Using a AS9100 QMS for a New ISO9001:2008 Location

#1
Hello everyone, I searched for my answer through the two forums but did not find anything. Here are the details...

My company has been registered to AS9100 for 15 years, we recently acquired a competitor and are retaining the plant in another state. We want to bring them up to ISO9001 since all that they manufacture is material that is to be used in our assembly and there are no design functions carried out there anymore. They are to be only fab from here on out.

My question is, is it possible to use our current QM which all processes carried out will meet, for the ISO90001 system? What changes will I need to make since we do not reference the standard anywhere (Only AS9100)?

Thanks
 
Elsmar Forum Sponsor

Big Jim

Super Moderator
#2
Hello everyone, I searched for my answer through the two forums but did not find anything. Here are the details...

My company has been registered to AS9100 for 15 years, we recently acquired a competitor and are retaining the plant in another state. We want to bring them up to ISO9001 since all that they manufacture is material that is to be used in our assembly and there are no design functions carried out there anymore. They are to be only fab from here on out.

My question is, is it possible to use our current QM which all processes carried out will meet, for the ISO90001 system? What changes will I need to make since we do not reference the standard anywhere (Only AS9100)?

Thanks
It isn't clear from your question as to if you mean to cover both locations under one registration or two registrations. The 1st response below is assuming you want to register both sites under one registration.

It may be possible, but without seeing the manual or visiting the sites that would be difficult to answer with certainty.

Most likely you can alter the manual to accommodate both sites. How you handle the scope of registration could at least in theory accommodate AS9100 at HQ and ISO 9001 at the remote site. Questions about scope should be discussed with your certification body.

A quality manual only needs three things: 1) scope statement with justification of any exclusions, 2) include or reference your written procedures, 3) a description of the interaction of your processes.

If you want to try to use the manual from the AS9100 site for a separate registration of the 2nd site, again, it depends at least partially on how the existing manual is structured. Your documentation (quality manual and written procedures) should have any of the AS enhancements that you don't intend to live by removed. If you get a copy of AS9100C you will find all of the aerospace enhancements in bolded and italicized print.

It may be easier to start over rather than try to remove the AS enhancements.

Good luck with whatever you decide to do.
 

John Broomfield

Staff member
Super Moderator
#3
Hello everyone, I searched for my answer through the two forums but did not find anything. Here are the details...

My company has been registered to AS9100 for 15 years, we recently acquired a competitor and are retaining the plant in another state. We want to bring them up to ISO9001 since all that they manufacture is material that is to be used in our assembly and there are no design functions carried out there anymore. They are to be only fab from here on out.

My question is, is it possible to use our current QM which all processes carried out will meet, for the ISO90001 system? What changes will I need to make since we do not reference the standard anywhere (Only AS9100)?

Thanks
Thermistor,

If you place no value on the processes you have bought then impose your management system on the acquired organization.

It may be better to retain the value of what you have bought. You could do this by analyzing and understanding the value adding processes of your acquisition. You can then bring these unique processes into your process-based management system.

You'll probably be sharing the support processes such as purchasing, recruiting, training, auditing, analyzing data and preventing nonconformity and stopping recurrence of nonconformity.

John
 
P

prathiba

#5
Hello Thermistor,

The process which involve in the current version of AS9100 aligns the standard with ISO 9001:2008 and has extra requirements regarding Regulatory Compliance and the following implement AS9100:


  • Identify the requirements of AS9100 and how they apply to the business involved.
  • Establish quality objectives and how they fit in to the operation of the business.
  • Produce a documented quality policy indicating how these requirements are satisfied.
  • Communicate them throughout the organisation.
  • Evaluate the quality policy, its stated objectives and then prioritise requirements to ensure they are met.
  • Identify the boundaries of the management system and produce documented procedures as required.
  • Ensure these procedures are suitable and adhered to.
  • Once developed, undertake internal audits to ensure the system carries on working.

As a result, ISO 9001:2008 is totally encompassed within AS9100 with these additional requirements applied specifically addressing aviation safety concerns.
 
Thread starter Similar threads Forum Replies Date
V AS9100 and AS9102 - Does our supplier have to do the FAI using the 3 AS9102 forms? Document Control Systems, Procedures, Forms and Templates 3
G Using the terminology EN/AS9100 vs. AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Is anyone using a commercial Configuration Management Software for AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
Z Using FMEA for Knowledge Management FMEA and Control Plans 6
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
J Including Repeats in DoE using Minitab Using Minitab Software 5

Similar threads

Top Bottom