The key to a successful implementation of an ISO 9001 quality management system (QMS) can be summed up as follows:
· Keep it simple
· Adapt the QMS to fit your business, not vice-versa
· It should be an integral part of the business, not an ‘add on’
Application of the philosophy ‘say what you do, then do what you say’ will result in a QMS that reflects how your business actually works.
ISO 9001 implementation process
1. Determine what your business does and how it is done.
The implementation process begins with the identification of the business processes, their relationships, management, records etc. Gap analysis is used to identify what needs to be done to address any areas falling outside the standard.
2. Build the Quality Management System.
Built around your existing business processes, procedures are the building blocks of the system. Documentation is kept to a minimum, there are only six mandatory procedures. Additional procedures are only documented as necessary. If the system is to work, it must be simple and not place additional demands on the normal business operation.
3. Communicate and roll out.
As elements of the system are completed, they are integrated into the business. During this period the system is reviewed and ‘fine tuned’ and made fully operational.
4. Pre-certification assessment audit.
Once there is sufficient evidence of successful implementation, an audit is usually carried out to assess the implementation and highlight any areas which may prevent or delay certification. Based on a successful outcome of this pre-assessment, the application for certification is initiated.
5. Certification audit.
There are two stages to the certification audit process. Stage 1 is a documentation review to check that all the required elements are in place. Stage 2 is a full audit to check that the system is operating effectively.
6. Certification and beyond.
Once certified, regular internal audits will be required to ensure the ongoing effective operation of the QMS.
The ISO 9001 certification is reassessed after three years.