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ISO 9001 Quality Manual

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Table of Contents

Approvals
Revision and Approval Record 
1.0 Scope
1.1 Introduction 
1.2 Applicability
1.3 Quality Policy Statement 
2.0 Company History 
3.0 Terms and Definitions
4.0 Context of the Organization
4.1 Understanding the Organization and Its Context 
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System 
4.4 Quality Management System and Its Processes
5.0 Leadership 
5.1 Leadership and Commitment
    5.1.1 General
    5.1.2 Customer Focus 
5.2  Policy
    5.2.1 Developing the Quality Policy 
    5.2.2
Communicating the Quality Policy  
5.3 Organizational Roles, Responsibilities and Authorities
5.4 Management Responsibilities
6.0 Planning
6.1 Actions to Address Risk and Opportunities
6.2 Quality Objectives and Planning to Achieve them
6.3 Planning of Changes
6.4 Work Environment 
7.0 Support 
    7.1.1 General
        7.1.1.1 Responsibilities for Determination of Required Resources
        7.1.1.2 Provision of Resources
    7.1.2 People 
    7.1.3 Infrastructure 
    7.1.4 Environment for the Operation of Processes 
    7.1.5 Monitoring and Measuring Resources
    7.1.6 Organizational Knowledge 
7.2 Competence
    7.2.1 General
    7.2.2 Competence, Awareness, Training
7.3 Awareness 
7.4 Communication
    7.4.1 General
    7.4.2 Internal Communication
    7.4.3 External Communication 
7.5 Documented Information
    7.5.1 General 
    7.5.2 Creating and Updating
    7.5.3 Control of Documented Information
8.0 Operation
8.1 Operation Planning and Control
    8.1.1 Planning of Product and Services Realization 
8.2 Requirements for Products and Services 
    8.2.1 Customer Communications 
    8.2.2 Determining the 
Requirements Related to Products and Services 
    8.2.3 Review of 
Requirements Related to Products and Services 
    8.2.4 Changes to 
Requirements for Products and Services 
8.3  Design and Development of
Products and Services
    8.3.1 General
    8.3.2 Design and Development Planning 
    8.3.3 Design and Development Inputs 

    8.3.4 Design and Development Controls    
        8.3.4.1 General
        8.3.4.2 Design and Development Review
        8.3.4.3 Design and Development Verification
        8.3.4.4 Design and Development Validation 
    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 
8.4.2 Type and Extent of Control
   8.4.2.1 Verification of Purchased Product 
   8.4.3 Information for External Providers
8.5 Production and Service Provision
   8.5.1 Control of Production and Service Provision  
    8.5.1.1 Validation of Processes for Production and Services Provision
   8.5.2 Identification and Traceability 
   8.5.3  Property Belonging to Customers and External Providers
   8.5.4 Preservation 
   8.5.5 Post Delivery Activities
 
   8.5.6 Control of Changes
8.6 Release of Products and Services 
8.7 Control of Nonconforming Outputs
9.0 Performance Evaluation

9.1 Monitoring, Measurement, Analysis, and Evaluation  
   9.1.1 General 
   9.1.2 Customer Satisfaction
   9.1.3 Analysis and Evaluation 
9.2 Internal Audit 
9.3 Management Review 
10.0 Improvement   
10.1 General 
10.2 Nonconformity and Corrective Action 
10.3 Continual Improvement
 

INTRODUCTION

XYZ COMPANY recognizes its responsibility as a provider of quality products/services. To this end, XYZ COMPANY has developed and documented a quality management system.  The quality management system complies with the international standard ISO 9001:2015, Quality management systems - Requirements.  This manual provides comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality.

This manual also governs the creation of quality related documented information.  It will be revised, as necessary, to reflect the quality system currently in use.  It is issued on a controlled copy basis to all internal functions affected by the quality management system and on an uncontrolled copy basis to customers and suppliers.  It may be issued to customers on a controlled copy basis upon customer request.

1.3 QUALITY POLICY

XYZ COMPANY accepts responsibility for the complete satisfaction of its customers.  We exercise this responsibility through adequate training of our employees, adherence to proven procedures, and total commitment to meeting and exceeding customer requirements, and to maintaining an organizational culture that fosters continuous improvement.

 

__________________________________

(Name), President 

5.0 LEADERSHIP

5.1 Leadership and Commitment

XYZ COMPANY'S top management maintains a leadership role and is committed to implementing, and maintaining a quality management system.  This commitment includes: ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, the quality policy is understood and implemented at all levels of the organization, quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. Management will make provisions for the necessary resources and personnel to maintain the system.  Management will review the system annually to determine its effectiveness.

