Scope of approval portion of AS9100 section 4.6, 04 (AS 9101, sec 4.6.2, Q4)

U

Unregistered

#1
#1
I am trying to understand the scope of approval portion of AS9100 section 4.6, 04. Could someone explain what is meant by scope of approval?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
B

BadgerMan

#2
#2
I am assuming that you are looking at the AS 9101 document, section 4.6.2, question 04?

"Does the supplier maintain a list of approved subcontractors and specify the scope of approval?"

I believe that it is requiring you to maintain an approved supplier/subcontractor listing (the results of your selection/approval/surveillance process) and that this listing must specifiy what they are allowed to supply in the way of products and/or services. As an example, just because a subcontractor is approved to supply you with nuts and bolts does not mean that you can use them as a plating or testing source unless their scope of approval includes those services too.

Hope this helps.

Does anyone else have a different interpretation?
 
S

sharvan003

#3
#3
Re: Scope of approval portion of AS9100 section 4.6, 04

yes badger , you are right.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M AS 9100 Scope for Repair Station with PMA approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A AS9100D, Clause 8.4.1.1 - External Provider Scope of Approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
Al Rosen Defining your Scope of Approval - AS 9100 7.4.1(a) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
T Vendor (Supplier) Approval Procedure - Scope of the procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Laboratory Scope - Submitted a new PPAP for approval and the SQA rejected it General Measurement Device and Calibration Topics 16
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
S 7.1.5.3.1 Internal Lab Scope IATF 16949 - Automotive Quality Systems Standard 14
Tagin Corporate HQ handles AR/AP - Outsourced or Out-of-scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D API Q1 clause (1.0) Scope Oil and Gas Industry Standards and Regulations 1
Q Considering addition of mass calibration to ISO17025 scope ISO 17025 related Discussions 6
C ISO13485 scope as Legal Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H IEC 62368-1 Scope of Testing CE Marking (Conformité Européene) / CB Scheme 3
A Laboratory scope on the IATF IATF 16949 - Automotive Quality Systems Standard 5
I Restricting scope to one part number for one customer IATF 16949 - Automotive Quality Systems Standard 6
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Kap.4.3 Determining the scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Internal Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 10
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
Enghabashy Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
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
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 7
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 19
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 2
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
K Medical Device Repairs and ISO 13485 Scope ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom