ISO 9001 6.3 - Planning of changes
In ISO 9001 6.3 Planning of changes, this section’s main objective is to manage changes to the QMS effectively to prevent unintended consequences and maintain organizational quality standards. This clause mandates that changes to the QMS are planned, implemented, and reviewed to maintain its integrity and effectiveness.
In this blog post we will be discussing the following:
· Purpose of Clause 6.3
· Core Requirements
· Practical Application
· Benefits of Adhering
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
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.
Purpose of Clause 6.3
What is the main purpose of clause 6.3? The purpose of clause this clause is to:
1. To Minimize risk associated with changes.
2. To Ensure changes to the QMS are well- planned and controlled.
3. To Maintain the QMS’s ability to meet requirements and deliver quality outcomes.
Core Requirements
The organization must consider the following when planning changes to the QMS:
1. The purpose of the changes and their Potential Consequences
· Clearly define why the change is necessary by:
o Addressing nonconformities
o Meeting new customer or regulatory requirements
o Improving efficiency or reducing costs
· Assess the potential impacts on
o Process effectiveness
o Customer satisfaction
o Compliance with regulatory requirements
o Resources and workforce
2. The integrity of the Quality Management System
· The changes must not compromise the QMS’s ability to:
o Meet quality objectives
o Satisfy customer and stakeholder requirements
· Ensuring all new elements are aligning with existing processes, policies and objectives.
3. Availability of Resources
· Identifying and allocating the necessary resources for implementing the change that includes:
o Personnel and their training
o Time and support systems
o Financial investments
o Tools, equipment and technology
4. Assignment of Responsibilities and Authorities
· Assignment of roles and implement changes
· Communicate roles and responsibilities
· Define responsibilities clearly avoiding confusion and ensuring accountability
Practical Application
As for practical applications, organizations must implement structured processes for managing changes. Often these processes include these steps:
1. Change Request and Initiation
o Identify risks and benefits
o Document the need for change
o Specify the objectives, scope, and expected outcomes
2. Change Impact Analysis
o Evaluate consequences on:
o Customer satisfaction
o Product or service quality
o Compliance with legal and regulatory requirements
3. Planning and Approval
o Develop a detailed change management plan, including:
o Actions required, Resources needed, and Timelines and milestones
4. Implementation
o Execute the planned changes
o Monitor progress and address issues that come up during implementation
5. Verification and Validation
o Ensure the QMS remains effective and compliant after the change
o Evaluate if the change achieved the intended outcomes
6. Documentation and Communication
o Communicate changes to affected personnel and provide necessary training
o Update QMS documentation
7. Monitoring and Review
o Incorporate feedback and make adjustments
o Continuously monitor the effectiveness of change
Benefits of Adhering
1. Ensures smooth and effective transitions during changes
2. Maintains consistent product and service quality
3. Reduces the risk of nonconformities and disruptions
4. Enhances customer satisfaction by proactively managing risks
In conclusion, 6.3 ISO 9001 Planning of changes, organizations can manage changes effectively, support continual improvement, and ensure their QMS remains robust and aligned with business objectives. . In the next blog post we’ll be discussing clause 7 Support, as we will be diving deeper into 7.1 – 7.5.
Related blog posts -
ISO 9001 – Planning Overview Clause 6: 6.1 – 6.3
ISO 9001 6.1 Actions to address risks and opportunities
ISO 9001 6.2 – Quality objectives and planning to achieve them
How to determine your QMS Scope of Certification
Improvement- The Seven Quality Management Principles
4 Steps to Achieving ISO 9001 Quality Management System Certification
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