Looking to implement ISO 9001? ISO 9001 is a wonderful way to show your customers that you are committed to giving them the best quality products available. While it's not a necessity, having an ISO 9001 certification is evidence that your business keeps to a certain standard and requirements when it comes to managing quality.
It can be a daunting task to think about implementing an entirely new system for your business. It's best not to look at the big picture and how much you have to do. Implementing ISO 9001 for your organization can take anywhere from six to nine months, so it's best to focus on one step at a time to ensure nothing is missed.
Continue reading to take a deeper look at these 8 steps and learn how to effectively implement ISO 9001 in your business.
You should absolutely purchase a copy of the ISO 9001 standard and review the key concepts. Everyone should have a firm grasp on the requirements of the standard, the documented procedure requirements, and the sort of documents and records required of you.
ISO 9001 provides a structure for the core requirements of a quality management system but is flexible so that it can suit all types of businesses. It's important for you to understand how the standard applies to your business specifically. This flexibility will allow you to meet the requirements set out in a way that makes sense for your organization.
It is essential when making any large changes to any business that you and everyone involved in your Top Management understand what it is you're trying to do.
Making sure that the people at the top of your management understand what ISO 9001 means for your business and why it's being implemented is absolutely key to everything running smoothly. Without everyone completely committed it becomes much more difficult to affect change throughout the business.
Once you have everyone on board you should analyze your current system and compare it to the ISO 9001 standard. You should have a good working knowledge of how close or far you are from meeting the standard requirements as it is. With this data, you can easily create to-do lists on how to modify your existing system to meet the standard.
The purpose of this gap analysis is to identify the areas in your company that require change in order to be compliant.
Our Quality Manual Template includes a 18-page gap analysis template which:
In doing this, you ensure that everyone involved in implementing the new system is on the same page. Make sure to check with all of your Top Management before beginning the next step just to be certain they understand the need for a new Quality Management System and that they are 100% committed to helping implement it.
Having a solid plan in place is essential to making the transition to a new system. When you have the right people on the job the process will be much easier to get through. Your team will create a workable plan that will set your business up for success.
To begin implementation, your Top Management should decide on and create an implementation team to head the effort. This team should be made up of managers from different areas of your business. An implementation team will ensure the success of your transition to the new Quality Management System.
The implementation team should be headed by the Management Representative that will oversee all parts of the implementation process. This person should hold a perfect understanding of the ISO 9001 standard. They will be the line of communication between the implementation team and the ISO 9001 registrar that will eventually certify your business.
The Management Representative should be a member of management that is respected and has a passion for managing and maintaining the Quality Management System far into the future.
It will be much easier to map out a plan for meeting the standards when you are aware of which processes within your organization coordinate with which requirements. It's extremely helpful to use flow charts and turtle diagrams to figure out exactly how your business gets from Point A to Point B when it comes to creating new products for customers.
You can do something as sophisticated as using computer software to define each step of the process, or simply use post-it notes on a wall. Once you can see the entire process in front of you, it's time to decide which of the items is a core process and which is a support process.
Examples of core processes are things such as design and delivery. These are the processes which contribute directly to getting the customer what they want. Support processes are not directly responsible for it but do help the core processes to do their job. These processes are things like training and facility maintenance.
In order to keep the transition to ISO 9001 running smoothly, there should be a structured plan set into place. Using the to-do list created from your analyses in step one, the implementation team should create milestones and deadlines to get things done.
Having a plan in place is key in implementing any system in a timely and effective manner. Without ensuring things are done at specific times under controlled conditions, they may get pushed aside and take much longer.
With a plan set out before you, it's time to let everyone in on the change. Every single person that works within your organization should be aware that change is coming. Hold seminars to let them in on the way things are going to change and why.
Make sure when you introduce the concept of such a large change that you tell your employees how it will affect them. Include research that supports why implementing ISO 9001 is a good thing for the business and for them. Let them know how their work might be changed in the process so that they are prepared.
Communication is key in implementing change. Keep everyone in the loop so that they don't feel they are being jilted in any way. Set up displays on notice boards that show the progress being made. Listen to any concerns or complaints. Make everything feel included.
The Quality Policy within your company is an integral part of keeping your business committed to meeting objectives and focusing on customer satisfaction. Your Quality Policy is one of the key things that will be used to measure your organization when determining the success of your Quality Management System.
There is no set definition of quality that applies to all businesses. Your definition of quality is one that is agreed upon by your Top Management team. It should build on your current values and identify objectives that are able to be measured to determine quality.
Quality Objectives are the way that the quality of your products will be measured. There isn't a specific way that ISO 9001 asks for objectives to be documented. Your quality objectives can be related to budget, business plans, or management review. It's important that these objectives suit both your business and your customers.
Once you have your Quality Policy in place you need to communicate it effectively to all members of your organization. You don't have to force the entire thing down their throat verbatim, but make sure they know where they can find a copy of the document if they should need it.
Try to shorten the key concepts of your Quality Policy into a few short sentences or a handful of keywords that make sense to employees at all levels. Do this for each department depending on what part of the Quality Policy directly correlates to the work they are doing. Put this shortened version up on notice boards so that they are always aware of it.
Every area of your organization should have managers and staff who are directly responsible for quality-related tasks and upkeep. You can create entirely new roles for these people or change already existing job descriptions to include the needed responsibilities.
You should have staff in each department that is capable of performing audits, maintaining documentation, conduct management reviews, and implement any needed changes. Make sure the people you choose to undertake these responsibilities are fully aware of what the job entails and how it relates to the Quality Management System.
Keeping records of your Quality Management System is required to be ISO 9001 certified. There are certain documents you are required to keep and others which may just be helpful in keeping everything running as it should.
Organizing and preparing your documentation is usually done according to the importance of the documents.
At the top, you have your Quality Manual. This includes your companies quality policy and objectives as well as how your quality system functions. It will have descriptions of all of the processes within your system and how they interact. You should always go back and refer to your Quality Manual as you implement changes to ensure all process descriptions are up to date.
Second, there are procedure documents. These documents detail all of the individual business processes and how they operate. They will show how each process is designed and controlled, including what checks are carried out to keep them in line.
Third, there are work instructions. These are very specific documents that detail the necessary instructions required to perform every task within the business.
Last, you have your forms and records. These are exactly what they sound like. Forms are used to collect information for record-keeping purposes. Records are required to show how your Quality Management System is operating and if it is up to standard.
To help you with 90% of the documentation, I recommend using a Quality Manual Template.
The Template includes everything you need for ISO 9001 documentation - quality policy, scope, what procedures you're planning to implement, flow charts, objectives and forms that ISO 9001 certification may require.
Your business probably already has extensive documentation going over processes and procedures, as well as forms and records.
It would benefit you to make a list of all of the documents that already exist and note their current status. Many of these documents may not be completed or up to date or might be lacking specific details required by the ISO 9001 standard. This list will give you a good idea of where to start in moving forward.
All of the documentation within your Quality Management System should be uniform in style and format so they are easy to navigate and read. Be sure to check what each type of document is required to have in it so that you can include these things in your template.
Having ready-made templates will make the daunting task of documenting your Quality Management System a lot easier to handle for everyone involved.
It is required that all documentation associated with your Quality Management System is well controlled and up to date. This ensures that your employees only have access to the most recent version of all documents.
Your Documents & Records Should Include:
Now it's time for the biggest step. You've done all of the work required to set up your business for success in transitioning to ISO 9001, all you have to do is launch your plan. You will start to see changes come into action and you will have to be mindful to ensure they go as planned.
Every employee is crucial to keeping your Quality Management System running as it should. It's time to train all of them on the parts of the system that are specific to their area of work. When they understand how their work affects the system they will be helping to move your business in the right direction.
Training Should Teach Your Employees:
Always go into training with a plan to equip each and every member of your team with the tools they require to be an effective part of your new Quality Management System.
Use your structured plan to begin putting your Quality Management System into action. Keep a close eye on every part of the plan as it begins to make sure things are moving forward. Monitor process performance and start internal audits to check that all standard requirements are being met.
It's essential to keep your implementation team on task. The Management Representative should have a checklist on hand at team meetings to review with everyone. Any problems that arise during the implementation process should be handled as promptly as possible.
This is also a good time to make sure documentation is being developed properly. Work instructions and forms should all be written and available to employees.
Two to three months after the documentation has been prepared and things have started being implemented, you should conduct internal audits to identify any problems within the scope of your Quality Management System. Any corrective measures that need to be taken should be taken without any delays. If needed, documentation should be revised.
Auditors will ensure that all procedures are well implemented, documented, and understood by the staff carrying them out. They will check that the system meets standard requirements, is effective, and is showing improvement.
