED INFORMATION ..10 3 SUMMARY OF KEY CHANGES ..12 PROCESS APPROACH .. 12 CONTEXT OF THE ORGANIZATION .. 12 SCOPE OF THE Quality Management System .. 12 LEADERSHIP .. 12 RISKS & OPPORTUNITIES .. 13 PRODUCTS & SERVICES.

ISO 9001:2015 Clause-by-clause Interpretation. www.iso9001help.co.uk ... To assess whether your organisation has a high-level, conceptual understanding of its internal and external ... Reviewing your organization’s context could include interviews with senior management, questionnaires, surveys and research. Cross-functional input is ...

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Transcription of Quality Management System Guidance - ISO 9001 Help

1 Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation 2017 Page 1 of 75 Table of Contents 1 INTRODUCTION .. 4 IMPLEMENTATION & DEVELOPMENT .. 5 MANAGING THE CHANGE .. 5 TOP Management COMMITMENT .. 6 SENIOR Management ENGAGEMENT .. 6 IMPLEMENTATION 7 GAP ANALYSIS .. 7 TEAM MEETINGS .. 8 CHOOSING YOUR REGISTRAR .. 8 2 DOCUMENTED INFORMATION ..10 3 SUMMARY OF KEY CHANGES ..12 PROCESS APPROACH .. 12 CONTEXT OF THE ORGANIZATION .. 12 SCOPE OF THE Quality Management System .. 12 LEADERSHIP .. 12 RISKS & OPPORTUNITIES .. 13 PRODUCTS & SERVICES.

2 13 DOCUMENTED INFORMATION .. 13 CONTROL OF EXTERNALLY PROVIDED PRODUCTS & SERVICES .. 13 NON-CONFORMING PROCESSES .. 13 4 ABOUT YOUR ORGANIZATION ..14 ORGANIZATIONAL CONTEXT .. 14 RELEVANT INTERESTED PARTIES .. 15 Quality Management System .. 16 Scope of the QMS .. 16 QMS Processes .. 17 Outsourced Processes .. 18 Documented Information .. 19 LEADERSHIP & GOVERNANCE ..23 LEADERSHIP & COMMITMENT .. 23 QMS Management .. 23 Customer Focus .. 24 CORPORATE POLICIES .. 24 Establishing the QMS Policies .. 24 Communicating the QMS Policies .. 25 ROLES, RESPONSIBILITIES & AUTHORITIES .. 25 COMMUNICATION .. 26 Internal Communication .. 27 Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation 2017 Page 2 of 75 External Communication.

3 28 QMS PLANNING ..30 30 Actions to Address Risks & Opportunities .. 30 QMS OBJECTIVES .. 39 Objectives .. 39 Objectives & Planning to Achieve Them .. 39 PLANNING FOR CHANGE .. 40 SUPPORT ..42 RESOURCES .. 42 General .. 42 People .. 42 Infrastructure .. 42 Environment for the Operation of Processes .. 42 Monitoring & Measuring .. 43 Organizational Knowledge .. 44 COMPETENCE .. 45 AWARENESS .. 46 OPERATION ..47 OPERATIONAL PLANNING & CONTROL .. 47 REQUIREMENTS FOR PRODUCTS & SERVICES .. 48 Customer Communication .. 48 Determination of Requirements for Products & Services .. 49 Review of the Requirements for Products & Services.

4 49 Changes to Requirements for Products & Services .. 50 DESIGN & DEVELOPMENT OF PRODUCTS & SERVICES .. 50 General .. 50 50 Inputs .. 51 Controls .. 51 Outputs .. 52 Changes .. 52 EXTERNALLY PROVIDED PROCESSES, PRODUCTS & SERVICES .. 53 General .. 53 Type and Extent of Control .. 54 Information for External Providers .. 54 PRODUCTION & SERVICE PROVISION .. 55 Control of Production & Service Provision .. 55 Identification & Traceability .. 55 Property Belonging to Customers or External Providers .. 56 Preservation .. 56 Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation 2017 Page 3 of 75 Post-delivery Activities.