6.0 PLANNING

6.1 Leadership and Commitment

When planning for the quality management system, XYZ COMPANY considers the risks and opportunities that need to be addressed.  Actions for addressing risks and opportunities are proportionate to their potential impact on the conformity of products and services.

6.2 Quality Objectives and Planning to Achieve Them.  

The management of XYZ COMPANY establishes annual key initiatives, which include quality objectives.  The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function's and employee's annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy including the commitment to continuous improvement.

7.0 SUPPORT

7.1 Resources

XYZ COMPANY management determines and provides adequate resources for the establishment, implementation, maintenance and continual improvement of the quality management system.  

The required resources for implementation and improvement of the quality system, and for addressing customer satisfaction, may include any of the following:  suppliers, information, infrastructure, work environment, and financial funds.  The principal means for determining and communicating resource requirements are management reviews of the quality system.  For details, refer to the Management Review Procedure.

9.0 PERFORMANCE EVELUATION

9.1 Monitoring, Measurement, Analysis, and Evaluation

Measurement and analysis activities that are required to assure product/services quality and contribute to continual improvement are planned, and defined statistical techniques are used for analyzing measurement data.

9.1.2 Monitoring and Measurement of Processes

XYZ COMPANY applies suitable methods for measurement and monitoring of those realization processes necessary to meet customer requirements.  These methods confirm the continuing ability of each process to satisfy the intended purpose.

9.1.3 Monitoring and Measurement of Product 

XYZ COMPANY measures and monitors the characteristics of the product/service to verify that requirements for the product/service are met. This is carried out at appropriate stages of the product/service realization process. Evidence of conformity with the acceptance criteria is documented. Records include the authority responsible for release of the product/service.
 

Inspection and Test Procedure1.0 Scope
1.1 Introduction 
1.2 Applicability
1.3 Quality Policy Statement 
2.0 Company History 
3.0 Terms and Definitions
4.0 Context of the Organization
4.1 Understanding the Organization and Its Context 
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System 
4.4 Quality Management System and Its Processes
5.0 Leadership 
5.1 Leadership and Commitment
    5.1.1 General
    5.1.2 Customer Focus 
5.2  Policy
    5.2.1 Developing the Quality Policy 
    5.2.2
Communicating the Quality Policy  
5.3 Organizational Roles, Responsibilities and Authorities
5.4 Management Responsibilities
6.0 Planning
6.1 Actions to Address Risk and Opportunities
6.2 Quality Objectives and Planning to Achieve them
6.3 Planning of Changes
6.4 Work Environment 
7.0 Support 
    7.1.1 General
        7.1.1.1 Responsibilities for Determination of Required Resources
        7.1.1.2 Provision of Resources
    7.1.2 People 
    7.1.3 Infrastructure 
    7.1.4 Environment for the Operation of Processes 
    7.1.5 Monitoring and Measuring Resources
    7.1.6 Organizational Knowledge 
7.2 Competence
    7.2.1 General
    7.2.2 Competence, Awareness, Training
7.3 Awareness 
7.4 Communication
    7.4.1 General
    7.4.2 Internal Communication
    7.4.3 External Communication 
7.5 Documented Information
    7.5.1 General 
    7.5.2 Creating and Updating
    7.5.3 Control of Documented Information
8.0 Operation
8.1 Operation Planning and Control
    8.1.1 Planning of Product and Services Realization 
8.2 Requirements for Products and Services 
    8.2.1 Customer Communications 
    8.2.2 Determining the 
Requirements Related to Products and Services 
    8.2.3 Review of 
Requirements Related to Products and Services 
    8.2.4 Changes to 
Requirements for Products and Services 
8.3  Design and Development of
Products and Services
    8.3.1 General
    8.3.2 Design and Development Planning 
    8.3.3 Design and Development Inputs 

    8.3.4 Design and Development Controls    
        8.3.4.1 General
        8.3.4.2 Design and Development Review
        8.3.4.3 Design and Development Verification
        8.3.4.4 Design and Development Validation 
    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 
8.4.2 Type and Extent of Control
   8.4.2.1 Verification of Purchased Product 
   8.4.3 Information for External Providers
8.5 Production and Service Provision
   8.5.1 Control of Production and Service Provision  
    8.5.1.1 Validation of Processes for Production and Services Provision
   8.5.2 Identification and Traceability 
   8.5.3  Property Belonging to Customers and External Providers
   8.5.4 Preservation 
   8.5.5 Post Delivery Activities
 
