Posts Tagged ‘ISO documentation’
ISO 9001 Documentation
As a third party auditor, I have seen so many examples of how not to document your quality management system. Most of the mistakes stem from lack of understanding of what the standard really does require. So many times I see companies who have paid someone to come in and document “their” system and nine out of ten times the system is either too complicated or does not reflect what they actually do. A full 90% of the non-conformances which are discovered during a surveillance audit have nothing to do with meeting the requirements of the standard, but are written against the requirements the company has imposed on themselves.
I’m here to tell you it doesn’t have to be so hard to meet the requirements of ISO 9001:2008 and manage your quality management system documentation. Hiring an outside consultant can be a great experience when the consultant facilitates the activities involved in developing your quality system, but leaves the ownership and management of the system to you. This is your system, not the consultants, and should be developed and implemented by your organization so it reflects the actual practices, processes and documentation of your organization.
There are only six required documented procedures and a quality manual that you “have to have “ , all other procedures that you develop are up to you. Don’t add procedures that do not add value to your processes. If you need a procedure to complete a process properly or a customer has required it of you, then you must have that procedure. If you want to have procedures for training purposes only, then call them just that. The key is to keep it simple and manageable, you’re in business to make a profit, not manage a monstrous quality management system. If you are not sure how to go about tackling ISO 9001 certification, call a reputable consultant, they can help set you on the right path. In the end, it is your system, and it should reflect what you do in a way that is transparent and easy to maintain.
ISO 9001 Documentation
The first step in implementing an ISO 9001 system is to document your management system by developing the required documentation which consists of a quality manual and six required procedures:
1. Control of documents
2. Control of records
3. Internal audits
4. Control of nonconforming product
5. Corrective action
6. Preventive action
The ISO 9001:2008 standard also allows you to further simplify you documentation by combining some of these procedures:
- Control of documents and records
- Corrective and preventive action
So, instead of six individual documents you might have four. Now, depending on the size and complexity of your organization and your employee training programs, you will need to add any additional procedures necessary to meet your organizations objectives and customer requirements.
Documentation can sometimes become a mine field during a registration audit because some organizations over document their system because they believe they have to detail everything. If your organization has little or no ISO 9001 training it is best to get training or hire a good ISO 9001 consultant who can help you develop your quality management system documentation. Don’t just spin your wheels, get help and save time and money!