The ISO 9001:2015 Quality Management System (QMS) has been approved by the International Organization for Standardization and is a mandatory regulation for most, if not all, international manufacturing organizations. The rules of ISO 9001 are simple, but the regulation of implementing the ISO 9001:2015 QMS requires a lot of attention to detail and it is easy to make mistakes. This article, “3 Simple Steps to Implement ISO 9001:2015,” aims to help manufacturing organizations and their managers learn how to implement a quality management system using the rules and requirements of ISO 9001:2015 and avoid making common mistakes.
What Is a Quality Management System?
Before looking at the simple steps to implementing an ISO 9001:2015 QMS, it is important to understand what a quality management system is. A quality management system is a formal system used to improve and control the quality of a product or service, from concept to delivery. This system consists of a framework, processes, personnel, and controls that together ensure that a customer receives the right product, at the right time and at the right quality level.
Quality management is a proactive approach to making sure that the customer receives what he/she is paying for. That requires a plan, a process, and personnel to assist in a continuous quality improvement. The ISO 9001 QMS is based on the following three principles:
There are several other principles included in the ISO 9001, but these three are the basis for all that follows. The key to creating a successful ISO 9001:2015 QMS is to use these principles to create an effective system that is capable of continuous improvement and adapts to the changing demands of your organization.
Understanding the Goals of ISO 9001:2015
The first step in implementing ISO 9001:2015 is to determine and understand your organization’s goals. There are four goals:
This article focuses on Quality Focus. Customer Focus and Safety Focus can be implemented in any product or service and are just as important as the other two. However, Quality Focus has a direct impact on your customers. It will also ensure that your organization is legally compliant and protects its brand from reputation damage. The ISO 9001:2015 QMS also allows for other certifications to be earned such as ISO 45001 (Occupational Health and Safety Management Systems) and COBIT 5. This article will use the term ISO 9001 QMS.
In many cases, the organization’s goals will drive the QMS. If the focus is on Quality, the QMS should include process, product, and customer. That is the traditional approach.
But, in many cases, the goals may not dictate a traditional ISO 9001 QMS approach. There may be other important factors. For example, if the company is looking to improve its reputation in the marketplace and its customer-focused goals suggest a focus on ISO 9001:2015, you may decide to develop a separate QMS. This decision may require an audit and/or consultation with a consultant before moving forward.
The purpose of a QMS is to provide an accurate understanding of your processes, products, customers, suppliers, and/or people. The QMS should show how all of these elements fit together to provide the best possible product to the customer. That is your business’ raison d’être.
Who Needs a Quality Management System?
An ISO 9001 QMS does not exist in a vacuum. It relies on the knowledge and skills of your people, processes, equipment, etc. If any of those three aspects of the business are not working properly, then your QMS will be ineffective.
If there is a problem with your people, the ISO 9001 QMS will not help. If there are problems with your processes, your organization may or may not learn how to fix them. If there are equipment problems or breakdowns, the ISO 9001 QMS may or may not fix them.
As a result, if you have any part of the quality function that does not work well, your organization will not achieve the goals of ISO 9001.
Who Needs to Implement a Quality Management System?
The organization needs to make a determination as to whether it is ready to implement a QMS. Most, if not all, organizations have some quality aspects that may or may not be working properly.
A key factor in determining if the organization is ready to implement an ISO 9001:2015 QMS is to assess whether the issues identified in the past three years are fixed, how fast they were fixed, or if they were fixed at all.
There will be many reasons why a quality management system may not have been implemented. If the cost of doing so was too high, the QMS may not have been purchased and implemented. If the quality management system is brand new and not yet implemented, there will be challenges getting it up and running.
If you find that you have to fix most of the issues identified in the past three years, you may not be ready to implement a QMS. The organization may need to do the following:
Develop a more detailed quality plan
Develop a more detailed quality process
Develop a more detailed quality management system
Develop a more detailed understanding of customer requirements
Develop more detailed procedures to document the quality processes
Improve the training of your people
Develop more detailed methods to monitor your processes, your people, and your customers
In other words, it will be hard to implement an ISO 9001:2015 QMS if the organization has not already implemented it in the past.
How to Implement an ISO 9001:2015 QMS
In this section, I will outline three simple steps to implement a quality management system. The steps do not require a lot of time, money, or skills. But, if any of these three is lacking, you may need to do more than three simple steps to make your organization more compliant and effective.
Step 1: Start with Training
The first step is to assess the current level of knowledge of your people. The first step is to make sure they know about quality and the ISO 9001 QMS.
One effective way to ensure your people understand the ISO 9001 QMS is to assign them to training. Most people in any company understand the ISO 9001 QMS, but they may not be aware of all the benefits it can bring. By training your people in the principles, rules, and benefits
of the ISO 9001 QMS, they will be able to implement it.
There are three major elements of an effective training program:
Understanding of the principles of ISO 9001:2015
Understanding of the benefits of ISO 9001:2015
Understanding of the rules of ISO 9001:2015
Understanding of the rules of ISO 9001:2015 will come more quickly than understanding the principles and benefits. But, if you are not sure how to implement a QMS, that is a good way to get started.
To make a QMS effective, all employees need to know how to:
Measure, evaluate, and improve the quality of products and services
Document customer requirements
Document customer service
Document equipment and materials used
Document compliance with a product’s/service’s requirement
Document personnel actions
Document safety (OSHA and other regulations)
Document training and other changes
Step 2: Determine the Products and/or Services You Provide
Determine which products or services you provide. This is the foundation of a successful QMS. It is not just about improving quality and safety, it is also about maintaining quality.
If your products or services are sold to more than one customer, you need to know how to keep customer satisfaction levels high, because high customer satisfaction is a key to customer retention and market share.
Step 3: Determine the People You Work With
Assess which people will work on implementing the ISO 9001:2015 QMS. They should include people involved with the processes that provide your products or services. This can include suppliers, vendors, product developers, production managers, etc. People involved with managing the quality processes should also be included.
There should also be people who understand the results of implementing a QMS, so that they can see the effectiveness of the program. Those people will likely include the people managing the results, and they will need to understand the quality aspects of the product, process, and/or service.
These three steps are simple to implement, but they do not require a lot of money or time. They also are not rocket science, but the key to implementing a quality management system that works is to make sure that you know what is going on, how to improve it, and what the results should be.
In this article, “3 Simple Steps to Implement ISO 9001:2015,” I outlined the three simple steps to implementing an ISO 9001 QMS: Start with Training, Determine the People You Work With, and Determine the Products or Services You Provide. The key to making the three steps work is to provide the training, understand how to identify the people that need to be involved, and determine the products and/or services that need to be provided.
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