practical quality plan - one person and small business qms … › pdf › faa-pma-iso9001... ·...
TRANSCRIPT
Your Company Name
(YOUR COMPANY NAME) PROPRIETARY INFORMATION Page 1 of 18
PMA and 14 CFR 21
QUALITY MANUAL
Origination Date: XXXX Document
Identifier: QMS-00 Quality Manual
Date: Latest Revision Date Document
Status: Draft, Redline, Released, Obsolete
Document Link:
Location on Server (if used)
Abstract: This document describes the quality management system for 14 CFR 21.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 2 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
REVISION LOG Issue Date Comment Author
Orig
DOCUMENT CHANGE RECORD
Issue Item Reason for Change
Changes to the Quality System are approved by the FAA Manufacturing Inspection District Office (MIDO) prior to implementation. The Company immediately notifies the FAA MIDO, in writing, of changes that affect inspection, conformity or airworthiness of approved articles.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 3 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
TABLE OF CONTENTS 1.0 ............................................................................................................................................................4 SCOPE
1.1 ............................................................................................................................. 4 Overview of Responsibility and Authority
1.2 .................................................................................................................................................. 5 Management Representative
1.3 ......................................................................................................................................................... 5 Internal Communication
1.4 .............................................................................................................................................................. 5 Management Review
Section A: Design Data Control ....................................................................................................................................5
Section B: Document Control........................................................................................................................................6 B1 .................................................................................................................................................... 6 Configuration Management
Section C: Supplier Control...........................................................................................................................................6
Section D: Manufacturing Control ................................................................................................................................8
Section E: Inspecting & Testing ..................................................................................................................................12
Section F: Inspection, Measuring and Test Equipment Control ..................................................................................13
Section G: Inspection and Test Status .........................................................................................................................14
Section H: Nonconforming Product and Article Control.............................................................................................14
Section I: Corrective and Preventive Action ...............................................................................................................14
Section J: Handling & Storage ....................................................................................................................................15
Section K: Control of Quality Records........................................................................................................................16
Section L: Internal Audits............................................................................................................................................16
Section M: In-Service Feedback..................................................................................................................................16
Section N: Quality Escapes .........................................................................................................................................17
Section O: Issuing Authorized Release Documents ....................................................................................................17
Section P: PMA Article Part Marking .........................................................................................................................18
Section Q: Shipping / Export of Completed Articles...................................................................................................18
Section R: Supplemental Requirements ......................................................................................................................18
Appendix 1: Organization ...........................................................................................................................................18
Appendix 2: Facility Layout........................................................................................................................................18
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 4 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
1.0 SCOPE This quality assurance manual is submitted to the Federal Aviation Administration (FAA) for information and conformance according to Regulatory Compliance requirements. This manual includes verification policies and procedures and instructions for the design, development and manufacture of Parts Manufacturer Approval (PMA) articles for various model aircraft under the authority of Title 14 Code of Federal Regulations (14 CFR).
This manual establishes and maintains a quality assurance system to ensure compliance and conformance with FAA-PMA Articles manufactured for use on certified aircraft or as detail components of an aircraft assembly.
Changes that impact inspection, conformity and airworthiness are only implemented into this manual with prior FAA approval.
The Company notifies the FAA in writing, in advance, when the manufacturing facility is relocated or expanded to other locations. Prior to shipping FAA-PMA parts from a new location, the new facility is evaluated and approved by the FAA.
The Company is committed to the ongoing maintenance and improvement of the quality management system; to ensure this, management focuses on deploying practical steps that positively support quality and environmental policies.
CUSTOMER FOCUS:
EMPOWERMENT:
INTELLIGENT MANAGEMENT:
WORKPLACE EXCELLENCE:
1.1 Overview of Responsibility and Authority The organizational chart in Appendix 1 is an overview of the management structure of the Company. See personnel roster for the name of the Responsible Authority (RA) in each branch of management that includes multiple assignments. In all cases, the appropriate person has
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 5 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
1.2 Management Representative The Accountable Manager of the Company has been assigned the role of Quality System Management Representative. The Accountable Manager is responsible for
The Accountable Manager is responsible for
In addition, the Accountable Manager
1.3 Internal Communication To ensure proper communication between and throughout all levels of employees within the Company, internal communication is
This system requires management to
1.4 Management Review Management Review meetings are conducted according to the QMS-04 Management Process Procedure. This procedure defines
Section A: Design Data Control A1 Copies of all drawings for FAA Approved articles are
A2 Design data is filed by Drawing Number and the latest revision is
A3 Minor design changes to the PMA Articles are
A4 Major design changes are
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 6 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
These design changes may require amendments or additions to:
A5 Material Review Board (MRB) is
Section B: Document Control Documents are controlled to ensure information is
The controls for documents are defined in the QMS-01
Control of Documented Information Procedure.
Paper records are controlled to provide evidence of conformity to requirements. The Company has established a documented procedure for control of electronic records. Electronic records are
B1 Configuration Management The configuration of products is controlled through advanced configuration management techniques that have been built upon the requirements of Configuration management is conducted according to the QMS-02 Configuration Management Procedure.
Section C: Supplier Control C1 Materials received are required to
Supplied items that support manufacturing and or assembly of FAA-PMA articles are inspected for
a. Reports of unsatisfactory conditions are
b. Review of documented unsatisfactory conditions increases An on-site visit may be required that verifies:
C2 Material is labeled to
C3 Materials are stored
C4 Vendors supply
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 7 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
Note: As part of the receiving inspection process, a comparison is made between the Supplier's packing sheet and the purchase order then each shipment is inspected for:
After acceptance of incoming shipments, the Responsible Authority
C5 When discrepancies are encountered during inspections, the material or shipment is according to the QMS-
14 Control of Nonconformities Procedure.
C8 Rejected articles are
C9 Requirements
Purchasing is treated as a process within the Company's quality system.
The Company does not The process is fully defined in the QMS-08 Purchasing Procedure.
C9.1 Purchasing Process
The purchasing process
C9.2 Purchasing Information
Purchase orders are used to transmit the Company's requirements to Suppliers.
C9.3 Verification of Purchased Product
Incoming materials are The process is defined in the QMS-09 Receiving Procedure.
C10 Identification and Traceability
All products are identified throughout product life cycle. This is fully defined in QMS-10 Production Process. Other identification and traceability requirements are
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 8 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
C11 Preservation of Product
The Accountable Manager
The instructions are detailed in the applicable job documentation and general rules are defined in the QMS-11 Shipping Procedure.
Section D: Manufacturing Control The Design and Development process ensures that design activities are conducted in a controlled manner, which is defined in the QMS-17 Design and Development Procedure. Instructions for Continued Airworthiness (ICA) are kept current with design changes.
D1 Materials received are required to
D2 A Shop Routing Sheet is used to document the number of pieces at each step of the manufacturing process and is used to annotate any losses. A shop routing sheet is used for
D3 The Company uses a folder for
D4 Parts are inspected to
D5 Small parts (sub-assemblies) are marked according to FAR 45.15(b) with a tag attached to the part or the packaging for the part.
D6 Parts are permanently marked or tagged with:
D7 Requirements:
The Company plans and carries out processes for product realization. In general, this includes assurances that:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 9 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
In-process inspection is conducted according to
These activities are fully defined in the QMS-10 Production Procedure. All products are identified throughout product life cycle. Other identification and traceability requirements are
D7.1 Production Documentation
Production operations are performed according to
In addition, the Company may utilize
These activities are fully defined in the QMS-10 Production Procedure and the QMS-17 Design and Development Procedure.
D7.2 Control of Production Process Changes
Only the Configuration Control Board may approve changes to production processes. The Company identifies and obtains Customer and/or regulatory authority approval for changes when
These activities are fully
defined in the QMS-10 Production Procedure and the QMS-17 Design and Development Procedure.
D7.3 Control of Production Equipment & Tools
Production equipment, tools and programs are
D7.4 Control of Work Transferred on a Temporary Basis Outside the Organization's Facilities
When the Company provides supplies for outside processing, such as acceptance testing, it is done under the following controls:
D7.5 Control of Service Operations
The Company services supplies returned to it for warranty work or repair - field servicing is(is not) performed. For such product work,
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 10 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
D8 Customer Property
Where Customer property is provided to the Company for processing or use, it is
Damaged or missing Customer property is
Government and Customer property is controlled according to the QMS-10 Production Procedure, specified contractual requirements and
D9 Preservation of Product
The Accountable Manager specifies, where required and according to contractual directives, instructions for
The instructions are detailed in the applicable job documentation and general rules are defined in the QMS-11 Shipping Procedure.
D10 Identification and Traceability
All products are identified throughout product life cycle. This is fully defined in the QMS-10 Production Procedure. Other identification and traceability requirements are
D11 Monitoring and Measurement of Product
To ensure the conformance of product to requirements, monitoring and measurement is conducted
The Quality Group is responsible for
Inspection methods may include but are not limited to:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 11 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
The inspection includes verification of compliance to:
Inspection by statistical sampling is applied, as appropriate and when specified, in
Authorized sampling plans for product acceptance are based on SAE ARP9013, Statistical Product Acceptance Requirements and documented in work instructions. The specified sampling plan for a designated application is
In the event supplies are needed prior to receipt of Certified Test Data, Certificate of Compliance or Analysis, approved Request for Deviation or Waiver or other limited risk condition, at least two applicable MRB members may
D11.1 Inspection Documentation
The engineering drawing, FAA-approved design data and/or other technical documentation provide the requirements for all deliverable supplies. In all cases, this includes
D11.2 First Article Inspection (FAI)
When required by purchase order or Customer specification, a First Article Inspection (FAI) is performed. The FAI is
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 12 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
D12 Competence, Training and Awareness
All Company personnel are hired on the basis of their ability to
The Company has implemented a training program that:
Management conducts periodic reviews of employee performance. Appropriate records of education, training, skills and experience are
The training program is defined in the QMS-06 Training
Procedure.
Section E: Inspecting & Testing E1 Request For Service Inspectors (RFS) determine that each completed part conforms to the design
data and is Inspectors perform the following:
E2 RFS Inspectors have access to FAA approved data and specifications when inspecting FAA-PMA articles. When witnessing acceptance tests, the Inspectors
E3 All inspection records described above and the record of disposition are
E4 Requirements
Inspection methods may include but are not limited to:
E4.1 In-Process Inspection
In-process inspections are conducted during production to
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 13 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
E4.2 Final Inspection
Once all operations are complete, the lot is submitted to Quality for a final inspection. This is performed according to an accepted sampling plan, The sampling plan is
Section F: Inspection, Measuring and Test Equipment Control F1 Tools, gauges and test equipment are
F2 Tools, gauges and test equipment that become inaccurate are
F3 Special tools, shop aids, master gauges or molds manufactured by RFS that are contracted with or purchased from a vendor are
F4 Inaccuracy of tools, gauges, test equipment and molds identified during periodic inspections are
a) The Company notifies MIDO of any quality escape. b) The Company processes actions according to Section N herein.
F5 Scales, shop aids and measuring devices used for inspection are
All inaccuracies are
Serviceable certifications are
Unserviceable tools are
F6 Requirements
All measuring and test equipment instruments and devices used to determine an article's conformance to specified requirements are
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 14 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
Section G: Inspection and Test Status G1 The inspector affixes an initial on the Inspection Record indicating
G2 Rejected components are
Section H: Nonconforming Product and Article Control H1 Nonconforming and rejected materials are
H2 Nonconforming parts may
H4 Major Change incorporation to FAA-PMA articles are first approved by FAA ACO and MIDO with PMA addition.
H5 Requirements
All supplies found to be nonconforming against specified requirements are
Procedures are available for receiving and processing feedback for in-service failures, malfunctions and defects. The procedures include
Procedures are available that establish a system for receiving, processing and tracking in-service failures. The procedures include provisions to Service problems, unairworthy conditions, unsafe features and unsafe characteristics are reported to the FAA according to FAR §21.3 (§21.9) and are
See the QMS-14 Control of Nonconformities Procedure.
Section I: Corrective and Preventive Action I1 Corrective actions review non-conformities of manufactured articles to:
cur
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 15 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
I2 Action is taken to:
I3 Preventive Action is taken to:
A ons
I4 Requirements
I4.1 Corrective Action
The Company has implemented and maintains a robust system for identifying and reporting nonconformities requiring corrective action. These nonconformities can
This process is defined in QMS-13 Corrective Action Procedure.
I4.2 Preventive Action
In addition to the preventive measures taken for corrective action requests (used to prevent recurrence of an existing problem) the Corrective and Preventive Action process is used to
This process is defined in the QMS-13 Corrective Action Procedure.
Section J: Handling & Storage J1 All materials are
J2 Acceptable finished products are
J3 Parts are
J4 Parts are
J5 Parts are
J6 Requirements: Preservation of Product
The Responsible Authority specifies, where required and according to contractual directives, instructions for
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 16 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
general rules are defined in the QMS-11 Shipping Procedure.
Section K: Control of Quality Records K1 The Company controls and distributes
approved changes are made available to:
And manage records as:
K2 The Company retains files for
Note: The Company ensures that only FAA approved data is used for manufacturing, instruction and support.
K3 Requirements: Control of Records
Paper records are
defined in procedure QMS-01 Control of Documented Information Procedure.
Section L: Internal Audits L1 Request For Service Inspectors conduct Internal Audits according to
See Internal Audit control log:
L2 Requirements: Internal Audit
Internal quality audits are conducted to ensure ongoing compliance with requirements of the Company's policies and procedures. This is accomplished by
The internal audit process is fully defined in the QMS-12 Internal Auditing Procedure.
Section M: In-Service Feedback Service Difficulty Reports (SDRs)
M1 When in service difficulties are discovered, they are reported to the FAA ACO and MIDO.
Note: The Company reports 14 CFR 21.3 conditions to the FAA ACO and MIDO within 24 hours, with the exceptions of weekends and recognized holidays.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 17 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
Self Disclosure Reporting
M2 When in-service difficulties are found for an article, they are reported to the FAA's geographic MIDO.
Airworthiness Directives (ADs)
M3 In the event that an Airworthiness Directive is issued by the FAA, the Company immediately implements applicable changes, if any, to articles affected by the AD.
- When appropriate, changes related to an AD are
Section N: Quality Escapes A quality escape is defined as any article that has been released from the quality system that does not conform to the applicable design data or quality system requirements.
N1 The Company notifies the FAA of any apparent quality escape by contacting the FAA MIDO office. Initial notice of a voluntary disclosure may be submitted orally, by electronic means or by written hardcopy.
N2 Notification is made in a timely manner, normally within 24 hours of the discovery of the apparent quality escape, with the exception of weekends and recognized holidays.
N3 Quality escape notifications include the following information:
Section O: Issuing Authorized Release Documents The Company may issue authorized release documents for
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Quality Manual
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 18 of 18 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
O1 The Company ensures that only qualified personnel issue authorized release documents. Evaluation of persons responsible for authorizing release documents includes
O2 FAA Form 8130-3.
The Company’s authorized personnel issue release documents using FAA Form 8130-3.
O3 Conditional Requirement.
When applicable, the Company may obtain airworthiness approvals from the FAA.
Section P: PMA Article Part Marking P1 PMA articles: Responsible Authorities permanently and legibly mark all FAA PMA articles with
the following:
P2 Sample of marking used on all PMA articles:
Your Sample Markings
P3
Section Q: Shipping / Export of Completed Articles Q1 All required documents are
Q2 Before exporting products to other Countries, FAA AC21-2 and Bilateral Agreements are reviewed for applicable requirements.
Q3 All shipping documents are followed and completed according to
Section R: Supplemental Requirements Supplemental FAA policies are defined in QMS-18 Supplemental Policies.
Appendix 1: Organization INSERT ORG CHART
Appendix 2: Facility Layout INSERT FACILITY MAP
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Company Name
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
ISO 9001 PMA and 14 CFR 21 QUALITY POLICIES HANDBOOK
Origination Date: XXXX Document
Identifier: QMS-00 QMS Quality Policies Handbook
Date: Latest Revision Date Document
Revision: Orig
Abstract: This quality handbook describes the quality management system policies and procedures that achieve conformance with ISO 9001, FAA AC 21-43, FAA Order 8120.22 and 14 CFR Part 21.137.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 2 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
REVISION LOG Issue Date Comment Author
Orig
DOCUMENT CHANGE RECORD
Issue Item Reason for Change
NOTE: Company policies herein are expressed from the perspective of "As-a-Matter-of-Fact". To apply this perspective, mentally add the phrase to the beginning of each paragraph herein. Delete this note prior to release of quality handbook.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 3 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
TABLE OF CONTENTS
Section 1: ...................................................................................................................................................................... 5 Scope
Section 2: .............................................................................................................................................. 5 Normative references
Section 3: ............................................................................................................................................ 5 Terms and Definitions
Section 4: ................................................................................................................................... 5 Context of the Organization
4.1 ..................................................................................................................................................5 Understanding the organization and its context
4.2 ........................................................................................................................5 Understanding the needs and expectations of interested parties
4.3 ................................................................................................................................5 Determining the scope of the quality management systemNon-Applicable Provisions of the QMS.............................................................................................................................................................................................5
4.4 ...................................................................................................................................................6 Quality management system and its processes4.4.1 .......................................................................................................................................................................................7 Vision and governing policies
4.4.2 ...........................................................................................................................................................................................8 Overview of documentation
4.4.3 ......................................................................................................................................................................9 Overall process sequence and interaction
Section 5: .............................................................................................................................................................. 9 Leadership5.1 ...............................................................................................................................................................................9 Leadership and commitment
5.1.1 ...........................................................................................................................................................................................................................9 General
5.1.2 ..............................................................................................................................................................................................................9 Customer focus
5.2 .................................................................................................................................................................................................................10 Policy5.2.1 .....................................................................................................................................................................................10 Establishing the quality policy
5.2.2 ...............................................................................................................................................................................10 Communicating the quality policy
5.3 .......................................................................................................................................10 Organizational roles, responsibilities and authorities
Section 6: ................................................................................................................................................................ 10 Planning6.1 ........................................................................................................................................................10 Actions to address risks and opportunities
6.1.1 ..................................................................................................................................................................................................10 Planning for the QMS
6.1.2 .................................................................................................................................................................................................10 Planning requirements
6.2 .............................................................................................................................................11 Quality objectives and planning to achieve them6.2.1 ....................................................................................................................................................................................11 Establishing quality objectives
6.2.2 .......................................................................................................................................................................................11 Achieving quality objectives
6.3 ..........................................................................................................................................................................................11 Planning of changes
Section 7: ................................................................................................................................................................. 11 Support7.1 ...........................................................................................................................................................................................................11 Resources
7.1.1 General .........................................................................................................................................................................................................................11 7.1.2 People ...........................................................................................................................................................................................................................11 7.1.3 ................................................................................................................................................................................................................12 Infrastructure
7.1.4 ................................................................................................................................................................13 Environment for the operation of processes
7.1.5 ...........................................................................................................................................................................13 Monitoring and measuring resources
7.1.5.1 .........................................................................................................................................................................................................................13 General
7.1.5.2 .............................................................................................................................................................................................13 Measurement traceability
7.1.6 ...........................................................................................................................................................................................13 Organizational knowledge
7.2 .......................................................................................................................................................................................................13 Competence
7.3 .........................................................................................................................................................................................................14 Awareness
7.4 .................................................................................................................................................................................................14 Communication
7.5 ..................................................................................................................................................................................14 Documented information7.5.1 .........................................................................................................................................................................................................................14 General
7.5.2 ..................................................................................................................................................................................................15 Creating and updating
7.5.3 ............................................................................................................................................................................15 Control of documented information
7.5.3.1 ..........................................................................................................................................15 Documents required by QMS and International Standard
7.5.3.2 .......................................................................................................................................................16 Activities for control of documented information
Section 8: .............................................................................................................................................................. 16 Operation
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 4 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
8.1 .................................................................................................................................................................16 Organizational planning and control
8.2 ...........................................................................................................................................................16 Requirements for products and services8.2.1 ............................................................................................................................................................................................16 Customer communication
8.2.2 ..................................................................................................................................17 Determining the requirements related to products and services
8.2.3 ...........................................................................................................................................17 Review of requirements related to products and services
8.2.3.1 .......................................................................................................................................................................................17 Ability to meet requirements
8.2.3.2 ..................................................................................................................................................................17 Retain documented information of review
8.2.4 ....................................................................................................................................................17 Changes to requirements for products and services
8.3 ...........................................................................................................................................17 Design and development of products and services8.3.1 ...........................................................................................................................................17 General through 8.3.6 Design and development changes
8.4 .....................................................................................................................18 Control of externally provided processes, products and services8.4.1 .........................................................................................................................................................................................................................18 General
8.4.2 ...........................................................................................................................................................................................18 Type and extent of control
8.4.3 ...............................................................................................................................................................................19 Information for external providers
8.5 ......................................................................................................................................................................20 Production and service provision8.5.1 ...............................................................................................................................................................20 Control of production and service provision
8.5.2 ......................................................................................................................................................................................21 Identification and traceability
8.5.3 ..............................................................................................................................................22 Property belonging to Customers or external providers
8.5.4 ..................................................................................................................................................................................................................22 Preservation
8.5.5 .................................................................................................................................................................................................22 Post-delivery activities
8.5.6 .......................................................................................................................................................................................................23 Control of changes
8.6 ......................................................................................................................................................................23 Release of products and services
8.7 ....................................................................................................................................................................23 Control of nonconforming outputs8.7.1 ...............................................................................................................................................................23 Identify and control nonconforming outputs
8.7.2 .................................................................................................................................................25 Retain documented information for nonconformities
Section 9: ........................................................................................................................................ 25 Performance evaluation
9.1 .........................................................................................................................................25 Monitoring, measurement, analysis and evaluation9.1.1 .........................................................................................................................................................................................................................25 General
9.1.2 ...................................................................................................................................................................................................25 Customer satisfaction
9.1.3 ...............................................................................................................................................................................................26 Analysis and evaluation
9.2 ......................................................................................................................................................................................................26 Internal audit9.2.1 ................................................................................................................................................................26 Conduct internal audits at planned intervals
9.2.2 ......................................................................................................................................................................................................26 Audit requirements
9.3 ..........................................................................................................................................................................................26 Management review9.3.1 .........................................................................................................................................................................................................................26 General
9.3.2 ..........................................................................................................................................................................................27 Management review inputs
9.3.3 ........................................................................................................................................................................................27 Management review outputs
Section 10: ........................................................................................................................................................ 27 Improvement10.1 ........................................................................................................................................................................................................27 General
10.2 .........................................................................................................................................................27 Nonconformity and corrective action10.2.1 .........................................................................................................................................................................27 Required actions for nonconformities
10.2.2 .........................................................................................................................................................................28 Required records for nonconformities
10.3 ..............................................................................................................................................................................28 Continual improvement
Section 11: ............................................................................................................ 28 PMA Article Part Marking 14 CFR 45.15
Appendix A: Cross-Reference Matrix to ISO 9001 and AC 21-43................................................................................................. 29 Appendix B: Company Process Cross Reference Matrix to ISO 9001 ........................................................................................... 30 Appendix C: Company Processes and Applicable Documents ....................................................................................................... 31 Appendix D: Outsourced Processes................................................................................................................................................ 32 Appendix E: Quality Objectives ..................................................................................................................................................... 33 Appendix F: Identification of Key Product Realization Processes ................................................................................................. 34 Appendix G: Facility Layout .......................................................................................................................................................... 35
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 5 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Section 1: Scope (Your Company's) quality management system (QMS) policies and procedures summarize top management's stategic view to improve the QMS, enhance Customer satisfaction and assure consistent delivery of products and services that achieve conformance with Customer and applicable statutory and regulatory requirements.
Section 2: Normative references Documents that are referenced herein are indispensable and their title's are displayed in Bold Italics.
Section 3: Terms and Definitions Unless otherwise noted, the Company applies the definitions of key terms according to ISO 9001, FAA AC 21-43, FAA Order 8120.22, 14 CFR Part 21.137 and the QMS-16 Definitions and Abbreviations Procedure.
Section 4: Context of the Organization
4.1 Understanding the organization and its context The Company determines, monitors and reviews internal and external issues that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure.
4.2 Understanding the needs and expectations of interested parties The Company considers the needs and expectations of interested parties that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure.
4.3 Determining the scope of the quality management system The Company's quality management system applies to all employees within all functional areas of the business operation.
The Company provides the following products and/or services:
Producer/Provider of [Your text]
NAICS code: [Your code(s)]
SIC code: [Your code(s)]
QMS policies and/or procedures outline responsibilities, methods, measurements and related performance indicators to ensure effective operation and control of the quality management system.
