Regulatory Open Forum

 View Only
  • 1.  Short Quality Manual

    Posted 24-Jan-2019 09:40
    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.

    ------------------------------
    Olivia Mullen
    Compliance / Regulatory Affairs
    Birmingham AL
    United States
    ------------------------------


  • 2.  RE: Short Quality Manual

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2019 13:29
    This message was posted by a user wishing to remain anonymous

    I knew someone several years ago who wrote a 7 page QM and it passed muster with a prominent ISO Registrar/NB. I did not see it myself and I can't recall how it was structured, but was pleased to hear it was possible. The typical 30 page QMs add absolutely no value in my opinion.


  • 3.  RE: Short Quality Manual

    Posted 25-Jan-2019 03:37
    Hey Olivia,

    succint and short quality manual is acceptable. Infact it is always better because you are not needed to revise this apex document every time with changes in your process. Important thing to take care is to include all applicable clauses,  mention any clause that does not apply with its rationale, put a preamble describing overall physiology to the clause that applies ( just very brief in couple of sentences)  and then cross refer the applicable SOP. Your SOP must include in-depth compliance to respective clause requirement.

    ------------------------------
    Rashida Najmi, Sr VP
    Quality, Regulatory and Pharmacovigilance
    Piramal Enterprises Ltd
    Bethlehem PA
    USA
    ------------------------------



  • 4.  RE: Short Quality Manual

    Posted 25-Jan-2019 06:40
    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

    ------------------------------
    James Bonds
    Director Regulatory Affairs
    Atlanta GA
    United States
    ------------------------------



  • 5.  RE: Short Quality Manual

    Posted 25-Jan-2019 08:31
    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.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------