6 Risks and Opportunities ISO 14001:2015

Elsmar Forum Sponsor

junior1505

Involved In Discussions
#3
Dear Jacquie Collins,
Aspect and Impact register is different with the Legal (Compliance) Register. In AI register, you trace the activities and process to the relevant and/or prescribed legislation and the action plans towards the same. Legal (Compliance) Register is where you depict the compliance of the said rule and/or clause for specific and what, when, how you have complied with what documentation and to whom or which board. These are two different issues.
 

John Broomfield

Staff member
Super Moderator
#4
One useful self-imposed rule is to say if an aspect is regulated then it is significant.

Then you add the regulated aspects to all the other aspects with significant beneficial and adverse environmental impacts.

You can then extend this table (conceptually or actually) to see all the process controls you need.
 

Randy

Super Moderator
#5
One useful self-imposed rule is to say if an aspect is regulated then it is significant.

Then you add the regulated aspects to all the other aspects with significant beneficial and adverse environmental impacts.

You can then extend this table (conceptually or actually) to see all the process controls you need.
1 -You are so totally incorrect, just because something is regulated doesn't make it significant

2 - Adding regulated aspects to all others is not required or necessary (your creating unnecessary step that can lead to failure)

3 - There isn't even a need for a table if the organization doesn't want one.

Hey Jacquie.....refer to "Annex A.6.1 Actions to address risks and opportunities" of your 14001 standard most of your questions can be answered there.

There's no wild science, crazy math or flawless legal knowledge needed, just do what works for you that supplies the result you need
 

John Broomfield

Staff member
Super Moderator
#6
1 -You are so totally incorrect, just because something is regulated doesn't make it significant

We know this. That is why I said it is self-imposed.
 
Thread starter Similar threads Forum Replies Date
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
Q Opportunities only derived from Risks? Detecting Risk & Opportunities in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Are Risks and Opportunities Required as Part of the Process Definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Risks and Opportunities associated to Legal Compliance - 6.1.3 ISO 14001:2015 Specific Discussions 4
O Examples of the external and internal issues and their risks and opportunities IATF 16949 - Automotive Quality Systems Standard 2
Q Risks and opportunities that could be associated with the purchasing department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H Depth in the organization for Interested Parties and Risks & Opportunities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
Q SWOT Outputs - Risks, Opportunities and Improvements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
M Informational Is Identification of Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 97
placebo_master Risks of executing a verification protocol against existing data ISO 13485:2016 - Medical Device Quality Management Systems 4
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Benefits and Risks Other US Medical Device Regulations 0
L Reduce risks as far as possible - Quartz Crystal ISO 14971 - Medical Device Risk Management 11
S Cyber Security and Safety Risks Medical Information Technology, Medical Software and Health Informatics 5
I Сorrespondence between hazards and risks ISO 14971 - Medical Device Risk Management 2
T Risks of failure to meet intended use ISO 14971 - Medical Device Risk Management 6
L Sampling Plan Risks AQL - Acceptable Quality Level 6
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 19
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4
Robert Stanley I'm @ RISK of not showing my RISKS! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
M Informational How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier Medical Device and FDA Regulations and Standards News 0
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
M FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Medical Device and FDA Regulations and Standards News 0
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Redundancy between Process risks and Process Performance indicators ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Sidney Vianna Guidance on Management of Psychosocial Risks in the Workplace Occupational Health & Safety Management Standards 5
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Practical guide to scan for Risks in all QMS systems without missing any ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Risks Examples in Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Source of practice to Evaluate Risks? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Does KPI for Processes need to be correlated with the specific Risks for Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
W Chinese Authorized Representative - What are the regulatory risks? China Medical Device Regulations 3
V Deleting Risks if a particular Risk has been Eliminated ISO 14971 - Medical Device Risk Management 3
A Informational Confusion about Risks for Processes in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44

Similar threads

Top Bottom