Management system guidance

8.5 Product and service provision

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8.5.6 Control of changes

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This is a new requirement for the organization to implement a process for responding to unplanned changes that are considered essential in order to ensure that products or services continue to meet their specified requirements, in such a way that conformity with requirements is maintained.

Changes should be documented and information retained about the changes, including who authorized the change and the actions arising from the change. In the olden days of ISO 9001:2008 this would have been addressed by Clause 7.3.7 Design and Development Outputs.

ISO 9000:2015 Term 3.3.10 defines change control as ‘activities for the control of the output after formal approval of its product configuration information’. The clause requires an organization to make changes in a thoughtful manner and to consider the potential impact to other process, products and possibly the customer. Key items to consider are:

1. Is the impact of the change evaluated to determine its affects to work in process or products already delivered?
2. What process control documentation (procedures, travellers, forms, etc.) will need updating as the result of change to be implemented?
3. Was the change approved prior to implementation including, where applicable, approval by the customer, statutory or regulatory authority?
4. Does retained documented information indicate the source of change and information on necessary actions and approvals?

You should seek objective evidence that your organization has implemented a process to control unplanned changes in accordance with the requirements set out above. If you need a procedure and forms to help control your business's product and service provision process, click here.

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More information on PDCA

Planning

Context

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

Planning

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

Support

ISO 9001:2015	ISO 14001:2015	ISO 45001:2018
6.1 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

Support

ISO 9001:2015	ISO 14001:2015	ISO 45001:2018
7.1 Resources	7.1 Resources	7.1 Resources
7.2 Competence	7.2 Competence	7.2 Competence
7.3 Awareness	7.3 Awareness	7.3 Awareness
7.4 Communcation	7.4.1 Communcation - General	7.4.1 Communcation - General
7.5 Documented Information	7.4.2 Internal Communcation	7.4.2 Internal Communcation
	7.4.3 External Communcation	7.4.3 External Communcation
	7.5 Documented Information	7.5 Documented Information

Operations

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 Customer Requirements	8.2 Emergency Preparedness	8.1.2 Eliminating Hazards
8.3 Design & Development		8.1.3 Management of Change
8.4 Purchasing		8.1.4 Outsourcing
8.5 Product & Service Provision		8.2 Emergency Preparedness
8.6 Release of Products & Services
8.7 Nonconforming Outputs

Checking

Monitoring, measurement, analysis and evaluation

ISO 9001:2015	ISO 14001:2015	ISO 45001:2018
9.1 Monitoring & Measurement	9.1.1 Performance Evaluation	9.1.1 Performance Evaluation
9.2 Internal Audit	9.1.2 Evaluation of Compliance	9.1.2 Evaluation of Compliance
9.3 Management Review	9.2 Internal Audit	9.2 Internal Audit
	9.3 Management Review	9.3 Management Review

Acting

Improvement

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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