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Quality Handbook is compliant with AS9100D

Table of Contents - Click here for PDF demo - opens in new tab

Section 1: Scope
Section 2: Normative References
Section 3: Terms and Definitions
Section 4: Context of the Organization
Section 5: Leadership
Section 6: Planning
Section 7: Resources
Section 8: Operation
Section 9: Performance Evaluation
Section 10: Improvement
Appendix A: Company Processes and Applicable AS9100D Clauses
Appendix B: Company Processes and Applicable Documents
Appendix C: Outsourced Processes
Appendix D: Quality Objectives
Appendix E: Identification of Key Product Realization Processes

Section 1:    Scope

(Your Company's) quality management system (QMS) policies and procedures summarize top management's strategic 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 AS9100D and the Definitions and Abbreviations Procedure.

Section 4:    Context of the Organization

4.1    Understanding the organization and its context
The Company... according to the Management Process Procedure.

4.2    Understanding the needs and expectations of interested parties
The Company considers... according to the 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...

The primary purpose of the Quality Handbook and QMS Procedures is to...

Copies of the handbook are controlled by...

This Quality Handbook has been developed by top management to...

Additional procedures and work instructions have been developed to... Where subordinate documents are referenced, they are shown in bold italics.

4.3.1    Non-Applicable provisions of the QMS
The Company cites...

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... which emphasizes the importance of:

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During Management Review (see 9.3), process resources are...

Every process has at least one QMS Procedure that defines it in greater detail that may...

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...

Process maps define the details of each process, which includes... The relationship between QMS procedures and their applicable AS9100D 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...

4.4.1    Vision and governing policies

...

4.4.2    Overview of documentation
The quality system documentation is comprised of a hierarchy of documents that flow from this Quality Handbook.

4.4.3    Overall process sequence and interaction

...

Section 5:    Leadership

5.1    Leadership and commitment
The Company's Management is...

5.1.1    General
The Company uses the quality management system to guide and validate its decisions and to... Management participation in the QMS is described in the Management Process Procedure.

5.1.2    Customer focus
The Company demonstrates leadership and commitment with respect to Customer focus by... according to the Management Process Procedure.

5.2    Policy

5.2.1    Establishing the quality policy
The Company's quality policy defines...

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 Responsibilities and Authorities Procedure to ensure...

The organization chart below describes the basic management structure of the Company. In all cases, the appropriate person has... which is further defined in the Responsibilities and Authorities Procedure.

All employees are empowered to...

The Quality Manager has been assigned the role of Responsible Quality Authority (RQA).
As RQA, the Quality Manager is responsible for:

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The Quality Manager has the responsibility and authority to...

5.3.1    Organization chart

...

Section 6:    Planning

This quality system was planned in advance and its documented policies and procedures were reviewed prior to implementation. Management affirms the QMS is...

The QMS documentation acts as the overall quality plan for the Company. As required, specific quality processes...

Quality system planning and control is treated as a process (called the Management Process) and is defined in the Management Process Procedure.

6.1    Actions to address risks and opportunities

6.1.1    Planning for the QMS
Planning for the quality management system includes... Management Process Procedure is used to address identified risks and opportunities...

6.1.2    Planning requirements
The Company determines the effectivity of actions taken to establish process controls that... according to the Management Process Procedure.

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 Management Process Procedure. Quality objectives 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 Configuration Management Procedure, which considers...

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... according to the Management Process Procedure, which considers...

7.1.2    People
The Company determines and provides the people necessary to... according to the Management Process Procedure and Training Procedure.

7.1.3    Infrastructure
The Company determines, provides and maintains the infrastructure necessary for... according to the Management Process Procedure.

The Company has determined and provides... and include a review of:

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The Company utilizes maintenance practices and skilled maintenance personnel to...

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 conformity of products and services. The work environment is...

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...

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 Calibration Procedure.

Measuring equipment is... according to the Calibration Procedure.

7.1.6    Organizational knowledge
The Company determines... The Company considers... according to the Proposal Development and Contract Review Procedure.

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...

All Company personnel are...

The Company has implemented a training program that:

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Management conducts...

7.3    Awareness
The Company affirms...

7.4    Communication
Internal and external communications that are relevant to the QMS are... according to the Management Process Procedure.

To ensure proper communication..., which is documented in the Management Process Procedure.

Management periodically...

Employees are encouraged to use the Request for Support (RFS) to submit suggestions for improvements. This system requires management to take action on quality related issues within the Company.

7.5    Documented information

7.5.1    General
The Company's quality management system includes documented information required by AS9100D and records necessary for the effectiveness of the quality management system.

The Company maintains all required documentation to...

All Managers are responsible for...

The quality system documentation is comprised of a hierarchy of documents that flow from this Quality Handbook (see 4.4.2).

All documents must...

The order of precedence of order-specific documentation is as follows unless otherwise directed by Customer requirements:

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7.5.2    Creating and updating
During creation and update of documented information, the Company reviews and approves documents... according to the Configuration Management Procedure. Controlled documents display... according to the Control of Documented Information Procedure.

The Company has developed a secure web-based document portal that enables... according to the Configuration Management Procedure.

7.5.3    Control of documented information

7.5.3.1    Documents required by QMS and international standard
Documents are controlled so that information on them is... For details, see Control of Documented Information Procedure and Configuration Management Procedure.

7.5.3.2    Activities for control of documented information
The Company controls... according to the Control of Documented Information Procedure. Superseded and/or obsolete documents may... according to the Configuration Management Procedure. Management provides guidelines for managing... according to the Management Process Procedure.