Non-Applicable Provisions of the QMS
The Company cites no exclusions to requirements of ISO 9001, FAA AC 21-43, FAA Order 8120.22 or 14 CFR Part 21.137.
(User Info: If your Company strictly builds-to-print or performs a service and doesn't design tools for the job, then take exception to "design" and other features herein and report exclusion in other paragraphs, such as paragraph 8.3. Delete this "User Info" prior to release of quality manual.)
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 6 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
4.4 Quality management system and its processes The Company's quality management system is fully documented and implemented and is maintained as needed to meet the requirements of the Company's vision and governing policies.
The Company uses a process-oriented method of management, which emphasizes the importance of:
During Management Review (see 9.3), process resources are discussed and allocated as applicable. Corrective action is taken to ensure processes achieve the desired results and continuously improve.
Every process has at least one QMS Procedure that defines it in greater detail that may include a process map.
For each process identified in use by the Company, the sequence and interaction of processes has been determined (see Process Orientation Checklist) and the process controlled by way of criteria and methods specific to that process, such as
Process maps define the details of each process, which includes The relationship between QMS procedures and
their applicable FAA AC 21-43 and ISO 9001 clauses is shown in Appendix A. See Appendix B for applicable Company processes and documents. Outsourced processes and their controls are defined in Appendix C. See Appendix E for identification of key realization processes.
The Company maintains all required documentation to effectively sustain its quality management system and to
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 7 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
4.4.1 Vision and governing policies
QUALITY POLICY The Company is committed to providing high
quality and high value products to its Customers,
ENVIRONMENTAL POLICY To prevent production and distribution of
products or waste materials that
PRACTICAL STEPS TO SUPPORT POLICIES
Customer Focus:
Workplace Excellence:
Empowerment:
Intelligent Management:
SEE SECTION 5 FOR DETAILS ON THESE PRACTICAL STEPS
COMPANY VISION To continually improve our processes, products and services to
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 8 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
4.4.2 Overview of documentation
The quality system documentation is comprised of a hierarchy of documents that flow from this Quality Handbook.
Corporate Vision and Governing
Policy
Quality Handbook Defines overall
Company policies and procedures
QMS Procedures Defines quality system
related processes in greater detail.
Work instructions and other job specific documentation
Forms Used to record data; once complete, they
become records.
Left blank intentionally
Cop
yrigh
t © Jn
F Specia
lties,
LLC. A
ll righ
ts res
erved
worl
dwide
.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 9 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
4.4.3 Overall process sequence and interaction
MANAGEMENT PROCESS MANAGEMENT INTERNAL AUDITING CORRECTIVE ACTION
Product Realization Processes Proposal Development and
Contract Review
Section 5: Leadership
5.1 Leadership and commitment The Company's Management is committed to
5.1.1 General
The Company uses the quality management system to guide and validate its decisions and to encourage the discovery of new areas of improvement. Management participation in the QMS is described in the QMS-04 Management Process Procedure.
5.1.2 Customer focus
The Company demonstrates leadership and commitment with respect to Customer focus by ensuring the maintenance and enhancement of Customer satisfaction through
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 10 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
according to the QMS-04 Management Process Procedure.
5.2 Policy
5.2.1 Establishing the quality policy
The Company's quality policy defines the purpose and context of the organization and its strategic direction, which includes a framework for
5.2.2 Communicating the quality policy
The Company's quality policy is available to interested parties and is maintained as documented information that is
5.3 Organizational roles, responsibilities and authorities Assignment of responsibilities and authorities for relevant roles are communicated and understood throughout the organization according to the QMS-05 Responsibilities and Authorities Procedure to ensure the quality management system conforms to the requirements of ISO 9001. Responsible authorities confirm processes are
Section 6: Planning
6.1 Actions to address risks and opportunities
6.1.1 Planning for the QMS
Planning for the quality management system includes consideration of the context of the organization and the needs and expectations of interested parties. QMS-04 Management Process Procedure is used to address associated risks and opportunities to achieve
Supplemental FAA policies are defined in QMS-18, Supplemental Policies.
6.1.2 Planning requirements
Proportionate actions are taken to address risks and opportunities that could impact requirements that are applicable to products and services according to the QMS-13 Corrective Action Procedure. The Company integrates and implements these actions into quality management system processes (see 4.4) and evaluates their effectiveness.
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 11 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
6.2 Quality objectives and planning to achieve them
6.2.1 Establishing quality objectives
The Company establishes and maintains documented information for quality objectives at relevant functions, levels and processes according to the QMS-04 Management Process Procedure. Quality objectives are measurable and consistent with the quality policy and are
6.2.2 Achieving quality objectives
The Company determines how to achieve its quality objectives according to
6.3 Planning of changes Changes to the quality management system are performed according to the QMS-02 Configuration Management Procedure, which considers the purpose of changes and potential consequences and
IMPORTANT:
The quality management system is maintained at its authorized revision level until planned changes are implemented.
Section 7: Support
7.1 Resources
7.1.1 General
The Company determines and provides the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system according to the QMS-04 Management Process Procedure, which considers
7.1.2 People
The Company determines and provides the people necessary for the effective implementation of its quality management system and operation and control of its processes according to the QMS-04 Management Process Procedure and QMS-06 Training Procedure.
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 12 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
ORGANIZATION CHART
PRESIDENT
7.1.3 Infrastructure
The Company determines, provides and maintains the infrastructure necessary for the operation of its processes to achieve according to the QMS-04 Management Process Procedure.
The Company has determined and provides the basic infrastructure needed to achieve conformity to product requirements. Infrastructure requirements are regularly reviewed during Management Review and include a review of:
The Company utilizes corrective maintenance and skilled maintenance personnel to
Left blank intentionally Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 13 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
7.1.4 Environment for the operation of processes
The Company determines, provides and maintains the environment necessary for the operation of its processes to achieve
according to the QMS-04 Management Process Procedure.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
When monitoring or measuring is used to verify the conformity of products and services, the Company determines and provides resources needed to
7.1.5.2 Measurement traceability
All measuring and test equipment instruments and devices used to determine an item's conformance to specified requirements are
according to the QMS-15 Calibration Procedure.
7.1.6 Organizational knowledge
The Company determines, maintains, uses and internally shares knowledge that is required to operate its processes. The Company considers the need for
7.2 Competence The Company determines and periodically reviews the necessary competence for Employees whose work affects the performance and effectiveness of the quality management system. The Company affirms Employee competence according to
the QMS-04
Management Process Procedure, QMS-06 Training Procedure and QMS-01 Control of Documented Information Procedure.
All Company personnel are hired on the basis of their ability to
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 14 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
The Company has implemented a training program that:
Management conducts periodic reviews of employee performance. Appropriate records of education, training, skills and experience are maintained.
The internal auditing process evaluates the effectiveness of training and
7.3 Awareness The Company affirms Employees and Contractors are made aware of the Company's quality policy and applicable quality objectives. In addition, Employees and Contractors are made aware of their
according
to the QMS-06 Training Procedure.
7.4 Communication Internal and external communications that are relevant to the QMS are determined, which includes
according to the QMS-04 Management Process Procedure.
To ensure proper communication between and throughout all levels of Employees within the Company, internal communication is
Management periodically communicates with employees to discuss Company policies and the status and effectiveness of the quality system and other information.
Employees are encouraged to
7.5 Documented information
7.5.1 General
The Company's quality management system includes
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 15 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
The order of precedence of order-specific documentation is as follows unless otherwise directed by Customer requirements:
7.5.2 Creating and updating
During creation and update of documented information, the Company reviews and approves documents prior to release for
The Company controls documented information to ensure it is according
to the QMS-01 Control of Documented Information Procedure.
7.5.3 Control of documented information
7.5.3.1 Documents required by QMS and International Standard
Documents are controlled so that the information on them is
For details, see QMS-01 Control of Documented Information Procedure and QMS-02 Configuration Management Procedure.
