ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach?

Q

QA compliance

#1
I am re-doing our QMS documents to add a common system with our sister companies. Is it better for the company to write the procedures using a process approach vs a compliance approach? Many of our SOP's should be work instructions and visa versa. (I have recently taken this over)
I have always done the compliance approach, but from what I am reading, the company is actually better protected using a process approach.
Thoughts?
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
Re: ISO 13485, ISO 9001 QMS and FDA reqmts.

I am re-doing our QMS documents to add a common system with our sister companies. Is it better for the company to write the procedures using a process approach vs a compliance approach? Many of our SOP's should be work instructions and visa versa. (I have recently taken this over)
I have always done the compliance approach, but from what I am reading, the company is actually better protected using a process approach.
Thoughts?
Your company's documents are for the people that work in the company and have to use the documents. Do what is best for them.

You should follow the process approach when performing internal audits. That does not mean that the documents should follow the process approach.
 
Last edited:

sagai

Quite Involved in Discussions
#3
this is one of my favourite.
I only would warn you not to confuse between documented process and documented procedure.
Process and procedure are NOT the same.
Standards and regulations are mostly requires documented procedure, which can not be the documented process.
Reason is simple, the process defined with its inputs and outputs, on the other hand, procedure are almost equal with work instruction, describing how to do something, not what are the inputs and outputs only.
br
Sz.
 
Q

QA compliance

#4
Thank you, Sagai!
I meant that I had always written to the standard and added extra required per company after that. I wondered if it would be better to first write our core processes as our main SOP's and go from there.
 

sagai

Quite Involved in Discussions
#5
:eek:
u do not have to write process definition, when it is not required by standard, or regulation, or there is no special request for that from your management.
:eek:
:notme:
Sz.
 
Thread starter Similar threads Forum Replies Date
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M Can veterinary implants be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 23
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Interesting Discussion Chapter 7.5 of ISO 13485 for manufacturers of mobile medical applications ISO 13485:2016 - Medical Device Quality Management Systems 4
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 5
E Theoretical project: Implementing ISO 13485:2016 into a start up acrylic bone cement manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO 13485: 2016 Lot numbering question ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Documented Evidence of Training ISO 13485: 2016 ISO 13485:2016 - Medical Device Quality Management Systems 33
D Customer Survey Example - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D Normative References for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
M Requirements ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
M ISO 13485 Clause 7.3.8 ---- on Business Transfer ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485--Question regarding performing calibrations in house. ISO 13485:2016 - Medical Device Quality Management Systems 13
I EN ISO 13485:2016/A11:2021 ISO 13485:2016 - Medical Device Quality Management Systems 0
A ISO 13485:2016 Clause 8.2.1 ISO 13485:2016 - Medical Device Quality Management Systems 3
FuzzyD ISO 13485:2016 Clause 8.2.6 ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Calibration Requirements- Assess and Record validity Previous measuring results ISO 13485:2016 - Medical Device Quality Management Systems 5
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
C ISO 13485 Clause 7.3.3 a) ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485, Clause 4.1.2 b) ISO 13485:2016 - Medical Device Quality Management Systems 12
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 2
B ISO 9001:2015 vs ISO 13485:2016 Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 9
K 3rd party auditor for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
chris1price MDSAP and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
D ISO 13485 Contained NC ISO 13485:2016 - Medical Device Quality Management Systems 3
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 36
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
J ISO 13485 for Metal Finishing Medical Device and FDA Regulations and Standards News 5
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20

Similar threads

Top Bottom