What does it mean to design and document your system?

When we talk about designing and documenting the system, we are talking about establishing the processes that will become the backbone of the Quality System, the processes that will fulfill the requirements of the standard. I suggest establishing teams for each section of the standard. These teams are made up of employees and managers that will be responsible for a particular process.

For example, purchasing staff would make up a team that will establish the process for meeting the purchasing requirements of the standard. Groups of 3 to 7 people work well for a team; the team size should be kept to a minimum but be appropriate for the size and complexity of the department. The approach this team will take is to evaluate the current process against the requirements of the standard. If you have performed a Gap Analysis, that information would be used for this step.

Once the team identifies what ISO 9001 requirements are not being met by the current process, they will identify how the process will be changed to address the requirements. Flow charting, interviewing employees and brainstorming ideas can all be used to come up with a new proposed process.

Another useful tool are the procedures from The 9000 Store. These procedures provide an example process and guidance for the team to use. Instead of starting from a blank slate, the team can review the procedure, compare it to the current process, modify the process to meet the standard and edit the procedure.

Once the team has a procedure prepared, they submit that to the ISO Steering team for approval. This gives the project a centralized review process so one group can see all the procedures and make sure that they will work well together.

The 9000 Store has procedures available, as well as a Quality Manual to help you get off to a great start on your ISO 9001 Quality Management System.

The Procedures, Quality Manual and Forms are available as a package.

 

ISO 9001 All in One Package

advertisement