Developing a QMS Manual for AS9100 and ISO 9001

L

L7daddy0

#1
We are currently ISO9001 registered and have recently purchased a plant that has no certification. It was determined that the new plant would need AS9100 registration/ certification due to their customer base. I modified my QMS (which has been audited 100+ times from 2nd/ 3rd party)to incorporate the clauses for AS9100 in bold italics, and when I submitted it for review, the person reviewing it said that I should address all clauses and sub clauses in the manual. I have designed my QMS on using the manual as a driving document, an overview. The procedures and work instructions are inputs, (where all clauses are defined and addressed), and appropriate parameter sheets and quality records (outputs) Should I move forward and submit it for the stage one, or do I need to address every sub-clause in the manual. Your collective feedback is greatly appreciated.
 
Elsmar Forum Sponsor
#2
We are currently ISO9001 registered and have recently purchased a plant that has no certification. It was determined that the new plant would need AS9100 registration/ certification due to their customer base. I modified my QMS (which has been audited 100+ times from 2nd/ 3rd party)to incorporate the clauses for AS9100 in bold italics, and when I submitted it for review, the person reviewing it said that I should address all clauses and sub clauses in the manual. I have designed my QMS on using the manual as a driving document, an overview. The procedures and work instructions are inputs, (where all clauses are defined and addressed), and appropriate parameter sheets and quality records (outputs) Should I move forward and submit it for the stage one, or do I need to address every sub-clause in the manual. Your collective feedback is greatly appreciated.
Welcome to the Cove! I'm sure that we've answered this type of question many times before! My take is that your quality manual as you describe has been adequate for use in the past and must, therefore, provide for something reasonable for AS9100 - as one of our contributors says "Show me the shall"!

On a side note, is the reviewer a consultant or auditor?
 
#3
We are currently ISO9001 registered and have recently purchased a plant that has no certification. It was determined that the new plant would need AS9100 registration/ certification due to their customer base. I modified my QMS (which has been audited 100+ times from 2nd/ 3rd party)to incorporate the clauses for AS9100 in bold italics, and when I submitted it for review, the person reviewing it said that I should address all clauses and sub clauses in the manual. I have designed my QMS on using the manual as a driving document, an overview. The procedures and work instructions are inputs, (where all clauses are defined and addressed), and appropriate parameter sheets and quality records (outputs) Should I move forward and submit it for the stage one, or do I need to address every sub-clause in the manual. Your collective feedback is greatly appreciated.
Neither ISO 9001:2008 or AS9100C require documented procedures for every shall. Whoever advised you of that is all wet. Throw him a towel.

This is old school thinking based on misconceptions from the early days of ISO 9001. Old misconceptions die hard.

Now ISO / TS 29001 (API Q1) is another matter. They require that your quality manual describes how you will address each shall. But you don't work in the Petroleum industry so you don't need to take that approach unless you want to.
 

DannyK

Trusted Information Resource
#5
The requirements for the AS9100 quality manual are found in clause 4.2.2

The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

There are 6 documented procedures that are mandatory.

If you meet the above, there should be no issues.
 

dsanabria

Quite Involved in Discussions
#6
The requirements for the AS9100 quality manual are found in clause 4.2.2

The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

There are 6 documented procedures that are mandatory.

If you meet the above, there should be no issues.

The interesting part here is who is disproving your ISO / AS documentation. I believe that it is time to take shop around for competent individuals


List of procedure (based on size and exclusion) for AS9100 shop.
The list below.(if you do not take exclusions).

4.2.3 Control of Documents
4.2.4 Control of Records
7.1 Documented processes (aka - Quality Plan)
7.3.6.1. Test Procedures
7.4.2 Purchasing - (requirements for approval of product, procedures,
processes and equipment, and Qualification of personnel)
7.5.2 Special Process
7.5.1.4 Technical Documentation
8.2.2 Internal audits
8.3 Control of NCR
8.5.2 Corrective Actions
8.5.3 Preventive Actions

List of Records
4.2.4 records
5.6.1 Management Review records
6.2 Training Records
7.1 Plannning Realization records
7.2.2 Contract Review Records
7.3.1 Design and Development Review
7.3.2. Design Inputs
7.3.4 Records of results
7.3.5 Records of Verification
7.3.6 Records of Validation
7.3.6.1 Records of parameters
7.3.7 Records of ECN
7.4.1 Records of Evaluation
7.4.2 Records retention flown don to suppliers
7.4.3 Purchased /suppliers records (C of C, A of C)
7.5.2 Special Process Records
7.5.3 Traceability of Records
7.5.4 Customer Product records
7.6 Records of Validation
8.2.2 Internal audits
8.2.4 Records of Results of Production inspection
8.2.4 Release of product
8.3 Records of NCR
8.5.2 Corrective Actions records
8.5.3 Preventive Actions records
 
#7
The interesting part here is who is disproving your ISO / AS documentation. I believe that it is time to take shop around for competent individuals


List of procedure (based on size and exclusion) for AS9100 shop.
The list below.(if you do not take exclusions).

4.2.3 Control of Documents
4.2.4 Control of Records
7.1 Documented processes (aka - Quality Plan)
7.3.6.1. Test Procedures
7.4.2 Purchasing - (requirements for approval of product, procedures,
processes and equipment, and Qualification of personnel)
7.5.2 Special Process
7.5.1.4 Technical Documentation
8.2.2 Internal audits
8.3 Control of NCR
8.5.2 Corrective Actions
8.5.3 Preventive Actions

List of Records
4.2.4 records
5.6.1 Management Review records
6.2 Training Records
7.1 Plannning Realization records
7.2.2 Contract Review Records
7.3.1 Design and Development Review
7.3.2. Design Inputs
7.3.4 Records of results
7.3.5 Records of Verification
7.3.6 Records of Validation
7.3.6.1 Records of parameters
7.3.7 Records of ECN
7.4.1 Records of Evaluation
7.4.2 Records retention flown don to suppliers
7.4.3 Purchased /suppliers records (C of C, A of C)
7.5.2 Special Process Records
7.5.3 Traceability of Records
7.5.4 Customer Product records
7.6 Records of Validation
8.2.2 Internal audits
8.2.4 Records of Results of Production inspection
8.2.4 Release of product
8.3 Records of NCR
8.5.2 Corrective Actions records
8.5.3 Preventive Actions records
That's a nice list, and many would find this to be a very useful set, but bear in mind that anything above What Danny K listed is above and beyond the requirements of either AS9100 or ISO 9001.
 

dsanabria

Quite Involved in Discussions
#8
That's a nice list, and many would find this to be a very useful set, but bear in mind that anything above What Danny K listed is above and beyond the requirements of either AS9100 or ISO 9001.
While there is no disagreement between experienced QMS individuals. New individuals developing or auditing might loose sight of the basic and take our statements as gospel.

We should not deviate from the concept of ISO definitions of documented procedures.

... and I quote
ANSI/ISO/ASQC Q 1 O0 13- 1995 - Guidelines for Developing Quality Manuals

4.1 Documented quality system procedures

Documented quality system procedures should form the basic documentation used for the overall planning and administration of activities which impact on quality.

In accordance with the IS0 9000 family, these documented procedures should cover all the applicable elements of the quality system standard.

They should describe (to the degree of detail required for adequate control of the activities concerned) the responsibilities, authorities, and interrelationships of the personnel who manage, perform, verify, or review work affecting quality, how the different activities are to be performed, the documentation to be used, and the controls to be applied.
 
#9
While there is no disagreement between experienced QMS individuals. New individuals developing or auditing might loose sight of the basic and take our statements as gospel.

We should not deviate from the concept of ISO definitions of documented procedures.

... and I quote
ANSI/ISO/ASQC Q 1 O0 13- 1995 - Guidelines for Developing Quality Manuals

4.1 Documented quality system procedures

Documented quality system procedures should form the basic documentation used for the overall planning and administration of activities which impact on quality.

In accordance with the IS0 9000 family, these documented procedures should cover all the applicable elements of the quality system standard.

They should describe (to the degree of detail required for adequate control of the activities concerned) the responsibilities, authorities, and interrelationships of the personnel who manage, perform, verify, or review work affecting quality, how the different activities are to be performed, the documentation to be used, and the controls to be applied.
I continue to agree. Please take special note "these documented procedures should cover all the applicable elements of the qualtiy system standard".

There is a difference between a "shall" (requirement) and a "should" (recommendation). An auditor cannot write a nonconformance for a "should".
 

dsanabria

Quite Involved in Discussions
#10
I continue to agree. Please take special note "these documented procedures should cover all the applicable elements of the quality system standard".

There is a difference between a "shall" (requirement) and a "should" (recommendation). An auditor cannot write a non-conformance for a "should".
A most educational conversation... and in total agreement.:applause:

and while we agree that no one should be giving NCR on "should".... an experienced auditor will read section b) of clause 4.2.2


On a side note

(Don't want to mislead new people into reading "Documented Procedure" and stooping at that point).:popcorn:



4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that includes

b) the documented procedures established for the quality management system, or reference to them,



and the question will be...

show me where are the rest of the documented procedure for the QMS that are not in the Quality Manual (as shown in the hierarchy of documents).:confused:




and the hierarchy...


ANNEX A (INFORMATIVE) Typical quality system document hierarchy
ANSI/ISO/ASQC 010013-1995

Document contents

Quality manual - (Level A) - Documented quality system procedures

Describes the quality system in accordance with the stated quality policy and objectives and the applicable standard. Describes the activities of individual functional units needed to implement the quality system elements


(Level B) - Describes the activities of individual functional units needed to implement the quality system elements

(Level C) - Other quality documents (work instructions, forms, reports, etc.) Consists of detailed work documents


NOfE 7 Any document level in this hierarchy may be separate, used with references, or combined.
 
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