How Does A Company Become ISO 9001 Certified?
Choose Your Approach
When making such a significant change in your organization, knowledge is power. ISO 9001 can be challenging to grasp. The requirements it lays out are numerous, but they are all there for a reason. Before taking any steps toward certification, it's crucial that you know exactly what's being asked of you.
You should decide, first and foremost, what sort of approach you want to take to certification. This will help you on your journey to certification. There are a few ways you can go about implementing ISO 9001 in your business:
In-House Implementation - People within your company set up ISO 9001 as it best fits your organization.
Hire a Consultant - Someone from the outside comes in to help set up ISO 9001. The cost is higher, and because they don't know your business inside and out, sometimes the resulting processes aren't the best fit.
Template or Certification Kit - A pre-made kit that helps those within your company more quickly and efficiently implement ISO 9001.
The most popular approach by far is to implement ISO 9001 in-house. Whether or not a company purchases an ISO Template or toolkit is up to them. These kits are relatively inexpensive and a great time saver if you do not have to have any prior experience; however, if you may feel you have a good enough grasp on the materials to be able to do it all yourself. By all means, go for it!
Learn All About ISO 9001
A big part of familiarizing yourself with ISO 9001 is understanding the requirements that you must meet and how they relate to your company. The standard breaks down these requirements into sections. With these sections, you can easily separate the processes within your organization into which section of the requirements they apply.
You should look to Sections 4-10 to find the standard's requirements.
The ISO 9001 Clauses
Scope - The scope of the standard
Normative References - References to supporting standards
Terms and Definitions - The terms you will find in the standard
Context of the organization - Thoroughly align your business objectives and intent with the quality management system
Leadership - Secure the total commitment of Top Management
Planning - Make a plan for the quality management system to address risks, opportunities, changes, and objectives
Support - What resources are needed for the quality management system
Operation - The processes required to meet the requirements for products and services
Performance Evaluation - Monitor, measure, analyze, and evaluate the quality management system
Improvement - Continually improve the quality management system
Prepare Your Team
You should decide on one person in your organization who will be the lead during the entire certification process. This person is generally a quality manager or leader already familiar with your organization's functions. Your leader will be known as your Management Representative.
The Management Representative will be responsible for implementing ISO 9001 in your business. They should have the appropriate authority to change operations and a firm grasp of ISO 9001 and how it works for your business.
If your company has more than one physical location, a Management Representative should be appointed for each one. One leading Management Representative should oversee the progress of the other local Management Representatives.
As well as the top person, every member of your Top Management team should be 100% on board with the change about to happen. It would be best if you had the support and understanding of every member of leadership. This is crucial for a smooth transition.
Training will be required for the Top Management team to ensure they know exactly what will happen.
Top Management Training Should Include
Internal, operational, and marketing benefits of ISO 9001
The costs and resources required for ISO 9001 certification
How they will be affected and what involvement is expected of them
After Top Management is ready to move forward, you should involve and inform the rest of your employees. ISO 9001 implementation will affect every level of your business and the processes that go into making it work. It's best to let everyone who works on these processes know early on what they are in for and gain their support.
Employee Training Should Include
How getting ISO 9001 certified works
How it will benefit them and their work
What is expected of them from their leaders
Support from all employees is crucial to the success of ISO 9001. If they feel threatened by a change they didn't know was coming, they may become more of a hindrance than a help. You should have meetings and seminars with groups of employees from the different sectors of your business and present all the needed information in a way they can understand.
Make a Plan
Construct an ISO 9001 Project Plan. Top management buy-in is essential to planning management reviews and ensuring that the whole process goes more smoothly.
A plan is best created when you have a team capable of reaching your objectives. Your team should be comprised of managers from the different areas of your company who have the authority to implement change in their area. They will all be under your Management Representative.
Having a team in place will make achieving certification that much easier. Each team member will have set responsibilities and be able to keep everyone in their area on task. The team will meet regularly during implementation to monitor progress, allocate resources, answer questions, and coordinate all facets of the new quality management system.
Once you know how you're already doing, it's time to sit down and make a plan for the future. You should create a timeline for implementation with set dates and deadlines to get things done. With a timeline in place, you can more easily stay on task without other things drawing your focus.
A gap analysis is an excellent way to see how the system you already have in place compares to the ISO 9001 standard. By doing this, you can make lists of what is already in place and what needs to be put in place to meet the requirements. You may be able to make to-do lists for each section of the standard.
