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How much work to get to 13485 from ISO 9001:2015?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Dec 4, 2015.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd suggest that, unless you are selling software, this is an over simplification of the task of implementing a QMS. There are many, many issues which cannot be addressed using software.
     
  2. ValeriaGar

    ValeriaGar Member

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    I just wanted to say that it can help and speed up. I'm not saying it solves all the problems. It is easier to organize the documentation, there are process templates that make the job easier. Less stress when the auditor comes. It is a tool that helps with the implementation and to manage QMS.
    Of course, you need both knowledge and experience, but if you don't have it, you have to make an effort to learn everything necessary for the implementation and make your job easier. And the other option is to pay a consultant.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And that is, of course, the road which people who lack knowledge and experience take: "We'll buy some software, so we can get it done quickly and easily" and it then does none of the things you mention. Let's not overlook, for a moment that a QMS isn't about management of documents. Experience shows, also that those who create the software, also have little to no actual practical experience of implementation. One very famous Lotus Notes-based software was written by a couple of people who had only ever been on a Lead Auditor course...

    Software can help with some basics like document control - Sharepoint does that. Software people understand document/version control - it's a major part of software development, as is corrective action (escalating actions needed to keep a development on track, in particular). In most other respects, I've yet to see a software package which is even close to being actually useful in supporting an implementation, only basic maintenance. Indeed, I've yet to encounter (and I've researched them extensively) that makes anyones' part in implementation "easier". Maybe one or two (document control for example) but nothing else. Often these templates are more "style over substance". Having 5, 6 or 7 sections to a procedure "Scope, Purpose, Definitions, Responsibilities, Procedure, Records, Change History" and so on, is an 18th century approach to documenting systems. No required and in my experience, the way to get people to avoid using those documents, because they are a bureaucracy...

    As for the audit, people (management and employees that is) who understand processes, process controls, process goals and performance etc. is what creates stress-free environments during audits. Nothing else.
     
    Last edited: Nov 4, 2020
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @ValeriaGar ;
    I am all for digitization within areas the are appropriate. Tracking of change point control (including documentation) and nonconformities/corrective actions (data base allowing pareto and trend of nonconformities by failure mode, customer, product, supplier, etc..etc..) come to mind and can indeed be extremely helpful tools.

    I would caution all viewers, however, to be extremely careful in regards to a software "QMS solution". A QMS is not a software or set of documents. It is much more than that. If a QMS and related activity (the aforementioned CPC and nonconformance tracking, etc...) can't be developed, understood, and managed WITHOUT a software, then a software is likely not going to help/be warranted. I would council that organization first develop PEOPLE (the Japanese refer to this as Hito zukuri) and culture specific to the QMS. Once the QMS is a functioning foundation of the organization, then software tools can be added, as/IF needed to support the activities.

    Hope this helps.

    Be well.
     
    ValeriaGar and Andy Nichols like this.

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