Filled AS9100 Sample Standard
Filled AS9100 Sample Standard
AS 9110 Rev. C
Street Address
Tel,
Cell Phone:
Email:
Web Site:
________________________________________________________________________
Quality Manual- Rev-A
QM-9110 -C Approved by: _________________ Date: __________ 1
INSERT YOUR COMPANY NAME HERE
Quality Manual QM-9110-C
__________________________________________________________________
Instructions:
The blue text and suggestions displayed in the manual are intended to offer some
options and to highlight the areas that need attention / update / replacement.
Review the text and suggestions and at a minimum replace or update them to reflect
the unique / customized information of your quality system requirements.
Use replace function – enter “Your Company” in find space, enter your company
name in replace space – system should make changes throughout the entire
document.
Additional details and instructions in the use of the QM-9110-C manual template are
included in a separate file “QMS-Template-Instructions”.
Additional documentation review.
Similarly, the blue text and suggestions displayed in the QMS documentation (that
will follow) for the procedures, instructions, attachments, forms, and flow diagrams
are intended to offer some options and to highlight the areas that require update or
replacement.
________________________________________________________________________
Quality Manual- Rev-A
QM-9110 -C Approved by: _________________ Date: __________ 2
INSERT YOUR COMPANY NAME HERE
Quality Manual QM-9110-C
__________________________________________________________________
Table of Contents – (this page)
Introduction
Section B References
a. Normative reference
b. Definitions
b. Revision Status
d. Safety Policy
e. Organization Chart
Clause 5 Leadership
Clause 6 Planning
Clause 7 Support
Clause 8 Operation
Clause 10 Improvement
________________________________________________________________________
Quality Manual- Rev-A
QM-9110 -C Approved by: _________________ Date: __________ 3
INSERT YOUR COMPANY LOGO/NAME HERE
P-423-A
Document Control Sample
1.0 Purpose
1.1 This procedure describes the process for controlling quality system documents.
2.0 Responsibilities
2.1 Management is responsible to ensure that personnel have access to and are
aware of relevant quality management system (QMS) documentation and
changes.
2.2 Management is responsible for assigning authors for documents.
2.3 The author is responsible for writing the document, creating related forms, getting
a document number and submitting the document to the department manager for
review.
2.4 Department managers are responsible for approving documents for their area of
responsibility and ensure that they are legible, identifiable and available where
needed.
2.5 The document control coordinator is responsible for assigning document
numbers, maintaining the master list, posting new and revised documents on the
network, distributing hard copies of documents and revising documents.
2.6 All employees are responsible for reviewing the documents as they use them and
submitting document change requests to update documents as necessary.
2.7 The network administrator is responsible for backing up the network daily.
2.8 Engineers are responsible for maintaining programs that control equipment. (If
you have programs, controllers with programs or other software controlling your
processes, the programs must be controlled.)
3.0 Definitions
3.1 Procedure: Document outlining specific work processes and how the
requirements of the AS9110B standard are being met.
3.2 Work Instructions: Step by step directions on how a task should be done.
3.3 Attachments: Documents used to further clarify or show examples of information
described in the procedures and work instructions.
3.4 Forms: Documents used to make a record of completing all or part of the
process described in procedures and work instructions.
3.5 Records: Completed forms or information generated as a result of the process
described in a document and retained as indicated in the Control of Quality
Records Procedure.
3.6 References: external documents or sources used in preparing documentation
and completing work.
3.7 Related Documents: Other documents that may need to be altered if the current
Document Control Page 1 of 2
Date printed 5/6/13 3:28 PM
INSERT YOUR COMPANY LOGO/NAME HERE
P-423-A
Document Control
4.0 References
4.1 None
5.0 Revisions
A Initial issue
The following instructions are used to assess the risks associated with the planning of the QMS processes
and to assign priorities for the actions needed to address the risks and opportunities.
The worksheet form F-610-001 provides for options / methods for risk analysis. Choose the option that is best suited for you – refer next page.
QMS - PROCESS IDENTIFICATION WORKSHEET - for AS 9110 Rev C - QUALITY MANAGEMENT SYSTEM – Form F-440-001 1
_________________________________________________________________________________________________________________________________________________
4.1 Understanding the organization and its context Organizational context P-400 President
4.2 Understanding the needs and expectations of Needs and expectations P-400 par 5.2
interested parties
4.3 Determining the scope of the quality management Scope of the QMS P-400 par 5.4
system
4.4 Quality management system and its processes Process interactions P-400 par 5.5
5.2.3 Establishing and communicating the safety Safety policy P-500 par 5.4 AS Committee
policy
Safety policy - attachment A-520-002
5.3 Organizational roles, responsibilities, and Roles, responsibility, and P-500 par 5.5
authorities authority
Management representative P-500 par 5.5.2
5.3.1 Accountable manager Accountable manager P-500 par 5.5.3
5.3.2 Quality manager Quality manager P-500 par 5.5.4
5.3.3 Other appointed managers Other managers P-500 par 5.5.5
6.1 Actions to address risks and opportunities Planning for the QMS P-600 Management rep
6.1.1 When planning for the QMS… Planning the QMS P-600, par 5.1
6.1.2 The organization shall plan … Risk management- QMS P-600, par. 5.3
Planning
Intend This first clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its
of context and (2) understanding the needs and expectations of interested parties. Together they require that you determine the issues
clause and requirements that can impact on the planning of the Quality Management System (QMS). In addition, the scope of the QMS and
the QMS processes along with their applicability and interactions need to be determined.
