Risk & opportunity assessment - ISO 14001

Q

qcstar

#1
#1
I'm quite lost in following concepts;

Risk & opportunity Assessment
Environmental aspect & impact
Hazard Identification and risk assessment...

No matter whatever I read about them,it get more confusing..

Can anyone help me understand the concepts.

Thanks
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Opportunity For Improvement vs Opportunity (Positive Risk) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
J Can a risk be an opportunity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Internal Audit - Risk and Opportunity (ISO 9001:2015 ) Internal Auditing 1
Q Risk/Opportunity in a combined ISO 9001 & 14001 System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
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 9
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 4
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 4
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
L Risk analysis Manufacturing and Related Processes 4
J Risk Analysis for Proficiency Testing Reliability Analysis - Predictions, Testing and Standards 1
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
M What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
D AS9100D 8.4.2 Note 2 Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Calculating Risk Estimation ISO 14971 - Medical Device Risk Management 29
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
H At what level (harm, hazardous situation, seq. of events, etc) is "risk" estimated? ISO 14971 - Medical Device Risk Management 12
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
B ISO 14001 Risk assesment ISO 14001:2015 Specific Discussions 4
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
S What is your favorite Usability Risk Analysis tool? IEC 62366 - Medical Device Usability Engineering 5

Similar threads

Top Bottom