Management system guidance

4.0 Context of the Organization

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4.3 Determining the scope of the management system

Defining the scope of your management system is a key step when developing any management system. The scope should concisely describe the activities, regulatory requirements, facilities, and remote locations that are to be covered under, and supported by quality management system.

From a review of the nature of your business's operations, products and services, the scope of the management system should be apparent by the extent of the processes and controls that your organization has already established.

Ensure the management system scope is relevant to external and internal issues (Clause 4.1), the requirements of relevant interested parties (Clause 4.2), and the nature of your organization's products and services. Consideration of the boundaries and applicability of the management system can include:

  1. The 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.

The management system scope must be retained as documented information in accordance with Clause 7.5.1, usually within the management system manual. The scope statement is normally shown on the certificate, for most registrars, 15 words or less, is generally sufficient. Here are two examples shown below:

'provision of marketing, sales, support, development and implementation of software solutions, located at...'.

'manufacture of precision machined components for aerospace and industrial customers, including the delivery of these activities to the requirements of ISO 9001, located at...'.

You may not design your products because your customers supply product specifications and drawings. In which case you can exclude the product design processes and requirements.

More information on PDCA


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


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


9.1 Monitor, Measure, Analyse and Evaluate 9.2 Internal Audit 9.3 Management Review


10.1 Improvement - General 10.2 Non-Conformity and Corrective Action 10.3 Continual Improvement

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