5 57 Control of Changes .. 57 RELEASE OF PRODUCTS & SERVICES .. 58 NON-CONFORMING PROCESS OUTPUTS, PRODUCTS & SERVICES .. 58 PERFORMANCE EVALUATION ..61 MONITORING, MEASUREMENT, ANALYSIS & EVALUATION .. 61 General .. 61 Customer Satisfaction .. 62 Analysis & Evaluation .. 63 INTERNAL AUDIT .. 63 Internal Audit Programme .. 64 Internal Audit Checklists .. 64 Management REVIEW .. 65 General .. 65 Inputs .. 66 Outputs .. 67 IMPROVEMENT ..68 68 NON-CONFORMITY & CORRECTIVE ACTION .. 68 CONTINUAL IMPROVEMENT .. 73 Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation 2017 Page 4 of 75 1 Introduction The purpose of this document is to outline a potential Quality Management System to meet the requirements of iso 9001 :2015.

6 The Quality Management System is designed to be implemented to function within current business practices and to serve as an effective tool to help your business grow and improve. The Figure below illustrates our methodology for the development of your QMS; using the plan, do, check and act process approach, to implement and deliver Management System objectives, stakeholder requirements and customer satisfaction. Figure 1: iso 9001 :2015 QMS & PDCA Interaction The application of the Quality Management System is scalable and generic; regardless of the size and type of organization. The elements that form a typical the QMS are the same; please refer to the figure below.

7 The primary goal is to achieve a set of consistent processes that provide a route for enhancing customer satisfaction, mitigation uncertainty and providing meaningful data for continuous improvement activities. You may decide to keep your current Quality Management System and simply amend them where necessary. Some of you may take this as an opportunity for a complete revamp of the Management System . Both courses of action are entirely reasonable, and this Guidance document will guide you through what the essential elements that you need to address in order become certified. Context of the Organization Scope of the QMS Leadership & Commitment Planning Support & Operation Performance Evaluation Improvement Operation PLAN DO ACT Internal & External Issues Needs & Expectations of Interested Parties CHECK Quality Management System Guidance iso 9001 :2015 Clause-by-clause Interpretation 2017 Page 5 of 75 The Quality Management System includes the processes and procedures required to achieve compliance to Quality requirements, as well as, highlight their interaction with other support processes.

8 Top Management must take responsibility for leadership, commitment and take active involvement for developing and maintaining the Management System . It is necessary to have well defined processes, both operational and support, to be able to realize the product or service. Customer satisfaction has to be measured and analyzed so that the organization can be improved continually. The implementation of a formal Management System is best handled as a specific project that is led by someone with project Management experience. Ideally they should be a key member of the organization s Management team and have sufficient authority and trust of the personnel involved.

9 In the ideal situation this person will also be the Management Representative, but skills in project Management are highly beneficial. Integration itself is not difficult to implement but rather, the concepts themselves are sometimes difficult to interpret and can therefore be difficult to apply in the real world. For instance, concepts such as non-conformances and corrective actions might seem burdensome at first but the outputs of these concepts will soon be an invaluable source of information that should be used to drive your corporate objectives. In order implement the Quality Management System , we recommend that you follow the steps in this Guidance documents.

10 Implementation & Development Begin with the assumption that you are already doing most of what ISO requires, you probably are! Many people talk about the high cost of implementing Management systems but this is a false assumption. If you do it right and understand the standards, then implementation should not be a problem since 75% of your Management System is already in place. Here are some initial review tasks to consider: 1. Compare actual performance with external standards, regulations, codes of practice and guidelines; 2. Review existing Management procedures; 3. Compare actual operations with internal policies and procedures; 4. Identify policies and procedures dealing with external contracts for services and suppliers; 5.


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