Never spring an audit on your employees. They should not feel surprised or like they aren't being involved in the entire transition process. Always plan the audits well in advance. Let everyone know when the audit will take place and what departments will be audited.
After you have done your internal audit and your Quality Management System has been up and running for six months or so, you should review the progress your business is making. This review will help your team identify any underlying issues and the corrective actions that need to be taken to get everything in line with requirements.
Management Review is a useful tool that will give you a precise look at the performance of your Quality Management System and any problems that have come about. You may find through your review that changes need to made to your quality policy or objectives.
Your Management Review Should Include:
With all of this information on hand, your team can successfully correct the direction in which your system is headed so that it's forward once more.
This is as straightforward as it gets. Once you have identified the places where your Quality Management System needs fixing, it's time to fix them. Take prompt action and get everything corrected. Don't forget to revise the necessary documentation related to anything you change.
If you neglect needed changes you will not be able to register your system. Certification bodies prefer at least three months of records related to refining your Quality Management System.
Integrate reviews into your regular management system and keep clear records of everything you review and change. It's vital that you have all of your documents up to date. Continue to ensure the result of your management reviews is functioning as it should.
Your Quality Management System has been up and running for three to six months and everything seems stable and ready to be registered. Now is the time for you to carry on with the certification process to officially become ISO 9001 certified.
Your registrar will perform a two-step audit to confirm your business meets the requirements set out by the ISO 9001 standard.
They will first audit your documentation. This can take place either at their personal office or within your organization. The registrar will ensure that your documentation is all in place and controlled in compliance with the standard. If you don't have your documentation in order there's no real reason to continue on with the rest of the audit.
If all of your documents meet the standard requirements, the registrar will come to your business to audit your processes.
There is always the option of carrying out a pre-assessment audit, which is basically like a practice audit. Your registrar will assess your Quality Management System around six weeks before registration takes place and give you advice on any corrective actions that should be taken before your audit. Some people find this advice invaluable to the registration process.
After your audit you will be given the opportunity to fix any non-conformances that the registrar found. It is paramount that you take any issues that do not comply with the ISO 9001 standard seriously and fix them without hesitation.
Common non-conformances found in audits are a lack of proper training for internal auditors, reports of audits were not completed or managed, or personnel were found to be auditing their own work.
Your registrar will perform a second audit to ensure that all of the non-conformances that were found have been properly taken care of. They will systematically evaluate your entire Quality Management System against the standard to ensure it meets all requirements.
There must be objective evidence that your system conforms to the ISO 9001 standard and that all procedures are being followed. The registrar will document all of this before you become certified.
Certification generally lasts for three years. Receiving your ISO 9001 certificate isn't the end, though. Your registrar will perform surveillance audits one or two times a year to ensure your Quality Management System continues to meet the standard.
It is required by the ISO 9001 standard that certified companies continue to show improvement in the effectiveness of their Quality Management System. You should always aim to satisfy customers by identifying processes in your system which can be improved.
Implement a system that makes continual improvement easy for your team to carry out. It's as simple as following a repeating four-step process for checking up on your Quality Management System.
1. Plan out a timeline for internal audits and management reviews. Make sure all objectives and processes are well established and understood to deliver results in compliance with your quality policy. Use feedback from employees and customers to identify where things are going wrong and put a plan into place to see that they are fixed.
2. Create a small sample of changes you wish to implement. Before you interrupt the flow of work by taking an action, it would benefit you and your system to ensure the change will actually work beforehand on a smaller scale.
3. Regularly check all products and processes against policies and customer requirements. Report the results of these checks. Check up on all key activities to ensure the output is conforming.
4. Put successful changes into action. If a change did well in testing then it's time to put it into the full system to improve it. Involve everyone that will be affected by the changes in making them. Ensure that all changes are documented and that everything is up to date and meets requirements.
Making such a large change can seem like moving mountains in the beginning. It's difficult to know where to start or what order to do everything in. But it doesn't have to be a hassle to implement a new Quality Management System in your business.
Just keep these 8 steps in mind:
Once your new system is in place you will begin to see big changes in how efficient your business is running.
Implementing ISO 9001 will offer you a practical way to improve and monitor all parts of how your business operates.
Take a deep breath and set aside the time to get everything in order. Don't overwhelm yourself by worrying about every step of the implementation process at once. Focus on one step at a time and before you know it your business will have a Quality Management System to be proud of.
ISO 9001 Implementation
Written: 28th July 2019
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard