Scope of Risk Management in ISO13485 vs. ISO 14971/EU MDD

C

cjssag

My reading of the EU MDD and ISO14971 seem to limit the identification, analysis and management of hazards to those that may result in harm to persons, ie. personal safety. ISO13485, on the other hand, apprears to be broader, going to any hazard that may cause a product to malfunction, fail to meet specs, and harm to persons. While this may be a distinction without a difference (if my reading is correct) for firms who must comply with both the EU MDD and ISO13485, I would appreciate receiving the opinion of more experienced members of the Forum. Thanks
 
Stijloor

Stijloor

Leader
Super Moderator
cjssag said:
My reading of the EU MDD and ISO14971 seem to limit the identification, analysis and management of hazards to those that may result in harm to persons, ie. personal safety. ISO13485, on the other hand, appears to be broader, going to any hazard that may cause a product to malfunction, fail to meet specs, and harm to persons. While this may be a distinction without a difference (if my reading is correct) for firms who must comply with both the EU MDD and ISO13485, I would appreciate receiving the opinion of more experienced members of the Forum. Thanks
Click to expand...

Can someone help?

Thank you!

Stijloor.
 
Y

yodon

Leader
Super Moderator
Sorry for the delay in replying... been a bit swamped.

I'm not sure I see much of an issue here. If a device fails to function properly, there's a potential for harm - almost inherently with the nature of the beast. The device is expected to do something medical related. If it doesn't do that, it could cause harm - whether it be directly (e.g., shock) or indirectly (e.g., fails to give accurate results which could cause an incorrect diagnosis or delayed treatment).

You need to be creative in identifying potential hazards and look beyond the obvious.

Not sure if that fully answers your question. If not, let me know and I'll try again.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
Z Risk Management related to IT scope Software Quality Assurance 1
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
Enghabashy Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
M Can Scope of Equipment Control be Tied to Risk? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Z Design verification test sample size under the scope of first in human study submission in Europe Medical Device and FDA Regulations and Standards News 3
L Review of Scope of Mangement System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Adding a Processing site to scope, shipping before certification? IATF 16949 - Automotive Quality Systems Standard 2
L AS9100 work for another site outside scope AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Audit Duration Calculation - ISO9001 + EN9100 with different scope General Auditing Discussions 2
S Smart Scope Fixturing Quality Tools, Improvement and Analysis 3
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
S 7.1.5.3.1 Internal Lab Scope IATF 16949 - Automotive Quality Systems Standard 15
Tagin Corporate HQ handles AR/AP - Outsourced or Out-of-scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D API Q1 clause (1.0) Scope Oil and Gas Industry Standards and Regulations 1
Q Considering addition of mass calibration to ISO17025 scope ISO 17025 related Discussions 6
C ISO13485 scope as Legal Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H IEC 62368-1 Scope of Testing CE Marking (Conformité Européene) / CB Scheme 3
A Laboratory scope on the IATF IATF 16949 - Automotive Quality Systems Standard 5
I Restricting scope to one part number for one customer IATF 16949 - Automotive Quality Systems Standard 6
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M AS 9100 Scope for Repair Station with PMA approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
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
Q Kap.4.3 Determining the scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Internal Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 10
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 7
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 19
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 2
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
Q The scope of ISO 21534 Other Medical Device Related Standards 0

Similar threads

Top Bottom