   8.5.6 Control of Changes
8.6 Release of Products and Services 
8.7 Control of Nonconforming Outputs
9.0 Performance Evaluation

9.1 Monitoring, Measurement, Analysis, and Evaluation  
   9.1.1 General 
   9.1.2 Customer Satisfaction
   9.1.3 Analysis and Evaluation 
9.2 Internal Audit 
9.3 Management Review 
10.0 Improvement   
10.1 General 
10.2 Nonconformity and Corrective Action 
10.3 Continual Improvement
 

INTRODUCTION

XYZ COMPANY recognizes its responsibility as a provider of quality products/services. To this end, XYZ COMPANY has developed and documented a quality management system.  The quality management system complies with the international standard ISO 9001:2015, Quality management systems - Requirements.  This manual provides comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality.

This manual also governs the creation of quality related documented information.  It will be revised, as necessary, to reflect the quality system currently in use.  It is issued on a controlled copy basis to all internal functions affected by the quality management system and on an uncontrolled copy basis to customers and suppliers.  It may be issued to customers on a controlled copy basis upon customer request.

1.3 QUALITY POLICY

XYZ COMPANY accepts responsibility for the complete satisfaction of its customers.  We exercise this responsibility through adequate training of our employees, adherence to proven procedures, and total commitment to meeting and exceeding customer requirements, and to maintaining an organizational culture that fosters continuous improvement.

 

__________________________________

(Name), President 

5.0 LEADERSHIP

5.1 Leadership and Commitment

XYZ COMPANY'S top management maintains a leadership role and is committed to implementing, and maintaining a quality management system.  This commitment includes: ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, the quality policy is understood and implemented at all levels of the organization, quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. Management will make provisions for the necessary resources and personnel to maintain the system.  Management will review the system annually to determine its effectiveness.

6.0 PLANNING

6.1 Leadership and Commitment

When planning for the quality management system, XYZ COMPANY considers the risks and opportunities that need to be addressed.  Actions for addressing risks and opportunities are proportionate to their potential impact on the conformity of products and services.

6.2 Quality Objectives and Planning to Achieve Them.  

The management of XYZ COMPANY establishes annual key initiatives, which include quality objectives.  The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function's and employee's annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy including the commitment to continuous improvement.

7.0 SUPPORT

7.1 Resources

XYZ COMPANY management determines and provides adequate resources for the establishment, implementation, maintenance and continual improvement of the quality management system.  

The required resources for implementation and improvement of the quality system, and for addressing customer satisfaction, may include any of the following:  suppliers, information, infrastructure, work environment, and financial funds.  The principal means for determining and communicating resource requirements are management reviews of the quality system.  For details, refer to the Management Review Procedure.

9.0 PERFORMANCE EVELUATION

9.1 Monitoring, Measurement, Analysis, and Evaluation

Measurement and analysis activities that are required to assure product/services quality and contribute to continual improvement are planned, and defined statistical techniques are used for analyzing measurement data.

9.1.2 Monitoring and Measurement of Processes

XYZ COMPANY applies suitable methods for measurement and monitoring of those realization processes necessary to meet customer requirements.  These methods confirm the continuing ability of each process to satisfy the intended purpose.

9.1.3 Monitoring and Measurement of Product 

XYZ COMPANY measures and monitors the characteristics of the product/service to verify that requirements for the product/service are met. This is carried out at appropriate stages of the product/service realization process. Evidence of conformity with the acceptance criteria is documented. Records include the authority responsible for release of the product/service.
 1.0 Scope
1.1 Introduction 
1.2 Applicability
1.3 Quality Policy Statement 
2.0 Company History 
3.0 Terms and Definitions
4.0 Context of the Organization
4.1 Understanding the Organization and Its Context 
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System 
4.4 Quality Management System and Its Processes
5.0 Leadership 
5.1 Leadership and Commitment
    5.1.1 General
    5.1.2 Customer Focus 
5.2  Policy
    5.2.1 Developing the Quality Policy 
    5.2.2
Communicating the Quality Policy  
5.3 Organizational Roles, Responsibilities and Authorities
5.4 Management Responsibilities
6.0 Planning
6.1 Actions to Address Risk and Opportunities
6.2 Quality Objectives and Planning to Achieve them
6.3 Planning of Changes
6.4 Work Environment 
7.0 Support 
    7.1.1 General
        7.1.1.1 Responsibilities for Determination of Required Resources
        7.1.1.2 Provision of Resources
    7.1.2 People 
    7.1.3 Infrastructure 
    7.1.4 Environment for the Operation of Processes 
    7.1.5 Monitoring and Measuring Resources
    7.1.6 Organizational Knowledge 
7.2 Competence
    7.2.1 General
    7.2.2 Competence, Awareness, Training
7.3 Awareness 
7.4 Communication
    7.4.1 General
    7.4.2 Internal Communication
    7.4.3 External Communication 
7.5 Documented Information
    7.5.1 General 
    7.5.2 Creating and Updating
    7.5.3 Control of Documented Information
8.0 Operation
8.1 Operation Planning and Control
    8.1.1 Planning of Product and Services Realization 
8.2 Requirements for Products and Services 
    8.2.1 Customer Communications 
    8.2.2 Determining the 
Requirements Related to Products and Services 
    8.2.3 Review of 
Requirements Related to Products and Services 
    8.2.4 Changes to 
Requirements for Products and Services 
8.3  Design and Development of
Products and Services
    8.3.1 General
    8.3.2 Design and Development Planning 
    8.3.3 Design and Development Inputs 

    8.3.4 Design and Development Controls    
        8.3.4.1 General
        8.3.4.2 Design and Development Review
        8.3.4.3 Design and Development Verification
        8.3.4.4 Design and Development Validation 
    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 
8.4.2 Type and Extent of Control
   8.4.2.1 Verification of Purchased Product 
   8.4.3 Information for External Providers
8.5 Production and Service Provision
   8.5.1 Control of Production and Service Provision  
    8.5.1.1 Validation of Processes for Production and Services Provision
   8.5.2 Identification and Traceability 
   8.5.3  Property Belonging to Customers and External Providers
   8.5.4 Preservation 
   8.5.5 Post Delivery Activities
 
   8.5.6 Control of Changes
8.6 Release of Products and Services 
8.7 Control of Nonconforming Outputs
9.0 Performance Evaluation

9.1 Monitoring, Measurement, Analysis, and Evaluation  
   9.1.1 General 
   9.1.2 Customer Satisfaction
   9.1.3 Analysis and Evaluation 
9.2 Internal Audit 
9.3 Management Review 
10.0 Improvement   
10.1 General 
10.2 Nonconformity and Corrective Action 
10.3 Continual Improvement
 

INTRODUCTION

XYZ COMPANY recognizes its responsibility as a provider of quality products/services. To this end, XYZ COMPANY has developed and documented a quality management system.  The quality management system complies with the international standard ISO 9001:2015, Quality management systems - Requirements.  This manual provides comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality.

This manual also governs the creation of quality related documented information.  It will be revised, as necessary, to reflect the quality system currently in use.  It is issued on a controlled copy basis to all internal functions affected by the quality management system and on an uncontrolled copy basis to customers and suppliers.  It may be issued to customers on a controlled copy basis upon customer request.

1.3 QUALITY POLICY

XYZ COMPANY accepts responsibility for the complete satisfaction of its customers.  We exercise this responsibility through adequate training of our employees, adherence to proven procedures, and total commitment to meeting and exceeding customer requirements, and to maintaining an organizational culture that fosters continuous improvement.

 

__________________________________

(Name), President 

5.0 LEADERSHIP

5.1 Leadership and Commitment

XYZ COMPANY'S top management maintains a leadership role and is committed to implementing, and maintaining a quality management system.  This commitment includes: ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, the quality policy is understood and implemented at all levels of the organization, quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. Management will make provisions for the necessary resources and personnel to maintain the system.  Management will review the system annually to determine its effectiveness.

6.0 PLANNING

6.1 Leadership and Commitment

When planning for the quality management system, XYZ COMPANY considers the risks and opportunities that need to be addressed.  Actions for addressing risks and opportunities are proportionate to their potential impact on the conformity of products and services.

6.2 Quality Objectives and Planning to Achieve Them.  

The management of XYZ COMPANY establishes annual key initiatives, which include quality objectives.  The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function's and employee's annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy including the commitment to continuous improvement.

7.0 SUPPORT

7.1 Resources

XYZ COMPANY management determines and provides adequate resources for the establishment, implementation, maintenance and continual improvement of the quality management system.  