Section 8:    Operation

8.1    Organizational planning and control
Processes that are used to achieve compliance with requirements for deliverable products and services are...

The Company applies the Proposal Development and Contract Review Procedure to engage Responsible Authorities and...

The Configuration Management Procedure is used to approve processes and control changes. Consequences of unintended changes are...

Inspection, testing and "on-time delivery" requirements are......

Project management is used to......

Key product realization processes include the following procedures:

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Quality objectives have been established for each key process. At times, additional quality objectives and measurements may...

Suppliers used for outsourced processes are approved according to 8.4 herein and the Purchasing Procedure. When the Company provides supplies for outside processing, such as acceptance testing, the work is performed under the following conditions:

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8.1.1    Operational risk management
Risk management for operational processes is conducted according to the Risk Mitigation and Planning Procedure. Proportionate actions are...

8.1.2    Configuration management
The configuration of products and services is controlled... according to the Configuration Management Procedure.

8.1.3    Product safety
The Company plans, implements and controls the processes... according to the Manufacturing Procedure.

8.1.4    Prevention of counterfeit parts
The Company... according to the Counterfeit Parts Prevention Procedure and Management Process Procedure.

8.2    Requirements for products and services

8.2.1    Customer communication
The Company communicates with its Customers by...

8.2.2    Determining the requirements related to products and services
The Company determines it can meet the claims for products and services it offers and affirms... according to the Proposal Development and Contract Review Procedure.

The Company captures all contractual and special requirements of the Customer, as well as......

8.2.3    Review of requirements related to products and services

8.2.3.1    Ability to meet requirements
Applicable functions within the Company review Customer requirements according to the Proposal Development and Contract Review Procedure...

The Company pays particular attention to...

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 affirms......

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..., which are defined in the Design and Development Procedure that includes policies for:

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8.4    Control of externally provided processes, products and services
The Company... does not...

8.4.1    General
The Company affirms externally provided processes, products and services conform to requirements according to the Purchasing Procedure and Receiving Procedure. The Company determines the controls to be applied to externally provided processes, products and services when...

8.4.1.1    External provider abilities
The Company determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers that is based upon... processes or products and services according to requirements and Purchasing Procedure.

8.4.2    Type and extent of control
The Company affirms externally provided processes, products and services...

8.4.3    Information for external providers
The Company affirms mandatory requirements are...

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 according to the Management Process Procedure and Manufacturing Procedure, which includes provisions for:

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The Company plans and carries out processes for product realization. In general, this includes assurances that:

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In-process inspection is conducted according to...

...the Manufacturing Procedure and Configuration Management Procedure.

8.5.2    Identification and traceability
The Company uses suitable means to identify outputs when it is necessary to ensure the conformity of products and services, and identifies the status of outputs with respect to...

QC stamps or registered names and initials of inspectors may...

8.5.3    Property belonging to Customers or external providers
When outside sources provide property for processing or use, it is suitably identified as such to...

Property is controlled according to the Manufacturing Procedure...

8.5.4    Preservation
According to contractual directives, instructions are detailed in the applicable job documentation... according to the Manufacturing Procedure and 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:

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8.5.6    Control of changes
To ensure continuing conformity with requirements, the Company reviews and controls...

8.6    Release of products and services
In-process inspections are conducted during production and service activities to ensure ongoing quality of work according to the Manufacturing Procedure. Products and services are released for delivery to Customers only...

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... Nonconforming outputs may be identified by... The Company takes appropriate actions based on... Nonconformances are corrected then reverified to confirm outputs are in compliance with requirements. When appropriate, the Company...

8.7.2    Retain documented information for nonconformities
Records used to disposition nonconformities clearly describe each nonconformance and includes...

Section 9:    Performance Evaluation

9.1    Monitoring, measurement, analysis and evaluation

9.1.1    General
The Company determines methods for monitoring, measurement, analysis and evaluation to ensure valid results by...

Documented information that is used for determining the acceptability of this quality management system may include, but are not limited to:

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9.1.2    Customer satisfaction
To monitor and measure Customer satisfaction and..., the Company collects information about:

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The Company continuously improves Customer satisfaction according to the Management Process Procedure.

9.1.3    Analysis and evaluation
The Company evaluates... according to the 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...

9.2.2    Audit requirements
The Company assigns Responsible Authorities to perform internal audits and report audit results to management according to the Internal Auditing Procedure.

9.3    Management review

9.3.1    General
Top management reviews the Company's quality management system at planned intervals to...

9.3.2    Management review inputs
Management review is planned and carried out according to the Management Process Procedure, which takes into consideration...

9.3.3    Management review outputs
Results from management reviews include...

Section 10:    Improvement

It is the goal of all employees to...

10.1    General
...

10.2    Nonconformity and corrective action

10.2.1    Required actions for nonconformities
When nonconformity occurs in products and processes, including..., the Company takes action and...

The Company affirms corrective actions are appropriate to the effects of nonconformities, and:

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10.2.2    Required records for nonconformities
The Company retains and maintains records regarding the nature of nonconformances, subsequent actions and...

10.3    Continual improvement

The Company continually improves...

Appendix A: Company Processes and Applicable AS9100D Clauses

...

Appendix B: Company Processes and Applicable Documents

... ... ...

Appendix C: Outsourced Processes

The following processes are outsourced and controlled as indicated:

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Appendix D: Quality Objectives

...

Appendix E: Identification of Key Product Realization Processes

...

11.0 REVISION HISTORY AND APPROVAL RECORD

Quality System Policies
QUALITY HANDBOOK
Rev: Orig (EO #??) Date: (your release date - mandatory)

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