9 steps for developing & certifying an ISO 9001 Quality Management System
Before you embark on developing a Quality Management System
Before you embark on developing a Quality Management System, it is essential to ensure that senior management is fully behind the need for a Quality Management System and is committed to supporting the development, implementation, ongoing maintenance and continuous improvement of the system.
Consistently positive communication about the Quality Management System from management to all staff will affect the way staff perceive the new system and will directly influence the success of the system’s implementation.
Management commitment is also critical to ensure that adequate time and resources are allocated to development, ongoing maintenance and continuous improvement of the system.
When working with a consultant, fewer resources are required as the consultant should develop the system for you.
If you decide to develop a system yourself, these are the steps you will need to follow:
Step 1 – Appoint a project leader
Appoint a project leader who has an interest in Quality Management and the authority within the business to drive it forward.
This person should ideally have a leadership / senior management role within the business. This will allow them to ensure that the processes needed for the Quality Management System are established, implemented and maintained and that an awareness of customer requirements is promoted throughout the organisation.
It is vital that they are a good communicator and have the respect of their co-workers.
The project leader should fully understand the management system and will steer the implementation by assigning tasks to relevant management and staff.
If you decide to develop the system internally, this person will also need to be able to unpack the requirements of the standard and apply them to your business.
Step 2 – Identify major functions within the business
Identify the major functions within the business and list the related processes for each function.
This forms the basis of the structure of your management system which should describe how your business operates.
Step 3 – Document business processes
Document each process, identify responsibilities and related records. This includes:
- the steps of the process
- who is responsible for critical steps of each process
- what records are kept to document progress through the process
- who completes them and
- where and for how long are they stored and who has access to them.
Ask the process manager and staff involved in the process to review the documentation. It can be enlightening to find out how the work is actually
performed as opposed to management’s perspective of the way it would be performed.
Step 4 – Review the system against the standard
Having documented the processes, the procedures need to be reviewed against the standard to ensure all of the requirements have been met.
Step 5 – Management approval
Ensure that management review and approve the whole system. Management approval needs to be documented and recorded for the certification auditor.
Step 6 – Training
Now the system documentation can be formally released to the staff. The staff will need to be trained in using the documentation and made aware of their responsibilities with regards to the Quality Management System.
Everybody should understand the parts of the Quality Management System that are relevant to them. The benefits of the system should be understood and staff should be encouraged to give feedback and suggestions to improve the parts of the system that affect them.
Step 7 – Conduct an internal audit of the system
Once the system has been successfully implemented, an internal audit of the system has to be conducted. An internal audit is a mandatory requirement of the standard; you must conduct at least one internal audit of the system before you can get certification.
The purpose of the internal audit is to determine whether work processes are operating in accordance with the documented procedures.
The auditor can use different techniques to obtain evidence to assess if the system is being followed; these include interviews, sampling, inspections and review of records.
The standard states that the person conducting the audit should have a clear understanding of:
- the standard’s requirements,
- the business’s requirements of the Quality Management System and
- be objective and impartial.
There are training programs available on how to conduct internal audits.
If you developed the system yourself, consider getting a consultant to conduct the first internal audit. An external consultant can give you professional feedback on the content, scope and implementation of the system and whether you are ready for certification.
Step 8 – Hold a management review meeting
The meeting has to review the results of the internal audit, any changes to the business and any changes to the Quality Management System, customer feedback and other areas as indicated by the standard.
Step 9 – Engage a certification body
Engage a certification body to conduct the certification audit. The certification audit is in two stages. The first stage checks that your documentation meets the requirements of the standard. The second stage checks that the business is following the documented procedures and keeping appropriate records. The stages can be consecutive but may also be separated by a period of time.
The 4 principles for successful implementation
The 4 critical principles that will allow you to successfully implement a Quality Management System in your business are:
- Keep your system simple, document how you are already operating your business;
- Ensure strong leadership and management commitment to the process;
- Assign the right person as a system coordinator; and
- Involve all staff in the process.
When developing your system, it is important to keep in mind that there is no need to re-invent the way that a business operates just because you are implementing a Quality Management System.
Yes, there will probably be some changes you will need to introduce in the business and there may be things that you can improve on, but changing the way you operate is not what you need do.
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