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    The Difference Between ISO and GMP Quality Systems

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    Avis Ng
    The key differences between ISO and GMP quality systems are: ISO focuses on establishing an effective quality system through business operations and satisfying customer needs, while GMP focuses on satisfying government regulatory requirements to prevent unsafe products from reaching the market. GMP places more emphasis on technical and scientific manufacturing principles to ensure high product quality, especially for pharmaceuticals and medical devices. While ISO provides a good general quality system, GMP appears more effective for manufacturing products where technical defects could endanger health.

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    The Difference Between ISO and GMP Quality Systems

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    Avis Ng
    5K views2 pages
    The key differences between ISO and GMP quality systems are: ISO focuses on establishing an effective quality system through business operations and satisfying customer needs, while GMP focuses on satisfying government regulatory requirements to prevent unsafe products from reaching the market. GMP places more emphasis on technical and scientific manufacturing principles to ensure high product quality, especially for pharmaceuticals and medical devices. While ISO provides a good general quality system, GMP appears more effective for manufacturing products where technical defects could endanger health.

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    The key differences between ISO and GMP quality systems are: ISO focuses on establishing an effective quality system through business operations and satisfying customer needs, while GMP focuses on satisfying government regulatory requirements to prevent unsafe products from reaching the market. GMP places more emphasis on technical and scientific manufacturing principles to ensure high product quality, especially for pharmaceuticals and medical devices. While ISO provides a good general quality system, GMP appears more effective for manufacturing products where technical defects could endanger health.

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    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    5K views2 pages

    The Difference Between ISO and GMP Quality Systems

    Uploaded by

    Avis Ng
    The key differences between ISO and GMP quality systems are: ISO focuses on establishing an effective quality system through business operations and satisfying customer needs, while GMP focuses on satisfying government regulatory requirements to prevent unsafe products from reaching the market. GMP places more emphasis on technical and scientific manufacturing principles to ensure high product quality, especially for pharmaceuticals and medical devices. While ISO provides a good general quality system, GMP appears more effective for manufacturing products where technical defects could endanger health.

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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
    customers.

    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
    identical.

    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
    you.

    [Note]
    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.
    2005/6/20

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