Exclusions or justification for non-applicability of IEC standards

B

Bryan Arriola

Registered
#1
#1
We are about to ship our samples to meet the IEC standards associated with FES medical devices, in relation to IEC 60601 General and collateral testing. If there are requirements that we cannot meet for example the emergency button, can the scope of compliance be omitted or justify why it does not meet? Doesn't that affect obtaining certification?

I was reading in this forum that it is recommended to accredit certain points of the general rule, more subjective points such as PEMS, it was possible to carry out internal documentation and then trace the compliance of said points
 
Download Free White Paper
Elsmar Forum Sponsor
Y

yodon

Leader
Super Moderator
#2
#2
Meeting standards gives you a presumption of conformity to applicable regulatory requirements. If you don't meet them, you may try to provide a risk-based justification why it wasn't necessary to meet but, indeed, it could certainly result in denial of certification.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Exclusions allowed in AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
H AS9100D Exclusions, if Not Excluded Is it Automatically Applicable? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L IATF 16949 8.3 Exclusions Manufacturing and Related Processes 5
H Exclusions to ISO9001:2015 Manufacturing and Related Processes 9
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F AS9120B - Exclusions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B ISO 13485 exemption and/or exclusions ISO 13485:2016 - Medical Device Quality Management Systems 5
M Eligibility for certification to IATF 16949 - Exclusions IATF 16949 - Automotive Quality Systems Standard 1
C ISO13485 exclusions for design and automation company ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 9001 2015 Exclusions - Product Design is purchased. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M AS9100D - Updating Scope Exclusions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
R Exclusions to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C TS 16949 Exclusions outside of clause 7.3 IATF 16949 - Automotive Quality Systems Standard 6
M Exclusions clause 7.3 - Our organization doesn?t design products - ISO/TS 16949 IATF 16949 - Automotive Quality Systems Standard 6
I AS9100 - What QMS Exclusions are allowed? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S How to document "Exclusions" in the Quality Manual AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 26
M TS16949 Exclusions - Design & Development is carried out by our parent company IATF 16949 - Automotive Quality Systems Standard 14
B TS16949 - 7.3 Design and Development Exclusions for a Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
x-files [Exclusions] 7.3 Design and development vs. Thermal Powerplant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Quality Manual Statements - ISO 9001:2008 Design and Development Exclusions Design and Development of Products and Processes 6
A ISO 9001 Certificate with EXCLUSIONS Statement Design and Development of Products and Processes 7
T Need Exclusions to be shown in ISO 9001 Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J ISO13485 Clause exclusions for a Medical Software Company ISO 13485:2016 - Medical Device Quality Management Systems 9
N Permissible Exclusions for QM ISO9001:2008 Audit and Consultancy Services Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Permissible ISO 9001 Exclusions/Omissions for the Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A ISO 13485 Section 7.3 Design & Development Exclusions ISO 13485:2016 - Medical Device Quality Management Systems 7
S ISO 9001 Clause 7 Exclusions and Justifications for a Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
L ISO 9001 Registration of 1 Plant in a Company - Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Question about Design Exclusions - Clause 7.3 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Quality System Manual - Exclusions from ISO 13485 Clause 7.5 ISO 13485:2016 - Medical Device Quality Management Systems 4
W ISO 9001:2008 Clause 7.3 Design and Development Exclusions Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Guidance on ISO 9001 Clause 7.3 Design and Development Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J AS9101C - Scoring for Unjustifiable Non-Addressed Clauses (Exclusions) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
W ISO 9001 Clause 7.3 Design and Development Sub-Clause Exclusions Design and Development of Products and Processes 14
T Exclusions for IT services - ISO 9001 Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R ISO 9001:2008 Permissible Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
L Same Quality Manual - Different Exclusions (multisite) - 7.3 Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Design authority for a plastic product for the HGV industry - Possible Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J MDD Class III Exclusions EU Medical Device Regulations 2
N What Exclusions to the ISO 9001 standard are allowed? Clause 1.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Exclusions from clause 7.5 (Production and Service Provision) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Permissible exclusions in ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Exclusions and Conflicting Quality Manuals between Plants and Divisons Quality Management System (QMS) Manuals 10
S Recruiting and Staffing Firm - Exclusions Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Exemptions and/or Exclusions from procedures Document Control Systems, Procedures, Forms and Templates 22
A Exclusions for Service/Construction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Product Realization Procedures and Exclusions for a Small Consulting Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
R Advice for Exclusions for Construction Company needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Acceptable QMS Scope Exclusions in a Multi-National Setting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
K Permissible Exclusions - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 158

Similar threads

Top Bottom