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

  • Thread starter Mario Alberto83
  • Start date
M

Mario Alberto83

#1
#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.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
B

Big Jim

Admin
#3
#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.
 
D

dsanabria

Quite Involved in Discussions
#4
#4
Big Jim said:
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.
Click to expand...
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
#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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T AS9100 Process Sequence and Interaction Map Example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Document Approver System AS9100 Doc Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Sam.F ISO9001/AS9100 Software Quality Assurance and Compliance Software Tools and Solutions 1
L Collateral Duty Inspectors - Ok for AS9100? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Production not following AS9100 std AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Process Sequence and Interaction Map AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B AS9100 applicability to aircraft operation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S Supplier AS9100 certificate suspended - still ship goods ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S Pros and cons to transition to AS9100 for non aerospace company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B AS9100 Certification Audit Accounting for Additional Customer QMS Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
Q AS9100 Facility Relocation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Do we need to raise concessions for every noted deviation under AS9100 Manufacturing and Related Processes 3
S Minimum Retention Time for Records of internal audit results as per AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
PowerJunkie Cancelling AS9100 Certification - How and Who to notify? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Exclusions allowed in AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
M Minimum/ mandatory core processes AS9100 Process Maps, Process Mapping and Turtle Diagrams 6
M Lack of qualified AS9100 Auditors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
F AS9100 and FAIR - When to do them AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P AS9100 and Raw Material Traceability AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B AS9100:D - Purchase Order required if ordering paint on supplier portal? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Calibration Records during AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M AS9100 examples of procedures, quality manual, etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
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
O AS9100 8.4.3 Supplier Terms and Conditions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S AS9100 Supplier Audit Checklist example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B AS9100 Design Authority questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q AS9100:D Counterfeit internal audit questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Q AS9100 Counterfeit Parts Prevention/Mitigation Work Instruction? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B SPOC 001/SPOC 002 AS9100 FAIR REQUIREMENTS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Kevin Walters AS9100 and AS9120 AATT Course and Test AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B AS9100 Calibration Register AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Crusader ASQ AS9100 Lead Auditor Training Career and Occupation Discussions 27
9 AS9100 Friendly ERP Recommendations Misc. Quality Assurance and Business Systems Related Topics 1
dpenbert AS9100 7.5.3 - Manual Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D AS9120 to AS9100 due to value added activities AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
P Can I exempt products/services from my AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P AS9100 and CAMO - Continuing Airworthiness Management Organization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
K AS9100 - Looking for advice on how to become a CB Auditor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D AS9100 Rev D - Clause 8.7 Control of Non conforming outputs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D AS9100 VS IATF 16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
W AS9100 Shelf Life Extension or Exemption AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Merging two AS9100 Companies: how to manage interim period AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9100 Section 8.4.2 - External provider test reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M Can we combine AS9100 and DO-254 certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A AS9100 - 7.1.5.2 In-House Calibration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
H AS9100 D - 8.1.2 Configuration Management for Build-to-Print Service Provider AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Transferring AS9100 to new Legal Entity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M Lapse in AS9100 Certificate AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom