Risk Impact - Risk Assessment Sample/Method per ISO 9001:2015

Q

QAMTY

Hi all
Does anybody can share a sample of how to apply risk assessment?
I refer to the methodology to use in order to evaluate the impact of the risk.
For example: I already detected the risk, i.e. delivery to client, ok I know it, I may have other in other process, (machine failure).

But how to apply to them the real impact? I have seen somewhere that is possible to assign likelihood, priority, and some other qualifiers.

Could you recommend what methodology to apply at evaluating risks
under iso 9001 2015?

thanks in advance
 
M

mpaul2277

QAMTY said:
Hi all
Does anybody can share a sample of how to apply risk assessment?
I refer to the methodology to use in order to evaluate the impact of the risk.
For example: I already detected the risk, i.e. delivery to client, ok I know it, I may have other in other process, (machine failure).

But how to apply to them the real impact? I have seen somewhere that is possible to assign likelihood, priority, and some other qualifiers.

Could you recommend what methodology to apply at evaluating risks
under iso 9001 2015?

thanks in advance
Click to expand...

The risk impact will be more dangerous when we consider the connected medical devices especially safety and life saving devices installed at Hospitals. In US the FDA is now on record requiring that manufacturers assess security risks and maintain medical device functionality and safety through carefully chosen cybersecurity controls. It will be high time to secure the networks with regular audits and documentations.

I have been using Opsfolio(from Netspective Communications LLC) and their supports for our cybersecurity risk framework, conduct comprehensive assessments, implement cybersecurity standards, and document your infrastructure, threats, vulnerabilities
 
Last edited by a moderator:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
qualprod Propose Aspects to evaluate risk impact? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
qualprod Risk impact can be modified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Difference between Environmental Impact and Risk ISO 14001:2015 Specific Discussions 7
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
T Risk based Impact Level related to Customer Complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Aspect Impact Analysis & Risk Assessment Technique Miscellaneous Environmental Standards and EMS Related Discussions 8
S Aspect vs. Impact and Hazard vs. Risk - Short/clear explanation & example Miscellaneous Environmental Standards and EMS Related Discussions 11
J Introducing a risk/impact assessment to nonconformity procedure ISO 13485:2016 - Medical Device Quality Management Systems 12
M Defining High/Medium Risk Impact Misc. Quality Assurance and Business Systems Related Topics 11
D CE product Risk assement CE Marking (Conformité Européene) / CB Scheme 3
M Q: In what circumstances can a clinical investigator submit an EFS/IDE for the Significant Risk Device? US Medical Device Regulations 1
T Article 22 procedure pack risk analysis EU Medical Device Regulations 1
S Risk analysis on patient monitor ISO 14971 - Medical Device Risk Management 5
John Broomfield NATURAL CAPITAL AT RISK Misc. Quality Assurance and Business Systems Related Topics 7
MaHoDie How deep should be risk control tracebility IEC 62304 - Medical Device Software Life Cycle Processes 3
D Objective Measures for Risk Acceptability? ISO 14971 - Medical Device Risk Management 6
D Risk Based Sample Size and Standards Compliance ISO 14971 - Medical Device Risk Management 2
austin_howell Labeling Controls affecting Probability and Risk ISO 14971 - Medical Device Risk Management 7
J Determination of software safety class (62304) prior to software risk analysis ISO 14971 - Medical Device Risk Management 3
Q Risk acceptance for missing DHR info and saving records ISO 13485:2016 - Medical Device Quality Management Systems 11
G FDA requirements for risk analysis US Food and Drug Administration (FDA) 2
T Corrective Action Risk Matrix AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
B Fluorescent Video System risk class EU Medical Device Regulations 6
A Risk Assessment for ISO 13485:2016 section 7?? ISO 13485:2016 - Medical Device Quality Management Systems 11
L HA vs risk analysis ISO 14971 - Medical Device Risk Management 2
Q Risk Controls in PFMEA ISO 14971 - Medical Device Risk Management 12
D What do you think of Chat GPTs answer to this Risk Acceptability question? ISO 14971 - Medical Device Risk Management 5
Richard Regalado Two risk assessments for ISMS IEC 27001 - Information Security Management Systems (ISMS) 0
M Risk-based approach to Test Method Validation for Design Verification? US Medical Device Regulations 5
N Effective use of a Risk Register - Bumper sticker or Mission Control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
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
J Risk, contingency, and MOC. General Auditing Discussions 1
K Help with ISO 14971: Benefit-Risk Analysis ISO 14971 - Medical Device Risk Management 3
T AS9100D Risk-Based Internal Audit Schedule AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
thisby_ Installation Related Issues and Risk Management ISO 14971 - Medical Device Risk Management 5
W Reconciling FMEA RPN ratings with Risk Acceptability ISO 14971 - Medical Device Risk Management 22
D How to address the content deviation of 'cannot apply criteria of risk acceptability prior to...' ISO 14971 - Medical Device Risk Management 1
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
T Risk based CA AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
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
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9

Similar threads

Top Bottom