4.0 Context of the Organization

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The quality management system documents include a quality manual template which is the ideal location to declare the scope of your QMS and define its boundaries of applicability.

4.3 Determining the scope of the management system

You will need to verify that your organization’s scope exists as documented information (which may be contained in the quality manual) in accordance with Clause 7.5.1a. Look for confirmation that your organization has determined the boundaries and applicability of its management system when establishing its scope, with reference to any external and internal issues referred to in Clause 4.1, the requirements of relevant interested parties referred to in Clause 4.2, and the nature of its products and services. Consideration of the boundaries and applicability of the management system can include:

  1. Range of products and services;
  2. Different sites and activities;
  3. External provision of processes, products and services;
  4. Common support provided by centralised functions;
  5. Processes, procedures, instructions, or site specific requirements.

The scope of your management system may include the whole of the organization, specific and identified functions within the organization, specific sections of the organization, or one or more functions across a group of organizations.

  1. Has your organization determined the boundaries and applicability of the management system to establish its scope?
  2. Has your organization effectively considered the following prior to determining the scope of the management system?
  3. Has your organization effectively considered the extent of its control and influence, context, external and internal issues, compliance obligations, physical and functional boundaries, activities, products and services?
  4. Has your organization made its scope available to all interested parties as documented information? A statement from your organization that the scope can be provided upon request may be accepted as objective evidence.

There is now essentially a process by which a scope must be determined; simply declaring a scope and excluding product-related aspects without evaluating the new considerations is not acceptable. Evaluate the process by which the scope was determined and review any process or procedure, if present. The lack of documented processes will require more reliance on objective evidence from interviews.

Check that this has been done in consideration of your organization’s context and your products. You should review any exclusions previously noted under ISO 9001:2008 for ongoing suitability and check that any legacy issues which limited the scope and omitted activities does not affect product conformity. Check that they are recorded and that the rationale for the exclusion is stated and justified.

From a review of the nature of the business's operations, products and services, the scope of the management mystem should be apparent by the extent of the processes and controls that the organization established. Check that this has been done in consideration of your organization’s context and its products.

You should review any exclusions previously noted under ISO 9001:2008 for ongoing suitability. Check that legacy issues which limited scope and omitted activities do not affect product conformity. Check that they are recorded and that the rationale for the exclusion is stated and justified.

When determining the scope, organizations must take into account context (internal and external issues and the requirements of interested parties) and also their products and services. The scope must state the types of products and services covered by the quality management system and provide justification for any requirement of the standard that cannot be applied. The scope must be retained as documented information, usually within the quality manual, and must record the rationale and justification for any exclusions.

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Planning

4.1 Understanding Context 5.1 Leadership and Commitment 6.1 Address Risk and Opportunity
4.2 Interested Parties 5.2 Policies 6.2 System Objectives and Planning
4.3 Determining Scope 5.3 Roles, Responsibility and Authority 6.3 Planning for Change
4.4 Management System Processes    
 

Doing

7.1 Resources 8.1 Operational Planning and Control 8.6 Release of Products and Services
7.2 Competence 8.2 Requirements for Products and Services 8.7 Non-conforming Outputs
7.3 Awareness 8.3 Design & Development of Products and Services 8.8 Emergency Preparedness and Response
7.4 Communication 8.4 Control of Externally Provided Products and Services 8.9 Accident and Incident Investigation
7.5 Documented Information 8.5 Product and Service Provision  
 

Checking and acting

9.1 Monitor, Measure, Analyse and Evaluate 10.1 General
9.2 Internal Audit 10.2 Non-Conformity and Corrective Action
9.3 Management Review 10.3 Continual Improvement
 

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