ISO 9001 Quality Policies Handbook

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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: Support
Section 8: Operation
Section 9: Performance Evaluation
Section 10: Improvement
Appendix A: Company Processes and Applicable 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 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.

The Company has always applied high quality standards as guidelines for its processes and operations but has revised its systems to fully comply with ISO 9001:2015. The Company is dedicated to the principle of maintaining the highest levels of quality and integrity in communicating with people inside and outside of its business operation.

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 and the Definitions and Abbreviations Procedure.

Section 4: Context of the Organization

4.1 Understanding the organization and its context
The Company considers, monitors and reviews internal and external issues that affect its ability to achieve intended results according to the 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 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 the ISO 9001 standard. (list your exclusions to ISO 9001)

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.

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

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

...

Section 5: Leadership

5.1 Leadership and commitment

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 ensuring the maintenance and enhancement of Customer satisfaction through...

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 ... according to the Responsibilities and Authorities Procedure to ensure the quality management system conforms to the requirements of ISO 9001. Responsible authorities confirm processes are...

IMPORTANT:
The quality management system is maintained at its authorized revision level until ...

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. The Management Process Procedure is used to address associated risks and opportunities to achieve...

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 Corrective Action Procedure. The Company integrates ... and evaluates their effectiveness.

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 consistent with the quality policy and are... monitored, communicated and updated as required to enhance Customer satisfaction (see Appendix D).

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... and...

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 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 Management Process Procedure and Training Procedure.

7.1.3 Infrastructure
The Company determines, provides and maintains the infrastructure necessary for the operation of its processes to achieve... according to the Management Process Procedure.

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...

7.1.5 Monitoring and measuring resources

7.1.5.1 General
The Company determines and provides resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services according to the Management Process Procedure, which ensures the provided resources are...

7.1.5.2 Measurement traceability
Measuring equipment is identified for traceability then calibrated and/or verified prior to use and safeguarded from... according to the 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 ... each Customer according to the Proposal Development and Contract Review Procedure.

7.2 Competence
The Company determines the necessary competence for Employees whose work affects the performance and effectiveness of the quality management system. The Company ensures Employee competence according to... the Management Process Procedure, Training Procedure and Control of Documented Information Procedure.

7.3 Awareness
The Company ensures 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 Training Procedure.

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

7.5 Documented information

7.5.1 General
The Company's quality management system includes documented information required by ISO 9001 and records necessary for the effectiveness of the quality management system.

7.5.2 Creating and updating
During creation and update of documented information, the Company reviews and approves documents prior to release for... according to the Configuration Management Procedure. In addition, the Company determines an appropriate document format, which may include...

7.5.3 Control of documented information

7.5.3.1 Documents required by QMS and International Standard
The Company controls documented information to ensure it is available and suitable for use when and where it is needed and is protected from... according to the Control of Documented Information Procedure.

7.5.3.2 Activities for control of documented information
The Company controls the distribution, access, retrieval, use, storage, preservation, ... 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 suitable for their purpose and are planned according to Section 6 herein. The Company applies Proposal Development and Contract Review Procedure to implement the processes and Configuration Management Procedure to approve processes and control changes. Consequences of unintended changes are...

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 Proposal Development and Contract Review Procedure and by obtaining... Additional Customer communication channels include... according to the Manufacturing Procedure.

8.2.2 Determining the requirements related to products and services
The Company ensures 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 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 Proposal Development and Contract Review Procedure before accepting a contract, which includes...

...

8.2.3.2 Retain documented information of review
The Company maintains a record for each review that includes new requirements for products and services.

8.2.4 Changes to requirements for products and services
When the requirements for products and services are changed, the Company applies Proposal Development and Contract Review Procedure to ensure Responsible Authorities are aware of changes. Applicable documents are revised according to the Configuration Management Procedure.

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 ensures design activities are conducted in a controlled manner that is defined in the Design and Development Procedure, which 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

8.4 Control of externally provided processes, products and services

8.4.1 General
The Company ensures that 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...

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 Purchasing Procedure. The Company retains documented information of these activities and any necessary actions arising from the evaluations.

8.4.2 Type and extent of control
The Company ensures that externally provided processes, products and services do not adversely affect the Company's ability... according to the Purchasing Procedure and Receiving Procedure.

8.4.3 Information for external providers
The Company ensures that mandatory requirements are... according to the Purchasing Procedure.

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 Management Process Procedure and Manufacturing 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... the Manufacturing Procedure. The Company controls the unique identification of outputs when...

8.5.3 Property belonging to Customers or external providers
Property used by the Company or under its control that is received from outside sources is controlled according to the Manufacturing Procedure.

8.5.4 Preservation
The Company preserves production and service outputs to the extent necessary... 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 Responsibilities and Authorities Procedure.

8.5.6 Control of changes
To ensure continuing conformity with requirements, the Company... according to the Configuration Management Procedure, Manufacturing Procedure and Design and Development Procedure.

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

8.7 Control of nonconforming outputs

8.7.1 Identify and control nonconforming outputs
The Company ensures outputs that do not conform to requirements are identified and controlled to prevent their unintended use or delivery according to the Control of Nonconformities Procedure. The Company takes appropriate actions based on...

When appropriate, the Company segregates, contains, returns or suspends delivery of products and services and requests Customer authorization for acceptance.

8.7.2 Retain documented information for nonconformities
Company records describe each nonconformance and includes Customer approval when applicable, actions taken and identification of Responsible Authorities.

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 ensure valid results by defining... according to the Management Process Procedure, Internal Auditing Procedure and Control of Documented Information Procedure.

9.1.2 Customer satisfaction
To monitor and measure Customer satisfaction and fulfillment of expectations, the Company may collect information about:

• ...
• ...
• ...
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The Company continuously monitors 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 information... according to the Internal Auditing Procedure.

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 ensure... according to the Management Process Procedure.

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... according to the Management Process Procedure.

Section 10: Improvement

10.1 General
The Company determines and selects... according to the Management Process Procedure.

10.2 Nonconformity and corrective action

10.2.1 Required actions for nonconformities
When a nonconformance occurs, including complaints, the Company reacts to the nonconformance and, as applicable, takes action... according to the Corrective Action Procedure and Control of Nonconformities Procedure. The Company evaluates the need for action to eliminate the cause of each nonconformance to prevent recurrence or occurrence somewhere else by... The Company ensures corrective actions are appropriate to the effects of each nonconformance.

10.2.2 Required records for nonconformities
The Company retains and maintains records regarding... actions and results of corrective actions according to the Control of Documented Information Procedure.

10.3 Continual improvement
The Company continually improves the suitability, adequacy and effectiveness of the quality management system according to the Management Process Procedure using...

Appendix A: Company Processes and Applicable ISO 9001 Clauses

Appendix B: Company Processes and Applicable Documents

Appendix C: Outsourced Processes

The following processes are outsourced and controlled as indicated:

• ...
• ...
• ...

Appendix D: Quality Objectives

APPENDIX E: Identification of Key Product Realization Processes

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REVISION HISTORY AND APPROVAL RECORD

Quality System Policy
QUALITY POLICIES HANDBOOK
Rev: Orig (EO #1) (Release Date is Mandatory)

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