Exclusion of chapter 7.5 production for clinical investigation

#1
We used to have a full ISO 13485 certification incl. production (7.5) for many years. The auditor of the certification body complained several years, that we don't produce and bring medical devices on the market (which is true). We do only develop up until a clinical investigation and then we sell the IP or spin off.
So we changed the scope and excluded 7.5 and he was happy.
No we got a new auditor (same Swiss certification body) and he now wants 7.5 back described completely, because we are planning a clinical investigation for a developed medical device (investigational device). The package for the investigational device currently has our company name prinetd as manufacturer.
We are now totally confused.
Do we need to describe 7.5 in our system for a clinical investigation only? We will never bring anything on the market ourselves.
 
Elsmar Forum Sponsor

somashekar

Leader
Admin
#2
We used to have a full ISO 13485 certification incl. production (7.5) for many years. The auditor of the certification body complained several years, that we don't produce and bring medical devices on the market (which is true). We do only develop up until a clinical investigation and then we sell the IP or spin off.
So we changed the scope and excluded 7.5 and he was happy.
No we got a new auditor (same Swiss certification body) and he now wants 7.5 back described completely, because we are planning a clinical investigation for a developed medical device (investigational device). The package for the investigational device currently has our company name prinetd as manufacturer.
We are now totally confused.
Do we need to describe 7.5 in our system for a clinical investigation only? We will never bring anything on the market ourselves.
Hi .. I hope your justification for Clause 7.5 non-application is well detailed. Hope you can share it here.
If I were in your place, I would rather state that 7.5.1 as Non-applicable with proper justification, likewise for the other Clauses 7.5.x. I would definitely have 7.5.8 applicable and then have a simple procedure to describe how product is identified in the clinical evaluation phase, and follow that in product identification at Clinical evaluation. Note that 7.5.8 is applicable throughout product realization (Clause 7)
Now, The device you have made for clinical / performance evaluation is not considerd to be released for use to the customer, ie., the design output transfer to manufacturing has not happened. You therefore suitably label the device as "clinical evaluation device - Not released for use to customer". You can have your company name for identification without using the word "Manufacturer". Please see Clause 7.3.7 where in, it is clearly mentioned that Validation shall be completed prior to release for use of the product to the customer. Clinical evaluation is a part of Design and development validation.
 
Thread starter Similar threads Forum Replies Date
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
P Exclusion of clause 8.2.3 Reporting to regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 7
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
Z Why Control Limits are not the same depending on type of exclusion of data points Using Minitab Software 7
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
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 exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C 6.3Infrastructure & 6.4Work environnement & contamination control exclusion ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
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
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
M Exclusion of IATF 16949 Clause 4.4.1.2 - Product Safety IATF 16949 - Automotive Quality Systems Standard 2
SATHYABALARAMAN Exclusion of IATF 16949 Clauses - 8.5.5.1 & 8.5.5.2 & Justification IATF 16949 - Automotive Quality Systems Standard 9
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
T Exclusion of 7.3 for infrastructure consulting company Service Industry Specific Topics 4
S Design and Development Procedure with Design Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Office that only manages Contracts - Exclusion of Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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
Crusader Service-Type Supplier Evaluation Exclusion? Supplier Quality Assurance and other Supplier Issues 12
tony s Permitted exclusion on ISO 9001 but not on ISO/TS 16949 Misc. Quality Assurance and Business Systems Related Topics 5
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Justification for Exclusion of Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 8
H New Multiple Sites - Scope Change or Exclusion(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 9001 Clause 7 Exclusion in a Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A We do not design anything brand new from scratch - Design Exclusion? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Non-Conformance for Not Taking Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M 7.5.2 Exclusion in a Contract Procurement Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Consultancy company - ISO 9001 Implementation and Design Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Exclusion to Purchasing - AS9100 Clauses 7.4.1 & 7.4.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Exclusion of Medical Device Reporting of Components for Medical Systems ISO 13485:2016 - Medical Device Quality Management Systems 4
somashekar Exclusion of Design and Development Controls for Class 2B Medical Devices EU Medical Device Regulations 8
S ISO9001 Exclusion 7.6 Control of Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
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 Permissible Exclusion for Clause 7.5.2 in a Real Estate Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
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
V Exclusion of 7.4.1 in a company that is part of a group ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Justifying Exclusion of Clause 7.3 in a Service Organization. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
B Customer Property Exclusion as it applies to Personal Data ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Exclusion of AS9100C Clause 7.1.1 and Clause 7.1.3 for a Small Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
J Labeling Contraindication vs. Clinical Trial Exclusion Criterion Other US Medical Device Regulations 7
B Design and Development Exclusion - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 13485 Requirements - Design Exclusion - Predicate Products Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 8
somashekar Definition Exclusion vs. Non-Application - Definitions in ISO 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1

Similar threads

Top Bottom