ISO13485 exclusions for design and automation company

C

cosina

Registered
#1
#1
Hi All,
I am new here, I have a question for a company that do not produce medical device, but they supply Design & Automation line to the Medical device Manufacturer which is their customer. Practically, they do not need to be certified ISO13485, but the customer request them to be certified ISO13485 in order for them to sign a business contract.
Their business are in design and automation, where they will build the machines and software (manufacturing line) for the customer. Test run the manufacturing line and then transfer the whole line to customer's premise.
Hence, I would like to enquire what are the exclusions can the company apply since they do not have any medical device products manufacture in their premise?
 
Download Free White Paper
Elsmar Forum Sponsor
M

Marcelo

Inactive Registered Visitor
#2
#2
ISO 13485 only allows for exclusions when regulatory requirements allow to (and only for design and development controls).

On the other hand, you can deem non-applicable requirements from clauses 6, 7 and 8 due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied.
 
somashekar

somashekar

Leader
Admin
#3
#3
cosina said:
Hi All,
I am new here, I have a question for a company that do not produce medical device, but they supply Design & Automation line to the Medical device Manufacturer which is their customer. Practically, they do not need to be certified ISO13485, but the customer request them to be certified ISO13485 in order for them to sign a business contract.
Their business are in design and automation, where they will build the machines and software (manufacturing line) for the customer. Test run the manufacturing line and then transfer the whole line to customer's premise.
Hence, I would like to enquire what are the exclusions can the company apply since they do not have any medical device products manufacture in their premise?
Click to expand...
Weird is this business world that does not understand the scope of a specific standard. It may be making a business sense, but what product and service you are into, nowhere calls for the ISO 13485. Now that we both understand this, if you contract with a CB, and he is ready to certify you to ISO 13485., then it will be another height of weirdness.
Can you ask your CB to respond back in writing telling that you cannot be certified to ISO 13485 because you are not making a medical device per the definition in the ISO 13485, however you are fit case for the ISO 9001, (perhaps you are) ..... and this helps your cause in the business contract... ??
.....just my 2 cents, others may disagree.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J ISO13485 Clause exclusions for a Medical Software Company ISO 13485:2016 - Medical Device Quality Management Systems 9
D 6 mandatory documents for ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
L ISO13485:2016 and Subsidiary Company ISO 13485:2016 - Medical Device Quality Management Systems 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
C ISO13485 scope as Legal Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 2
L Non Applicability of Clauses in ISO13485 for Medical Devices Medical Device and FDA Regulations and Standards News 4
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
B ISO13485 Risk managment implementation for suppliers ISO 14971 - Medical Device Risk Management 2
chris1price ISO13485: 2016 Amendment coming? ISO 13485:2016 - Medical Device Quality Management Systems 13
B ISO13485 Standard Documentation Packages ISO 13485:2016 - Medical Device Quality Management Systems 2
J The necessity and benefit of ISO13485:2016 for a manufacturer of class I devices ISO 13485:2016 - Medical Device Quality Management Systems 3
F Is USB-IF standard compliant with ISO13485? Medical Device and FDA Regulations and Standards News 3
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 9
A When will ISO13485 Update be Released? EU Medical Device Regulations 1
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 11
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
V Iso13485 certification vs CE technical audit ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO13485:2016 7.5.6 Process Validation Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
D Customer Audit Finding ISO13485:2016 7.6 ISO 13485:2016 - Medical Device Quality Management Systems 7
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S PPT for ISO13485:2016 Employee Training (Request) ISO 13485:2016 - Medical Device Quality Management Systems 0
qualityegghead ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
R ISO13485/ISO9001 Convenient Document Management System Document Control Systems, Procedures, Forms and Templates 3
S ISO13485 2016 - What the upshot is of failing to upgrade on a medical diagnostic device ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO9001 & ISO13485 QMS for 2 types of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M ISO13485 Documentation packs (manual, procedures, forms etc) ISO 13485:2016 - Medical Device Quality Management Systems 3
H ISO13485:2016 Measurement System - Methods General Measurement Device and Calibration Topics 4
C ISO13485/9001 clause 6.3 (Infrastructure) ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO13485:2016 Cl. 7.5.1 - Production and Service Provision - Medical Device Repairs ISO 13485:2016 - Medical Device Quality Management Systems 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M ISO13485:2016 - Exemption vs. Not Applicable ISO 13485:2016 - Medical Device Quality Management Systems 16
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO13485:2016 Clause 6.3 - Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO13485:2016 Clause 4.2.3 - Changes in Technical File Requirements ISO 13485:2016 - Medical Device Quality Management Systems 18
T ISO13485 cert expired - Product still CE Marked CE Marking (Conformité Européene) / CB Scheme 1
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
C Is there a strong market out there for ISO13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 11
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
L ISO13485 past practice labeling vs customer requirement Other ISO and International Standards and European Regulations 2
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3

Similar threads

Top Bottom