The Company controls and distributes design data and changes. Release and distribution of new (or revised) FAA approved drawings and/or (major) process specifications and latest approved changes are made available to:
And manage records as:
The Company retains files for
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 16 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Note: The Company ensures that only FAA approved data is
7.5.3.2 Activities for control of documented information
The Company controls the content, change disposition, revision level, access, use, retention, distribution and retrieval, preservation of legibility and storage of documented information that is maintained as evidence of conformity to
Section 8: Operation
8.1 Organizational planning and control Processes that are used to achieve compliance with requirements for deliverable products and services are monitored, measured and analyzed, suitable for their purpose and are planned according to Section 6 herein (including special processes and airborne software) that have been identified and defined by FAA-approved design data. In planning the processes for product realization, management affirms
The Company applies the QMS-07 Proposal Development and Contract Review Procedure to engage Responsible Authorities and
The Company applies QMS-02 Configuration Management Procedure to approve processes and control changes. Consequences of unintended changes are
Suppliers used for outsourced processes are approved according to 8.4 herein and the QMS-08 Purchasing Procedure.
8.2 Requirements for products and services
8.2.1 Customer communication
The Company communicates with its Customers by providing information relative to its products and services according to the QMS-07 Proposal Development and Contract Review Procedure and by obtaining
Additional Customer communication channels include
according to the QMS-10 Production Procedure.
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 17 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
8.2.2 Determining the requirements related to products and services
The Company determines that it can meet the claims for products and services it offers and ensures requirements for products and services are defined, which includes
according to the QMS-07 Proposal Development and Contract Review Procedure.
8.2.3 Review of requirements related to products and services
8.2.3.1 Ability to meet requirements
The Company reviews Customer requirements according to the QMS-07 Proposal Development and Contract Review Procedure before accepting a contract, which includes
8.2.3.2 Retain documented information of review
The Company establishes and maintains a record for each contract review that includes
8.2.4 Changes to requirements for products and services
When the requirements for products and services are changed, the Company
8.3 Design and development of products and services
8.3.1 General through 8.3.6 Design and development changes
The Company's design and development process is conducted in a controlled manner according to the nature, duration and complexity of design and development activities, stages and controls, which are defined in the QMS-17 Design and Development Procedure that includes policies for:
8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes
Instructions for Continued Airworthiness (ICA) are kept current with design changes.
8.3.7 Copies of all drawings for FAA Approved articles are
8.3.8 Design data is filed by Drawing Number and the latest revision is
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 18 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
8.3.9 Minor design changes to the PMA Articles are
8.3.10 Major design changes are
These design changes may require amendments or additions to:
8.4 Control of externally provided processes, products and services The Company accepts responsibility for
8.4.1 General
The Company affirms externally provided processes, products and services conform to requirements according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure. The Company determines the controls to be applied to externally provided processes, products and services when
The Company determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers that is based upon
according to requirements and QMS-08 Purchasing Procedure. The Company retains documented information of these activities and any necessary actions arising from the evaluations, which includes
8.4.2 Type and extent of control
The Company affirms externally provided processes, products and services do not adversely affect the Company's ability according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure. The Company takes into consideration
The Company plans, implements and controls processes to prevent counterfeit or suspect counterfeit parts according to the QMS-03 Counterfeit Parts Prevention Procedure and QMS-04 Management Process Procedure.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 19 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Material received is accompanied by a certification record and verified as noted on the Approved Supplier List. Supplied items that support production and or assembly of FAA-PMA articles are
a. Reports of unsatisfactory conditions are documented and nonconforming parts are segregated. All affected Suppliers are informed of possible FAA audit.
b. Review of documented unsatisfactory conditions increases Supplier surveillance to a more frequent basis. An on-site visit may be required that verifies:
c.
d.
e.
Note: As part of the receiving inspection process, a comparison is made between the Supplier's packing sheet and the purchase order then each shipment is inspected for:
f.
g.
h.
8.4.3 Information for external providers
The Company ensures that mandatory requirements are adequately documented prior to communicating with Suppliers according to the QMS-08 Purchasing Procedure. When the Company provides supplies for outside processing, such as acceptance testing, the work is performed under the following conditions:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 20 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
8.5 Production and service provision
8.5.1 Control of production and service provision
The Company implements production and services under controlled conditions according to the QMS-04 Management Process Procedure and QMS-10 Production Procedure. The engineering drawing, FAA-approved design data and/or other technical documentation provides the requirements for all deliverable supplies.
A Shop Routing Sheet is used to
The Company services supplies returned to it for warranty work or repair - field servicing is(is not) performed. For such product work,
Inspection methods may include
The Company plans and carries out processes for product realization. In general, this includes assurances that:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 21 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
In-process inspection and nondestructive testing (NDT) is conducted according to work instruction or other controlled document to
"Request for Service Inspectors" (RFS) determine that each completed part conforms to the design data and is safe for installation on type certificated products. Inspectors perform the following:
RFS Inspectors have access to FAA approved data and specifications when
When witnessing acceptance tests, the Inspectors have access to FAA approved data used to verify and validate any test.
All inspection records described above and the record of disposition are
The Responsible Authority completes the required inspection form, and by signing off, is
The Company does not perform work operations where the resulting quality of the work cannot be ascertained prior to delivery. When the Responsible Authority determines that a latent deficiency is discovered,
8.5.2 Identification and traceability
The Company uses suitable means to identify outputs when it is necessary to ensure
The inspector affixes an initial on the Inspection Record indicating
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 22 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Rejected components are
8.5.3 Property belonging to Customers or external providers
When outside sources provide property for processing or use, it is
Property is controlled according to the QMS-10 Production Procedure, specified contractual requirements, and
8.5.4 Preservation
According to contractual directives, instructions are detailed in the applicable job documentation for
The Company preserves production and service outputs to ensure conformity to requirements according to the QMS-10 Production Procedure and QMS-11 Shipping Procedure.
8.5.5 Post-delivery activities
The Company meets requirements for post-delivery activities associated with the products and services according to
The Company provides as applicable:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 23 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
8.5.6 Control of changes
To ensure continuing conformity with requirements, the Company according to the QMS-02 Configuration
Management Procedure, QMS-10 Production Procedure and QMS-17 Design and Development Procedure. The Company identifies and obtains Customer and/or regulatory authority approval for changes when
8.6 Release of products and services In-process inspections are conducted during production and service activities
according to the QMS-10 Production Procedure. Products and services are released for delivery to Customers only after
The Company is responsible for issuing FAA Form 8130-3 for new, rebuilt and altered articles. Authorized Responsible Authority(s) that issue Form 8130-3 are
The Company retains and maintains records for the release of products and services that includes
8.7 Control of nonconforming outputs
8.7.1 Identify and control nonconforming outputs
The Company affirms outputs that do not conform to requirements are according to the QMS-14 Control of Nonconformities Procedure.
Nonconforming outputs may be identified by the Customer and internal and external sources. The Company takes appropriate actions based on
Procedures are available that establish a system for receiving, processing and tracking in-service failures, malfunctions and defects. The procedures include
Service problems, unairworthy conditions, unsafe features and unsafe characteristics are reported to the FAA according to FAR §21.3 (§21.9) and are
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 24 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Nonconforming and rejected materials are
Nonconforming parts may be reworked to achieve conformity, provided
Major Change incorporation to FAA-PMA articles are first approved by FAA ACO and MIDO with PMA addition.
Service Difficulty Reports (SDRs)
When in service difficulties are discovered, they are reported to the FAA ACO and MIDO.
Note: The Company reports 14 CFR 21.3 conditions to the FAA ACO and MIDO within
Self Disclosure Reporting
When in-service difficulties are found for an article, they are reported to the FAA's geographic MIDO.
Airworthiness Directives (ADs)
In the event that an Airworthiness Directive is issued by the FAA, the Company
When appropriate, changes related to an AD are
A quality escape is defined as
The Company notifies the FAA of any apparent quality escape by contacting the FAA MIDO office. Initial notice of a voluntary disclosure may
Quality escape notifications include the following information:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 25 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
8.7.2 Retain documented information for nonconformities
Records used to disposition nonconformities clearly describe each nonconformance and include
according to the QMS-14 Control of Nonconformities Procedure. The Company retains and maintains records according to the QMS-01 Control of Documented Information Procedure.
Section 9: Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The Company's determines methods for monitoring, measurement, analysis and evaluation to
according to the QMS-04 Management Process Procedure, QMS-12 Internal Auditing Procedure and QMS-01 Control of Documented Information Procedure.
Documented information that is used for determining the acceptability of this quality management system may include, but are not limited to:
ports
9.1.2 Customer satisfaction
To monitor and measure Customer satisfaction and fulfillment of expectations, the Company collects information about: (adjust "your list" as required - keep mandatory items - delete this note prior to release of quality handbook)
(mandatory)
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 26 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
ance (mandatory) (mandatory)
The Company continuously improves Customer satisfaction according to the QMS-04 Management Process Procedure.
9.1.3 Analysis and evaluation
The Company evaluates according to the QMS-04 Management Process Procedure.
9.2 Internal audit
9.2.1 Conduct internal audits at planned intervals
The Company conducts internal audits at planned intervals to provide information according
to the QMS-12 Internal Auditing Procedure and QMS-04 Management Process Procedure
Request for Service Inspectors conduct Internal Audits according to
See Internal Audit Control Log:
(Log headings: )
9.2.2 Audit requirements
The Company assigns Responsible Authorities to
9.3 Management review
9.3.1 General
Top management reviews the Company's quality management system at planned intervals to ensure
according to the QMS-04 Management Process Procedure. Cop
yrigh
t © Jn
F Specia
lties,
LLC. A
ll righ
ts res
erved
worl
dwide
.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 27 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
9.3.2 Management review inputs
Management review is planned and carried out according to the QMS-04 Management Process Procedure, which takes into consideration
9.3.3 Management review outputs
Results from management reviews include
according to the QMS-04 Management Process Procedure.
Section 10: Improvement It is the goal of all employees to continually improve the effectiveness of the quality management system through the use of
10.1 General The Company determines and selects according to the QMS-04 Management Process Procedure.
10.2 Nonconformity and corrective action
10.2.1 Required actions for nonconformities
When a nonconformity occurs in products and processes, including according to the QMS-13 Corrective Action Procedure and QMS-14
Control of Nonconformities Procedure. The Company evaluates the need for action to review, analyze, control, correct and eliminate the root cause of nonconformities, including
Corrective actions are reviewed for nonconformities of produced articles to:
Action is taken to:
The Company affirms corrective actions are appropriate to the effects of nonconformities, and:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 28 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
10.2.2 Required records for nonconformities
The Company retains and maintains records regarding according to the QMS-14 Control of Nonconformities Procedure and
QMS-01 Control of Documented Information Procedure.
10.3 Continual improvement The Company continually improves
according to the QMS-04 Management Process Procedure using
Section 11: PMA Article Part Marking 14 CFR 45.15 Responsible Authorities permanently and legibly mark all FAA PMA articles with the following:
1. 2. 3. 4.
If a part is too small or is impractical to mark,
Sample of marking used on all PMA articles:
Your Sample Markings
Shipping / Export of Completed Articles
All required documents are
Before exporting products to other Countries, FAA AC 21-2 and Bilateral Agreements are reviewed for applicable requirements.
All shipping documents
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 29 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix A: Cross-Reference Matrix to ISO 9001 and AC 21-43
FAA AC 21-43A 10/01/15 Quality System (a – o)
Federal Aviation
Regulation
Quality Manual and ISO 9001 Paragraph Numbers
Procedure Number
2.3 Design Data Control: 21.137(a) 7.5.3 Control of documented info 8.3.6 Design changes
QMS-01 Control of Documented Info QMS-17 Design and Development
2.4 Document Control: 21.137(b) 7.5.3 Control of documented info QMS-01 Control of Documented Info
2.5 Supplier Control: 21.137(c)
8.4 Purchasing 8.4.1 Supplier evaluation 8.4.2 Purchasing information 8.6 Verification of purchased product 8.5.2 Identification & traceability 8.5.4 Preservation 8.7 Control of nonconformities
QMS-08 Purchasing QMS-09 Receiving QMS-10 Production QMS-14 Control of Nonconformities
2.6 Manufacturing Process Control:
2.7 Inspection and Testing:
21.137(d) 21.137(e)
7.5.3 Control of documented info 8.1 Planning of product realization 8.3.6 Design changes 8.5.1 Control of production 8.5.2 Identification & traceability 8.5.3 Customer property 8.5.4 Preservation 7.1.5 Control of measuring equipment 8.6, 9.1.1 Monitoring & measurement of product 8.7 Control of nonconformities
QMS-01 Control of Documented Info QMS-10 Production QMS-14 Control of Nonconformities QMS-15 Calibration
2.8 Inspection, Measuring and Test Equipment Control:
2.9 Inspection and Test Status:
21.137(f) 21.137(g)
7.1.5 Control of measuring equipment 8.5.2 Identification & traceability 8.6, 9.1.1 Monitoring & measurement of product
QMS-10 Production QMS-15 Calibration
2.10 Nonconforming Product and Article Control:
21.137(h) 8.7 Control of nonconformities QMS-14 Control of Nonconformities
2.11 Corrective and Preventive Actions:
21.137(i) 10.2 Corrective action QMS-13 Corrective Action
2.12 Handling and Storage: 21.137(j) 8.5.4 Preservation QMS-10 Production 2.13 Control of Quality Records: 21.137(k) 7.5.3 Control of documented info QMS-01 Control of Documented Info
2.14 Internal Audits: 21.137(l) 9.2 Internal audit QMS-12 Internal Auditing
2.15 In-Service Feedback: 21.137(m)
5.1.2 Customer focus 8.3.6 Design changes 8.7 Control of nonconformities 10.2 Corrective action
QMS-00 Quality Manual QMS-13 Corrective Action QMS-14 Control of Nonconformities QMS-17 Design and Development
2.16 Quality Escapes: 21.137(n) 8.7 Control of nonconformities 10.2 Corrective action
QMS-13 Corrective Action QMS-14 Control of Nonconformities
2.17 Authorized Release 21.137(o) 8.6 Release of products QMS-06 Training
Left blank intentionally Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 30 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix B: Company Process Cross Reference Matrix to ISO 9001
Process Applicable ISO 9001 Clauses
Configuration Management See 8.3.1 for 8.3.6, 8.5.6 Design and Development Changes, Control of Changes (was
) Control of Documents 7.5.2, 7.5.3 Creating and Updating, Control of Documented Information (was ) Control of Records 7.5.2, 7.5.3 Creating and Updating, Control of Documented Information (was ) Control of Nonconformities 8.7 Control of Nonconforming Outputs (was nformances) Corrective Action 10.2 Nonconformity and Corrective Action (was ) Internal Auditing 9.2 Internal Audit (was )
Management
4.4 Quality Management System and its Processes (was rements) 7.5 Documented Information (was ) 5.1, 5.1.1 Leadership and Commitment, General (was ) 5.1.2 Customer Focus (was ) 5.2, 5.2.1, 5.2.2 Policy, Developing the Quality Policy, Communicating the Quality Policy (was
) 6.0 Planning (was ) 5.3 Organizational Roles, Responsibilities and Authorities (was thority) 5.3 Organizational Roles, Responsibilities and Authorities (was ) 7.4 Communication (was munication) 9.3 Management Review (was ) 7.1.1, 7.1.2 General, People (was ) 7.2 Competence (was sources) 7.1.3 Infrastructure (was ) 7.1.4 Environment for the Operation of Processes (was ) See 8.3.1 for 8.3.6, 8.5.6 Design and Development Changes, Control of Changes (was
) 8.2.1 Customer Communication (was ) 8.5.1, 8.5.5 Control of Production & Service Provision, Post Delivery Support (was ) 7.1.5 Monitoring and Measuring Resources (was ) 9.1.1 Measurement, Analysis & Improvement: General (was ) 9.1.2 (was ) Customer Satisfaction 9.1.1 General (was ) 9.1.3 Analysis and Evaluation (was ) 10.1 General, Continual Improvement (was )
Production
8.1 Operational Planning and Control (was ) 8.5.1, 8.5.5 Control of Production and Service Provision, Post Delivery Support (was ) 8.5.2 Identification & Traceability (was ) 8.5.3 Property Belonging to Customers or External Providers (was ) 8.5.4 Preservation (was ) 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was )
Proposal Development & Contract Review
8.2.2 Determining the Requirements Related to Products and Services (was )
8.2.3 Review of Requirements Related to Products and Services (was irements)
Purchasing 8.4.1, 8.4.2 General, Type and Extent of Control (was process) 8.4.3 Information for External Providers (was )
Receiving
8.6 Release of Products and Services (was product) 8.5.2 Identification & Traceability (was ) 8.5.3 Property Belonging to Customers or External Providers (was ) 8.5.4 Preservation (was ) 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was )
Shipping
8.2.2 Determining Requirements Related to Products and Services (was )
8.5.1, 8.5.5 Control of Production and Service Provision, Post Delivery Support (was ) 8.5.2 Identification & Traceability (was ) 8.5.4 Preservation (was ) 8.7 Control of Nonconforming Outputs (was )
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 31 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix C: Company Processes and Applicable Documents
Process Applicable Company Procedures Applicable Company Records Corrective Action QMS-13 Corrective Action Corrective action records 10.2 (was )
Design & Development
QMS-17 Design & Development
Realization processes and resulting product meet requirements 8.1 (was ) Design and development planning 8.3.2 (was ) Design inputs records 8.3.3 (was ) Design review records 8.3.4 (was ) Design verification records 8.3.4 (was ) Design validation records 8.3.4 (was ) Design and development outputs 8.3.5 (was ) Design change records see 8.3.1 for 8.3.6 (was
) Internal Auditing QMS-12 Internal Auditing Internal audits 9.2 (was )
Management
QMS-00 Quality Handbook QMS-01 Control of Documented Info QMS-02 Configuration Management QMS-04 Management Process Procedure QMS-05 Responsibilities & Authorities QMS-06 Training QMS-15 Calibration QMS-16 Definitions and Abbreviation
Management review minutes 9.3.1 (was ) Training records 7.2, 7.3 (was ) Calibration records 7.1.5 (was )
Production QMS-10 Production QMS-14 Control of Nonconformities
Traceability records (if required) 8.5.2 (was ) Records of loss, damage or nonconformances 8.5.3 (was ) Records of release authority of inspected product 8.6 (was ) Records of first article inspection 8.6 (was ) Control of nonconformities 8.7 (was )
Proposal Development & Contract Review
QMS-07 Proposal Development & Contract Review
Contract review records 8.2.3 (was )
Purchasing QMS-08 Purchasing Supplier evaluation records 8.4.1, 8.4.2 (was )
Receiving QMS-09 Receiving QMS-14 Control of Nonconformities
Records of loss, damage or nonconformances 8.5.3 (was ) Control of nonconformities 8.7 (was )
Shipping QMS-11 Shipping QMS-14 Control of Nonconformities
Records of loss, damage or nonconformances 8.5.3 (was ) Control of nonconformities 8.7 (was )
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 32 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix D: Outsourced Processes The following processes are outsourced and controlled as indicated:
Direct shipment may be performed according to the latest revision of SAE ARP9114, Direct Ship Guidance for Aerospace Companies.
The following restrictions apply:
(1)
(2) (3)
(4)
(5) The Buyer obligates the Supplier to: (a) (b) (c) (d) (e) (f)
(g) (h)
(i)
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 33 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix E: Quality Objectives
Process Quality Objective Metric
Corrective Action
Design & Development
Internal Auditing
Management
Production
Proposal Development & Contract Review
Purchasing
Receiving
Shipping
User Info: (Delete the following User Info prior to release of quality manual)
The quantity of quality objectives listed above should be evaluated and adjusted to meet actual value-added goals of the business operation. The objectives that are listed above are
Left blank intentionally Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 34 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix F: Identification of Key Product Realization Processes
C
U
S
T
O
M
E
R
Market Research
Sales
Business Plan and Objective
Management Responsibility
Key Product Realization Processes
Quote
RFQ
Management Review
R
e
s
o
u
r
c
e
Production
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
QMS-00 Policies Handbook
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 35 of 35
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix G: Facility Layout (Insert your facility map)
8 Mandatory Procedures
(delete this table prior to release of quality handbook)
22 Mandatory Forms
(delete this table prior to release of quality handbook)
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Company Name
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
MANAGEMENT PROCESS PROCEDURE
Origination Date: XXXX Document
Identifier: Management Process Procedure
Date: Latest Revision Date Project: Customer, Unique ID, Part Number
Document Status:
Draft, Redline, Released, Obsolete
Document Link:
Location on Server (if used)
Abstract: This document describes the management review process.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
REVISION LOG Issue Date Comment Author
0-0
DOCUMENT CHANGE RECORD
Issue Item Reason for Change
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
TABLE OF CONTENTS
1.0 ................................................................................................................................................... 4 PURPOSE
2.0 .................................................................................................................................................... 4 THEORY
3.0 .................................................................................................................. 4 MANAGING AS A PROCESS
4.0 ............................................................................................. 4 PROCEDURE: MANAGEMENT REVIEW
5.0 .................................... 6 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES
6.0 ...................................................... 7 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION
7.0 ........................................................................................ 8 PROCEDURE: RESOURCE MANAGEMENT
Appendix A: PROCESS MAP.............................................................................................................................. 10
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
1.0 PURPOSE This document defines the Management process, including or making reference to procedures for the various activities within the Management process.
2.0 THEORY The Company believes in “intelligent management,” which enables the Company to make decisions based on
3.0 MANAGING AS A PROCESS The Company recognizes that it has to manage processes identified in the Quality Management Policies and Procedures Handbook; however, management itself must also be treated as a process. This means
Management is responsible for implementation and application of the following QMS requirements:
4.0 PROCEDURE: MANAGEMENT REVIEW 4.1 The management of the Company performs formal management review of the Quality Management System a minimum of
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
4.2 This review shall include
4.3 Minutes of the meetings are taken and maintained. The Management Review Report Template may be used as a guide for the records or may be completed and retained as the record.
4.4 The Management Review meeting should include analysis of the following inputs:
4.5 Management shall use action items or the corrective action system to take recorded actions as a result of review topics in an effort to
See the QMS-13 Corrective Action Procedure.
4.6 Management shall determine internal issues that affect its ability to achieve intended results, which may include, but are not limited to:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
4.7 Management shall determine external issues that affect its ability to achieve intended results, which may include, but are not limited to:
5.0 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES 5.1 Each process identified in the Quality Management System has at least one objective. The objective is
5.2 Each process objective
5.3 Top management will
5.4 Throughout the year, assigned managers and staff will
5.5 During Management Review
5.6 When a process does not meet a goal,
5.7 The current metrics, standings, previous goal and revised goals shall be (See Section 4.0)
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
5.8 Over time, management shall assess performance of each process against the goals according to the
QMS-13 Corrective Action Procedure.
6.0 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION 6.1 Internal communication is an important facet of the way the Company does business. By this we mean that information must be able to flow in all directions, from
The following methods are used for internal communications:
6.2 External communications that are relevant to the quality management system must
6.2.1 Confidential Company Information
Company Employees must not reveal Confidential Company Information to External Parties except to the extent such disclosures are necessary
6.2.1.1 Basic Company Information
Company Employees must not communicate Basic Company Information to External Parties except to the extent that such communication is part of their normal responsibilities. For example,
Only Authorized Responsible Authorities may communicate about the Company or its business, or communicate as a representative of the Company, with any of the following External Parties:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Only Authorized Responsible Authorities may communicate about the Company or its business or communicate as a representative of the Company on
6.2.1.2 Written Company Information
All Written Company Information must conform to guidelines established from time to time.
All Written Company Information must be approved by the appropriate Responsible Authority before it is communicated to any External Party.
With respect to any Written Company Information regarding new business, clients, or other contract counterparties, or other Third Parties with a business relationship with the Company, care must be exercised to
Written Company Information regarding must also be
approved by the appropriate Responsible Authority.
7.0 PROCEDURE: RESOURCE MANAGEMENT 7.1 The management of resources is a critical component to the management activities of the Company.
Resources requiring such management includes:
Cop
yrigh
t © Jn
F Specia
lties,
LLC. A
ll righ
ts res
erved
worl
dwide
.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
7.2 Like other management activities, resource management must
7.3 To manage resources, top management must
7.4 During Management Review, managers shall
7.5 From that data, top management can
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Appendix A: PROCESS MAP
Objective:
INPUT from other processes
INPUT from other processes
Conduct Management Review Meeting according to Section 4.0. Review all agenda items and current data against most current internal and external issues.
Management must research why goal is not being met.
continued next page…
Objective met?
MANAGEMENT
Owner:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
from previous page…
Left blank intentionally
NO
YES
OUT
ALL other processes
Planning, resources or controls needed?
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Management Process Procedure
PAH/PMA (…)
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".
