Do I need both AS9100 and ISO9001?

K

kanklam

We are a small machine shop with a 4-year-old ISO 9001:2008 cert and are now going after certification to AS9100C. Once we achieve the AS certification, is it necessary to maintain the ISO cert? Seems redundant and a waste of money. Anybody dealing with similar issue?
 
N

natecsss

When you acheive AS9100 certification it automatically comes with an ISO 9001 certification so you aren't wasting money at all.
 
M

Michael_M

Trusted Information Resource
The AS9100 standard takes the ISO standard and adds to it, so if you have AS9100 you have fulfilled the ISO9001.

For example, in the ISO9001 7.4.2 Purchasing Information section, it has items a through c. These are required by ISO9001. The AS9100 standard adds item d through i which are required by AS9100. The AS9100 standard adds the new requirements in bold text so you know what was ISO and what is AS9100. Below is what the AS9100 standard looks like using 7.4.2:

c) quality management system requirements,

d) the identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data,

In all cases, to get the AS9100 certification, you must adhere to everything (both bold and non-bold items).
 
Last edited:
J

Jeff Frost

More than likely you will have to request an ISO 9001 registration certification from you CB in addition to AS9100. Definitely get a stand-a-lone ISO 9001 as I have had a fair share of customers who would not accept AS9100 because of they did not know what it was.
 
D

DannyK

Trusted Information Resource
natecsss said:
When you acheive AS9100 certification it automatically comes with an ISO 9001 certification so you aren't wasting money at all.
Click to expand...

It primarily depends on the scope of your certificate but in most cases, companies that receive AS9100 do not have a separate ISO 9001 certificate.
The only situation that I can remember is when the scope for ISO 9001 included another product line and it was not part of AS9100 scope.
 
A

AndyN

Moved On
DannyK said:
It primarily depends on the scope of your certificate but in most cases, companies that receive AS9100 do not have a separate ISO 9001 certificate.
The only situation that I can remember is when the scope for ISO 9001 included another product line and it was not part of AS9100 scope.
Click to expand...

Many CBs issue both certificates.
 
R

RCW

Quite Involved in Discussions
AS9100 and ISO9001 were both on the single certificate I received from my registrar.

I would like to throw a spin into this conversation though.....

How is this going to shake out with the ISO9001:2015 revision? I haven't run across any statements that said that AS9100 was going to follow the new ISO9001:2015 format for its next revision.

It was fine to get the ISO9001 certification at the same time as AS9100 but if it now requires running two different versions / flavors at the same time, I don't know if ISO9001 is worth it. (P.S. I am currently running ISO13485 at the same time so I am already familiar with co-habitating multiple QMSs)
 
B

Big Jim

Admin
RCW said:
AS9100 and ISO9001 were both on the single certificate I received from my registrar.

I would like to throw a spin into this conversation though.....

How is this going to shake out with the ISO9001:2015 revision? I haven't run across any statements that said that AS9100 was going to follow the new ISO9001:2015 format for its next revision.

It was fine to get the ISO9001 certification at the same time as AS9100 but if it now requires running two different versions / flavors at the same time, I don't know if ISO9001 is worth it. (P.S. I am currently running ISO13485 at the same time so I am already familiar with co-habitating multiple QMSs)
Click to expand...

The IAQG has published that they intend to follow in about a year and have already published a draft.
 
  • Like
Reactions: RCW
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
M Medical Device Distribution in Canada - Do we need both MDEL and MDL? Canada Medical Device Regulations 14
M Do I need to comply with both the MDD and the PED for my Medical Device? EU Medical Device Regulations 8
Project Man Do I need both a Supplier Return form and a Supplier Corrective Action Report form? Quality Manager and Management Related Issues 17
C UL & CSA (Canadian Standards Association) Mark - Need to go to both parties for it? Various Other Specifications, Standards, and related Requirements 4
S Frustration with Attitude of both Upper & Lower Management - Need To Vent Coffee Break and Water Cooler Discussions 33
K Need Help With IATF 16949 Audit NC IATF 16949 - Automotive Quality Systems Standard 6
F Defining the need to perform the Proximity magnetic fields immunity tests (IEC 61000-4-39) according to the IEC 60601-1-2 ed.4.1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D FDA combo product-need to define direct & indirect impact regarding safety,quality & regulatory.Can anyone point me in right direction-SupplierMgmt 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Does a Pass or Fail IP test need UoM on the report? Measurement Uncertainty (MU) 0
P Do Barcode scanners need validation in Medical device manufacturing? Manufacturing and Related Processes 6
S ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system' Management Review Meetings and related Processes 13
S Need guidance for Software validation Qualification and Validation (including 21 CFR Part 11) 5
R Do I need to get calibration certificate from ISO 17025 for IATF Audit IATF 16949 - Automotive Quality Systems Standard 8
H Electronic Replacement parts need CE? CE Marking (Conformité Européene) / CB Scheme 0
G Need for update of Declaration of Conformity EU Medical Device Regulations 4
D Do I need MDSAP? ISO 13485:2016 - Medical Device Quality Management Systems 5
bryan willemot Wanted: in need of start up Lock out Tag out program in Excel or Word, your help is much appreciated Occupational Health & Safety Management Standards 3
Q Does a gage used for a visual verification need to be calibrated? Manufacturing and Related Processes 7
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 1
J Do we need to raise concessions for every noted deviation under AS9100 Manufacturing and Related Processes 3
M Need to set up a "crisis management and business continuity plan" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
R Customer Returns / RMA's & the need for NCR's AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
T Need advice on what inspection equipment to buy. General Measurement Device and Calibration Topics 2
Sam.F Do heat treatment ovens need calibration? General Measurement Device and Calibration Topics 25
T Need 5 why’s help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
H Need guidance on importation of Custom-made devices into Japan Japan Medical Device Regulations 1
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
leftoverture REACH Folks - We Need Common Sense! RoHS, REACH, ELV, IMDS and Restricted Substances 23
B Whose waste carrier licence do I need? ISO 14001:2015 Specific Discussions 8
I I need some fun examples of teaching the 5 Whys Lean in Manufacturing and Service Industries 43
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 19
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C I need some clearing on requirements of Asuring the validity of results ISO 17025 related Discussions 2
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8
E Need some peer advice Quality Manager and Management Related Issues 18
S Need clarification on UKCA and "Approved Body" UK Medical Device Regulations 7
S What types of changes need to be notified to NBs? Registrars and Notified Bodies 1
B Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 2
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5
C Need to understand difference between an actual Calibration vs. a Calibration check General Measurement Device and Calibration Topics 3
S How many tester quantity we need on the line based on the cycle time and peak volume Manufacturing and Related Processes 3

Similar threads

Top Bottom