A Quality Manual should be reflective of what the company does from a regulatory requirements perspective, and I would argue that should also reflect what the company does as a business. It should NOT be a copy and paste of the ISO regulation. James, that auditor you mention is very shortsighted. If you reference ISO 13485:2016 Section 4.2.2 Quality Manual there are 4 requirements: 1. Scope and rationale for non-applicability, 2. documented procedures or reference to them, 3. description of interactions, and 4. documentation structure. There is
nothing that states a quality manual must match the standard clause by clause.
Reference to the ISO 13485 Handbook there is also nothing about clause by clause - with a reference to ISO/TR 10013. These all say the same thing as the 4 points above. Sadly ISO 13485:2016 still has Quality Manual there where ISO 9001:2015 removed any requirement for quality manual. When you look at ISO 9001 there are items like context of organisation, interested parties, etc., this so-called quality manual should describe
what the company does and should not be a repeat of ISO 13485. It irks me to no end when auditing a quality system and reviewing the quality manual that is an exact repeat of the standard. So my personal opinion is that a quality manual can be 7 pages or 30 pages; whichever an organisation needs, but it should clearly describe what they do, relationships with internal and external parties, scope of quality system, etc. You can include a clause by clause, but do not repeat the standard, describe in a short summary how document control is managed, management review is done, product planning, and so on.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Jan-2019 06:40
From: James Bonds
Subject: Short Quality Manual
I had quite the opposite reaction at our recertification audit last year, which included upgrades to MDSAP and ISO 13485:2016. The auditors insisted that the Quality Manual match the standard from section 4 clause by clause. Our manual had statements in the Scope section that specifically excluded sections that were inapplicable (for instance, we are a primarily a single use disposable device company, so we stated that installation and servicing were out of scope). Our auditors said that we should still list those sections and be redundant in stating that we had no activities regarding installation and servicing, among others. The auditors stated that this was in accordance with their NB auditing procedures, which of course they couldn't make us aware of prior to the audit and couldn't share during the audit.
Regards,
James
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James Bonds
Director Regulatory Affairs
Atlanta GA
United States
Original Message:
Sent: 24-Jan-2019 09:39
From: Olivia Mullen
Subject: Short Quality Manual
I have seen a trend mentioned in a few places about moving towards a short quality manual, i.e. includes the scope, references to procedures and a flow chart showing process interactions. I am considering moving towards this with our company (a smaller medical device manufacturer of class IIa devices that's been in business for 32 years) and I would appreciate any feedback from people that have taken this approach and passed an audit. At our last 13485 / MDSAP audit, I don't recall the auditors more than glancing at our manual as most of the objective evidence is included in our procedures. I also understand that ISO 9001 no longer requires a Quality Manual.
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Olivia Mullen
Compliance / Regulatory Affairs
Birmingham AL
United States
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