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INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D
__________________________________________________________________
1
AS 9100 D
Quality Management Systems
Quality Manual / Documented Information
Document No. QM-9100-D
Street Address
City, State, Zip
Tel,
Cell Phone:
Email:
Web Site:
INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D
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7
Section C Document information
a. Distribution control list
As required with procedure P-750 for Control of documented information.
Quality Manual latest revision: Letter: ___
Date of Issue: _______________ Issued by: ___________________________________
The status of the quality manual and/or description of changes are provided in the revision
status page of this manual.
Controlled copies are issued to:
Copy No. 1 President
Vice President
Copy No 2 Treasurer / Bookkeeper / Accountant
Administrative Officer
Copy No. 3 Quality Manager
Management representative / Quality team leader
Copy No. 4 Operations Manager
Technical Manager
Materials Manager
Copy No. 5 Human Resources Manager
Education/training Officer
The master copy is held by the Management representative / Quality team leader.
This manual is issued and controlled by the Management representative / Quality team
leader.
All matters or inquiries relating to its contents or usage are to be referred to that individual.
It is the responsibility of all holders of the above controlled copies to:
Ensure that this manual is read by and available to the personnel under their control.
Ensure that superseded pages are returned to the Management representative /
Quality team leader.
Uncontrolled copies of this manual will be identified with the word "uncontrolled" in bold
letters across this page
INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D
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For example, the FD-810-001 Process Flow Diagram represents each step in the
manufacturing process and includes other relevant factors associated with the steps.
Process Flow Relevant Factors
1
Sources of
Materials
2
Hauling,
Transportation
3 - Existing
Operations and
Production
3. a - New
Production
4. Products,
services for
delivery
Raw materials, products
and other components are
purchased and received
5. Deliveries to
customers
Approved suppliers,
Incoming inspections
Personnel - Manpower
Equipment -Trucks
Manpower – Laborers
Machines – Automation
Quality control –
Operator self-inspect
(x) New Machines
Manpower – Laborers
Training – machines,
maintenance
Operator self-inspect,
Products, Sub-
assemblies, Components.
Servicing
Sales and Marketing
Manpower - Drivers
Equipment –Trucks
Permits
6. Income - Invoice for
products/services
delivered
INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D
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Section D Document information – Form F-750-001
This list of Documented Information covers the AS 9100 D standard clauses 4 through 10 and
provides the responsibility, approval date, and revision status for the documents.
The QM designation indicates a Quality Management System Manual.
The P designation indicates Procedures.
The WI designation indicates Work Instructions.
The number following the document numbers listed in the Document column below identifies the
clause of the standard that the document is associated with.
Additional documented information relevant to procedures and instructions is outlined in the
spreadsheets of Master Documentation Lists, form F-750-003.
Doc. # Description Responsibility Approve
date
Revise
date
Revise
date
Quality Management System
QM-9100-D QMS Manual President
Clause 4 – Context of the Organization
P-400 Organizational context President
Clause 5 – Leadership
P-500 Leadership President
Clause 6 – Planning
P-600 Planning for the QMS Management
Representative
P-612 Risk management
process
Management
Representative
Clause 7 – Support
P-710 Resource management Operations
manager
P-715 Control of monitoring
and measuring
equipment
Management
representative
P-720 Competence and
awareness
H R manager
P-740 Communication Management
representative
P-750 Control of documented
information
Management
representative
WI-750-001 Document numbering
system
Management
representative
INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D
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Section R Records Documentation Matrix – Form F-750-002
This section of the Manual contains the Records Documentation Matrix.
The last column indicates where in the QMS the documents are used.
A sample of the latest attachment, form, registers and flow diagram is included.
Additional documented information relevant to attachments, forms, registers and flow diagrams is
outlined in the Records table, form F-750-004.
Doc # Description of document 1st Rev.
Date
Last Rev.
Date
Used with Manual,
Procedure, Instruction
Attachments
A-520-001 Quality Policy P. 9 Manual QM-9100-D / P-500 / P-740
A-530-001 Organization Chart P. 10 Manual QM-9100-D / P-500 / P-600/
P-740
A-600-001 PDCA guidelines P-600 / P-740
A-840-001 Guideline- Evaluation and
selection of providers
P-840
Forms
F-440-001 QMS-Process
identification worksheet
P-400 / P-600 / P-810
P-851
F-440-002 Organizational context
worksheet
P-400 / P-600
F-610-001 Risk and opportunity
worksheet
P-600 / P-740 / P-811
P-1010
F-612-001 Risk management plan P-612
F-612-002 Risk list P-612
F-620-001 Quality objectives planning
record
P-600
F-710-001 Equipment problem report P-710 / P-715
F-710-002 Resource maintenance
record
P-710
F-715-002 Calibration register P-715
F-720-001 Training action plan P-720
F-720-002 Group training record P-720
F-720-003 Job description P-720
F-720-004 Employee training
summary
P-720
INSERT COMPANY NAME/LOGO HERE
AS 9100 Rev D - Quality Management Systems – The Gap Analysis Checklist ___________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________
IAQG-Oct-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 1 of 76
This gap analysis checklist is prepared for use in evaluating a Quality Management System (QMS) against the requirements of the new Aerospace standard. The AS 9100 Rev D standard includes the requirements of ISO 9001:2015 and specifies additional aviation, space, and defense (ASD) industry requirements.
