AS9100 4.1 How can I know/monitor applicable regulatory/statutory requirements?

  • Thread starter Mario Alberto83
  • Start date
M

Mario Alberto83

#1
Hi everybody, this is my first post (I am very emocional I am true hehe)and would like to take advantage to say that I am very grateful to all of you guys since you have helped me a lot in understanding QMS world and implementing my ideas in the organizations I have worked for. This is a wonderful tool for all the qty related people.

My question is:

How can I know and monitor what the statutory/regulatory requirements apply to the product/QMS? I am involved in the initial AS9100 certification process of the company I work for and I am a little confused about this.

I work for a company in Mexico that will provide products/services to local and abroad companies. Who should be the responsible department to review local and abroad regulations related to product/QMS?

How are those requirements usually flown down?

Thanks again everybody and would like to have your response in my first thread.
 
Elsmar Forum Sponsor

Big Jim

Super Moderator
#3
You are pretty much expected to be aware of the regulatory environment of the industry you function in.

Sometimes customers are very good at flowing down those requirements, but their lack of doing so does not absolve you of the need to be aware of them yourself.

As Sydney mentioned, those who deal with the technology, such as engineers, may have heightened awareness, but so could those who perform contract review as they have the opportunity to see the lots of contracts. 7.2.1 specifically requires you to include statutory and regulatory requirements when gathering requirements, as does 7.3.2. Part of due diligence when reviewing contracts (7.2.2) may require you to look for some that you may not be aware of.
 

dsanabria

Quite Involved in Discussions
#4
You are pretty much expected to be aware of the regulatory environment of the industry you function in.

Sometimes customers are very good at flowing down those requirements, but their lack of doing so does not absolve you of the need to be aware of them yourself.

As Sydney mentioned, those who deal with the technology, such as engineers, may have heightened awareness, but so could those who perform contract review as they have the opportunity to see the lots of contracts. 7.2.1 specifically requires you to include statutory and regulatory requirements when gathering requirements, as does 7.3.2. Part of due diligence when reviewing contracts (7.2.2) may require you to look for some that you may not be aware of.
Agree :applause:

In essence - if you work in electronics you should aware of the customers requirements, environmental laws, Import / export laws /requirements, ITAR... etc. If not sure - send an e-mail to your customers and request assistance in identifying them (if you didn't do it during contract review) and finally - as you become educated... add them to your risk management process.
 
M

Mario Alberto83

#5
Thanks a lot Sidney, Jim and David for your assistance. I have seen posts of you in many threads and you have helped me many times before.

You are right, I have conducted contract reviews in the past and I remember a bunch of legal requirements shown, it is clearer to me now.
I was thinking in the begining about those country specific federal laws like work conditions, health and safety, control of pollution, etc. but I see they are not related to product or QMS, I was confused.
 
Thread starter Similar threads Forum Replies Date
briteme4 ASL - AS9100 / Supplier Survey Supplier Quality Assurance and other Supplier Issues 3
Crusader AS9100 7.5.2 NOTE Approval methods identified AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Can a organization use a disclaimer "pending AS9100 Certification" in Marketing Information? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K AS9100 and ISO9001 together AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Do AS9100 Registrar Auditors have nonconformity quotas? General Auditing Discussions 18
L Heading dies as "tooling" and AS9100 Manufacturing and Related Processes 2
L Heading dies as "tooling" and AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
SocalSurfer Can you recommend an enterprise QMS for new AS9100 startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Open Positions During AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C AS9120 or AS9100 Cert pertaining to inventory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
W Major NCRs within AS9100 - What is the most frequent reason for Major NCRs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
R AS9100 - 8.4.2 - Receiving Inspection Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
NDesouza AS9100 - D Capacity Planning Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
B FAR/Prime Contractor Flow-down Tool - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M When is FAI required? AS9100 8.5.1.3 and 8.4.3 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Ethics and Legality AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
classical_quality AS9100 Surveillance Audit - advice on drafting strong responses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
L AS9100 - Infrastructure or Product? Inflight internet connectivity network AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
R AS9100 DELTA FAI - Sub-supplier for plating changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
G AS9100-8.1.2 Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R AS9100 REV D gap analysis matrix AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E Recommendations for CBs south of England AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E AS9100 installtion procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0

Similar threads

Top Bottom