Date Printed: Form Rev: Orig
Footnote:
1 Counterfeit part prevention processes should consider:
Left blank intentionally
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Company Name
(YOUR COMPANY NAME) PROPRIETARY INFORMATION Page 1 of 7
MANAGEMENT REVIEW REPORT
Origination Date: XXXX Document
Identifier: Name, Number, Unique ID
Date: Latest Revision Date Document
Status: Draft, Redline, Released, Obsolete
Document Link:
Location on Server (if used)
Abstract: This document provides the management review report.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 2 of 7 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
CREATION LOG Issue Date Comment Author
0-0
REVISION RECORD
Issue Item Reason for Change
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 3 of 7 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
Please complete each section - this form may used as the final report or used as a template to type and publish more formal Management Review Meeting records. At all stages, management must consider proper, proactive measures to take to improve the Company and determine where it is necessary to apply corrective action. Record corrective actions (NCR’s) filed in last section of this template.
Date of Review: Recorded by:
In Attendance:
NAME TITLE
Absent:
NAME TITLE
ITEM 1: Review of the Quality Policy for current adequacy and the need for changes to it. Review the Quality Policy to ensure it still represents the Company’s goals.
ITEM 2: Internal audit results. Report on the status of
ITEM 3: Status of MR System corrective actions. Review
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 4 of 7 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
ITEM 4: Review of resources needed to maintain and improve the effectiveness of the quality management system. Discuss
ITEM 5: Review the effectiveness of current training programs and the effectiveness of additional training for designated individuals. Include
ITEM 6: Review of Suppliers and Subcontractors. Discuss
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 5 of 7 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
ITEM 7: Review of quality objectives, data and goals. Review
Process Quality Objective Data Metric Current Standing
Goal
Management
Corrective Action
Internal Auditing
Proposal
Development and Contract Review
Purchasing
Receiving
ITEM 8: Discuss Customer feedback and complaints not already discussed as part of the NCR system review.
ITEM 9: Discuss the overall performance of the quality system, any changes to the Company that may affect the quality system or vice-versa. Include
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
PAH/PMA (…)
Your Company Name
Rev: Orig
Page 7 of 7 This document may not be disclosed or reproduced in whole or in part without prior written
permission from a representative of the Company with the authority to grant such permission.
ITEM 10: Note other recommendations for management to
ITEM 11. Note follow-up activities from prior Management Review issues.
ITEM 12. Set date for next Management Review:
ITEM 13. NCR’s FILED AT THIS MEETING:
Line Item Corrective? Nature of Issue
1
2
3
4
5
6
ITEM 14. OTHER ACTION ITEMS ASSIGNED:
Action Item Assigned to: Required Response Date
ITEM 15. ITEMS FOR FOLLOW-UP AT NEXT MEETING:
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Logo
ACTION ITEM
Date: Action Item Number: Meeting: Due Date:
Form Rev: Orig
Signature: _______________________________ Date: ___________________________________ Cop
yrigh
t © Jn
F Specia
lties,
LLC. A
ll righ
ts res
erved
worl
dwide
.
Your Logo
ACTION PLAN Page: _____ of _____ Date: _____________
Department: Responsible Authority:
Form Rev: Orig
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Logo
Page 1 of 3
This document expires 30 days after printing unless marked "Released". Date Printed:
Work Instruction
CHANGES TO ISO 9001:2015CAGE: Your#
The main changes in ISO 9001:2015 are:
i. The adoption of a Higher Level Structure (HLS) as set out in Annex SL of ISO Directives Part 1. 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation
10. Improvement ii.
iii. iv. v.
vi. vii.
viii. ix.
ISO 9001:2008 certifications will not be valid after three years from publication of ISO 9001:2015, which was September 15, 2015.
Organizations using ISO 9001:2008 are recommended to take the following actions:
i. ii.
iii.
iv.
v.
Here's how ISO 9001:2015 aligns with the format for "Plan - Do - Check - Act":
PLAN
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Logo
Page 2 of 3
This document expires 30 days after printing unless marked "Released". Date Printed:
Work Instruction
CHANGES TO ISO 9001:2015CAGE: Your#
DO
CHECK
ACT
Mandatory and recommended procedures and forms:
8 Mandatory Procedures
1. Determining the scope of the QMS (4.3) 2. Support operation of processes (4.4.2.a) 3. Quality policy (5.2.1, 5.2.2.a) 4. Quality objectives (6.2.1) 5. Control of documented information from external providers (7.5.3.2) 6. Plan, implement and control processes (8.1) 7. Determine controls to be applied and criteria for evaluation, selection, monitoring and re-
evaluation of external providers (8.4.1) 8. Implement audit program (paragraph 9.2.2)
Recommended Procedures (when applicable)
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Logo
Page 3 of 3
This document expires 30 days after printing unless marked "Released". Date Printed:
Work Instruction
CHANGES TO ISO 9001:2015CAGE: Your#
22 Mandatory Forms
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.
14. 15. 16. 17. 18. 19. 20. 21. 22.
Now that the ISO 9001 standard is a little more complex, are you wondering how to begin a quality control plan? We'll help you facilitate the changes in ISO 9001 as quickly and efficiently as possible with our "as-a-matter-of-fact" approach and with our no charge/no-expiration support by phone and email.
Purchase the updated ISO 9001:2015 standard at:
ANSI.org Webstore
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
IMPACT ANALYSIS REPORT
Form Rev: Orig
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Your Company Name
PROPRIETARY INFORMATION PAGE 1 of 6
This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
PROCESS ORIENTATION CHECKLIST
Origination Date: XXXX Document
Identifier: Name, Number, Unique ID
Date: Latest Revision Date Project: Customer, Unique ID, Part Number
Document Status:
Draft, Redline, Released, Obsolete
Document Link:
Location on Server (if used)
Abstract: This document describes an orientation checklist to understand a process.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
CAGE: xxxxx
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION PAGE 2 of 6
This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
REVISION LOG Issue Date Comment Author
0-0
DOCUMENT CHANGE RECORD
Issue Item Reason for Change
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
CAGE: xxxxx
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION PAGE 3 of 6
This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
Defined properly, a quality management system is viewed as a system of processes. After identifying organizational support and process realization processes or departments that affect quality, a documented procedure or process map is
The traditional approach to quality management has confused practitioners that are used to “compliance to requirements”. The traditional standards-based approach will prevent proper application of the quality system and diminish the return on investment in the PDCA cycle to continuously improve the QMS and its processes. Once processes are properly identified and defined, the PDCA cycle can then be effectively applied to drive improvement in the processes and in the QMS.
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
CAGE: xxxxx
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION PAGE 4 of 6
This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
Process Name:
Question Answer
(N/A if not applicable) Process Characteristics Who owns the process? Who is responsible for performing and overseeing the process?
Support Process Question With Who - training, knowledge, skills What criteria have been established for Operator competency?
Support Process Questions With What - equipment, installations What machines, materials, safety equipment, test equipment, computer systems and software are used in the process?
Support Process Questions With What Key Criteria - measurements, assessments What in-process/final verification criteria are associated with the output?
Input - what should be received Upon what inputs does the process operate, e.g., document(s), materials, tooling, schedule, etc?
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
CAGE: xxxxx
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION PAGE 5 of 6
This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
Process Name:
Question Answer
(N/A if not applicable)
Output - what should be delivered What output does the process produce?
Support Process Questions Performance indicators How is the process identified throughout the process? How is inspection status identified throughout the process?
Support Process Question How - instructions, procedures, methods What instructions are available to Operators? Are documents/work instructions approved?
Workmanship Process Map Step 1: (name) Is this a key characteristic in the process?
Process Map Step 2: (name) Is this a key characteristic in the process?
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.
Document Name or ID
CAGE: xxxxx
Your Company Name
Rev: Orig
PROPRIETARY INFORMATION PAGE 6 of 6
This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
Process Name:
Question Answer
(N/A if not applicable)
Process Map Step 3: (name) Is this a key characteristic in the process? If so, what happens to the defectives?
Process Map Step 4: (name) Is this a key characteristic in the process? If so, what happens to the defectives?
Repeat questions listed above for each remaining Steps in the process map ------------------ Improvement Resources
Copyri
ght ©
JnF Spe
cialtie
s, LL
C. All r
ights
reserv
ed w
orldw
ide.