> These 8 quality management principles and techniques that
> they are required to know?
Where in ISO 9001:2000 does it say there are 8 quality management principles and techniques that someone has to know? I would like to know where it comes from because I seem to have missed it somehow.
I would definitely go through the changes (we're talking upgrade, right?) with your internal auditors. While it is not required per se, I would go through a round of internal audits prior to the registrar coming.
Each of the registrar's auditors I 'experienced' in upgrade audits was Ok with the fact that none of my clients did a round of internal audits (but they were each surprised and expected problems and they said so), but I went through the differences with my clients so they knew what the rquirements are and how to approach auditing them, not to mention addressing them. When you come out of an audit with 0 findings it's hard to complain that the company needed a round of internal audits to the new standard. A registrar might require a round, but the standard does not and the registrars I have dealt with did not specifically require them.
What I am saying is I see stuff like this:<hr>
PeterH wrote in message
news:
[email protected]
> I recently attended an ISO9001:2000 workshop for QA managers upgrading
> from ISO9001:1994. I was left with a couple of questions in my mind
> that weren't clearly explained. You may be able to help me.
> Q1. Can exemptions be sought from ALL subclauses of Clause 7 (ie Cl
> 7.1 to 7.6 inclusive) as per Clause 1.2? The presentation notes I was
> given only mentioned Cls 7.3 to 7.6 being exempt.
> Q2. The workshop notes stated that procedures must be documented (ie
> they are mandatory) for Cls 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2 and 8.5.3
> and that other clauses can be verbal, if necessary, for the remainder.
> Where in ISO 9001:2000 does it mention these mandatory requirements
> and that some can be verbal? In what way can procedures be verbal and
> still be auditable?
> Q3. What are the main things to look for when changing from
> ISO9002:1994 to the new ISO9001:2000. Is it simply that the company
> would need to review how much design it does that was once excempt
> from the requirements of ISO9002 that may now be required to be
> included under ISO9001:2000?
> regards
> PeterH
From: "Dave & Rachael"
Newsgroups: misc.industry.quality
Subject: Re: Some 9001:2000 Questions
Date: Tue, 12 Feb 2002 21:27:59 -0000
Here's my experiences of going through certification:
Q2: The procedures called for in the standard are mostly common sense ones you would need regardless of whether you are using the ISO9000-series of standards. Effective document control does not happen by chance.
Our approach was to develop a high-level management plan that contained the objectives we planned to meet over the coming three years (it is updated each year). To support those objectives, we developed a series of simple process maps that described the steps taken to meet those objectives. Where necessary, those steps were supported by lower-level Quality plans that in turn referenced procedures. The progress of the objectives were monitored by the top-level Management Board using a traffic light system (green = OK, amber = minor weakness, red = major weakness) in a balanced scorecard.
What the Standard is trying to say is don't create procedures for the sake of it. If you need a procedure, and it will be used, create it.
Q3: The main changes for me were: - the use of the eight Quality Management principles - integrating the Quality Management System into the business planning activities - development of processes (don't underestimate this task - processes and procedures are different) - changes of auditing practices (processes + data replace procedures in many cases) - trying to communicate a technical subject such as process management to non-Quality staff
Two main pluses were: - we have LRQA as our assessors and they had created a transition checklist - we formed a working group of the Management Board to answer each question (over 100 of them, it took eight hours over three sessions) - we introduced the Management Board to the standard through mini-workshops (over three months) lasting about ten minutes where we brainstormed how we met the eight Quality Management Principles
By the time we had finished, the Management Board had bought in and knew what was going on. It was a big effort - don't underestimate it. From start to finish, the transition takes about a year for an organisation of about 150 staff.
We're talking tons of bucks here. I hope that's for an implementation from scratch. And if the person means there are only 150 people in the company where he states "...an organisation of about 150 staff..." a year is a long time. Is that everybody or does he mean only office personnel by using the word 'staff'? A year for a transition is way, way too long. Every client I have has already had stuff like goals and objectives at every level of the company. That's what any good company will be doing anyway. If a company currently does not have those, how do they control their operations? How do they advance and improve?
I'm just using the above as an example. My point is to take a close look at the 'new' requirements and make sure you're not already doing something but never really thought of what you are doing in light of the new standard before.
The 'process approach' thing also galls me. Practically every client I have worked with in implementations since 1994 has used flow charts for level IIs as a minimum. These flow charts already show where functional groups interact and how (also defining communication channels). The flow charts themselves describe their processes. This said, they have taken a 'proess approach' for years. This is a smoke screen of confusion in my opinion.
Bottom line: Make sure you understand the changes and make sure you're not already doing what they require before you start a crusade for change as many seem to be making this out to be.
Just my opinion... I've been through 3 upgrade audits and 2 implementations to the 2000 standard from scratch and all have been smooth audits with one exception where 1 of two auditors was a pain in the butt. But - all were successful. In two upgrades 0 nonconformances were identified. But - You never know. I could be missing something obvious. :thedeal: