Management of Change – ISO 9001

Management of change is a systematic way to handle changes within an organization to effectively deal with the change and to capitalize on possible opportunities. It involves adapting to the change, controlling the change, and effecting new change.

ISO 9001:2015

Management of change is addressed in multiple requirements of ISO 9001, including:

  • maintaining the quality management system (see 4.4.1),
  • organizational roles, responsibilities and authorities (see 5.3.e),
  • planning of changes (see 6.3),
  • operational control (see 8.1),
  • control of changes (see 8.5.6),
  • internal audit program (see 9.2.2),
  • management review (see 9.3), and
  • corrective actions (see 10.2.1.f).

These clauses on changes to the QMS are described below:

4.4 Quality management system and its processes

4.4.1 

The organization must establish, implement, maintain, and continually improve a quality management system. Management of change is necessary to adequately maintain the QMS.

The organization must determine the processes needed for the quality management system and their application throughout the organization, and:

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results.

5.3 Organizational roles, responsibilities and authorities

Top management must assign the responsibility and authority for:

e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

6.3 Planning of changes

When the organization determines the need for changes to the quality management system, the changes must be carried out in a planned manner (see 4.4).

The organization must 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.

8.1 Operational planning and control

The organization must control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

8.5.6 Control of changes

The organization must review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organization must 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.

9.2 Internal audit

9.2.2 

The organization must:

a) 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.

9.3 Management review
9.3.2 Management review inputs

The management review must be planned and carried out taking into consideration:

b) changes in external and internal issues that are relevant to the quality management system.

9.3.3 Management review outputs

The outputs of the management review must include decisions and actions related to:

b) any need for changes to the quality management system.

10.2 Nonconformity and corrective action

10.2.1

When a nonconformity occurs, including any arising from complaints, the organization must:

f) make changes to the quality management system, if necessary.