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The difference between ISO and GMP quality systems

Philip Lee, PhD

ISO is a set of general procedural standards proposed for business operations

around 1987, while GMP Act was proposed by US congress as a legal requirement for
pharmaceutical industry in 1965. The core of ISO is a quality system, which
requires the top management level appoints a representative to initiate a project in
order to establish and complete the quality system operation within a time frame as set
in advance at the commence of the project. However, recent ISO has changed to
focus on establishing “an effective quality system”. The main reason for this trend
is that the old ISO systems did not realize “an effective system or operation” required
a leader with executive power to solve all kinds of problems they have encountered.
The old ISO system only required a quality representative to make the quality system
to work. Many companies have established their quality system successfully, but
they were not effective. The common problem is that the top management people
often demand the quality representative to break the rules. This is a terrible outcome.
This is probably you can see the ISO mark everywhere, but customers do not feel any
improvement of the product quality. The recent ISO has corrected this problem, at
least I have seen it in ISO 13485 (2003 edition). This is the only solution to ISO
problems, as long as the top management people joint the quality system as the team
leader, the quality system would become more effective. If the person with the
highest power does not joint the quality team, I would say the quality system is
bullshit. Based on my previous experience, the top management or executive
people are always afraid of joining the quality system. I don’t blame them, because
the final goal of an ISO quality system is solely to satisfy customer’s needs. You
don’t need to have perfect or the highest product quality, as long as your product
quality has satisfied your “customer”. This is totally different from the GMP quality
system, which have to satisfy government regulatory requirements, not your

The FDA always proposed some GMP rules in the form of “guidance” to represent
their current thinking. In 1978, there was a major revise of these GMP rules, which
we called it as current GMP (CGMP). And it probably will introduce new concepts,
such as PAT, in the near future, if it becomes effective in 2006, we probably can call it
CGMP:2006. The main purpose of GMP is to prevent products with bad quality
entering the market to endanger people’s life. To make high quality product, you
need to understand many scientific and technical principles in the manufacturing
process. This is especially true for pharmaceutical and medical device industries.
Many European countries require a medical device product fulfill ISO 13485 at
registration, but the US requires have posted some CGMP scientific and technical
rules in addition to ISO 13485. From my viewpoints, these are the missing parts of
ISO system. Hopefully many years from now, the two systems would become

In summary, the ISO quality system is consisted of more business operations than
technical considerations. It is a very good quality system in general, but for the
manufacturing some specific products, the GMP quality system appears to be more
effective to prevent some products with inherent technical defects to entering market.
From the standpoint of a consumer, I would rather buy a high quality product, not a
consistent problem, if such product is used to maintain my health. At last, if your
company is already ISO certified, you need to strengthen technical profiles of your
products, which I would estimate you need at least 60% more work to improve your
product inherent quality. If your company is already in compliance to GMP, I would
say you only need 20% more effort to get an ISO certificate. Good luck to all of

The intention of writing this short article is solely for the purpose of training the
new employees of my company; because I don’t want them think ISO is identical to
GMP. Recognition of the true meaning of product quality is my expectation.