Management system guidance

4.0 Context of the Organization

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4.3 Determining the scope of the management system

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The guidance shown on this page is relevant to ISO 9001, ISO 14001 and ISO 45001. 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 the management system.

The scope of registration and certification will need to reflect precisely and clearly the activities covered by your organization's management system; any exclusion to non-applicable requirements of the standards should be documented and justified in the manual. No single business-related activity should exist outside of the scope. You should discuss the scope of registration very early in your contact with the registrar, prior to or during the selection process.

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. If you need a procedure to help determine and document your organization's scope, click here.

Look for confirmation that your organization has determined the boundaries and applicability of the management system to establish its scope with reference to any 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. Auditors will challenge your organization if any activities, products and services that would likely have a significant impact on the environment or those that impact health and safety are omitted from the scope. Your organization’s scope determinations should be reasonable and consistently applied.

Ensure that your organization has considered its degree of control and influence over its activities, products and services from a life cycle perspective. The degree of control needs to be determined for environmental aspects associated with such things as procured goods and services, outsourced processes, product performance requirements, end of life treatment (recycling, disposal, etc.).

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 requirements, 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.

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More information on PDCA

Planning

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
4.1 Organizational Context 4.1 Organizational Context 4.1 Organizational Context
4.2 Relevant Interested Parties 4.2 Relevant Interested Parties 4.2 Relevant Interested Parties
4.3 Management System Scope 4.3 Management System Scope 4.3 Management System Scope
4.4 QMS Processes 4.4 EMS Processes 4.4 OH&S Management System
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
5.1 Leadership & Commitment 5.1 Leadership & Commitment 5.1 Leadership & Commitment
5.2 Quality Policy 5.2 Environmental Policy 5.2 OH&S Policy
5.3 Roles, Responsibilities/Authorities 5.3 Roles, Responsibilities/Authorities 5.3 Roles, Responsibilities/Authorities
    5.4 Consultation & Participation
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities
6.2.1 Quality Objectives 6.1.2 Environmental Aspects 6.1.2 Hazard Identifcation
6.2.2 Planning to Achieve Objectives 6.1.3 Compliance Obligations 6.1.3 Legal & Other Requirements
6.3 Planning for Change 6.1.4 Planning Action 6.1.4 Planning Action
  6.2.1 Environmental Objectives 6.2.1 OH&S Objectives
  6.2.2 Planning to Achieve Objectives 6.2.2 Planning to Achieve Objectives
 

Doing

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
7.1.1 Resources - General
7.1 Resources 7.1 Resources
7.1.2 People 7.2 Competence 7.2 Competence
7.1.3 Infrastructure
7.3 Awareness 7.3 Awareness
7.1.4 Operational Environment 7.4.1 Communcation - General 7.4.1 Communcation - General
7.1.5 Monitoring & Measuring 7.4.2 Internal Communcation 7.4.2 Internal Communcation
7.1.6 Organizational Knowledge 7.4.3 External Communcation 7.4.3 External Communcation
7.2 Competence 7.5 Documented Information 7.5 Documented Information
7.3 Awareness    
7.4 Communcation    
7.5 Documented Information    

 

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8.1 Operational Planning & Control
8.1 Operational Planning & Control 8.1.1 General
8.2.1 Customer Communication 8.2 Emergency Preparedness 8.1.2 Eliminating Hazards
8.2.2 Determining Requirements
  8.1.3 Management of Change
8.2.3 Reviewing Requirements   8.1.4 Outsourcing
8.2.4 Changes in Requirements
  8.2 Emergency Preparedness
8.3.1 Design Development - General    
8.3.2 Design Development - Planning
   
8.3.3 Design Development - Inputs    
8.3.4 Design Development - Controls    
8.3.5 Design Development - Outputs    
8.3.6 Design Development - Changes    
8.4.1 External Processes - General    
8.4.2 Purchasing Controls    
8.4.3 Purchasing Information    
8.5.1 Production & Service Provision    
8.5.2 Identification & Traceability    
8.5.3 3rd Party Property    
8.5.4 Preservation    
8.5.5 Post-delivery Activities    
8.5.6 Control of Changes    
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
9.1.1 Performance Evaluation 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.1.2 Customer Satisfaction 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.1.3 Analysis & Evaluation 9.2 Internal Audit 9.2 Internal Audit
9.2 Internal Audit 9.3 Management Review 9.3 Management Review
9.3 Management Review    
 

Acting

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
10.1 Improvement - General 10.1 Improvement - General 10.1 Improvement - General
10.2 Nonconformity & Corrective Action 10.2 Nonconformity & Corrective Action 10.2 Incident, Nonconformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement 10.3 Continual Improvement
 

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