In the checklist, each requirement is expressed as a question that the user (auditor / assessor) can use to evaluate your QMS capabilities. You will need to have copies of the AS 9100 D and ISO 9001:2015 standards to use along with this checklist so that, if required, you can refer to the requirements and the clarification sections of Annex A.
While the structure of the AS and ISO standards are the same when comparing the contents, the additional ASD requirements are highlighted in yellow in the relevant sections of the checklist and the intent of the main clauses of the new standard is shown in blue font.
After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy each section of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and what needs to be developed.
In the space for ‘currently in place’, list or reference the procedures or other documents, or evidence that you have reviewed and that will provide information for the new QMS. Take notes on the status of the documents, that is, will they need to be revised for the new system, or can they be used as is? Also note where processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed.
While you do want to know if documented information is in place and if procedures and processes are being complied with, compliance is not your main focus for this audit. Remember that the final outcome of this audit should be a list of things that your company needs to do to comply with AS 9100 Rev D.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
--- QUALITY MANAGEMENT SYSTEMS REQUIREMENTS
Currently
in Place
Compliant YES / NO?
If No - % Completed
Items
Needed
4 CONTEXT OF THE ORGANIZATION
Intend of
clause
This first clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its context and (2) understanding the needs and expectations of interested parties. Together they require that you determine the issues 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.
INSERT COMPANY NAME/LOGO HERE
AS 9100 Rev D - Quality Management Systems – The Gap Analysis Checklist ___________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________ IAQG-Oct-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 3 of 76
4.3 Determining the scope of the quality management system
To establish the scope of the QMS, does your company determine the boundaries and applicability of the QMS?
When determining the scope of the QMS, do you consider the:
External and internal issues (per 4.1)?
Requirements of relevant interested parties (per 4.2)?
The products and services of your company?
When a requirement of AS 9100 D can be applied, is the requirement applied by your company?
When requirements cannot be applied, and in order to claim conformity to AS 9100 D, how do you determine if your ability or responsibility to ensure conformity of products and services are not affected?
Is the scope of the QMS available and maintained as documented information?
Does the scope state the products and services covered by the QMS?
Does your company provide justification for any instance where a requirement of the standard cannot be applied?
INSERT COMPANY NAME/LOGO HERE
AS 9100 Rev D - Quality Management Systems – The Gap Analysis Checklist ___________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________ IAQG-Oct-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 4 of 76
4.4 Quality management system and its processes
4.4.1 As required by the standard, do you establish, document, implement, maintain and continually improve the QMS?
Does the QMS also address customer and applicable statutory and regulatory quality management system requirements?
Does your company determine the processes needed for the QMS, their interactions and applications throughout your company?
That is, for the QMS processes do you determine the:
Inputs required and the outputs expected from the processes?
Sequence and interaction of the processes?
Criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of the processes?
Resources needed and ensure they are available?
Assignment of the responsibilities and authorities for these processes?
Risks and opportunities (per 6.1), and plans to implement the appropriate actions to address them?
See also Operational risk management (per 8.1.1)
INSERT COMPANY NAME/LOGO HERE
AS 9100 Rev D Quality Management Systems - The Internal Audit Checklist ___________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________ Audit conducted by: _____________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 3 of 79
4.3 Determining the scope of the quality management system
To establish the scope of the QMS, does your company determine the boundaries and applicability of the QMS?
When determining the scope of the QMS, do you consider the:
External and internal issues (per above clause 4.1)?
Requirements of relevant interested parties (per above clause 4.2)?
The products and services of your company?
When a requirement of AS 9100 D can be applied, is the requirement applied by your company?
When requirements cannot be applied, and in order to claim conformity to AS 9100 D, how do you determine if your ability or responsibility to ensure conformity of products and services are not affected?
Is the scope of the QMS available and maintained as documented information?
Does the scope state the products and services covered by the QMS?
INSERT COMPANY NAME/LOGO HERE
AS 9100 Rev D Quality Management Systems - The Internal Audit Checklist ___________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________ Audit conducted by: _____________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 9 of 79
5.2 Policy
5.2.1 Developing the quality policy
Has your top management established, implemented and maintained a quality policy that:
Is appropriate to the purpose and context of the organization?
Provides a framework for setting and reviewing quality objectives?
Includes a commitment to satisfy applicable requirements?
Includes a commitment to continual improvement of the QMS?
5.2.2 Communicating the quality policy
Is your quality policy:
Communicated, understood and applied within your company?
Available as documented information?
Available to relevant interested parties?
Additional Questions
INSERT COMPANY NAME/LOGO HERE
AS 9100 Rev D Quality Management Systems - The Internal Audit Checklist ___________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________ Audit conducted by: _____________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 24 of 79
7.5.2 Creating and updating
When creating and updating documented information, does the company ensure:
Identification and description, such as a title, date, author, or reference number?
Format, such as language, software version, graphics and media, such as paper, electronic?
Review and approval for suitability and adequacy?
NOTE: Approval implies authorized persons and approval methods are identified for the relevant types of documented information, as determined by the organization.
Additional Questions
7.5.3 Control of documented Information
7.5.3.1 Do you control the documented information required by the QMS and by the AS 9100 D standard to ensure that it is:
Available and suitable for use, where and when it is needed?
INSERT YOUR COMPANY LOGO/NAME HERE
P-920-A
Internal Audits
Internal audits Page 1 of 5
Date printed 11/9/16 1:39 pasdite
1.0 Purpose/Scope
1.1 This procedure describes the process for performing Internal Audits at Your Company.
1.2 The procedure applies to the audit of the QMS where performance is evaluated.
2.0 Responsibilities and Authorities
2.1 The President has the prime responsibility and approval authority for this procedure.
2.2 In support of the President, the Quality team / AS steering committee is responsible to ensure that internal audits are conducted at planned intervals.
2.3 Additional responsibilities for the Quality team leader / Management representative / audit coordinator, lead auditor, auditors, management staff, employees, and the corrective action coordinator are detailed in relevant paragraphs of section 5.0 below.
3.0 References and Definitions
3.1 Reference
3.1.1 This document relates to clause 9.2 of the AS 9100 D standard, Internal audit.
3.2 Definition
3.2.1 Audit Team: May be one or more auditors, including the lead auditor.
4.0 Resources
4.1 None
5.0 Instructions
5.1 In support of the procedure P-910 for Monitoring, measuring, analysis and evaluation, this procedure addresses the internal audits of the QMS.
5.1.1 Internal audits are conducted to ensure that the QMS conforms to Your Company’s own requirements and to those of the AS 9100 D standard, is effectively implemented and maintained, and continues to be suitable, adequate and effective.
The company’s own requirements include customer and applicable statutory and regulatory quality management system requirements.
5.1.2 The President / Quality team / AS steering committee ensure that internal audits are conducted at planned intervals at a minimum of two times per year.
At the call of the President, internal audits may be conducted more frequently based on performance and results observed during previous audits.
Performance indicators can be evaluated to determine whether the
INSERT YOUR COMPANY LOGO/NAME HERE
P-920-A
Internal Audits
Internal audits Page 4 of 5
Date printed 11/9/16 1:39 pasdite
5.8.1 The audit coordinator or management staff person is responsible for initiating corrective actions.
5.8.2 The audit team holds a closing meeting with the representatives of the area audited, including a management person with responsibility for the area audited.
All observed non-conformances are explained and the status of the area audited is summarized.
5.8.3 The lead auditor prepares an internal audit report on form F-920-004. The report includes:
A summary of the findings
A table of corrective action requests
A copy of each corrective action request
5.8.4 The audit report is distributed to the attendees of the opening and closing meetings.
5.9 The lead auditor puts all audit records into the audit file.
5.9.1 The records included are the internal audit plan, the auditors’ checklists, and the internal audit report, including the table of corrective action requests.
5.9.2 The records are retained, with the procedure P-750 for Control of documented information, as evidence of the implementation of the audit program and the audit results.
6.0 Forms and Documented Information
6.1 Forms
6.1.1 F-920-001 Applicable Procedures by Work Area
6.1.2 F-920-002 Audit Checklist
6.1.3 F-920-003 Internal Audit Plan
6.1.4 F-920-004 Internal Audit Report
6.1.5 F-1020-001 Corrective action request - CAR
6.2 Documented information / Related processes
6.2.1 P-600 Planning for the Quality management system
6.2.2 P-750 Control of documented information
6.2.3 P-910 Monitoring, measuring, analysis and evaluation
6.2.4 P-930 Management review
6.2.5 P-1020 Nonconformity and corrective action
7.0 Opportunities and Risks
