SBS - The best value in QMS software

ISO 13485:2016 Clauses related to process matrix

Thomas Dorner

Starting to get Involved
#1
Hi,

I am very new to ISO 13485 and wonder if this forum can help me to develop a process matrix.

We have functional areas, which I am struggling with to relate to iso clauses. In other words, I am looking for examples that others might have in place and they are willing to share, to get an better idea which clauses relate to what function. Confusing? Well, it is to me.

I appreciate all the help I can get, to develop such a matrix.

Thank very much in advance for your help,
Tom
 
Elsmar Forum Sponsor

William55401

Involved In Discussions
#2
Welcome to the Cove. I see that there is no response so far and here's a quick take to get things moving. Thomas, this is a big topic. There is no one way to deploy a QMS standard. Orgs (lead by 5 - Mgmt Responsibility) decide how best to deliver results. That means, how are they organized and deciding who does what? Rarely, is a single function responsible for getting something done. Sure, certain functions may lead (and own and maintain the QMS procedures) for an element of the standard. However, other functions, beyond the owner, participate to deliver results. With all the above as prelude, here's a typical deployment IMHO. Others, please jump in. (The numbers below refer to sections from 13485)
  • 4 Quality Mgmt System - Owned by Quality Function
  • 5 Mgmt Responsibility - Owned by Top Mgmt and Deployed to functional mgmt
  • 7 Product Realization
    • Design & Development. Engineering owns this core process with all impacted functions actively participating (that means they have roles in the Design Control procedures
      • Marketing
      • Design Assurance (Pre Production Quality)
      • Risk Mgmt - 14971 fun
      • Reg Affairs
      • Mfg answers the question of how do they plan. Big area here is process validation
      • Purchasing / Sourcing / Supply Chain - this group has many names depending on the org
  • 8 Measurement, analysis and improvement
    • Typically, quality owns the Complaint, NC, and CAPA processes. All impacted functions participate (but rarely Marketing).
This is what I can share for now. Hope this helps. Have fun. Enjoy the ride.
 
Last edited:

Tagin

Trusted Information Resource
#4
In other words, I am looking for examples that others might have in place and they are willing to share, to get an better idea which clauses relate to what function. Confusing? Well, it is to me.
Thinking of it in this way causes the confusion. Been there, done that. :) It's understandable to try to relate them that way, but its not how it works. As Sidney's matrix example illustrates, a requirement in a clause may apply to multiple processes. So, what you want to do for each function (aka process) is go process by process and ask: how does each requirement in each clause apply to this process?

Then, afterwards, you can look at each clause listed and see if there are no processes covering a particular clause or requirement, and those will be the gaps you need to fill in, either with other processes, or modifications/enhancement to existing processes.
 
Thread starter Similar threads Forum Replies Date
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
C What falls under the 'Customer Property' according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
F ISO 13485:2016 Quality Policy Requirements Other ISO and International Standards and European Regulations 18
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
J ISO 13485:2016 sample exam/test ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational Questionário – Análise crítica sistemática – ISO 13485:2016 (Portuguese-only) Medical Device and FDA Regulations and Standards News 0
M Informational ISO 13485:2016 under systematic review Medical Device and FDA Regulations and Standards News 5
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
D ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control ISO 13485:2016 - Medical Device Quality Management Systems 2
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2

Similar threads

Top Bottom