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 and
is implemented in accordance with ISO 26000:2010, Guidance on social responsibility. 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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