What will change in the upcoming update of ISO 14001?

N

nljong25

#1
Hi there,

I understand that there's a update of ISO 14001 upcoming.
Does anybody know what the major changes will be?

Jeroen
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
The revision is still being worked on. There will be some grammer changes and maybe more emphasis on regulatory compliance. It's still up in the air.

Go to the ISO home page and check out what TC-207 is doing.
 
B

Bruce Wade

#3
Rumor is, the revision will look alot more like EMAS, be numbered more like ISO 9001:2000, for easier inclusion in combined systems, and require much more responsiveness to interested third parties.

ISO 14001:1996 requires the organization only "consider" communication with interested third parties, and to document this decision. It is within the standard to "consider" and decide not to communicate environmental issues, such as aspects and impacts, with interested third parties other than regulatory and legal authorities. Rumor is, like EMAS, the revision will not allow "consideration" and decision not to communicate...
 
N

nljong25

#5
I received a copy of 14001/CD this morning in PDF-format. I will check the differences. I first have to translate it to dutch. :-\
 
S

Serge Daiman

#6
Hi all,
Randy is right. The revision is more of a grammar improvement, with main discussion going about which phrase should be put into bullets and which bullet list should be converted into a phrase. A few more explanatory paras, or sometimes text is rewritten to be (hopefully) more specific. No additional requirements I have noticed, except maybe for legal comliance -- not what you'd expect, but "an organization shall establish and maintain (a) procedure(s) for periodically evaluating compliance with applicable environmental legislation and regulations to meet the organization’s commitment to compliance".
Best regards,
Sergey
 
Thread starter Similar threads Forum Replies Date
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Y Algo change significancy Medical Information Technology, Medical Software and Health Informatics 0
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 2
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
P Notified Body Approval of Change EU Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N China - Start manufacturing before change approval? China Medical Device Regulations 1
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
U Change Management vs Change Control? Design and Development of Products and Processes 4
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom