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ISO 9001:2015 “6.3 Planning of changes” requirement

ISO 9001 is a well-known standard for implementing a quality management system. It aims to improve processes and increase customer satisfaction. In 2015, a new version was released, which brought changes from the last version, which was released in the year 2008.

Every standard needs to be reviewed to ensure that its best practices keep up with and adapt to global changes. In this article, we are going to talk about the “6.3 Planning of changes” requirement, which is a “new” requirement that emerged in the 2015 revision of ISO 9001.

 

“6.3 Planning of changes”

To better understand the 9001 proposal, let’s look at the beginning of item 6.3 and what we can understand from it.

“When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned and systematic manner (see 4.4).”

The first point we need to understand is that changes must be properly planned. Every company and its employees need to propose ideas and suggestions for improvement, that’s a fact!

However, these ideas should NOT be executed in any way, without first carrying out a good planning. Understanding what the variable points are and analyzing if they are really necessary are some of the points that we need to take into account.

In addition to being necessary to plan these changes, they must also be systematic. This means that companies must act in an organized manner, following rules that have an execution logic that does not harm areas of the company that are not involved in the possible change.

Item 6.3 also contains 4 topics that suggest proposals that an institution should consider. They help us to better understand what the organization should analyze when making changes to its management system.

 

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.

 

Now let’s understand better item by item. To do this, let’s take a simple example:

Let’s imagine that I have a small company with 10 employees, and we produce MDF furniture (which is a plywood material). Each professional works in a sector producing the pieces in pieces until they are completed.

Due to a new demand from customers, I have the proposal to start working producing furniture with different wood, Pinus. For this, I will need to hire new employees and find a new space within my company.

In other words, our change, then, will be to create a new production line using a different raw material.

 

a) The purpose of the changes and their potential consequences.

The company must understand the purpose of the change, why to change certain processes, activities, products or services. If there really is a need, then, understand what the impacts of this change might be.

Thus, we need to understand what are the consequences that changes can generate. There will always be positives or negatives, and the company needs to be able to manage them. And here, managing means maximizing the positives and absorbing the negatives with the least possible impact!

Based on our example above, there are a few questions that can help us better understand the change, plan for it! Let’s look at these questions and answer them thinking about our example.

  • What is my purpose of change?

Expand my business and work with another type of material, to meet a new demand.

  • What changes can this generate?
  • The need to open a new space in my layout, to produce the parts and accommodate new employees;
  • Need to hire new professionals capable of working with this type of material and people to manage the new location;
  • Need to look for new suppliers.
  • What consequences can the change generate?

One risk may be that we are unable to maintain the same quality standard for new furniture.

 

b) The integrity of the quality management system

You should analyze how changes may affect your management system. Because in all organizations there are standards, rules and principles that must be respected.

Processes should not be modified without first verifying how to adapt the system to this change. These changes can negatively affect other processes and activities.

Therefore, at this point of planning, the company needs to assess the possible impacts in a systemic way, due to the increase in staff, new space and new materials, as well as customer satisfaction. Will the new production line affect the old one?

 

c) The availability of resources

There is no way for you to propose and initiate changes without first analyzing whether the company has the necessary resources to do so.

These resources range from money to equipment, employees, raw materials and other necessities. Every change must be planned to be successfully achieved.

Following our example from the beginning, the company must carry out an excellent planning of the costs of new materials and professionals, the availability of raw materials and the space needed for the new activities.

 

The allocation and reallocation of responsibilities and authorities

Thinking about our history from the beginning, the company will need to allocate new people for management and production. Each of these people will have responsibilities in the new activities and will need to make them clear. Otherwise, it is more complicated to fulfill them.

When we speak of authorities, we are referring to the power that people have to carry out their tasks. For example, a competent professional, when identifying the type of raw material (MDF or Pine), has the authority to choose which machinery to use to produce the furniture.

 

The importance of applying the requirement “6.3 Planning of Changes” in your management system.

It is important to seek to apply the requirements so that changes in the quality management system bring efficient solutions, avoiding undesirable results. Requirement 6.3 that can guide this, and help the company to follow good practices, helping to ensure more significant changes.

In short, it is necessary to consider the purpose of the changes, what are the possible consequences of them, analyze the availability of resources and organize responsibilities. By following this “step by step”, the probability of success will be incredibly higher!

QMS

QMS Certification Services is a fully accredited third-party International Certification Body. Operating since 1994, QMS is one of the oldest and most experienced certification bodies auditing and certifying thousands of organizations globally. We have built a great reputation for first-class service, market-leading pricing, and a hassle-free process for our clients. International Recognition: QMS Certification Services is accredited by IAS (INTERNATIONAL ACCREDITATION SERVICE) – a member of the IAF (International Accreditation Forum). All Certificates of Approval are issued under the IAS accredited system in the USA. QMS has auditors and clients all over the world, allowing for multi-country certification for clients.

1 comment

  • This is truly a great blog thanks for sharing. Excellent and decent post. We Personalized Quality Assurance Services (PQAS) are leading ISO 9001 Certification Consultants, most widely accepted business management system worldwide which is generic and can be replicated across all forms of businesses. From manufacturing to professional services,

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