The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > Quality Management Systems Standards > ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Please define "Statutory and Regulatory Requirements"


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Atul's
Quality Forum Online

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related LinkedIn Groups

ISO 9001 for Small Businesses

ISO 9001:2015 Revision Discussions

Information Security Community

Medical Devices Group

Quality and Regulatory Network

FDA (Food and Drugs)

AS91XX Series - Tips and Advice

Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 4 votes, 5.00 average. Display Modes
  Post Number #1  
Old 30th November 2005, 03:56 PM
KosmoQA's Avatar
KosmoQA

 
 
Total Posts: 51
Question Please define "Statutory and Regulatory Requirements"

In our most recent ISO meeting, I was asked what the meaning of "Statutory and Regulatory Requirements" is. I do not know. It is mentioned numerous times in the ISO9001:2000 standard. Does anyone have a definition?
Thanks to KosmoQA for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 30th November 2005, 04:11 PM
D.Scott's Avatar
D.Scott

 
 
Total Posts: 1,592
Statutory requirements are laws (statutes) covering certain things. Aside from everyday statutory requirements like speed limits and traffic laws, there are statutes that apply to the business world. An example would be OSHA (Occupational Safety and Health Act) or a local law on dumping waste.

Regulatory requirements are standards or rules that are set up to regulate something. An example here would be some of the EPA emission standards. These aren't laws like a speed limit but are limits imposed by a regulatory commission.

I am sure there are better examples somewhere but these are the ones I could think of quickly. If you need further explanation, I am sure others can help out too.

Dave
Thanks to D.Scott for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 30th November 2005, 04:11 PM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,149
Quote:
In Reply to Parent Post by KosmoQA

In our most recent ISO meeting, I was asked what the meaning of "Statutory and Regulatory Requirements" is. I do not know. It is mentioned numerous times in the ISO9001:2000 standard. Does anyone have a definition?
Statutory = Laws; legal requirements

Regulatory pertains to those parts of a business that are subject to regulation, such as EPA requirements, FMVSS regulations for motor vehicles, OSHA regulations, etc.

The two are not mutually exclusive; there are statutory (law) requirements for compliance with certain regulations.
Thanks to Jim Wynne for your informative Post and/or Attachment!
  Post Number #4  
Old 30th November 2005, 04:20 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,163
Law & Order....

Quote:
In Reply to Parent Post by JSW05

Regulatory pertains to those parts of a business that are subject to regulation, such as EPA requirements, FMVSS regulations for motor vehicles, OSHA regulations, etc..
These are good examples, but in the TYPICAL CONTEXT of ISO 9001 implementation, EPA/OSHA are NOT part of the regulatory requirements the ISO 9001 Standard is referring to. Think of product/service regulatory requirements coming, for example from the FAA, FDA, FCC, DOT, European Directives, RoHS, WEEE, etc...

For more information, see the attached file.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: doc APG_Statutory_Regulatory.doc (103.5 KB, 569 views)

Last edited by Sidney Vianna; 30th November 2005 at 07:16 PM.
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #5  
Old 30th November 2005, 04:41 PM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,149
Quote:
In Reply to Parent Post by Sidney Vianna

These are good examples, but in the TYPICAL CONTEXT of ISO 9001 implementation, EPA/OSHA are NOT part of the regulatory requirements the ISO 9001 Standard is referring to. Think of product/service regulatory requiremenst coming, for example from the FAA, FDA, FCC, DOT, European Directives, RoHS, WEEE, etc...
You are correct, sir. But I was giving a general definition, and the ISO standard refers to applicable regulatory requirements, so I thought that was already covered.
  Post Number #6  
Old 1st February 2006, 07:33 PM
Marc's Avatar
Marc

 
 
Total Posts: 24,813
Also see this discussion thread: Is there a difference between legal and regulatory requirements?
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > Quality Management Systems Standards > ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem? Robert in SF Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and other related Regulations) 2 18th May 2016 07:33 PM
"Value" and "Overhead(s)" of implementation of "CSV - Validation requirements" v9991 Qualification and Validation (including 21 CFR Part 11) 1 22nd November 2009 07:31 PM
Any other statutory & regulatory requirements other than FAA Joy Federal Aviation Administration (FAA) Standards and Requirements 4 21st July 2009 10:50 AM
Statutory and regulatory requirements (7.2.1c) virajs ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions 3 15th October 2008 05:40 PM
Statutory Requirements - 7.3.2 - Applicable statutory and regulatory requirements rui12524 TS 16949 - International Automotive Quality Systems Standard 1 3rd April 2003 12:49 PM



The time now is 04:15 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies" -- The Elsmar Cove is *Copyright Free*.
A Peachfarm LLC Internet Property