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 1 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
8 OPERATION
Intent This clause requires that your company plan, implement and control the processes required for the QMS and to implement the
of actions to address risks associated with operational processes. Operational planning and control include systems for configuration
clause management, product safety, prevention of counterfeit and unapproved part, installation of approved parts. In addition, systems for
customer related processes, design and development, control of external providers, control of production and service provision, and
including identification and traceability, preservation of products, and control of nonconforming outputs are required.
______________________________________________________________________________________________________________________________
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 26 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
of its life?
______________________________________________________________________________________________________________________________
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 27 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
the customer?
______________________________________________________________________________________________________________________________
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 28 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
This checklist is based on the information provided in the 2016-11 revision of the AS 9110 Rev C, SAE international aerospace standard. The
checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the
standard. You will see questions on the checklist that refer to the standard and for each clause, provisions are made for additional questions.
The auditors are expected to keep in mind that the standard does not require mandatory procedures for the various QMS processes; however,
the auditors will expect documented information to be available because in the clauses of the standard, the phrase such as ‘documented
procedures’ is used to specify that a process, a method, a system, a work instruction, or an arrangement be documented.
The auditors must use a great deal of discretion and therefore must be careful and thoughtful prior to establishing a deficiency against a
requirement. Evidence for visible top management leadership, commitment and quality management action must be looked for.
The bold numbers and tittles used in the first two columns of the checklist indicate the “Requirements” and may be referred to on nonconformity
reports prepared by the auditor.
During assessment of each requirement, auditors record the status of the evaluation by indicating in the right-hand column a
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 1 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
related to the external and internal issues?
Additional Questions
Additional Questions
______________________________________________________________________________________________________________________________
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 2 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
External and internal issues (per 4.1)?
Additional Questions
______________________________________________________________________________________________________________________________
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 3 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
Does the QMS also address customer and applicable
statutory and regulatory quality management system
requirements?
______________________________________________________________________________________________________________________________
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 4 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
to ensure that they achieve intended results?
IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 5 of 77
Risk-Based-Thinking
in
AS 9110 Rev C
AS 9110 Rev C
Internal Auditor Training
Trainer’s Guide
AS9110Store
Overview
These course materials are meant to train people to conduct internal quality audits within
your organization, which are necessary to meet the internal audit requirements of the
AS 9110 REV C standard.
We recommend that you print this guide as you’ll need the PowerPoint speaker notes to
lead the class. This guide contains everything the instructor needs to lead the class.
Notes:
x It is assumed that the instructor has certified Lead Auditor credentials or equivalent
experience. This is not meant as a self study course.
x It is recommended that the first audit the student is involved with be under the
leadership of a lead auditor who has audit experience.
$SURFHVVDSSURDFKDOORZVDQRUJDQL]DWLRQWRV\VWHPDWLFDOO\
HYDOXDWHHDFKSDUWRIWKHLUEXVLQHVV
<RXDUHWKHQDEOHWRORRNDWHDFKSRUWLRQDQGPHDVXUHWKHUHVXOWV
DJDLQVWWKHGHVLUHGREMHFWLYH
,QWKLVH[DPSOHZH¶YHXVHGDEDNHU\WRGHPRQVWUDWHKRZDQ
RUJDQL]DWLRQLVDFWXDOO\DV\VWHPRISURFHVVHV
7KHRXWSXWRIRQHSURFHVV SXUFKDVLQJ LPSDFWVWKHLQSXWRI
DQRWKHUSURFHVV SURGXFWLRQ
,IWKHSXUFKDVLQJSHRSOHRQO\EX\WKHOHDVWH[SHQVLYHLQJUHGLHQWVLW
PD\QHJDWLYHO\LPSDFWWKHTXDOLW\RIWKHEUHDG
:KHQFKDQJHVWRGHVLJQLQSXWVDQGRXWSXWVDUHQHHGHGWKHWHDPLGHQWLILHV
UHYLHZVDQGFRQWUROVWKHFKDQJHV
'RFXPHQWHGLQIRUPDWLRQUHVXOWLQJIURPWKHGHVLJQDQGGHYHORSPHQWSURFHVV
DQGLQFOXGLQJGHVLJQFKDQJHVDUHFRQWUROOHGDQGUHWDLQHGZLWKSURFHGXUH3
&RQWURORIGRFXPHQWHGLQIRUPDWLRQ
+DYH\RXLPSOHPHQWHGDSURFHVVDQGFULWHULDIRUQRWLI\LQJWKH
FXVWRPHUSULRUWRWKHLPSOHPHQWDWLRQRIFKDQJHVWKDWDIIHFW
FXVWRPHUUHTXLUHPHQWV"
$UHGHVLJQDQGGHYHORSPHQWFKDQJHVFRQWUROOHGLQDFFRUGDQFHZLWK
WKHFRQILJXUDWLRQPDQDJHPHQWSURFHVVUHTXLUHPHQWVSHU"
7KHSURMHFWPDQDJHUGRFXPHQWVWKHSURSRVHGFKDQJHDQGWKHUHDVRQIRUWKH
FKDQJHRQDGHVLJQFKDQJHUHTXHVW
:KHQDGHVLJQFKDQJHLVPDGHWKHSURMHFWJRHVWKURXJKYHULILFDWLRQDQG
YDOLGDWLRQEHIRUHEHLQJUHOHDVHGWRHQVXUHWKHUHLVQRDGYHUVHLPSDFWRQ
WKHFRQIRUPLW\WRUHTXLUHPHQWV
$GHVLJQFKDQJHLVYHULILHGDQGYDOLGDWHGDVQHFHVVDU\EHIRUHDSSURYDO
7KHFKDQJHLVDSSURYHGE\WKHRULJLQDODSSURYHUVRIWKHSURMHFWSODQ
Introduction to AS 9110 C - Employee Newsletter #11
Watch for our next newsletter for more introduction to AS 9110 C, what it will mean to
you and your coworkers.