The required resources for implementation and improvement of the quality system, and for addressing customer satisfaction, may include any of the following:  suppliers, information, infrastructure, work environment, and financial funds.  The principal means for determining and communicating resource requirements are management reviews of the quality system.  For details, refer to the Management Review Procedure.

9.0 PERFORMANCE EVELUATION

9.1 Monitoring, Measurement, Analysis, and Evaluation

Measurement and analysis activities that are required to assure product/services quality and contribute to continual improvement are planned, and defined statistical techniques are used for analyzing measurement data.

9.1.2 Monitoring and Measurement of Processes

XYZ COMPANY applies suitable methods for measurement and monitoring of those realization processes necessary to meet customer requirements.  These methods confirm the continuing ability of each process to satisfy the intended purpose.

9.1.3 Monitoring and Measurement of Product 

XYZ COMPANY measures and monitors the characteristics of the product/service to verify that requirements for the product/service are met. This is carried out at appropriate stages of the product/service realization process. Evidence of conformity with the acceptance criteria is documented. Records include the authority responsible for release of the product/service.
 

1.0 Receiving Inspection and Test

1.1 All purchased material which influences the manufacture of, or is intended for use as part of, deliverable products is subject to inspection and/or testing by Receiving Inspection. Upon receipt of products, receiving personnel verify the quantity of delivered units, check marking and identification of packages, and inspect all packages for any signs of tampering or damage. If all these checks and inspections are satisfactory, receiving personnel signs the delivery receipt. If not, any shortages or damages are noted on all copies of the delivery receipts.

1.2 The received containers are then moved to the designated inspection area, a copy of the purchase order is retrieved, and the packing slips are removed from the containers. Upon opening the containers, the goods are verified against the purchase order and the packing slip, and are examined visually for any signs of damage. The purchase order is stamped "RECEIVED" and is signed and dated by the receiving inspector. All receiving inspections are logged in the Receiving Inspection Log.

1.3 On critical parts and components, as determined by the Quality Manager, a precision inspection/test is performed. This type of inspection includes:

Review of material certificates, supplier inspection records, compliance certificates, and any other relevant documentation delivered with the product

Random sampling based on statistical technique specified

Visual inspection to detect any damage or other visible problems

Performing measurements and testing against specified requirements as required

Recording the sample size, actual measurements, and inspection test results on the Inspection/Test & Audit Report

1.4 Where it is not practical to perform receiving inspection upon receipt, provisions are made to perform source inspection at the supplier's facility.

1.5 The Quality Manager determines the extent and scope of receiving inspection based on the importance of the item and the suppliers' control methods and performance. The Quality Manager may request that suppliers provide objective evidence of conformance (i.e., material certifications, certificates of conformance, test data, first article inspection, and SPC data). Objective evidence provided by suppliers may be used as the basis for reducing/waiving receiving and source inspection.

1.6 Upon acceptance, products are identified with an "ACCEPT" tag [green sticker] and moved to stock. In the event that product which is designated for receiving inspection is released to production due to urgency, it shall be positively identified and recorded in receiving inspection records.

2.0 In-process Inspection and Test

2.1 In-process inspection/testing is conducted to ensure that the product/process conforms to specified requirements. The inspection/testing is normally carried out by production personnel. Random audits of the in-process inspection/testing process are conducted by quality control personnel.

2.2 The Quality Manager determines the extent and scope of in-process inspection/testing based on the importance of the item, control methods, and previous performance.

3.0 Final Inspection and Test

3.1 For acceptance of completed products, final inspection/testing is utilized. This includes a verification of satisfactory receiving and in-process inspections/tests, as well as completion of the remaining inspections/tests to assure that the finished products/processes conform to specified requirements. Products are not released, and processes are not approved until all inspection/test activities have been satisfactorily completed and the appropriate documentation is available and authorized. All final inspections are logged in the Final Inspection Log. On critical parts and components, as determined by the Quality Manager, a Final Inspection/Test & Audit Report is completed.

3.2 The Quality Manager determines the extent and scope of final inspection/testing based on the importance of the item, control methods, and previous performance.

4.0 Inspection and Test Records

4.1 Inspection/test records, which show clearly whether the product/process has passed or failed the defined acceptance criteria, are established and maintained.

5.0 Nonconforming Material/Products

5.1 All material/products that are found to be nonconforming are identified and segregated and/or quarantined, and appropriately dispositioned per the Control of Nonconforming Product Procedure.

 

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