ISO 9001:2000 Processes and Procedures



What is the difference between the processes and procedures of ISO 9001:2000


A process may be "Incoming Product Verification". Your procedure would outline how you verify product on receipt.



I. The "official" definitions:

Process - Set of interrelated activities which transforms inputs into outputs.
(ISO 9000:2000, Point 3.4.1)
Procedure - Specified way to carry out an activity or a process.
(ISO 9000:2000, Point 3.4.5)

II. Analysis:

ISO 9001:2000 requires you to identify your processes first. Once that they become clear and are understood, a decision should be made about the need to document it in its entirety, or partially. The basis for this decision are:
a) Analysis of the standard requirements. There are several process or activities that the standard requires to be documented.
b) Usefulness or purpose of documenting. If somebody in the organization is going to use the documentation for analysis, improvement or training purposes.
c) If the activity or process is critical for the customer or if the customer has asked to provide evidence or control of the specific point.

IV. Conclusions

- ISO 9000:2000 provides a definition of process and procedure.
- A procedure can be a representation of the "official" or accepted way to perform an activity or a whole process.
- The definition of what to document is dependant of several factors.
- The idea or "intent" of the new ISO is to avoid the "departamentalization" of procedures, the goal is to identify processes accross funcitonal boundaries to improve added values.


Fully vaccinated are you?
What is a Process?

Some thoughts:

From: "Dave & Rachael" [email protected]
Newsgroups: misc.industry.quality
Subject: Re: What is a process?
Date: Sat, 10 Nov 2001 00:38:45 -0000

Holmes biz [email protected] wrote in message
news:[email protected]...
> My company is in the middle of a merger, and one of the activities going on is
> coordination of both companies' policies, processes, methodologies, etc. Of
> particular focus is the effort to align one of the former company's project
> management process with the other former company's quality management process
> (well designed but with a primary emphasis on validation and IT processes.)
> Then a question came from one of the line managers : What is a process? People
> in a management level meeting stuttered and stammered their answers, but no one
> came away from it thinking that a satisfactory definition had surfaced.
> So anyone in this ng : What is a process?

Here's some thoughts:

1. A process meets objectives: a procedure meets a specific task
2. A process is an interrelated collection of procedures
3. A system is an interrelated collection of processes
4. A process flows from customer requirement to customer acceptance - it flows to a conclusion (eg a project) or flows in cycles (eg feedback loops and plan-do-check-act cycles)
5. A process consumes 'resources' to convert 'inputs' into 'outputs' under 'controlled' conditions
6. The effectiveness of a process can be objectively measured

A good starting point would be a textbook on TQM.

Hope this is some help.
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