Guidance and/or assistance on Transition to AS9100 Rev D

O

orion1984

#1
#1
We are in the process of upgrading our Quality Management System to meet AS9100 rev D.
Can someone please provide some guidance and/or assistance on what needs to be done.

Thanks.
 
Download Free White Paper
Elsmar Forum Sponsor
howste

howste

Thaumaturge
Trusted Information Resource
#2
#2
Re: Transition to AS9100 Rev D

orion1984 said:
We are in the process of upgrading our Quality Management System to meet AS9100 rev D.
Can someone please provide some guidance and/or assistance on what needs to be done.

Thanks.
Click to expand...
Welcome to the forums! :bigwave:

I'm sure we can help, but that's a pretty generic question. What have you already done? When is your next audit?

In general the steps are these:

1) Get a copy of the standard
2) Do a gap analysis to identify what needs to be addressed to meet the new requirements.
3) Using the information from step 2, develop a plan/schedule to implement actions to meet each gap identified.
4) Update QMS documents and practices to meet the new requirements and verify effectiveness (probably with internal audits).
5) Provide any training that may be appropriate to make relevant people aware of changes to ensure effectiveness of the implementation.

Steps 4 & 5 are probably done simultaneously per the plan/schedule. Results of the activities should be reviewed regularly by leadership to ensure timeliness and effectiveness.
 
Last edited:
E

Eredhel

Quality Manager
#3
#3
Re: Transition to AS9100 Rev D

Something you may not be aware of. You can do your Stage I audit now and use it as a gap analysis and then do your Stage II audit later. There can be a 6 month gap between them if I remember correctly. If you're already at ISO9001 it's a handy approach.
 
O

orion1984

#5
#5
Re: Transition to AS9100 Rev D

Thanks for your response. I am interested in Quality manual and procedure changes.
 
E

Eredhel

Quality Manager
#6
#6
orion1984 said:
We are scheduled for a surveillance audit, those are not done in stages.
Click to expand...
You will have to do a Stage I and a Stage II audit prior to initial certification. But you don't have to do them back to back. If I misunderstand the audit requirements for certification, Stage I and II, then I'm sure someone will be able to step in and correct me. Are you already certified to any QMS yet, like ISO 9001?
 
O

orion1984

#7
#7
We are already certified to AS9100C. I don't think we are required to do Stages 1 & 2 audits to upgrade to rev D.
 
B

BoardGuy

#9
#9
IAQG has a number of support materials at http://www.sae.org/iaqg/organization/9100.htm

Review Introduction Section 0.1 of 9100D about how it is not the intent of the Standard to imply uniformity of structure, alignment of documentation or use of specific terminology. This is important as you are not required to use the clause structure or verbiage of Revision D in you quality manual, procedures or work instruction. For the quality manual you could add a cross-reference list to the manual showing how the system meets the requirements.

Another important element in Section 0.1 is found on Page 6 (SAE version of 9100), just before Section 0.2. It defines the verb form of “Shall, Should, May and Can” and denotes that information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. This guidance does not form requirements of the standard unless it is applicable to your business model and organization context.
 
B

Big Jim

Admin
#10
#10
There is a very thorough gap analysis worksheet provided by the IAQG on their web site.

www.iaqg.org

On the right hand side near the top you will find a box stating "9100:2016 Support Materials". Click on that.

The Gap Analysis is 2nd from the bottom of the 9100:2016 list.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
dgrainger Informational MHRA Guidance: Crafting an intended purpose in the context of Software as a Medical Device (SaMD) UK Medical Device Regulations 0
S Need guidance for Software validation Qualification and Validation (including 21 CFR Part 11) 5
A Guidance on Supplier Qualification - Phase 1 pharma manufacturing Supplier Quality Assurance and other Supplier Issues 3
A Post Market Surveillance Respiratory Device Guidance ISO 13485:2016 - Medical Device Quality Management Systems 1
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 5
A Guidance on qualifying a statistical analysis provider Various Other Specifications, Standards, and related Requirements 2
H Need guidance on importation of Custom-made devices into Japan Japan Medical Device Regulations 1
dgrainger Informational Guidance on In-House manufacturing UK Medical Device Regulations 0
Sidney Vianna ISO 37301 - Compliance management systems – Requirements with guidance for use Other ISO and International Standards and European Regulations 3
N Shelf life guidance EU MDR, class 1 and class 2 Medical Devices EU Medical Device Regulations 2
D Guidance for Medical records software/template ISO 13485:2016 - Medical Device Quality Management Systems 1
A Awareness of Guidance and Policies - how do you keep track? Canada Medical Device Regulations 2
S Software design document NMPA guidance and consultant China Medical Device Regulations 4
L Guidance for validation - mixing homogeneity Qualification and Validation (including 21 CFR Part 11) 0
Y Is there any EU Significant change guidance issued? EU Medical Device Regulations 5
T Using NICE for guidance during CER CE Marking (Conformité Européene) / CB Scheme 0
I ANDA Human Factors Guidance US Food and Drug Administration (FDA) 0
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
Watchcat CDRH Proposed New Guidance Documents, FY2022 Other US Medical Device Regulations 2
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
S In Need of GIDEP Guidance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Can anyone explain UKRP guidance relating to Northern Ireland? UK Medical Device Regulations 2
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Guidance for health institutions on in-house manufacture and use UK Medical Device Regulations 1
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
Aymaneh AAMI TIR45 guidance wanted IEC 62304 - Medical Device Software Life Cycle Processes 4
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
B EU MDR Perscription product guidance EU Medical Device Regulations 1
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 5

Similar threads

Top Bottom