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[PDF] “Context Of the Organization” ISO 9001:2015 - - Quality Support Group

Is ISO 9001:2015 a template for an effective Quality Management System or an effective Business Management System? 2 QMS BMS Page 3 ©2015 QSG, 

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4 1 Understanding the organization and its context Clause 4: SAMPLE OF SWOT ANALYSIS STRENGTHS Provide justification for any ISO 9001:2015

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www iso9001help co uk Quality Procedure Context of the Organization Definition Interested party Stakeholder that can affect, be affected by, or perceive 

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Clause 4 1 – Understanding the Organization and its Context Why did ISO 9001:2015 add these requirements? Examples of relevant internal issues

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9 fév 2017 · facilitated by considering issues related to values, culture, knowledge and performance of the organization (Taken from ISO 9001:2015 (E)) 

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this presentation) focus on new ISO 9001:2015 requirements that are basic ( aerospace) quality management system pillars ▻ Interested parties are a critical aspect of how an organization identifies its internal definition for Interested Party: ▻ “Person The Organization needs to review its “context” at planned intervals,

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ISO 9001:2015 is the new business improvement tool that helps drive continual improvement and deliver Context of the organization Consider the combination of internal and external Examples include suppliers, customers or competitors

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Clause 4 1 - Understanding the organization and its context implemented ISO 9001:2008 and have already defined the scope of the QMS in the Quality example, Installation: The process of converting a box of components into a working 

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Context of the organization • Understanding the organization and its context ISO 9001:2015 provides no suggested methods to analyse the context of an organisation, For example, in determining the scope for a small distribution business

pdf “Context Of the Organization” ISO 9001:2015

Understand how “Context of the Organization” is integrated into your Quality Management System or Is ISO 9001:2015 a template for an effective Quality Management System or an effective Business Management System? QMS BMS Agenda (*) Understand the Organization and its Context Analyzing the External Environment

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Website: nsi.org.uk

Page 1 of 39

© NSI 2016

Annex A to 9001:2015 Guidance document for

approved companies

A step by step guide on how to

interpret each clause

June 2016

A step by step guide on how to interpret each clause

June 2016 Page 2 of 39

© NSI 2016

Contents

Introduction................................................................................................................................................................ 5

What is a Quality Management System (QMS)? .................................................................................................................... 5

Plan ² Do ² Check ² Act cycle.............................................................................................................................. 5

PLAN: Clause 4 ² Context of the organisation .............................................................................................. 6

Clause 4.1 - Understanding the organization and its context .......................................................................................... 6

What are internal and external issues? ........................................................................................................................... 6

Clause 4.2 - Understanding the needs and expectations of interested parties ........................................................ 8

Clause 4.3 - Determining the scope of the QMS ................................................................................................................... 9

Clause 4.4 - QMS and its processes ............................................................................................................................................ 9

Process .......................................................................................................................................................................................... 9

Process approach ..................................................................................................................................................................... 9

PLAN: Clause 5 - Leadership ............................................................................................................................. 12

Clause 5.1 - Leadership and commitment .............................................................................................................................. 12

Clause 5.1.1 - General ........................................................................................................................................................... 12

Clause 5.1.2 ² Customer focus .......................................................................................................................................... 13

Clause 5.2 ² Policy ............................................................................................................................................................................. 13

Clause 5.2.1 - Establish ......................................................................................................................................................... 13

Clause 5.2.2 ² Communicate ............................................................................................................................................. 13

Clause 5.3 - Organisational roles, responsibilities and authorities ............................................................................... 14

PLAN: Clause 6 - Planning ................................................................................................................................. 14

Clause 6.1 - Actions to address risks and opportunities................................................................................................... 14

Clause 6.1.1 - Actions to address risks and opportunities .................................................................................... 14

Clause 6.1.2 ² Planning for the QMS .............................................................................................................................. 15

Clause 6.2 - Quality objectives and planning to achieve them ...................................................................................... 16

Clause 6.2.2 ............................................................................................................................................................................... 16

Clause 6.3 ² Planning of changes ............................................................................................................................................... 17

PLAN: Clause 7 ² Support .................................................................................................................................. 17

Clause 7.1 - Resources .................................................................................................................................................................... 17

Clause 7.1.2 - People............................................................................................................................................................. 18

Clause 7.1.3 ² Infrastructure .............................................................................................................................................. 18

Clause 7.1.4 - Environment for the operation of processes ................................................................................. 18

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© NSI 2016

Clause 7.1.5 - Monitoring and measuring resources .............................................................................................. 19

Clause 7.1.5.2 - Measurement traceability ........................................................................................................ 19

Clause 7.1.6 - Organisational knowledge ..................................................................................................................... 20

Clause 7.2 ² Competence ............................................................................................................................................................... 20

Clause 7.3 ² Awareness ................................................................................................................................................................... 20

Clause 7.4 - Communication ........................................................................................................................................................ 21

Clause 7.5 ² Documented information..................................................................................................................................... 21

Clause 7.5.2 ² Creating and updating ............................................................................................................................ 22

Clause 7.5.3 - Control of documented information ................................................................................................. 22

Clause 7.5.3.2 ................................................................................................................................................................ 22

DO: Clause 8 ² Operation .................................................................................................................................. 23

Clause 8.1 - Operational planning and control .................................................................................................................... 23

Clause 8.2 - Requirements for products and services ........................................................................................................ 23

Clause 8.2.1 - Customer communication ..................................................................................................................... 23

Clause 8.2.2 - Determining the requirements for products and services ....................................................... 24

Clause 8.2.3 - Review of the requirements for products and services ............................................................. 24

Clause 8.2.3.1 ................................................................................................................................................................ 24

Clause 8.2.3.2 ................................................................................................................................................................ 25

Clause 8.2.4 - Changes to requirements for products and services ................................................................. 25

Clause 8.3 - Design and development of products and services .................................................................................. 26

Clause 8.3.1 - General ........................................................................................................................................................... 26

Clause 8.3.2 - Design and development planning ................................................................................................... 26

Clause 8.3.3 - Design and development inputs ......................................................................................................... 26

Clause 8.3.4 - Design and development controls ..................................................................................................... 27

Clause 8.3.5 - Design and development outputs ..................................................................................................... 27

Clause 8.3.6 - Design and development changes .................................................................................................... 27

Clause 8.4 - Control of externally provided processes, products and services ....................................................... 27

Clause 8.4.1 ² General .......................................................................................................................................................... 28

Clause 8.4.2 - Type and extent of control .................................................................................................................... 28

Clause 8.4.3 - Information for external providers ..................................................................................................... 29

Clause 8.5 - Production and service provision ...................................................................................................................... 29

Clause 8.5.1 - Control of production and service provision ................................................................................. 29

Clause 8.5.2 - Identification and traceability............................................................................................................... 30

Clause 8.5.3 - Property belonging to customers or external providers .......................................................... 30

Clause 8.5.4 - Preservation ................................................................................................................................................. 31

Clause 8.5.5 - Post- delivery activities ........................................................................................................................... 31

Clause 8.5.6 - Control of changes ................................................................................................................................... 32

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© NSI 2016

Clause 8.6 - Release of products and services ...................................................................................................................... 32

Clause 8.7 - Control of nonconforming outputs .................................................................................................................. 32

Clause 8.7.1 ............................................................................................................................................................................... 32

Clause 8.7.2 ............................................................................................................................................................................... 32

CHECK: Clause 9 - Performance evaluation ................................................................................................ 33

Clause 9.1 - Monitoring, measurement, analysis and evaluation ................................................................................. 33

Clause 9.1.1 - General ........................................................................................................................................................... 33

Clause 9.1.2 - Customer satisfaction .............................................................................................................................. 34

Clause 9.1.3 - Analysis and evaluation .......................................................................................................................... 34

Clause 9.2 - Internal audit .............................................................................................................................................................. 35

Clause 9.2.2 ............................................................................................................................................................................... 35

Clause 9.3 - Management review ............................................................................................................................................... 35

Clause 9.3.1 - General ........................................................................................................................................................... 35

Clause 9.3.2 - Management review inputs .................................................................................................................. 35

Clause 9.3.3 - Management review outputs ............................................................................................................... 36

ACT: Clause 10 - Improvement ........................................................................................................................ 36

Clause 10.1 - General ....................................................................................................................................................................... 36

Clause 10.2 ² Non-conformity and corrective action......................................................................................................... 37

Clause 10.2.1 ............................................................................................................................................................................. 37

Clause 10.2.2 ............................................................................................................................................................................. 38

Clause 10.3 - Continual improvement ...................................................................................................................................... 38

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June 2016 Page 5 of 39

© NSI 2016

Introduction

What is a Quality Management System (QMS)?

A QMS is a tool to help an organisation to manage quality. One thing a QMS LVQ·P LV ÓXVP POH quality manual! The quality manual is a means of recording how quality is managed within your organisation so everyone does their job in a consistent way, delivering a consistent and quality product or service. In other words, a quality manual reflects the business and the quality management system.

Plan ² Do ² Check ² Act cycle

The clauses and requirements of the standard are all based on the Plan ² Do ² Check ² Act (PDCA) cycle. PDCA is integral and operates at the process level and at an overall system level. A step by step guide on how to interpret each clause

June 2016 Page 6 of 39

© NSI 2016

PLAN: Clause 4 ² Context of the organisation

Clause 4.1 - Understanding the organization and its context Although the ISO E001201D VPMQGMUG GRHVQ·P SUHVŃULNH POH PHPORG IRU GHPHUPLQLQJ POH context of the organisation, there are some logical steps and milestones.quotesdbs_dbs2.pdfusesText_2