ISO 9001 clause 6.3 planning of changes |QMS Change Management|
Summary
TLDRThis video delves into ISO 9001:2015's Section 6.3, focusing on the planned approach to quality management system (QMS) changes. It emphasizes understanding the purpose and potential impacts of changes, maintaining QMS integrity, considering resource availability, and adjusting responsibilities and authorities. The key takeaway is the necessity for a structured method when implementing QMS changes, ensuring that they are well-considered and executed to avoid negative consequences.
Takeaways
- 📚 The video script discusses ISO 9001:2015, specifically focusing on Clause 6.3, which is about the planning of changes within a quality management system (QMS).
- 🛠️ When an organization identifies the need for changes to its QMS, these changes must be implemented in a planned and systematic manner.
- 🔍 The organization must consider the purpose of the changes and their potential consequences, essentially asking 'Why are we making this change and what might happen as a result?'
- 💡 Integrity of the QMS is crucial; changes should not negatively affect the existing quality management system.
- 📈 Point C emphasizes the importance of considering the availability of resources needed to implement the changes, including personnel and technology.
- 🔄 Point D discusses the necessity of considering the allocation or reallocation of responsibilities and authorities within the organization to facilitate the changes.
- 🤔 The script prompts viewers to reflect on several questions: What are you trying to achieve with the change? What are the potential consequences? What resources are required?
- 👥 It also asks about the effects of changes on staff or their roles, highlighting the importance of understanding how changes impact personnel.
- 🔍 The video encourages viewers to consider if the changes might affect other areas of the organization, emphasizing a holistic approach to change management.
- 👍 The video concludes by encouraging viewers to subscribe to the channel for more upcoming videos on ISO 9001:2015, indicating a series of educational content.
- 📝 The script serves as a summary of the requirements for Clause 6.3, ensuring that viewers understand the need for a structured approach to change within a QMS.
Q & A
What is the main topic of the video script?
-The main topic of the video script is the discussion of ISO 9001:2015, specifically focusing on Clause 6.3, which deals with the planning of changes within a quality management system (QMS).
Why is it important to plan changes in a QMS?
-Planning changes in a QMS is crucial to ensure that the changes are carried out in a controlled and systematic manner, reducing the risk of negative impacts on the organization's quality management system.
What does the organization need to consider when planning changes to the QMS?
-The organization must consider the purpose of the changes, their potential consequences, the integrity of the QMS, the availability of resources, and the allocation or reallocation of responsibilities and authorities.
What is the purpose of considering the purpose of the changes in the QMS?
-Understanding the purpose of the changes helps the organization to identify what they are trying to achieve, which is essential for the successful implementation of the changes.
What potential consequences should be considered when planning changes to the QMS?
-The potential consequences include any negative impacts that the changes might have on the QMS, such as disruptions to processes, increased costs, or decreased efficiency.
How does the organization ensure the integrity of the QMS during changes?
-The organization ensures the integrity of the QMS by carefully planning changes to minimize disruptions and maintain the effectiveness and efficiency of the system.
What types of resources might be needed to implement changes in the QMS?
-Resources needed could include personnel, technology, financial resources, and training materials to support the change process.
Why is it important to consider the allocation or reallocation of responsibilities and authorities when planning changes?
-Allocating or reallocating responsibilities and authorities ensures that the right people are in place to manage and execute the changes, which is critical for the success of the change process.
How can the organization determine the need for changes to the QMS?
-The organization can determine the need for changes through various means such as internal audits, customer feedback, or performance metrics that indicate areas for improvement.
What are the potential effects of changes on staff roles within the organization?
-Changes may require staff to learn new skills, adapt to new processes, or take on different responsibilities, which can affect their roles and job satisfaction.
How can changes to the QMS affect other areas of the organization?
-Changes to the QMS can have a ripple effect across the organization, potentially impacting areas such as customer satisfaction, regulatory compliance, and overall business performance.
Outlines
📚 ISO 9001:2015 Class 6.3 - Planning of Changes
This paragraph introduces the discussion on ISO 9001:2015's Class 6.3, which focuses on the planning of changes within a quality management system (QMS). The speaker emphasizes that any changes determined necessary by the organization should be implemented in a planned manner. Key considerations for planning changes include understanding the purpose of the changes and their potential consequences, ensuring the integrity of the QMS, assessing the availability of resources, and considering the allocation or reallocation of responsibilities and authorities. The speaker poses questions to guide the understanding of Class 6.3: What is the goal of the change? What are the potential consequences? What resources are needed? How might the change affect staff or their roles? Could the change impact other areas? The paragraph concludes with a call to action for viewers to subscribe for more informative videos.
Mindmap
Keywords
💡ISO 9001 2015
💡Class 6.3
💡Quality Management System (QMS)
💡Planned Manner
💡Purpose of Changes
💡Potential Consequences
💡Integrity
💡Resources
💡Reallocation of Responsibilities
💡Authorities
💡Consequences on Staff
💡Subscription
Highlights
Introduction to ISO 9001:2015 Class 6.3 Planning of Changes
Organizations must plan changes to the quality management system (QMS) when needed
Changes should be executed in a planned and organized manner
Point A: Understanding the purpose of changes and their potential consequences
Point B: Ensuring the integrity of the QMS during changes
Point C: Considering the availability of resources for implementing changes
Point D: Allocating and reallocation of responsibilities and authorities
Importance of assessing the impact of changes on staff and their roles
Evaluating the potential effects of changes on other areas of the organization
The need for a systematic approach to managing changes in the QMS
Strategic planning to achieve the organization's goals through QMS changes
Ensuring that changes are aligned with the organization's quality policy and objectives
Involvement of relevant stakeholders in the planning of QMS changes
Risk assessment as part of the planning process for QMS changes
Implementation of a change control process to manage QMS modifications
Monitoring and review of changes to ensure they meet the intended outcomes
Encouraging feedback and continuous improvement post QMS changes
Conclusion and call to action for subscribing to the channel for more insights
Transcripts
hello hope you are doing well and safe
in last video we discussed the class 6.2
of iso 9001 2015. in this video we will
discuss the class 6.3 planning of
changes now let's come to read the class
6.3 when the organization determine the
need for changes to the quality
management system the changes shall be
carried out in a planned manner
the organization shall consider point a
the purpose of the changes and their
potential consequences
explanation
why are you changing it and what could
happen when you make the change
the next point
the Integrity of the quality management
system
mean to say ensure that the quality
management system does not get affected
negatively the point C the availability
of resources mean to say thought about
what you need to achieve it for example
what are the people and technology and
Etc
the point D the allocation are
reallocation of responsibilities and
authorities
mean to say considered what changes need
to be made in the organization to make
it happen
so the understanding of class 6.3 is
that given the organization determine
the need for changes to the qms the
changes shall be carried out in a
planned Manner and the organization
should consider the following questions
what are you trying to achieve
and what are the cons consequences
and what resources are required and what
are the effects if these changes are
done on the staff or their roles and
could change affect other areas as well
hope you understand the requirements of
class 6.3 if you like this video please
subscribe our channel for upcoming
videos thank you
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