Conduct Initial Status Survey In ISO 9001 Standards
ISO 9001 does not require duplication of effort or redundant system. The goal of ISO 9001 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organization’s existing quality management system, if there is one — with the requirements of the standard (ISO 9001:2008).
For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared.
With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place.
Unless they are very much out of date, these documents should not be discarded.
Rather, they should be incorporated into the new quality management system.
Documents requiring modification or elaboration should be identified and listed. This exercise is some times referred to as ” gap analysis”. During these review processes, wide consultation with executives and representatives of various unions and associations within the organization is required to enlist their active cooperation.
In the review process, documents should be collected, studied and registered for
further use, possibly after they have been revised. Before developing new quality
management system documentation, you need to consider with which quality
requirements or department you should start. The best is to select an area where
processes are fairly well organized, running effectively and functioning satisfactorily.
The basic approach is to determine and record how a process is currently carried out.
We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times.
Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2008). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g. inspection/test reports, inspection/test certificates).
In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes.
In general, the steps to follow are the following:
a. Ascertain and establish the following:
What is the present operation/process? What already exists?
b. Analyze the relevant sections of the quality standard – ISO 9001:2008:
What is actually required?
c. If necessary, supplement and change operational arrangements in accordance
with the standard, develop documents and records, and describe operations/
processes:
What is the desired operation/process?
The gap analysis can be done internally, if the knowledge level is there. Or a formal pre-assessment can be obtained from any one of a large number of ISO 9001 consulting, implementing, and registration firms.
