The FAQ (frequently asked questions) section.

Over the years that we've been running this website, we have answered more than 700 of your questions - some of them more than once!

On this page we'll show you some of the more frequent Questions and Answers - if your question isn't here then please do make use of our Quality advice for free! service.

FAQ Topics
Getting Started	Document Control
Implementation Problems	External Audits

Q - Where can I download the text of the ISO 9001 standard on the Internet for free?

A - You can't! The Standards published by ISO are all copyrighted - so they are not available anywhere for free. You can download a copy of the ISO 9000 series of documents from www.standards.com.au - but you'll still have to pay for it ..... Downloading the documents is good in that you get your copy immediately - however, in order to enforce the copyright arrangements the files have been electronically 'locked' so that only one copy of each file can be printed.

Q - I'm working in a little engineering company (10 employers) as quality manager. We are trying to work under ISO-9001 but we find some difficulties because we are just at the beginning of the process. How do we start ?

A - Take a look at our tutorial on Process-based Quality Systems.

Q - Our company is looking into ISO certification and I have recently been appointed the Quality Systems Manager. My expertise in this area is limited and I am starting from ground zero trying to get the QC department in line with this concept.

A - There may well be a need for a 'mind-shift' - away from 'detection' into 'prevention'. Traditional Quality is all about Inspection - sorting out the good ones from the bad ones. Modern thinking favours systems that are based around prevention - you may need to get some assistance to sell the idea to top management - and then start a process of cascading the new ideas down the organisation.

Q - I am writing a quality manual for a manufacturing company based on the ISO 9001 standard. Our management structure is based on teams of 3-4 individuals. Most of the ISO information I have read on the subject of management responsibility always mention a specific position or individual that bears the quality responsibility. My question is, will ISO allow quality responsibility to be assigned to a team or group of individuals?

A - Why not? The 'positions' nominated in your Quality System can be job titles - which can assign responsibility to the members of multiple teams. Probably the simplest way to document this is to have a 'Project File' for each project / job - which maps Quality Responsibilities onto individual named team members ... - this should be fairly easy to adminster..

Q - I am a Document Control Supervisor. My company is going through a fast track certification process for ISO 9001. We had a pre-audt and the auditor said we need to set a system for external documents. This is completely new to me. I know some of these documents exist here at the company, like UL standards and of course the ISO standard, but what else is required. Do you have a definition of what constitutes an external document and the requirement to control it?

A - Re external documents - the Standard does require that you control 'all document that relate' to ISO 9001 - including documents of external origin. This (typically) includes :- - Standards - Customer drawings - External specifications (e.g. process or product specs) - Reference material and so on. I tend to apply the same test for External Documents as I do for Internal documents - e.g. 'What would happen if I was looking at the wrong version/issue of this document - what would the possible impact be ?' If the answer is 'none' - then don't bother with controlling it. If the answer is 'all hell could break loose' then you'd better find some way of controlling it. For external docs this could be as simple as a handwritten list showing the name of each doc, the current issue, and where it lives. When updated versions become available then find some way to withdraw the old ones - or mark them 'obsolete' - and you've done it.

Q - I've been charged with the definition and implementation of document control procedures that adhere to ISO 9000 requirements. I'm new to this standard, as is my East Coast US company, and don't agree with some declarations made by management representatives. Could you please shed some light on the accuracy of these statements?

1. Software is a quality document/record/data, and must be controlled as such. - The software that we produce (our product)

2. To conform with ISO 9000, all printed documents must include the disclaimer "Not controlled when printed". - Seems self evident, like "This document is written in English".

3. To conform with ISO 9000, all printed documents must have a cover sheet that specifies relevant control information. - As opposed to including name, approver, date, reason for change etc. within the document. After close examination of the ISO standard and guidelines, I find nothing that supports these views. Any insights you can provide will be greatly appreciated.

A - There's an awful lot of mumbo-jumbo surrounding the implementation of ISO 9000 systems - you have given some good examples here. Answers in brief.....

1. No - the 'product' is not part of document control - it's the product. As such it may be subject to configuration / version control, it may need to be identified, to have traceability - all these good things. But it's not got a lot to do with Document Control.

2. Only true if that's the way you've written your system. There are many other ways of shwoing which documents are controlled and which ones are not.

3. This is another example of 'one way to do it' - by no means the only way... See our Document Control procedure for another (better!) way.

Q - I am a QA Manager (rookie) in a Company seeking for ISO 9001/EN46001 certification. We hired a consultant and he supplied us with a model Quality Manual. After that I reworked it substantially in order to adjust to our situation and now it is approved. The Procedures are now almost finished and we have to start with implementation. My problem is that the CEO of the Company

1.Never read original ISO9001

2.Considers Quality Manual + Procedures completely unnecessary (just nice fiction!) and tells me to throw them away and: a) prepare forms, b) prepare instructions how to fill the forms, c) training = tell people where are the forms located, so when necessary they take forms and fill them. d) management responsibility - WHAT IS IT? Just have forms ready and people will fill'em.

Our consultant and me had several heavy arguments with the CEO about understanding of ISO9001 and I am quite pessimistic about our certification perspectives in this situation.

A - You have a problem. How you address it depends to a large extent on the sort of person you are - a sticker or a quitter <g>. There's no shame in quitting - in some cases it will be better for you and your health than slogging away trying to change something that will never change. In this case - walk. There are other companies out there who have better leaders and will be more appreciative of your talents.

If you decide to 'stick with it' - then be aware that it could be a long hard struggle. You will need some allies in senior management - people who are prepared to help you to change the company culture - with or without the CEO's assistance.

One good way of bringing people 'onside' is to have a few good 'quality' successes - instances where doing things the right way has resulted in real financial benefit to the company, made life a great deal easier, or delighted a customer. Collect enough of these and then you'll find that perceptions of Quality, and that QA Manager guy, become more positive. You need to get people saying and doing the right things before the External Auditors come in - they won't be impressed if the CEO's still got the same attitude - but they will have seen similar situations in the past, and will understand the problems that you face. Good luck.

Q - I would like to enquire about what would be the likely questions that the auditor would ask during the certification audit. Please enlighten me. Thanks.

A - You have asked a really _big_ question....

What the Auditors want to prove is that :-

a) Your documented system complies with the requirements of ISO 9k
(This is often done at a Document Review - which is a paper-based exercise, taking place some time before the 'real' audit. At this stage each clause of the Quality Manual will be checked to ensure that it addresses the requirements of the Standard, and then the procedures themselves are examined to make sure that they satisfy the Standard. No 'face-to-face' auditing takes place - it's just an examination of the documentation. It's not unusual at this stage to have a list of small amendments, that should be incorporated by the time of the real audit)

b) You are doing what it says in your documents

This is the Audit proper - where the auditor will examine the operation of your system, by looking for evidence that people are actually doing what it says in your Quality Manual / Procedures. One of the most common lines of questioning goes like this :-

Auditor - Tell me how you check incoming Goods

Auditee - We examine each box to make sure it's not damaged, and that the shipping number corresponds to the one on the delivery note, then we open the box and check the contents against the delivery note and the copy of the purchase order. Then we staple the delivery note to the purchase order and pass them back to the Purchasing Office - just like it says in the Procedure.

Auditor - Fine - can you show me ?

The most useful phrase that any auditor can use is 'show me' - because the auditor can then see for themselves _exactly_ what's going on...... Do remember that the Auditor is there to help you - and if you don't understand what they are saying then do ask them to explain! Most Auditors are human - though I have met a one or two individuls in the past who made me wonder.....