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Other ISO 9000 topics:

Improving business

Explanation of ISO 9000

ISO 9000 Compliance versus Certification

Documents Needed for ISO 9000

Rationale Approach to Quality Policy Manual

Records Required by ISO 9001

Internal ISO 9000 Audits

Comparing ISO 9000 and TQM

Gaining ISO 9000 certification

Reasons Company Becomes Certified

Simple Plan for Registration

Steps to Achieve Registration

Sample quality manual

Table of Contents

0.0 Introduction

1.0 Scope

2.0 References

3.0 Definitions

4.0 Quality System Requirements

4.1 Management Responsibility

4.2 Quality System

4.3 Contract Review

4.4 Design Control

4.5 Document Control

4.6 Purchasing

4.7 Purchaser Supplied Product

4.8 Product Identification and Traceability

4.9 Process Control

4.10 Inspection and Testing

4.11 Inspection, Measuring, and Test Equipment

4.12 Inspection and Test Status

4.13 Control of Nonconforming Product

4.14 Corrective Action

4.15 Handling, Storage, Packaging, and Delivery

4.16 Quality Records

4.17 Internal Quality Audits

4.18 Training

4.19 Servicing

4.20 Statistical Techniques

Also see:

Weekly Feedback Blog

ISO 9000 Survey Results

Strategies to Succeed in Business

Succeed with TQM

Succeed in eCommerce

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Reader questions and feedback on ISO 9000 to succeed in business. Also refer to excellence, quality, TQM, standards, international, success, Ron Kurtus, School for Champions. Copyright © Restrictions

Answers to Readers' Questions on ISO 9000:

Reasons for ISO 9000

The following 5 comments and questions have been sent in. They are listed according to date.

List of first 10 items

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Purpose of getting ISO 9000 certfied

Question

February 23, 2009

I would first of all like to know that
1. which type of industry requires iso certification e.g exporter , importer , manufacturer etc
2. what is the purpose of getting iso certified
3. what are the benefits
etc & etc

gurdip singh - India

17320

Answer

Almost every industry could use ISO 9000. Usually, customer companies require ISO 9000 certification from their suppliers. But certification is also used as a marketing tool to advertise that the company produces quality goods.

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Documents required for ISO 9000 registration

Question

May 13, 2008

Pl kindly send me the detail information as well documents required for iso registration...

Jyotika - India

15946

Answer

It is good to check with the ISO 9000 Registrar for documents they require. Also see: http://www.school-for-champions.com/iso9000/documents.htm and http://www.school-for-champions.com/iso9000/records.htm

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Would like to take ISO 9000 course

Question

March 17, 2008

My company would like me to take a ISO 9000 course A.S.A.P.

lorraine - USA

15561

Answer

I'm sorry but we do not offer a course on ISO 9000. You're free to use our material to help you with your studies. Perhaps you could check with your local college on courses they may offer.

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Wants info on ISO 9000 and Six Sigma

Question

February 14, 2004

can u mail me details of 2 indian company having ISO 9000 or SIX SIGMA AND answer of the following question of that company?

Q What were the state of affairs before quality certificate ISO 9000
A)financial aspect to it
B) HR
C) production

Q What made you aspire for quality management certificate? what are their expectation?

Q What is the state of affairs after quality certificate ISO 9000 With regard to costing
Reduction in quality related cost example maintaince, inspection warrantee

Q Are they looking forward to upgrade their current quality management?

sweta -

2365

Answer

There are many companies that are registered in ISO 9000 or use Six Sigma. Many advertise the fact. Look in your local area at successful companies and contact their Quality Assurance manager to find if they use those tools. You can also check with local Quality Consultants to find companies.

Either one could give you the name of an ISO 9000 registrar in your location. Prices vary with area, so it is best to talk to people directly for the information.

Best wishes in your efforts.

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Starting QA department

Question

October 29, 2003

Thank you for the article "Reasons a Company Becomes Certified in ISO 9000". I was very helpful as a part of my research in answering that very question. Our company is in the biotech field and we just created our QA dept. My background is FDA/cGMP, however my experience with ISO is relatively limited. Our products are not FDA regulated yet, I am developing quality systems of which part is determining how ISO fits into that picture. Many departments, especially outside production, have expressed that they don't want to be buried in procedures and paperwork - which from cGMP background "if it isn't documented, it didn't happen" is my natural mindset. However, I'm learning that with ISO that doesn't necessarily have to be the case. The problem is that as my research continues, I'm trying to solve the problem of envisioning a system that does not involve written procedures at all levels. Do you have any suggestions of specific information or a direction that might be helpful in my quest to "envision" what a Quality Management System under ISO would look like or be composed of?

Thank you again for your site and helpful articles.

Sincerely,

J. DeCristo

Jeff -

1010

Answer

One of the big things that ISO 9000 does is to specifically define what the company does and what each department is supposed to do, as well as who are the responsible people. This is then defined in the Quality Manual, which is the first and major ISO 9000 document. Once that is started, it is amazing how many companies that have areas that either have no clue what they are doing or who is responsible.

But note that looking at the whole company is something that the top management must first buy into. You must make sure that is what they envision the QA department to do.

Also, make sure you really need to be certified in ISO 9000. There must be a competitive advantage or customer requirement for a company to invest in the process. I feel it is often sufficient to use ISO 9000 as a guide, if it isn't really necessary to become certified.
See: www.school-for-champions.com/iso9000/compliance.htm

In following ISO 9000, you really don't need procedures at all levels. In fact, the next level of documentation after the Quality Manual may just give and outline of what a department is supposed to do and not give step-by-step procedures.

It is true that documentation of what was done is important for a number of reasons. People will accept documentation if it protects the company for legal or financial reasons. What most object to is mindless documentation, where the person doesn't know what happens to the piece of paper after he fills it out.

Note that in starting your QA department, take a look at our Total Quality section at www.school-for-champions.com/tqm/. It may give you a few ideas.

Best wishes in establishing your department, and let me know how things turn out.

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Summary

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