SBS - The Best Value in QMS software

Must the AS9100C quality manual contain the procedures and QMS documents?

F

FMS-Steve

#1
Ok have a question on AS9100C Quality Manaul we would like to have a very short manual do I have to have all procedures and documents in the manual?
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
Re: AS9100 Certification Scope Content

AS9100 clause 4.2.2c says that the manual needs to either contain or reference the procedures. This means that you could have one "big honkin' manual" that includes all of the information, or you could have a much smaller manual that is very high-level. I prefer to have a relatively short manual, so I just reference the procedures in the manual.
 
M

MrMiagi

#3
Yes, I agree, it should. A reference page to Level II procedures will comply for the QM. Your Level III work instructions can be referenced in the Level II procedures. Keep your QM short with your business model in mind. The quantity should be the work instructions.

-MrMiagi

Does not the pebble entering the water begin fresh journeys? Probably, but no one really gives a RA!
 

WCHorn

Rubber, Too Glamorous?
Trusted Information Resource
#4
Remember that the quality manual is often requested by customers and other agencies. It should not contain information that is confidential or proprietary. If you consolidate everything into the quality manual, you risk revealing information you might not want in the public domain.
 

John Broomfield

Staff member
Super Moderator
#5
Ok have a question on AS9100C Quality Manaul we would like to have a very short manual do I have to have all procedures and documents in the manual?
FMS-Steve,

These days the Quality Manual is a brief description of the management system that is especially useful for new employees.

It refers to the procedures either in the text or via an attachment that lists the procedures and process owners.

Do not rewrite the system standard for auditors (although this used to be common practice).

Try writing it in the present tense so it describes what actually happens instead of what shall happen. This makes it much easier to read and understand.

John
 
Thread starter Similar threads Forum Replies Date
C AS9100C Audit must include FAA Part 145 (FAA Repair Station)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet Must COPQ always be quantified as a monetary ($) amount? IATF 16949 - Automotive Quality Systems Standard 2
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
A Read instruction manual - What Graphic Symbol must I use? US Food and Drug Administration (FDA) 7
M What kind of instrument that must be calibrated? General Measurement Device and Calibration Topics 3
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Customer VDA Audit - We must provide refresher training? VDA Standards - Germany's Automotive Standards 4
J Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting ISO 13485:2016 - Medical Device Quality Management Systems 13
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
Q IATF 16949 - Product audit - Must each product be audited? IATF 16949 - Automotive Quality Systems Standard 6
G From an ISO 17025 auditor perspective must micrometer calibration check anvil flatness? General Measurement Device and Calibration Topics 4
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
T Must all Disposable Medical Devices be DEHP Free for MDR? EU Medical Device Regulations 1
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
S Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
A ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented? Management Review Meetings and related Processes 15
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
M Contacting a "Must Use" (aka Sole Source) Supplier's Registrar Supplier Quality Assurance and other Supplier Issues 6
T Auditor states my Oven Thermocouples must be Calibrated General Measurement Device and Calibration Topics 18
K Must I update the Quality Policy? (ISO 9001:2008) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
U Must every procedure be proceeded by a policy? Document Control Systems, Procedures, Forms and Templates 2
P Must all parts of a product be RoHS compliant? EU Medical Device Regulations 5
N Must electrodes for Rx/prescription stimulators be Rx only? Other US Medical Device Regulations 2
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
F Electronic Signatures (21CFR Part 11) - Must They Appear on Printed Documents Document Control Systems, Procedures, Forms and Templates 9
R What are the "Must Have" Specs and Standards for AS9100 Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
L Must we do Receiving Inspection for everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
U Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited labs? ISO 17025 related Discussions 8
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
leftoverture Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
N Must Employees Be Evaluated Annually? Training - Internal, External, Online and Distance Learning 19
A Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540? ISO 17025 related Discussions 38
D How long must we provide service parts to Ford? IATF 16949 - Automotive Quality Systems Standard 7
E Must Patent Numbers be Shown on Product Labels? Other Medical Device and Orthopedic Related Topics 18
Ronen E FDA Must Have New Authorities to Regulate Pharmacy Compounding US Food and Drug Administration (FDA) 8
P Trip to the USA - Must-Eat Food? Holiday Planning Coffee Break and Water Cooler Discussions 57
Colin What QMS Internal Audits must cover and ISO 9001 Internal Auditing 19
R Is insulation between F type applied part and other parts a must? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Must Forms be referenced in applicable Procedures? Supplier Quality Assurance and other Supplier Issues 6
U Must We Audit Critical Suppliers? How often? Supplier Quality Assurance and other Supplier Issues 7
S Integrating a Multi-Management System - What documents & records must we have? Various Other Specifications, Standards, and related Requirements 6
R Risks which must be Distinctly Identified - Harm, Hazard, Severity ISO 14971 - Medical Device Risk Management 7

Similar threads

Top Bottom