6.3 Planning of Changes

6.3 Planning of Changes for ISO 9001 ensures that once your processes are determined; your organization must identify the risks and opportunities or benefits associated with changes to these processes.

ISO 9001:2015 ISO 9001:2008 Summary of Changes
6.0 Planning For The Quality Management System 5.4.2 Quality Management System Planning

Title only

6.1 Actions To Address Risks And Opportunities

5.4.2

Quality Management System Planning This is a new requirement that requires a process to be implemented to determine and evaluate applicable risks. The organization will be expected to have an understanding of this requirement and be prepared to explain how they are managed within their quality system.
8.5.3 Preventive Action
6.2 Quality Objectives And Planning To Achieve Them 5.4.1 Quality Objectives This requirement is amended to ensure that quality objectives are relevant to the conformity of products and enhancing customer satisfaction.

Quality objectives should be analyzed to assign resources, identify responsible parties, establish a timeline, and determine evaluation practices.
6.3 Planning Of Changes 5.4.2 Quality Management System Planning This is a new requirement. Organizations should retain documented information relating to planning and implementing changes that impact the QMS.

 

In order to realize the benefits associated with the identified risks and opportunities, subsequent changes may be needed.

These changes could relate to any aspect of any process, such as:

  • Inputs
  • Resources
  • Personnel
  • Activities
  • Controls
  • Measurements
  • Outputs

Changes are intended to be beneficial but they need to be carried out when determined by your organization as relevant and achievable. In addition, consideration of newly introduced risks and opportunities should also be taken into account.

How do Changes Occur?

To achieve the benefits associated with changes, your organization should consider all types of change that may occur. These changes may be generated, for example, in:

  • Processes and procedures
  • Documented information
  • Infrastructure
  • Tooling
  • Process equipment
  • Employee training
  • Supplier evaluation
  • Stakeholder management
  • Interested party requirements

You should seek and record evidence that your organization has retained documented information relating to planning and implementing changes that impact upon the QMS.

implementation of changes to the QMS

Integrating Changes to the QMS

Ensure that the organization has planned how to integrate and implement the changes into their QMS processes. Check that your organization has considered:

1. The reason for the change; e.g. context of the organization (see 4.1), needs of interested parties (see 4.2), customer feedback, complaints analysis, audit results, performance trends, risk reduction or realizing an opportunity (see 6.1), continual improvement, organization growth, launch of new products/services, organization restructuring etc.

2. Assessing the purpose of the change(s) and potential impact using a risk-based thinking approach to ensure the integrity of the QMS is maintained i.e. focus on priorities, avoid disruption, ensure business continuity, maintain product/service reliability, protect the customer, maintain capability, continue to meet internal/external requirements etc.

3. The resources required to enable the change such as people, knowledge acquisition, infrastructure, environment, budget, trials/tests, ongoing monitoring, structured reviews etc.

4. Determination of responsibility and authority for the change e.g. process owner, lead process users, end users etc., including the necessary communication, training and ongoing review to ensure the change is effective (i.e. the planned activities continue to be realized and planned results are being achieved).

 

ISO 9001 Clauses - PLAN

 

Author: Richard Keen
Updated: 15th October 2019

Richard Keen

Richard Keen

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