To be compliant, ISO 9001:2015 requires the organization to identify and implement any changes to the quality management system, its processes or its outputs (products or services) in a planned manner.
The following clauses of ISO 9001:2015 focuses on change management:
1. Clause 4.4.1 g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
2. Clause 5.3 e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
3. Clause 6.3 Planning of changes: When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
4. Clause 188.8.131.52 Control of Documented information c): control of changes (e.g. version control)
5. Clause 8.1 Operational planning and control: The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
6. Clause 8.2.1 b) Communication with customers shall include; handling inquiries, contracts or orders, including changes;
7. Clause 8.2.4 Changes to requirements for products and services: The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
8. Clause 8.3.6 Design and development changes The organization shall retain documented information on: The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
9. Clause 8.5.6 Control of changes: The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
10. Clause 9.2.2 a) The organization shall plan, establish, implement and maintain an audit program including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;
11. Clause 9.3.2 b) (Management Review inputs) The management review shall be planned and carried out taking into consideration: b) changes in external and internal issues that are relevant to the quality management system;
12. Clause 9.3.3 b) the outputs of Management review shall include decisions and actions related to: any need for changes to the Quality Management System.
13. Clause 10 NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.
14. Clause 10.2.1 f) when a nonconformity occurs, including any arising from complaints, the organization shall: make changes to the quality management system, if necessary.
The three stages of Controlled Change Management:
Change management starts with identifying the change requirement. The following are the some of the changes that generally take place in an organization:
1. Change in the scope of the Quality Management system
2. Policy change
3. Product change (technology improvement, raw material change, change in customer requirement etc.)
4. Process change (Quality Improvements and Productivity increase)
5. Procedure change (equipment changes, new equipment, Raw material changes etc.)
6. Change in Employees (new positions, New recruitments, resignations, Long leave etc.)
7. Change in Management (Mergers, take-overs etc.)
8. Changes in Requirements (customer requirements, Legal requirements, QMS requirements etc.)
The change control process is as follow:
Simple Change Management Plan as per clause 6.3 of ISO 9001:2015:
(This template may be used as input to Management review, as required by Clause 9.3.2)