Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated

#1
Our product is media for the cell and gene therapy industry, and it is not regulated. Our customer requires us to become certified to ISO 13485:2016. Can we claim an exclusion to Design and Development?
 
Elsmar Forum Sponsor

engemerson

Starting to get Involved
#3
hello you can delete the item yes, as long as you don't have a product that is developed by you. (machining service is provided, for example, manufactures according to the drawing sent by your customer).
whether or not regulated, it needs a project and that it is within its QMS.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#5
Our product is media for the cell and gene therapy industry, and it is not regulated. Our customer requires us to become certified to ISO 13485:2016. Can we claim an exclusion to Design and Development?
Absolutely not. You are design responsible, so you cannot justify an exclusion or non applicability of the product design process and still claim conformity with 13485.
 
#7
Yeah, I know - I wanted verification from others because I was told by someone internal to my company that because we were not a device, and are not regulated overselves, we would not have to follow D&D - I was able to present data from the introduction section of the standard itself that almost convinced them.
 
#8
We were in the same position, looking at the part in the intro that says you may exclude parts of 6,7, and 8 if they are not applicable. But if you are conducting D&D they are applicable. Our only exclusions are for servicing, sterile and implantable items. We use risk assessment to justify varying levels of control over for example reagents purchased for research purposes or for product manufacturing.
 

LUFAN

Involved In Discussions
#9
Our only exclusions are for servicing, sterile and implantable items. We use risk assessment to justify varying levels of control over for example reagents purchased for research purposes or for product manufacturing.
Just to clean up some language, only section 7.3 can be "Excluded", all other sections would be "Not Applicable." Make sure to reference it like that in your quality manual. I've seen findings be issued for that despite how ticky tack it is, it's explicitly stated in the document as quoted below.

“If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.”

“If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.”
 
#10
You do not design or manufacture a medical device, so complying with ISO 13485 does not quite make sense. You say your customer is requiring it. I would ask them why. The design and development section of the standard my be excluded because you do not design or manufacture a medical device. On the other hand, this section does not say design and development of a medical device, it says design and development of "product." Murky.
However, if you follow ISO 9001 (which makes more sense in my opinion), design and development does apply to you. Perhaps it makes sense to reach out to your supplier and see if they would accept a certification to ISO 9001.
 
Thread starter Similar threads Forum Replies Date
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
K Design and Development Exclusion Quality Management System (QMS) Manuals 1
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
S Design and Development Procedure with Design Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Justification for Exclusion of Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 8
somashekar Exclusion of Design and Development Controls for Class 2B Medical Devices EU Medical Device Regulations 8
Y Clarification on ISO 9001 - Exclusion of Design and Development, Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Design and Development Exclusion - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Design and Development, Support parts - Clause 7.3 Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Can this be a case for Design and Development Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 64
D Do we need to include ISO 9001 Clause 7.3? Design and Development Exclusion Design and Development of Products and Processes 8
Q Sister Company makes Cables & Wires - Design & Development Exclusion Design and Development of Products and Processes 1
R Design and Development exclusion? We repair and refurbish electric motors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Design & Development in Food and Beverage Services - Permissible exclusion or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
H Exclusion of Design and Development Requirements (7.3 & sub-clauses) in TS16949? Design and Development of Products and Processes 9
M Exclusion of Design and Development - Construction and Renovation of Premises Design and Development of Products and Processes 11
Q Exclusion of Design and Development Controls - ISO 13485 Section 1.2 Design and Development of Products and Processes 6
S EN AS 9100 Permissible Exclusion and Provision - Aerospace design and development Design and Development of Products and Processes 4
C ISO 9001:2000 clause 7.3 Design & Development Exclusion - Collagen casing for sausage Design and Development of Products and Processes 19
I Design & Development - Exclusion of 7.3 - We Manufacture to Customer Prints Design and Development of Products and Processes 14
K Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validation Design and Development of Products and Processes 6
J Acceptable Wording in the Quality Manual - Design and Development Exclusion Quality Management System (QMS) Manuals 12
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
D IATF 16949 Design Exclusion Clauses which can be N/A IATF 16949 - Automotive Quality Systems Standard 7
I ISO 9001 Scope - Exclusion of Design in an engineered solutions company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
B AS9100 - Exclusion for 7.3 Design and Developement as we do not design AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Can Design & Dev (7.3) Be An Exclusion For A Facilities-based Service Company? Service Industry Specific Topics 7
M TS16949 Design Exclusion when Design is done in a different Facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A We do not design anything brand new from scratch - Design Exclusion? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Consultancy company - ISO 9001 Implementation and Design Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
armani ISO 9001 Clauses 7.5.1 and 7.5.2 - Exclusion for Design Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Service Provider in NC Programing and Design - Exclusion clause in AS 9100 Rev C Quality Manager and Management Related Issues 5
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
J ISO 13485 Requirements - Design Exclusion - Predicate Products Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Exclusion of clause 7 design sub clauses? Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Design Validation - Justifiable Exclusion for an Electrical Engineering Consultancy Design and Development of Products and Processes 11
S Design Exclusion - Drawings with Material Specifications from Outside Source AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 38
Casana Exclusion of 8.3 for Design only scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J TS 16949 - Design Exemption - Seeking a procedure/exclusion verbiage IATF 16949 - Automotive Quality Systems Standard 3
N Design: To claim exemption, or not to claim exemption (exclusion) Design and Development of Products and Processes 23
A Exclusion of Purchasing Process - Consumer Electronics Product Design House Design and Development of Products and Processes 1
J Design Exclusion for AS9100B and not ISO 9001 - 7.3 Design conflicts Design and Development of Products and Processes 16
D Company doesn?t design product - Exclusion of clause 7.3 Design and Development of Products and Processes 14
T TS 16949 Clause 6.2.2.1 - Product Design Skills Exclusion Design and Development of Products and Processes 1
B Design Exclusion Text - Will an auditor buy this? Design and Development of Products and Processes 14

Similar threads

Top Bottom