Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and...

armani

Involved In Discussions
#1
Anybody has an example for implementing 6.1.1 (and 6.1.3 NOTE) ....."determine risks and opportunities associated with compliance obligations"?
What this means? How to approach?
Do I have to identify risk and opp for every compliance obligations?? - this would man hundreds of risks etc.
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and

Anybody has an example for implementing 6.1.1 (and 6.1.3 NOTE) ....."determine risks and opportunities associated with compliance obligations"?
What this means? How to approach?
Do I have to identify risk and opp for every compliance obligations?? - this would man hundreds of risks etc.
Here is a thread that might give you a better understand between the differences of the 2008 vs 2015. It breaks it down very well. Look at the file attached. It might help you answer your question.

https://elsmar.com/Forums/586980-post1.html

The 2015 standard requires the organization to determine the risks associated with the Quality Management System and what type of mitigation to reduce or eliminate the risks. I would presume, your Organization already has something that identifies the risks. Most Organizations do. They just may not document them.

Just my opinion.

Edit Note: This reply appears to be a response with respect to ISO 9001 rather than ISO 14001.
 
Last edited:
Thread starter Similar threads Forum Replies Date
W Compliance Obligations - legislative, regulative and others Miscellaneous Environmental Standards and EMS Related Discussions 4
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 4
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
L AS9146 Implementation and Compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 2
R Foam mattresses used in hospitals - compliance with MDR requirements? EU Medical Device Regulations 6
E Machines in Europe not in compliance with the EC directive CE Marking (Conformité Européene) / CB Scheme 0
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R Role of quality compliance in SAP Software Quality Assurance 2
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
T Rumours that class 1 NS, NM, NR devices will have a new deadline for MDR compliance EU Medical Device Regulations 3
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
I CAP/CLIA Environment - Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 3
M Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR Medical Device and FDA Regulations and Standards News 5
lilybef Medical Devices & US TAA (Trade Agreement Act) Compliance - 2019 Hospitals, Clinics & other Health Care Providers 5
M How is Class I Medical Device Compliance Enforced? EU Medical Device Regulations 7
N Comprehensive Compliance Matrix for Internal Audit Checklist Other Medical Device Regulations World-Wide 1
Kuldeep Singh Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine CE Marking (Conformité Européene) / CB Scheme 3
Kuldeep Singh IEC 60601-1-9 Compliance mendatory or Not - CT Scan machine CE Marking (Conformité Européene) / CB Scheme 8
L IEC 60601-1-11 IP22 Compliance - Ingress protection testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Relevance of Offsite backups process compliance and ISO 27001 certification. IEC 27001 - Information Security Management Systems (ISMS) 3
A System for Compliance Management (Medical Device) Qualification and Validation (including 21 CFR Part 11) 4
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
E Compliance to standards (ISO 80369) but the ID is out of specification Other ISO and International Standards and European Regulations 0
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
C Person Responsible for Regulatory Compliance - The RA guy/girl Employment Act EU Medical Device Regulations 4
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier Medical Device and FDA Regulations and Standards News 0
S Saving QMS documents in cloud drive - Compliance with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
E IEC 60601-1-2 compliance for accessories - Electromagnetic compatibility of the ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom