ISO 9001 Change Management Procedure

ISO 9001 Change Management Procedure

This ISO 9001 change management procedure template can assist your business comply with ISO 9001, Quality Management System clauses:

  • 6.3. Planning for Changes.
  • 8.3.4. Changes in Requirements for Products and Services
  • 8.5.6. Control of Changes.


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What is ISO 9001 Change Management?

Change management as it relates to ISO 9001 is a process that helps ensure changes to a product, service or system are introduced in a controlled and systematic way.

It helps to ensure that changes are properly planned, tracked and implemented, and that the impacts of those changes are understood and controlled to achieve the benefits desired.

Change management is an important part of any ISO 9001 quality management system (QMS) and is especially critical in environments where products or services are highly regulated or there is a need to meet stringent quality assurance standards or particular customer requirements.

What is an ISO 9001 Change Management Procedure?

An ISO 9001 change management procedure is a formal process that has been designed around the ISO 9001 2015 standard. It can be used to ensure that any changes made to a company’s processes, products, or services are properly documented and approved.

When followed the procedure will also prevent unplanned or unauthorized changes from being made, which could potentially lead to problems or disruptions in the company’s operations.

The Change Management Process

The change management approval process is the sequence of steps or activities that a company uses to introduce meaningful changes to its products, services, or processes.

Change management processes will follow the general steps outlined below. Each step within this process may be detailed in change request documentation, to clarify the change, if needed.

Step 1.

Upon identifying and considering a change (proactive or reactive), a change request must be assessed by the controlling person, to determine the nature of the change, e.g. emergency, major, minor or if further information is required.

The ISO 9001 Change Management Process
                                    The ISO 9001 Change Management Process

Step 2.

Depending on the nature of the change, it may need to be recorded in an approval form and put forward to management or other interested parties for review and approval.

Step 3.

The applicable person or manager will review the change request and will either:

  • Reject the change.
  • Assess the change using a risk management approach.
  • Approve the change.

Step 4.

If approved the change implementer(s) will communicate the proposed change to the relevant persons. If not approved the reasons why need to be communicated to the impacted persons.

Step 5.

The change implementer(s) will then undertake the tasks to accomplish the change within the designated time frames.

Step 6.

A post-implementation review should then be undertaken to assess whether the change was successful or if it requires further modification.

Note: If necessary, training should be given to all persons that participate in any new work or operational processes. Top management should retain all documented information related to the change and any continual improvement evidence for auditing purposes.

Contents of this ISO 9001 Change Management Procedure

  • Approval.
  • Purpose.
  • Scope.
  • Terms and Definitions.
  • Responsibility and Authority.
  • Change Management Overview.
  • Change Management Process Flowchart.
  • The Change Management Process.
  • Communication of Change and Training.
  • Related Procedures, Forms and Documents.
  • Review Criteria.
  • Record Management.
  • References.

Why Choose to Buy this ISO 9001 Change Management Procedure

This 8-page ISO 9001 change management procedure template can assist you ensure that changes to a product, service or system are carried out in a planned way.

This procedure can be applied to process quality management, risks and operating procedures. It could be applied equally to all workers too, inclusive of permanent, temporary or contracted personnel without being too time-consuming.

After purchasing this template you will be able to:

  • Very easily edit and customize the template to create your own procedure.
  • Apply your own style, format and brand to the procedure.
  • Use it in any industry or sector regardless of the size or type of organization.

Availability and Use of this Change Management Procedure

  • This procedure is accessible to you right now by clicking the ‘Buy Now’ button.
  • The procedure will be delivered to you in fully editable Microsoft Word format for immediate and full use in your business.
  • There are no subscriptions, contracts or ongoing costs.

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