What is ISO 9001 Certification Requirement of Planning Clause# 6

What is ISO 9001 Certification Requirement of Planning Clause# 6

ISO 9001ISO 9001 Certification is Quality Management System Certification. This 9001 Certification is possible when the organization implement this standard in the organization. ISO 9001:2015 Standard has 10 clause   but the requirements for implementation is given in Clause # 4 to Clause # 10.  Where for ISO 9001 Certification, the organization has prepared the by implementing ISO 9001 Standard requirements. In view of user awareness about requirements for QMS Standards, our Experts has published the Blogs on  requirements of Clause #4 & Clause # 5. Now we are taking opportunity to Explain the requirements of Clause # 6, which is equally important for implementation and Certification point of view. In this Blog we will try to explain the Requirement of This clause along with documents required to be maintained by the organization while implementation. So that it could helps the organization for better implement and get ISO 9001 Certified.

 

Requirements of ISO 9001:2015 – Planning (Clause # 6)

  • This clause has Three sub- Clause
  • Actions to address risks and opportunities
  • Quality objectives and planning to achieve them
  • Planning of changes

Actions to address risks and opportunities

As per requirements of this clause of ISO 9001:2015 – The organization has to do the Risk Analysis (of Internal and External Issue along with the Need & Expectations of Interest party) on part of activities which has potential impact on product and service conformity and finding the Opportunity for further improvements by adoption of new practices, the launch of new products, the opening of new markets, the targeting of new customers, the formation of partnerships, the use of new technology, and other desirable and viable options for meeting the needs of the organization or its customers. All these Risk analyses and finding opportunity is done by the organization in view to

  • Assurance that the quality management system will produce the desired result
  • Amplify desirable effects
  • Avoid or mitigate unfavorable outcomes.
  • Achieve progress and improvements in the entire system and process

The Following Documents / Record may be prepared by the organization to keep the compliance of this sub-clause

  • SOP – Risk Assessment methods and Criteria
  • Risk Assessment Record
  • Record of Actions Taken on Significant Risk and Opportunity (If any) for further Improvements

Quality objectives and planning to achieve them

As per the requirements of this sub-Clause, the organization derive the Objective of QMS from Its Quality Policy and Risk Assessment outcome and make the Plan How the Quality Objective will be achieved. While Establishing the Quality Objective the organization has to take care the Followings

  • The Quality Objective should be consistent with the quality policy.
  • It should be measurable.
  • It should be relevant and appropriate to the activities of the organization
  • It should be monitored time to time
  • It should be communicated across the organization and Interested party (if possible)
  • It should be update time to time – as when required or needed
The Following Documents / Record may be prepared by the organization to keep the compliance of this sub-clause
  • Quality Objective
  • Quality Objective Monitoring Record

Planning of changes

When the organization determines that changes to the quality management system are required, the changes must be implemented in a planned manner. The organization must consider the following factors:

  1. a) The purpose of the changes and their potential consequences.
  2. b) The integrity of the quality management system.
  3. c) The availability of resources.
  4. d)The assignment or reallocation of responsibilities and authorities.

 

The Following Documents / Record may be prepared by the organization to keep the compliance of this sub-clause
  • Record of Changes in the Quality Management System (If any)
  • Changes in Quality Objective (If any)
  • Changes in Recourses, Infrastructure and Responsibility (If any

Closing Thought

The above Explanation on Requirements of ISO 9001:2015 clause # 6 , will boost the understanding on requirements of Documentation requirements of ISO 9001 of this clause , which will help the organization for effective implementation of this clause and maintain the records for ISO 9001 Certification .

Also Read – What is ISO 9001: 2015 Requirements of Leadership( Clause#5)

 

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