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Insight Report Vol. 3, Number 4

A legal look at the ISO 9000

"ISO9000, A Legal Perspective,"

Having been involved with the ISO9000 as a certified lead assessor, assisting our clients achieve certification to this International Standard for Quality - I learned some interesting facts concerning the legal aspects of being ISO9000 Certified, from a book titled, "ISO9000, A Legal Perspective," written by James W. Kolka, PhD, JD.

The ISO 9001 registration is a significant accomplishment for a company. It represents a powerful methodology and is backed by a paper trail validating a strong management system in the event of a lawsuit. However as the book reveals this use of a paper trail, represents a significant degree of exposure should paper trail demonstrate weak controls and the a lack of a sound quality assurance system.

The good news and the bad news are identical; a paper trail exists in the event of a lawsuit.

The book is mainly written for the corporate attorneys of companies that are ISO9000 registered. It is intended to help them understand the requirements of the ISO standard in order to be able to better protect themselves. Conversely, plaintiff attorneys should understand and know what ISO9000 in order to be able to use it against the company.

The book outlines Key Points concerning the Legal Implementations of an ISO 9001-based Quality Management System(QSM).

If the absence of a quality system exposes a company to liability lawsuits when its practices and behaviors are contrasted with the structured practices and behaviors of a registered quality systems, then ISO9001/2/3 registration soon may become the price of doing business in the United States. It will become the minimum hurdle for US businesses.

In the event of a lawsuit...

If a company has a registered ISO9001 based QMS, the documentation can be obtained through discovery to determine whether the requirements under Clause 4.4, Design Control, have been satisfactorily addressed and audited. The key for any company’s defense will be adequate and effective documentation.

The areas to look at are:

If a company’s quality management program is well-constructed and well-documented, it should be able to sustain the scrutiny of a legal challenge. The caliber of documentation will be crucial. The key to any company’s defense will be adequate and effective documentation.

If a company is registered to ISO 9002 because it chose to exclude Design Control from the rigors and scrutiny of registration, it should anticipate potential legal challenges on this point.

If a company has not registered and/or does not have at least an internal QA system, it is vulnerable to a challenge on each and every clause and sub clause of ISO9001.

All participants in the ISO9001/2/3 quality assurance process are vulnerable to liability exposure. This includes the company itself, the consultants who help construct the quality system, the third-party that serves as the registrar and the auditors employed by the registrar.

For consultants, registrars and auditors, the quality of their professional advice, expertise and competence – or lack thereof – exposes them to the same liability for professional malpractice that affects the activities of doctors and lawyers.

Attorneys should prepare for a veritable explosion of ISO9001/2/3 registrations in the marketplace because of customer pressures (e.g., the automotive industry and QS-9000). Also, another level of growth will be fueled by the use of ISO 9001/2/3 as a conformity assessment requirement in US - and EU-regulated industries.

You must remember that it is a fully documented QA system that records work results demonstrating performance to documentation. ISO 9001 can be a powerful methodology that provides a paper trail documenting compliance with an effective quality system in the event of a lawsuit. Conversely, it also can represent a significant degree of exposure if the paper trail reveals a weak quality system that documents failure to adhere to the QA system. As previously stated, the good news and the bad news are identical: a paper trail exists in the event of a lawsuit.

Now, if one were take this information on the possible liabilities attributed to being ISO9000 Certified and add the US FDA GMP compliance requirements as well as the other legal requirements of the FDA as it relates to mislabeling and misbranding, then a company’s liability could be increased 10 fold.

It is not easy assuring compliance to your QMS but once you implement it, it’s improper use and documentation could be very costly to your company in the event of a liability issue relating to your products.

A Quality Management System is a great tool to have at your disposal, but it must be managed correctly to be of any real value. Incorrect use as well as a lack of compliance could result in problems you did not bargain for when you decided to achieve ISO9000 certification.

Next Month’s Insight Report –

The next Insight Report Vol. 3 #5

Update of FDA Warning Letters and Legal Actions

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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