FAQs On ISO 9001 Standards

This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support the publication of ISO 9001:2008 and the revision of ISO 9004. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world.
The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards.

ISO 9001 Standards Certification

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. Its similar to the man who chooses not to take the course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him dont care that he didnt take the exam. It is only those who dont know him that he will have difficulty convincing.

Many organizations were driven to seek ISO 9001 certification by pressure from customers rather than as an incentive to improve business performance and therefore sought the quickest route to certification. The critics called this coercion and like most command and control strategies, believed it resulted in managers cheating just to get the badge. What was out of character was that suppliers that were well known to customers were made to jump through this hoop in order to get a tick in a box in a list of approved suppliers. It became a necessary evil to do business. Certainly when perceived as a means to get a badge, the standard was no more than a marketing tool. It could have been used as a framework for improvement but the way it was imposed on organizations generated fear brought about by ignorant customers who mistakenly believed that imposing ISO 9001 would improve quality. To achieve anything in our society we inevitably have to impose rules and regulations what the critics regard as command and control but unfortunately, any progress we make masks the disadvantages of this strategy and because we only do what we are required to do, few people learn. When people make errors more rules are imposed until we are put in a straightjacket and productivity plummets. There is a need for regulations to keep sharks out of the bathing area, but if the regulations prevent bathing we defeat the objective, as did many of the customers that imposed ISO 9001.

What’s the difference between ISO 9001 and CMM?

Understanding the difference between ISO 9001 Standards and CMM means recognising a cultural understanding of quality. -Microsoft and many other software companies govern quality with the 80-20 rule,” said David Smith, vice president of Technology Futures, a technology forecasting company in Austin, TX. -The rationale is, ‘it’s a real product if 80 percent of the problem can be addressed and the remaining 20 percent is part of the business model.’ But the reality is the software industry’s business model is not a business model of total quality. And that is part of the challenge when you compare a CMM model against an ISO 9001 Standards model.”

The problem, as Smith sees it, is a conflict between the approaches to quality of ISO 9000 Standards and CMM programs, on the one hand, and the business model that corporations use on the other. -When you’re developing a product, the hardest problems to fix are the last 20 percent,” noted Smith.

Smith highlights three critical elements for understanding ISO 9001 and CMM:

• Understanding and documenting the true requirements is a key element in both standards.
• Document how you write the software code so other people can understand its value.
• Understand the requirements outlined in the program management and business models. It means understanding the maximum payback from the ISO and CMM levels. This is difficult to achieve because it requires both management and supervisory hats.

Software in the original description of ISO 9001 is different from software that runs on a computer, explains Mark Paulk, a senior member of the technical staff at Carnegie Mellon’s SEI.

Paulk’s advice: Understand the essence of ISO 9001 so you can compare it to CMM. ISO 9001’s definition of software is more general and includes music, entertainment, or anything involving the creation of an intangible product.

-But the original bias of the standard was strongly toward the manufacturing environment, where all the historical work had been done,” said Paulk. -And that is one of the criticisms of the early releases of the standards. One of the objectives of the ISO 9000 revisions was it failed to make the standard more comfortable to users in other environments.”

ISO 9000 Total Quality Management

TQM is infinitely variable and adaptable. Although originally applied to manufacturing operations, and for a number of years only used in that area, TQM is now becoming recognised as a generic management tool, just as applicable in service and public sector organisations. There are a number of evolutionary strands, with different sectors creating their own versions from
the common ancestor.

ISO 9000 Standards Training DVD

ISO 9000 Standards Training DVD
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The Introduction to ISO 9001:2008 DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

Document Review In ISO 9001 Standards

Document Review In ISO 9001 Standards

The ISO 9001 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It
could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in
connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the
information)
Reviews may be random or periodic. Random reviews are reactive and arise
from an error or a change that is either planned or unplanned. Periodic reviews
are proactive and could be scheduled once each year to review the policies,
processes, products, procedures, specification etc. for continued suitability. In
this way obsolete documents are culled from the system. However, if the
system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process
in installed the redundant elements including documentation and equipment
should be disposed of.

Assessment to ISO 9000 Standards

Assessment to ISO 9001 Standards
Once all the requirements of ISO 9001 have been met, it is time for an external audit. This should be carried out by a third party, accredited certification body. In the UK, the body should be accredited by UKAS. The chosen certification body will review the quality manuals and procedures. This process involves looking at the companys evaluation of quality and ascertains if targets set for the management program are measurable and achievable. This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.
After a successful audit, a certificate of registration to ISO 9001 will be issued. There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.