SBS - The Best Value in QMS software

ISO 13485 QMS sequence of implementation

racglobal

Involved In Discussions
#1
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!
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
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

Involved In Discussions
#3
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

Staff member
Super Moderator
#4
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

Post Responsibly
Staff member
Admin
#5
Thread starter Similar threads Forum Replies Date
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 9
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
R ISO 13485 purchasing QMS and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
S Saving QMS documents in cloud drive - Compliance with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
P QMS software recommendations for a small ISO 13485 company Quality Manager and Management Related Issues 5
S ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485:2016 - Validate our use of software that impacts on the QMS ISO 13485:2016 - Medical Device Quality Management Systems 12
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
A How do we implement a Process Approach ISO 13485:2016 - Existing GMP QMS Other ISO and International Standards and European Regulations 2
J ISO 13485:2016 QMS: Outsourced Processes ISO 13485:2016 - Medical Device Quality Management Systems 11
E ISO 9001 vs ISO 13485 or both? A QMS for a Design and Development Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Implementing ISO 13485 with an ISO 9001:2008 QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
N ISO 13485 Certification - Device Technical File in conjunction with QMS development ISO 13485:2016 - Medical Device Quality Management Systems 5
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
Q ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach? ISO 13485:2016 - Medical Device Quality Management Systems 4
A LEAN ISO 13485 QMS: How many Level 3 Procedures? ISO 13485:2016 - Medical Device Quality Management Systems 7
M ISO 13485 vs. TS 16949 - One or two QMS in a company ISO 13485:2016 - Medical Device Quality Management Systems 2
Y Training on the Basics of a QMS (Quality Management System) for ISO 13485 Training - Internal, External, Online and Distance Learning 4
A ISO 13485 Internal Audits Must Cover All Elements of QMS? Internal Auditing 13
T ISO 13485 QMS Documentation template wanted ISO 13485:2016 - Medical Device Quality Management Systems 3
A Paperless Compliance - Planning to set up an ISO 13485 compliant QMS ISO 13485:2016 - Medical Device Quality Management Systems 11
W ISO 13485, ISO 9001, and AS9100 Combined QMS Manual Quality Management System (QMS) Manuals 14
T Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision ISO 13485:2016 - Medical Device Quality Management Systems 5
P Can I perform an ISO 13485 audit? I'm a registered RABQSA QMS and AS9100 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 3
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
A How to do Equipment Validation - Establishing our ISO 13485 QMS procedures Qualification and Validation (including 21 CFR Part 11) 34
H cGMP calendar and ISO 13485 - Does ISO 13485 QMS require a cGMP calendar? ISO 13485:2016 - Medical Device Quality Management Systems 10
apestate Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
C ISO 13485:2003 QMS Flow - I have just put together my first draft ISO 13485:2016 - Medical Device Quality Management Systems 15
C Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485 Quality Management System (QMS) Manuals 3
R ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist ISO 13485:2016 - Medical Device Quality Management Systems 26
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom