Is Risk Management Process compliant to ISO 14971 in absence of Hazardous Situations?

alimary15

alimary15

Involved In Discussions
Good afternoon,

I would like to know your opinion of the following topic:

Within an organization, would you say the Risk Management Process is complaint to ISO 14971 when there is no definition or documentation of hazardous situations?

Would a Risk Analysis that indicates Hazard, Cause ( intended as "events that lead to the Hazard") still be compliant to the ISO standard even though no Hazardous Situations ( Patient is exposed to Hazard) and sometimes no Harm were properly identified and documented?

To my understanding it is a requirement of the standard ( section 4.4) to have hazardous situations identified and documented.

Thank you very much
 
M

Marcelo

Inactive Registered Visitor
Re: Hazardous situation- Compliance with ISO 14971

Cause ( intended as "events that lead to the Hazard")
Click to expand...

This is wrong, please note that cause, in the context of ISO 14971, are initiating causes that leads to harm, not hazards.

Hazardous Situations ( Patient is exposed to Hazard) and sometimes no Harm were properly identified and documented?
Click to expand...

If there?s no exposure to hazard, there?s no harm, and there?s no risk involved. So no, if no hazardous situation is defined, it?s obviously not in accordance with ISO 14971 (although you do not need to defined ALL hazardous situation.

This is very clear in the title and requirement of 4.4:

4.4 Estimation of the risk(s) for each hazardous situation
Reasonably foreseeable sequences or combinations of events that can result in a hazardous situation shall be considered and the resulting hazardous situation(s) shall be recorded.
Click to expand...
 
alimary15

alimary15

Involved In Discussions
Re: Hazardous situation- Compliance with ISO 14971

Thanks Marcelo... It is as I supposed but being pretty unexperienced I wanted to have a confirmation. This will make a nice finding for my internal audit :p
 
alimary15

alimary15

Involved In Discussions
Re: Hazardous situation- Compliance with ISO 14971

I might have another question. Is it a requirement of ISO 14971 to identify and document the HARM related to each hazardous situation?
 
M

Marcelo

Inactive Registered Visitor
Re: Is Risk Management Process compliant to ISO 14971 in absence of Hazardous Situati

Is it a requirement of ISO 14971 to identify and document the HARM related to each hazardous situation?
Click to expand...

4.3 requires that you estimate the risk of hazardous situation, which means estimating probability of occurrence of harm and severity of the harm. You cannot estimate them if you don?t know the harm.

Please take a look at Figure E.1 for pictorial representation of the different definitions.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 13
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Streamlined Risk Management Process - Focus on Compliance with Standards ISO 14971 - Medical Device Risk Management 5
V Common Errors while Implementing Risk Management Process ISO 14971 - Medical Device Risk Management 9
S Do HF Accessories need to perform a Risk Management Process of 60601-1:2005? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L ISO13485 Cl. 7.1 Process Flow (Product Realization & Risk Management requirements)? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Who should "own" the Risk Management Process? ISO 14971 - Medical Device Risk Management 5
D Risk Assessment - Problem Management Process - Seeking Model/Example Software Quality Assurance 1
S KPIs (Key Performance Indicators) and Risk Management Process (ISO14971:2007) ISO 14971 - Medical Device Risk Management 5
B What to include in a "Risk management/FMEA" process FMEA and Control Plans 3
M Risk Management Process Workbook - Attached Files FMEA and Control Plans 28
Q Risk Management ISO 14971 - Probability of Occurrence ISO 14971 - Medical Device Risk Management 8
Z Risk Management SOP ISO 14971 ISO 14971 - Medical Device Risk Management 1
M Risk Management Plan ISO 14971 - Medical Device Risk Management 13
thisby_ Installation Related Issues and Risk Management ISO 14971 - Medical Device Risk Management 5
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
G Help:Risk Management - Accessories US Food and Drug Administration (FDA) 1
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
A Risk Management Team IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S Risk Management File - Procedure Packs ISO 14971 - Medical Device Risk Management 3
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
T Risk Assessment and Management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 1
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
U Supply risk management Manufacturing and Related Processes 4
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 9
D Cybersecurity and Risk Management: Loss of confidentiality IEC 62304 - Medical Device Software Life Cycle Processes 5
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5

Similar threads

Top Bottom