What does this clause mean? 4.2.3 - Legal and Other Requirements

B

berseak

legal for this clause what is a meaning?
legal only related environment.
or all legal and other requirements related to company?
I'm so confuse.

Thank you.
 
Q

qusys

Trusted Information Resource
berseak said:
legal for this clause what is a meaning?
legal only related environment.
or all legal and other requirements related to company?
I'm so confuse.

Thank you.
Click to expand...

Yes, given that you are speaking about ISO 14001.
For instance, "legal" could be referred to mantain some records ( emissions in air,water etc..) for a certain amount of year.
"Other requirements" are also related to laws, regulation, statutory that applied to the organization in a country where there is the manufacturing facilities.
 
somashekar

somashekar

Leader
Admin
berseak said:
legal for this clause what is a meaning?
legal only related environment.
or all legal and other requirements related to company?
I'm so confuse.

Thank you.
Click to expand...
It means all the legal requirements of your land concerned to environmental protection and prevention of pollution, and which are assessed to be applicable to your establishment.
 
K

kgott

berseak said:
legal for this clause what is a meaning?
legal only related environment.
or all legal and other requirements related to company?
I'm so confuse.

Thank you.
Click to expand...

Legal requirements are the the laws of the land that relate to your company's operation and goods and services provided to customers.

Other requirements are things like

  • customer requirements
  • an organisations decision to comply with certain standards such as ISO 9001, 14001 and 18001.
Other requirements are also things that are implied. When you and I buy a TV we do not need to tell the retailer that the TV must comply with xyz manufacturing standard as we expect that the people who make the TV will ensure that it is made to xyz manufacturing standard.
 
J

JackPack

A question I have is how did you guys identified all the legal requirements (other requirements are alittle bit more obvious)? Seems like our Facilities Manager or our legal department has no clue as to what legal requirements are associated with different aspect of our operations, from simple things like running a diesel generator, HVAC, etc. I guess we might have to ask for assistance from a third party specialist?
 
drgnrider

drgnrider

Quite Involved in Discussions
Years ago we used an Environmental Consultant to create our original SPCC & SWP3 plans, and have continued to use them to update those plans as well as some of the more complex federal reports. Our relationship with these folks has evolved to where they assisted us in 14001 implementation and identification of the "legal requirements" (Federal, State, DOT, etc.) that apply to us. They have even assisted us in how to do some of our corporate reporting requirements.
 
D

db

JackPack said:
A question I have is how did you guys identified all the legal requirements (other requirements are alittle bit more obvious)? Seems like our Facilities Manager or our legal department has no clue as to what legal requirements are associated with different aspect of our operations, from simple things like running a diesel generator, HVAC, etc. I guess we might have to ask for assistance from a third party specialist?
Click to expand...

The vast majority of companies I run across understand some of their legal requirements, but rarely know about many. I always suggest brining in an environmental compliance expert to detail what requirements are necessary. Here in the US, most states have pretty good publication on state and federal requirements, but normally won't get down to the municipality level. Make sure your compliance consultant is aware of your local requirements.

On a related note, I have a company that is in an industrial park that has some park level requirements. These would fall under the "other requirements to which the organization subscribes".
 
LRE67

LRE67

Involved In Discussions
Sometimes those pesky little requirements show up where you don't even expect them to be. For instance our monthly water bill that gets sent to the county has this little diddy buried down at the bottom in the small print section.
"All water customers are required to comply with the state-mandated cross connection control program" which means we have to have backflow prevention devices installed at all our water connections. So this requirement is included in our "Other Requirements" column.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Does the word "claim" in ISO 9001 Clause 8.2.2 mean "requirement"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 9001 Clause 7.3.2 (a) Functional & performance requirement - what does it mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D What does Zero Defects mean? TS 16949 Clause 7.1.2 AQL - Acceptable Quality Level 6
L What does "This applies equally to purchased product" mean? TS 16949 clause 8.3.4 IATF 16949 - Automotive Quality Systems Standard 2
L TS 16949 Clause 4.2.2 c - Interaction of Processes - What does this mean? IATF 16949 - Automotive Quality Systems Standard 184
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
M IATF Clause 8.4.2.2 - What procedures does this apply to? IATF 16949 - Automotive Quality Systems Standard 1
D Does IATF 16949:2016 Clause 7.3 (now 8.3) Apply to "Grandfathered" Products IATF 16949 - Automotive Quality Systems Standard 4
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
L What exactly does Configuration Management in ISO 9001, Clause 7.5.3 means? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Does dental unit need to meet the requirements of clause 14 (PEMS)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Does the Layout Design of a PCB fall under clause 7.3 in ISO 9001 Design and Development of Products and Processes 7
X Audit Findings - The Process/Clause Matrix does not identify all the processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
S Does ISO 9001 Clause 7.3 Design and Development apply? Design and Development of Products and Processes 18
J Customer Property ISO 9001:2008 Clause 7.5.4 - Does this include E-mails? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P General Production Procedure - Does anyone have a sample? Clause 7.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Does TS 16949 Clause 7.5.3 require our product to have traceability? IATF 16949 - Automotive Quality Systems Standard 31
N Poor control of testing chemicals ? which ISO 13485/9001 clause does it contravene? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Which supplier does clause TS 16949 clause 7.4 refer to? IATF 16949 - Automotive Quality Systems Standard 5
Howard Atkins What does the internal audit procedure for TS 16949 need to include? Clause 8.2.2 General Auditing Discussions 7
R 4.2.3.1 Engineering Specifications - Intent? What does this clause apply to? IATF 16949 - Automotive Quality Systems Standard 7
D ISO 9001 Clause 7.5 Production and Service Provision - What does 'Service' apply to? Service Industry Specific Topics 37
K Release Authorization - Does the authorization have to be from quality? Clause 8.2.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Egypt: Does egypt allows Multiple Registrations of the Same Product? Other Medical Device Regulations World-Wide 3
R When Does Remediation Make Sense? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Does a Pass or Fail IP test need UoM on the report? Measurement Uncertainty (MU) 0
T What does "fully verify" mean exactly in process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D What does a contract manufacturer have to do to comply with for MDR? EU Medical Device Regulations 2
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
C GTIN & GS1 - what does the law say ? CE Marking (Conformité Européene) / CB Scheme 5
R Does anyone know how ASQ exam requirements are verified? Professional Certifications and Degrees 3
P Does cybersecurity apply to my product? EU Medical Device Regulations 5
Q Does a gage used for a visual verification need to be calibrated? Manufacturing and Related Processes 7
M Does any one know if company is allowed to submit appeal for rejected registration file Other Medical Device Related Standards 0
B Does TUS require load thermocouples? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
G When does containment event not require 100% sort? Nonconformance and Corrective Action 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom