ISO 9001 clause 6.3 planning of changes |QMS Change Management|

Industrial Trainings Academy

6 May 202302:20

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

00:00

📚 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

ISO 9001 2015 refers to the international standard that specifies requirements for a quality management system (QMS). It is the cornerstone for businesses and organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements. In the video, it is the standard being discussed, specifically focusing on class 6.3 which deals with the planning of changes within the QMS.

💡Class 6.3

Class 6.3 is a specific section within the ISO 9001 2015 standard that addresses the planning of changes. It emphasizes the need for organizations to approach changes to their QMS in a structured and planned manner to ensure the integrity and effectiveness of the system are maintained. The video script discusses the requirements of this class in detail.

💡Quality Management System (QMS)

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It is a key component in ensuring that an organization consistently meets customer and regulatory requirements. The video script mentions the need for changes to be made to the QMS in a planned manner to avoid negative impacts.

💡Planned Manner

The term 'planned manner' refers to the systematic and organized approach to implementing changes. In the context of the video, it means that when an organization determines the need for changes to its QMS, these changes should be carefully planned to consider various factors and their potential consequences, as outlined in class 6.3.

💡Purpose of Changes

The 'purpose of changes' pertains to the reasons behind the modifications to the QMS. It is essential for an organization to understand why it is making changes to ensure that the objectives are clear and aligned with the organization's goals. The video script asks viewers to consider the purpose and potential consequences of the changes.

💡Potential Consequences

Potential consequences are the possible outcomes or effects that may result from making changes to the QMS. Understanding these consequences is crucial for assessing the risks and benefits associated with the changes. The video script highlights the importance of considering these when planning changes.

💡Integrity

Integrity, in the context of the QMS, refers to the maintenance of the system's completeness, consistency, and accuracy. The video script emphasizes ensuring that changes do not negatively affect the integrity of the QMS, meaning the system should continue to function effectively after the changes.

💡Resources

Resources in this context include the personnel, technology, and other assets required to implement changes within the QMS. The video script mentions the importance of considering the availability of these resources when planning changes to ensure that the necessary support is in place.

💡Reallocation of Responsibilities

Reallocation of responsibilities refers to the redistribution of tasks and duties among staff members as a result of changes to the QMS. The video script points out the need to consider how changes may necessitate adjustments in the roles and responsibilities of the organization's staff.

💡Authorities

Authorities in the QMS context refer to the decision-making power and the right to assign tasks and responsibilities. The video script suggests that changes to the QMS may require a reassessment of who has the authority to make certain decisions or assign tasks.

💡Consequences on Staff

This term refers to the impact that changes to the QMS may have on the staff, such as alterations in their roles or the way they perform their duties. The video script advises considering the effects of changes on staff members to ensure a smooth transition and maintain morale.

💡Subscription

In the context of the video script, 'subscription' is a request for viewers to subscribe to the channel to receive updates on upcoming videos. It is a common practice on platforms like YouTube to grow an audience and ensure viewers do not miss new content.

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