SBS - The Best Value in QMS software

ISO 9001 Legal Compliance and Legal Register Requirements

#1
Hello all - can anyone advise under what ISO 9001:2015 clause there would be reason for not maintaining a legal register or being compliant to a known obligation other than one which is imposed on the organisations product or service?

Many thanks
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
1st, there's no requirement to maintain any kind of register of any type

2nd, what kind of obligation are you referring to?
 

Pancho

wikineer
Super Moderator
#3
Hello all - can anyone advise under what ISO 9001:2015 clause there would be reason for not maintaining a legal register or being compliant to a known obligation other than one which is imposed on the organisations product or service?

Many thanks
It is a bit hard to parse your question. The long clause after "there would be reason for" starts with a negative phrase, "not maintaining a legal register", then an "or" conjunction to a second phrase. I do not know whether the negation in the first phrase applies only to that phrase or to both. But since you used "or" rather than "nor", I'll say this:

There is no reason in the standard for "not maintaining a legal register". In other words, you cannot use the standard to excuse not maintaining a legal registration you are required to have for reasons not in the standard.

There ARE reasons in the standard for "being compliant to a known obligation other than the one...". There likely are several more than one obligation that is imposed on your product or service. Your customer, the law and your own organization impose obligations. Obviously you will need to meet your customers' requirements as per your contract. Section 8.2.3.1(a) and other sections of the standard cover this. On legal obligations, section 8.2.2 of the standard requires you to comply with "any applicable statutory or regulatory requirements", as well as "those considered necessary by the organization". You are also required to "meet the claims for the products and services" that you offer. Other sections expand on these requirements: 8.2.3.1(d), 8.3.3(c), 8.5.5(a) etc.
 

John Broomfield

Staff member
Super Moderator
#4
Hello all - can anyone advise under what ISO 9001:2015 clause there would be reason for not maintaining a legal register or being compliant to a known obligation other than one which is imposed on the organisations product or service?

Many thanks
Glenn,

Many products have to fulfill legal requirements so designers need to stay up to date with new and changed statutes, laws and regs.

This is why organizations subscribe to updating services.

Such services may obviate the need for maintaining a register.

John
 

Kronos147

Trusted Information Resource
#5
Check out 4.1, 4.2

"4.1 Understanding the Organization and Its Context
The organization shall determine external and internal issues...

The organization shall monitor and review information about these external and internal issues.

4.2 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall....

The organization shall monitor and review information about these interested parties and their relevant requirements."
 
Thread starter Similar threads Forum Replies Date
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
A Is the Labour Code one of the legal requirements of ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K ISO 9001:2015 and its Legal Ramifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B ISO 9001 Implementation for the Legal Department in my company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Legal Requirements - ISO 9001 Clause 7.2.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Legal Requirements - How to address this in ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Can an ISO 9001 Certificate have Remote Locations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D ISO 9001 - 8.4.1 Evaluate All Suppliers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
Sidney Vianna ISO 9001 News ISO 9001 Quality Check - spinning facts in LinkedIn ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A ISO 9001 Internal Audits - No production right now due to furloughs Internal Auditing 5
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K ISO 9001 Auditing in a Healthcare setting Process Audits and Layered Process Audits 15
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Business Continuity Planning in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17

Similar threads

Top Bottom