The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Information Resources - Papers - Articles - Etc. > Definitions, Acronyms, Abbreviations and Interpretations
Forum Username

Elsmar Cove Forum Visitor Notice(s)


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access

Courtesy Quick Links

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

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
differences (general), legal requirements, regulations and regulatory requirements, regulatory requirements
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 1st February 2006, 09:57 AM
HDR HDR is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Feb 2004
Location: United States
 
Posts: 8
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 43
Karma: 10
HDR has less than 100 Karma points so far.
Question Legal and Regulatory Requirements - Differences

Is there a difference between legal and regulatory requirements?

If yes, can someone provide me a clear definition of each?


THANK YOU ...

HR

Sponsored Links
  #2  
Old 1st February 2006, 10:00 AM
Jim Wynne's Avatar
Jim Wynne Jim Wynne is offline
Cross Forum Moderator

 
Registration Date: Jan 2005
Location: Southeast Wisconsin
 
Posts: 14,077
Thanks Given to Others: 2,051
Thanked 5,993 Times in 3,820 Posts
Blog Entries: 2
Karma Power: 1531
Karma: 42502
Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.
Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.Jim Wynne is appreciated, and has over 1700 Karma points.
Have a look at this thread: Please define statutory and legal requirements

__________________

It is difficult to get a man to understand something, when his salary depends upon his not understanding it. --Upton Sinclair
Sponsored Links

  #3  
Old 1st February 2006, 01:27 PM
km214's Avatar
km214 km214 is offline
Inactive Registered Visitor

 
Registration Date: May 2004
Location: U.S.A.
Age: 46
 
Posts: 42
Thanks Given to Others: 18
Thanked 2 Times in 2 Posts
Karma Power: 46
Karma: 20
km214 has less than 100 Karma points so far.
Look! Legal and Regulatory

Law is defined as: Main Entry: 1law
Pronunciation: 'lo
Function: noun
Etymology: Middle English, from Old English lagu, of Scandinavian origin; akin to Old Norse log law; akin to Old English licgan to lie -- more at LIE
1 a (1) : a binding custom or practice of a community : a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority (2) : the whole body of such customs, practices, or rules

Regulation is defined as:Main Entry: 1reg·u·la·tion
Pronunciation: "re-gy&-'lA-sh&n, "re-g&-
Function: noun
1 : the act of regulating : the state of being regulated
2 a : an authoritative rule dealing with details or procedure <safety regulations> b : a rule or order issued by an executive authority or regulatory agency of a government and having the force of law
3 a : the process of redistributing material (as in an embryo) to restore a damaged or lost part independent of new tissue growth b : the mechanism by which an early embryo maintains normal development
synonym see LAW

Therefore, they are synonyms of each other and usually used interchangably..
Thank You
  #4  
Old 1st February 2006, 03:47 PM
BSMITH BSMITH is offline
Involved - Posts

 
Registration Date: Feb 2005
Location: Metairie, LA
Age: 65
 
Posts: 99
Thanks Given to Others: 2
Thanked 16 Times in 9 Posts
Karma Power: 49
Karma: 550
BSMITH is appreciated, and has over 500 Karma points.BSMITH is appreciated, and has over 500 Karma points.BSMITH is appreciated, and has over 500 Karma points.BSMITH is appreciated, and has over 500 Karma points.BSMITH is appreciated, and has over 500 Karma points.BSMITH is appreciated, and has over 500 Karma points.
Laws vs Reglations

Laws are usually more general or less specific than regulations. An example in the U.S. is the Clean Water Act (a law); the regulations that implement the Clean Water Act are those in Title 40 of the CFR (Code of Federal Regulations). In some cases individual Federal agencies have their own regulations that dictate how they implement the Act. State laws and regulations pretty much work the same way; in some cases the State law implements a Federal law; in other cases there is no comparable Federal law.

A more detailed discussion can be found at: http://www.epa.gov/epahome/lawintro.htm
Thank You to BSMITH for your informative Post and/or Attachment!
  #5  
Old 1st February 2006, 05:40 PM
Jennifer Kirley's Avatar
Jennifer Kirley Jennifer Kirley is online now
Forum Moderator

 
Registration Date: Jan 2004
Location: Maine, USA
 
Posts: 5,478
Thanks Given to Others: 3,351
Thanked 3,118 Times in 1,782 Posts
Karma Power: 648
Karma: 28663
Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.
Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.Jennifer Kirley is appreciated, and has over 1700 Karma points.
Good discussion, and I liked BSmith's answer very much.

__________________

"If you only have a hammer, you tend to see every problem as a nail." Abraham Maslow
  #6  
Old 22nd January 2014, 01:25 AM
Fransus Fransus is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Jan 2014
 
Posts: 1
Thanks Given to Others: 0
Thanked 3 Times in 1 Post
Karma Power: 3
Karma: 25
Fransus has less than 100 Karma points so far.
Re: Is there a difference between legal and regulatory requirements?

Many people are confused about the difference between laws and regulations. Laws and regulations are rules. But, they differ in how they came into being. The difference between laws and regulations is:

Laws are enacted by a governing body, in the U.S. an elected governing body called Congress. Similar elected bodies enact laws in other countries. Enacted laws are enforceable in court. The Food, Drug and Cosmetic Act (FD&CA)is an example of an enacted law.

Regulations are laws made by agencies. Agency-made laws are called regulations. As with enacted laws, agency-made laws, regulations, are enforceable in court. Regulations made by the FDA are examples of agency-made law.

Enacted laws and agency-made laws, which are called regulations, are similar in that they state legal requirements and are enforceable in court. Regulations are limited in this way:

An agency can create regulations only if an enacted law authorizes it to do so. A law authorizing an agency to make regulations is called a “Rules Enabling Statute.” (A statute is an enacted law that has been given a number and published in an official book of statutes, or “codified.”) An agency can create regulations only to implement or enforce the enacted law.

A section of the enacted law, FD&CA, authorized the creation of the FDA, and authorized the agency to make regulations to carry out the FD&CA. FDA cannot in its own discretion broaden, or narrow, the FD&CA.

In contrast to regulations, FDA guidelines are not laws, and are not in themselves enforceable in court. Similarly, standards, which are collective works setting forth specifications and methods for achieving them, by organizations having interest and expertise in the subject area, are not in themselves, legally enforceable. Sometimes, however, a standard is “incorporated by reference” into an enacted law or regulation thereby making that standard a part of the law.

A common mistake in the medical device world is where people fail to recognize the distinction between regulations, which state legally enforceable requirements, and other types of authority, such as guidelines and standards, or internal procedures, which are useful for establishing norms and procedures, but do not state the legal requirement.

I am a regulatory and compliance lawyer and a scientist. Lawyers are the professional group with the training and qualifications to interpret rules, like enacted laws and regulations, and evaluate how well an organization’s procedures and practices meet the legal requirements.

In contrast, scientists, physicians, engineers, and other technicians have the special skills to design and execute protocols and procedures. Some technical people have the skills to design procedures and test plans to demonstrate that the technology performs, or is likely to perform, as intended and designed. While different from legal/regulatory interpretation, the skills to develop and execute a test plan to demonstrate that a device does, and will continue to, do what you intended it to do, are critical to medical device development.

Regards, Fransus

Last edited by Fransus; 22nd January 2014 at 01:46 AM. Reason: formatting
Thank You to Fransus for your informative Post and/or Attachment!
  #7  
Old 22nd January 2014, 01:43 AM
Randy's Avatar
Randy Randy is offline
Super Moderator

 
Registration Date: Jun 1999
Location: Greenwood (Ft Smith area), Arkansas, USA
Age: 63
 
Posts: 8,230
Thanks Given to Others: 48
Thanked 2,696 Times in 1,656 Posts
Karma Power: 925
Karma: 20062
Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.
Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.Randy is appreciated, and has over 1700 Karma points.
Send a message via Skype™ to Randy
Re: Is there a difference between legal and regulatory requirements?

Very good answer Fransus, but if you'll check you're in a discussion that pretty much ended 8 years ago.

For the sake of this discussion within the context of ISO 9001 the answer is pretty much NO, there is no difference unless you'd like to consider contract requirements as "legal".

__________________

We who have seen war, will never stop seeing it. In the silence of the night, we will always hear the screams. Joe Galloway
  #8  
Old 22nd January 2014, 07:16 AM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
Forum Administrator

 
Registration Date: Dec 2005
Location: Massachusetts, USA
Age: 50
 
Posts: 5,689
Thanks Given to Others: 1,759
Thanked 2,675 Times in 1,677 Posts
Karma Power: 400
Karma: 16206
Ajit Basrur is appreciated, and has over 1700 Karma points.
Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.
Re: Legal and Regulatory Requirements - Differences

Welcome to the Cove, Fransus and a great start

Your clarification on the subject is great !

__________________

You can’t use up creativity. The more you use, the more you haveMaya Angelou
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Information Resources - Papers - Articles - Etc. > Definitions, Acronyms, Abbreviations and Interpretations

Do you find this discussion thread helpful and informational?


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
7.4.1.1 Statutory & Regulatory Conformity: Legal Requirements of which Country? morteza ISO/TS 16949 - International Automotive Quality Systems Standard 4 5th May 2012 10:21 AM
TGA Guidelines on Australian & EU Medical Device Regulatory Requirements Differences bio_subbu Other Medical Device Regulations World-Wide 5 29th December 2010 01:01 AM
Update Service for Legal & Regulatory Requirements quality1 ISO 14001 and Environmental Related Standards 3 11th January 2009 06:50 PM
Commitment and Compliance with Legal & Regulatory Requirements SaintStan ISO 14001 and Environmental Related Standards 2 13th September 2007 10:59 AM
Legal Requirements - How Legal Requirements apply to environmental aspects? ISO 14001 ugurkavi ISO 14001 and Environmental Related Standards 7 9th May 2006 07:18 AM



The time now is 06:15 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".