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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[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,
[PDF] Clause 4: Context of the Organization - DOE
4 1 Understanding the organization and its context Clause 4: SAMPLE OF SWOT ANALYSIS STRENGTHS Provide justification for any ISO 9001:2015
[PDF] QMS Context of the Organization Procedure - ISO 9001 Help
www iso9001help co uk Quality Procedure Context of the Organization Definition Interested party Stakeholder that can affect, be affected by, or perceive
[PDF] Context of the Organization and Interested parties - ASQ Fox Valley
Clause 4 1 – Understanding the Organization and its Context Why did ISO 9001:2015 add these requirements? Examples of relevant internal issues
[PDF] Understanding Context of the Organization - Quality Digest
9 fév 2017 · facilitated by considering issues related to values, culture, knowledge and performance of the organization (Taken from ISO 9001:2015 (E))
[PDF] Communication of Changes - SAE International
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,
[PDF] ISO 9001:2015 - BSI
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
[PDF] A step by step guide on how to interpret each clause - National
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
[PDF] ISO 9001:2015 & ISO 14001:2015 An Organisations View - NSAI
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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©2015 QSG, Inc.
"Context Of the Organization" ISO 9001:2015Bob Deysher
Senior Consultant Quality Support Group, Inc. bob.deysher@qualitysupportgroup.com©2014 QSG, Inc.
©2015 QSG, Inc.
Expected Outcome
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? 2QMS BMS
©2015 QSG, Inc.
Agenda (*)
• Understand the Organization and its Context - Analyzing the External Environment - Analyzing the Internal Environment • Understanding the Needs and Expectations ofInterested Parties
• Determining the Scope of the QualityManagement System
• Putting it all Together (*) ISO 9004 is used extensively in preparing this presentation 3©2015 QSG, Inc.
ISO 9001:2015 Structure
4 Context of the organization 5 Leadership
10 Improvement 6 Planning for the quality management system
7 Support
8 Operations
9 Performance and evaluation
Understanding of the organization and its context Understanding the needs and expectations of interested parties
Scope of management systems QMS Leadership and commitmentQuality policy
Organizational roles, responsibilities and authorities Action to address risk and opportunity Quality objectives Planning of changes
Resources Competence Awareness Communication Documented Information Release of products and services Operations planning and controlDetermination of requirements for products and services Design and development of products and services Control of externally provided products and services Production and service provisions Control of non-conforming process outputs, products and services Monitoring, measurement. analysis and evaluation Internal audit Management review Nonconformity and corrective action Continual Improvement
Plan Do Check Act
General
4©2015 QSG, Inc.
Understanding the Organization and its Context
5This is a New Requirement
The organization should understand their internal and external environments • Determine the issues that are relevant to the organization in both environments • Assess those issues, and if not mitigated, which could prevent the success of quality management system implementation • Using these issues, understand how they will influence the quality changes in their organization on a continual basis.
ISO/DIS 9001, clause 4.1
©2015 QSG, Inc.
Understanding the Organization and its Context Analyzing the External Environment 6 • Your organization may already be doing this type of analysis • Are you doing any strategic planning, market research, orbenchmarking which identifies external issues which are being acted on in your business/quality management system?
• Does it drive your Vision, Mission, Quality Policy, Strategic Planning,Business Objectives,Policy Deployment, etc.?
• Can you demonstrate how you are doing it? • Unfortunaterly, ISO 9001:2015 provides no suggested methods to
analyze the context of an organization©2015 QSG, Inc.
Understanding the Organization and its Context Analyzing the External Environment 7• There are many models that can help an organization understand the strategic nature of their industry and how they fit into that environment.
• In the absence of any demonstrable activities, SWOT is a simple model. S - Strengths W - Weakness O - Opportunities T - Threats©2015 QSG, Inc.
Understanding the Organization and its Context
8Analyzing the Internal Environment
Understanding the structure/hierarchy and positions of the organization related to the scope at the levels: • Who sets the policies and strategic directions of the organization? • Who coordinates and manages the operations? • Who is involved in production, service and support activities?
©2015 QSG, Inc.
Understanding the Organization and its Context
It is necessary to identify the structures comprising the various bodies and relations between them (hierarchical and functional).
• These include segregation of duties, responsibilities, authority and communication within the organization that should be studied. • The functions outsourced to the subcontractors should also be identified. 9Analyzing the Internal Environment
©2015 QSG, Inc.
Understanding the Organization and its Context
The structure of the organization may be of different types: • The divisional structure: each division is under the authorityof a division director responsible for strategic, administrative and operational decisions within this unit.
• The functional structure: functional authority exercised overproceedings, the nature of work and sometimes the decisions or planning (e.g. production, information technology, human resources, marketing ...).
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