Is it mandated to keep all the regulations?

S

s_warin

#1
In ISO 9001 many places mentioned about statutory and regulatory such as clause 7.2.1 c), 7.3.2 b), is it mandated to identify and control the statutory and regulatory documents?:vfunny:
 
Elsmar Forum Sponsor
#2
mandated mandates

In 7.2.1 you are required to: "determine..."
In 7.3.2 you are required to :determined and records maintained"

In the first case, the organization must determine what the regulations are "related to the product". This does not say you must have them listed and maintain a list, although that may be one way to control them. You need to ensure that all product mandates are known (determined).

Design inputs are slightly different. In this clause, you must maintain records of the inputs ("relating to product requirements"). That would include the regulatory stuff.

In both cases, the standard clearly states the requirements as related to the product. This information could be considered "documents of external origin" and controlled through 4.2.3 f)
 
S

s_warin

#3
Thank you, Dave.
Why identify and control?
4.2.1 d) says that documents needed by the organization to ensure the effective planning, operation and control of the processes.:vfunny:
 
D

David Mullins

#4
The other other Dave here.

It certainly depends on what you say in your QMS, however, if you're serious about compliance you need to be able to access the latest info, which therefore suggests control is required. If you prove access via internet, or what ever, then that's OK.

I'd go with referencing critical legislation relating to your product or service, and make sure you can access them in their lastest version. 'Cause there is a lot of legislation that applies to companies, and I've yet to find a company that has ALL the bases covered.

Of special mention is that your certifier will probably be ecstatic if you have made even the smallest effort to control these external docs. Also note that external docs are a pain to control, so do so with a minimalist approach.

Cheers.
 
Thread starter Similar threads Forum Replies Date
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
GStough Customer-Mandated Suppliers Supplier Quality Assurance and other Supplier Issues 8
E Label Regulations mandated by China FDA China Medical Device Regulations 5
S Sterilization Validation Accreditation - A mandated standard requirement? ISO 13485:2016 - Medical Device Quality Management Systems 5
SteveK IEC 60601-1 Mandatory vs. Mandated Standard? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H How Effective is Mandated Risk Management? ISO 14971 - Medical Device Risk Management 1
N Chrysler mandated LPA, Subjective Questioning, Appeal to Nobler Senses Process Audits and Layered Process Audits 1
Howard Atkins Global Sullivan Principles - Does any one know if this is mandated by any one? Customer and Company Specific Requirements 4
W Where is it mandated to use 300 pieces for a capability study APQP and PPAP 13
Marc Systems Requirements Mandated by EN46001 and EN46002 ISO 13485:2016 - Medical Device Quality Management Systems 4
D Retention List - Documents and Records with mandated retention periods QS-9000 - American Automotive Manufacturers Standard 9
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
R How to keep track of employee read-only training ISO 13485:2016 - Medical Device Quality Management Systems 13
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
D What are the important things to keep track of in product audit checklist? Software Quality Assurance 3
Ed Panek Ideas to keep quotes for consulting service accurate on not inflated Consultants and Consulting 11
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
Sidney Vianna Interesting Discussion How major corporations in the West keep failing to uphold their pledges of abolishing child labor in their cocoa supply chains Sustainability, Green Initiatives and Ecology 3
J ISO 15223-1: Keep dry vs. humidity limitation label symbol Other Medical Device Related Standards 2
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
S. Moore Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
Q Is Handwritten Raw Data required to keep with Electronic Records? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
E Design Dossier/DHF Updates - What to Keep EU Medical Device Regulations 2
L Product Safety Officer - How to keep VW Happy VDA Standards - Germany's Automotive Standards 24
T How to keep Customer Engineering Specifications & CSRs Up to Date IATF 16949 - Automotive Quality Systems Standard 6
AnaMariaVR2 FDA to keep closer eye on diagnostics: FDA chief US Food and Drug Administration (FDA) 0
AnaMariaVR2 How to Keep the Fizz in Your Biz The Reading Room 0
H Best place to keep myself updated on EU Regulatory Changes EU Medical Device Regulations 7
T What Can Be Done to Keep Operations Trainers Busy? Training - Internal, External, Online and Distance Learning 3
V Device Retains - How many people keep retains of finished devices and why? US Food and Drug Administration (FDA) 6
Q Material Changes - To keep questions and answers as records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J SR-001 Revision - Keep watching for the new revision of SR001 (It is expected soon) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Antonio Vieira Do you still keep old numbers of Quality Progress in paper format? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
C Controlling QMS - We are expanding globally and want to keep our QMS Confidential Quality Manager and Management Related Issues 20
A Do you keep up your CCT (Certified Calibration Technician) Certification? General Measurement Device and Calibration Topics 3
P Self Motivation - How to keep it when overwhelmed with problems? Career and Occupation Discussions 13
Q Do we need to keep MSDS documents for all "chemicals" used in the factory? Occupational Health & Safety Management Standards 4
K How you keep yourself motivated in tough times? Career and Occupation Discussions 15
T From Manufacturer to Distributor - Still keep ISO 9001:2008 Certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Documents required to display/keep during ISO 9000 Audit in EPCC firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Mr.Happy Dbase or Excel file to keep track on our internal failures (Non conform products) Document Control Systems, Procedures, Forms and Templates 8
Q How should I Keep my various types of records .. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T How much information should I keep in my Master Document Register? Document Control Systems, Procedures, Forms and Templates 8
D Training Records - Requirement to keep original copy of training/assessment form? Records and Data - Quality, Legal and Other Evidence 12
R How long do I keep expired Calibration Certificates General Measurement Device and Calibration Topics 8
Marc Flying will be a real pain now - New rules keep passengers in seats Travel - Hotels, Motels, Planes and Trains 7

Similar threads

Top Bottom