SBS - The best value in QMS software

Documentation and procedures to support AS9100 Clause 7.1e

A

awmaier

#21
#21
Yes, 7.1e and 7.5.1.5 are very much alike.

Also, Rev C has indeed been released.
It was issued in Janurary of 2009, as listed on the front of the standard, if you have one.
The reason that you cannot be Certified to Rev C is because there are no auditors who can certify you.
They are still working to agree upon how to train the auditors.
 
Last edited by a moderator:
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#22
#22
awmaier said:
They are still working to agree upon how to train the auditors.
Click to expand...
Not really. The IAQG is in the process of selecting a single provider to develop a training package which will be used to train and qualify all aerospace assessors, around the World, to 9100:2009, 9110:2009 and 9120:2009.

The main reason for the delay is the fact that the revised 9101 standard has not been approved yet. We have several on-going threads on 9100C and 9101D.
 
A

awmaier

#23
#23
Correct. The 9101 is the Audit Checklist. Until this checklist is completed, auditors cannot be trained to it, and therefore cannot certify to the new Rev.
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#24
#24
awmaier said:
Correct. The 9101 is the Audit Checklist. Until this checklist is completed, auditors cannot be trained to it, and therefore cannot certify to the new Rev.
Click to expand...
The revised 9101 will no longer be a checklist, but a standard on how to plan, perform and report audit results for 9100, 9110 and 9120.
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#26
#26
awmaier said:
Are you saying that the new 9101 will not include a checklist?
Click to expand...
One of the areas of contention, in the development of the new 9101 document, is the inclusion of an appendix titled Objective Evidence Record - OER - or not. Such OER would require auditors to capture the observed objective evidence they gained access to, during the audit. The new 9101 will not provide for a quantified score, either.

Attached, you will find the table of contents of the latest DRAFT of the 9101D document. As you can tell, it is a complete departure from the current checklist mind-set.
 

Attachments

J

joanas bruning hicks

#28
#28
JoeOB;

Let me know if you are still looking for direction on this. I work for a registrar and can set up a conference call with an AS auditor for clarification.

Thanks;
 
K

kiwisfly

#30
#30
Hi Howste,
There are no copyright markings on the draft AS9101:2009. Sidney has already posted the contents page so why not post the whole thing, surely it is in everyone's interest to make the rest of the document available for review / comment, even if our responses are made in this forum. (the intention of my original post at top of FAQ Thread)

Would someone on one of the IAQG committees care to comment?

Cheers,

:bigwave:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M ISO13485 Documentation packs (manual, procedures, forms etc) ISO 13485:2016 - Medical Device Quality Management Systems 3
V Design & Documentation of Control Systems and Procedures Document Control Systems, Procedures, Forms and Templates 11
L Storage Cabinets for Quality Documentation (Procedures and Records) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K Revising Procedures, Process Documentation and Forms - Questions about ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Office, Pdf, Special Forms for Procedures? Economical Documentation Document Control Systems, Procedures, Forms and Templates 11
S Controlling Documentation - Which procedures to control Document Control Systems, Procedures, Forms and Templates 12
C Documentation of training and retraining procedures, specifically how training should Document Control Systems, Procedures, Forms and Templates 6
S Documentation Tree Example - Any standard numbering system for procedures Document Control Systems, Procedures, Forms and Templates 14
J What Flowchart Software Do You Use for Procedures and other Documentation? Quality Assurance and Compliance Software Tools and Solutions 142
Raffy Documentation of ISO 9001:2000 especially on the six procedures Document Control Systems, Procedures, Forms and Templates 6
Raffy ISO 9001:2000 Documentation - Necessary to "paraphrase the standards" in procedures? Document Control Systems, Procedures, Forms and Templates 2
B Calibration of CNC Machines - Does anyone have written documentation procedures? General Measurement Device and Calibration Topics 2
Marc Canned Documentation - Buying Forms and Procedures - Are the worth it? Document Control Systems, Procedures, Forms and Templates 1
A ISO 9000 Documentation Requirements - Procedures and job instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
NDesouza COTS Items CoC for FAI Documentation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
F PPAP Documentation Control APQP and PPAP 8
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0

Similar threads

Top Bottom