3. Getting Started with your ISO 9001 Quality Management System
There are several things you can do to prepare the ground for implementing an ISO 9001 Quality Management System. These steps will save you time and money, particularly if you are using an outside consultant to help you prepare documentation. Your initial preparation will create a solid foundation on which to build the Quality Management System.
Select your Management Representative
The Management Representative is the key co-ordinator for the development of the quality system and, once the system has been certified, assumes responsibility for on-going system maintenance and effectiveness of operation.
Rather than developing the QMS themselves, the management representative acts as a project manager for the ISO 9001 certification ‘project’.
Ongoing duties include reporting on the Quality Management System to “top Management” – typically through reports and management review meetings, and promoting awareness of quality throughout the organisation. They also will act as a liason to external parties for quality managements system related matters – e.g., coordinating audit schedules.
Construct a Process Map
A process map is a visual description of the activities in your business. You will need to identify your key business processes and how they interact.
Your process map will need to include your processes for:
- resource management – people and infrastructure
- product/service realisation – purchasing from suppliers, actual production, customer services, delivery, etc
- management activities – planning, system review, document control
- measurement, analysis and improvement – customer complaints, audits, corrective and preventive actions,
Select a Certification Body
Talk to several companies and compare prices. Make sure that the certification body you select has auditors with experience in your industry. You should book them in early and keep them informed of your system development program.
Identify key documents / forms / templates
It is essential that you start to identify key documents that you are already using that may need to be brought under version control in the quality system. These will be documents that affect/control the quality of the product and/or service you provide. For example:
- External Documents – Standards, Customer supplied documents / drawings
- Forms / Templates
- Work Instructions
- Safe Work Procedures
- Standard Operating Procedures
- Quality Plans
- Inspection & Test Plans
- Meeting Minutes
- Material Safety Data Sheets
To prepare for bringing these documents into the quality system, you should:
- Make hard copies of all forms / templates used throughout the organisation.
- Identify who “owns” each document – they will become the “document controller” for that document.
- Identify where the “masters” of these documents are located eg., on a server, someone’s hard drive, etc.
- Review current version control procedures – by date of issue, revision numbers?
Draft an Organisation Chart
This is critical, as without this essential information you will be unable to correctly delegate effective roles and responsibilities for the development and maintenance of your quality system.
- Specify full names
- Establish correct job titles
- Locate any existing job/position descriptions and review them with appropriate personnel & managers.