ISO 13485 QMS sequence of implementation

[racglobal]

Hi everyone

While we are familiar with the QMS, for a company starting a QMS from zero, what is the recommended sequence of implementation? My thinking is to start with document control, training procedure and design control. Implement these documents and have everyone train on these procedures. And then implement all of the rest 20+ procedures including regional regulatory requirements. Getting people to train on each procedure as it is completed rather than waiting until all the SOPs to be implemented. I'd like to hear some insight from the experts in this forum.

Thanks!

 

[Tagin]

Assuming this is not a brand new company....my inexpert thoughts for an approach for a small company:

• Start with a gap analysis to identify where compliance to the standard is weak/missing.
• Document control system.
• Document the processes you have now (unless they are wildly not in compliance with the standard), and work outwards/downward from there.
• Create needed processes/procedures for remaining gaps.
• Train and implement.
• Monitor/revise.

Company personality and philosophy (and recalcitrance) is a big player in this, so YMMV. But however you do it, try to ensure that you build a QMS that supports your business, rather than forcing your business to be hamstrung by your QMS.

 

[racglobal]

Assuming this is not a brand new company....my inexpert thoughts for an approach for a small company:

• Start with a gap analysis to identify where compliance to the standard is weak/missing.
• Document control system.
• Document the processes you have now (unless they are wildly not in compliance with the standard), and work outwards/downward from there.
• Create needed processes/procedures for remaining gaps.
• Train and implement.
• Monitor/revise.

Company personality and philosophy (and recalcitrance) is a big player in this, so YMMV. But however you do it, try to ensure that you build a QMS that supports your business, rather than forcing your business to be hamstrung by your QMS.

To clarify, this is a brand new company.

 

[yodon]

I don't disagree with @Tagin but I would normally start with the Quality Manual. Set the framework for who the company is, what's applicable, etc.

No doubt that document and record control is a 'foundational' process so that's certainly done early on.

Things will need to be done in parallel. For example, if you train on procedures, you need some clue as to what your training program will be. Depending on what you're doing, you may need to get purchasing controls in early and/or design controls.

By the way, you mention "20+ procedures" - where did this number come from? Seems a bit high for a startup.

 

[Sidney Vianna]

I'd like to hear some insight from the experts in this forum.

You might benefit from the advice coming from the ISO TC 210:

​

Clicking on the above picture takes you to a preview of a publication with guidance on the implementation of the standard. You can decide later if purchasing the book is worthwhile. If so, ISO 13485:2016 - Medical devices - A practical guide