Quality Management System (QMS) Requirements Manual
Title: Revision Record
Approved By: Revision Date: Oct. 2, 2001
Revision Record
Title: Table of Contents
Approved By: Revision Date: Oct. 2, 2001
Page i
Table of Contents
Page 1 1. Scope
This QMS Requirements Manual defines the policies, objectives, responsibilities, and requirements for the organization’s quality management system (QMS). The QMS Requirements Manual:
?Establishes the framework for providing outstanding value to customer through process improvement, increasing quality, and productivity
?Provides direction to personnel in defining and implementing effective, flexible, and compliant quality plans and processes/procedures
?Provides evidence to customers, suppliers, and employees commitment to establishing and maintaining practices that maximize product and process quality ?Establishes the benchmark/criteria for measuring progress and improvement
?Emphasizes prevention over detection.
Figure 1 shows the QMS organization including senior management responsibilities. All personnel within the organization are responsible for implementing QMS policies and requirements as they pertain to them. The QMS Requirements Manual includes the specific QMS policies, requirements, and process references. Specific implementation processes are included in the QMS Process Manual as referenced herein. The QMS Requirements Manual is divided into the following sections:
?Section 1 (Scope) provides an introduction to the QMS Requirements Manual including its scope, contents, and the QMS organization
?Section 2 (References) identifies external and organizational documents used to develop and support implementation of the QMS Requirements Manual ?Section 3 (Quality Policy and Objectives) defines the organization’s quality policy and specific, measurable quality objectives
?Sections 4 through 8 include specific QMS policies, responsibilities, requirements, and implementation process references (QMS Process Manual
sections)
?Annex A (Traceability Matrix) includes an ISO 9001 to QMS Requirements Manual traceability table.
Page 2
Figure 1. QMS Organization
The Vice President, Quality, has overall responsibility for establishing and maintaining the QMS Requirements Manual.
Title: References
Approved By: Revision Date: Oct. 2, 2001
Page 1 2. References
The following references were used to support the development of the QMS Requirements Manual. These references support the establishment, maintenance, and implementation of the QMS.
External References:
Company References:
Title: Quality Policy and Objectives
Approved By: Revision Date: Oct. 2, 2001
Page 1 3. Quality Policy and Objectives
Quality Policy
Quality is integral to everything we do. We continuously seek ways to improve our processes and products. Quality is everyone’s responsibility. We meet customer requirements and provide both employee and customer satisfaction in the performance of our work while offering the best value, quality, and service.
Quality Objectives
Quality objectives are defined and measured continuously in the improvement of the QMS. Quality objectives for the organization include continual improvement in: ?Process cycle time
?Productivity
?Product defect rate
?Customer satisfaction
?Estimating schedule and effort.
The company President, General Manager, is responsible for defining and maintaining the overall quality policy and objectives defined in this section. Sections 4.0 – 8.0 of this manual include specific policies for each requirement area. QMS planning processes included in the QMS Process Plan define the specific measurements and objectives relating to the appropriate process areas.
Page 1 4. Quality Management System
The quality management system (QMS) defines the processes needed to ensure the quality of products and to continuously improve processes. QMS overall and documentation requirements are specified in the following sections.
Page 1 4.1 Quality System Requirements
Policy:
QMS processes are defined including their interfaces, controls, and monitoring, measurement, and analysis methods.
Responsibility:
The Vice President, Quality, is responsible for defining and maintaining quality system requirements policy, requirements, and processes.
Requirements:
The organization shall:
4.1.1Establish, document, implement, and maintain a QMS and continually improve its
effectiveness.
4.1.2Identify needed QMS processes and their application.
4.1.3Determine QMS process sequence and interaction.
4.1.4Determine criteria and methods needed to ensure process operation and control is
effective.
4.1.5Ensure the resources and information needed to support process operation and
monitoring is available.
4.1.6Monitor, measure, and analyze QMS processes.
4.1.7Implement needed actions to achieve planned results and continually improve
QMS processes.
4.1.8Manage QMS processes in accordance with the requirements defined in this
manual.
4.1.9Control and identify outsourced processes that affect product conformity to
requirements.
QMS Process Manual References:
QMS Process Manual – all sections
Page 1 4.2 Quality System Documentation
Policy:
Quality system documentation provides the direction and instructions for implementing, controlling, and improving QMS processes and recording results.
Responsibility:
The Vice President, Quality, is responsible for defining and maintaining quality system documentation policy, requirements, and processes.
Requirements:
4.2.1 General
4.2.1.1Provide a QMS that includes:
a.Documented statements of a quality policy and quality objectives
b. A quality manual
c.Documented procedures as identified in this manual
d.Documents needed by the organization to ensure the effective planning,
operation and control of its processes
e.Records defined in this manual and referenced procedures.
4.2.2 Quality Manual
The organization shall:
4.2.2.1Establish and maintain a quality manual that that includes:
a.The scope of the QMS
b.Reference to QMS documented procedures
c. A description of the interaction between QMS processes.
4.2.3 Control of Documents
The organization shall:
4.2.3.1Control documents requirements by the QMS.
4.2.3.2Establish a documented procedure to defined the controls needed to:
Page 2
a.Approve documents for adequacy prior to issue
b.Review and update as necessary and re-approve documents
c.Ensure that changes and the current revision status of documents are identified
d.Ensure relevant versions of applicable documents are available at points of
use
e.Ensure that documents remain legible and readily identifiable
f.Ensure that documents of external origin are identified and their distribution
controlled
g.Prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
4.2.4 Control of Records
The organization shall:
4.2.4.1Establish and maintain records to provide evidence of QMS conformity to
requirements and effectiveness.
4.2.4.2Ensure records are legible, readily identifiable, and retrievable.
4.2.4.3Establish a documented procedure that defines the controls needed for record
identification, storage, protection, retrieval, retention, and disposition.
QMS Process Manual References:
? 4.1 Document Management
? 4.2 Records Management
? 4.3 Manual Preparation & Maintenance
Page 1 5. Management Responsibility
The quality management system (QMS) defines the mechanisms and methods for management involvement, review, and direction. Specific QMS requirements for management responsibility are specified in the following sections.
Page 1 5.1 Management Commitment
Policy:
Senior management ensures quality management system establishment, implementation, and improvement.
Responsibility:
The company President, General Manager, is responsible for defining and maintaining management commitment policy, requirements, and process.
Requirements:
The organization shall:
5.1.1Communicate to the organization the importance of meeting customer as well as
statutory and regulatory requirements.
5.1.2Establish the quality policy.
5.1.3Ensure that quality objectives are established.
5.1.4Conduct management reviews.
5.1.5Ensure the availability of resources.
QMS Process Manual References:
5.1 QMS Planning
Title: Customer Orientation and Focus
Approved By: Revision Date: Oct. 2, 2001
Page 1 5.2 Customer Orientation and Focus
Policy:
Customer requirements are determined and met.
Responsibility:
The company President, General Manager, is responsible for defining and maintaining customer orientation and focus policy, requirements, and process.
Requirements:
The organization shall:
5.2.1Ensure customer requirements are defined, understood, and are met with the
purpose of enhancing customer satisfaction.
QMS Process Manual References:
5.3 Customer Focus
Title: Quality Policy and Objectives
Approved By: Revision Date: Oct. 2, 2001
Page 1 5.3 Quality Policy and Objectives
Policy:
Quality policy and objectives provide the overall intentions and direction for the quality management system.
Responsibility:
The company President, General Manager, is responsible for defining and maintaining overall quality policy and objectives.
Requirements:
The organization shall:
5.3.1Ensure the quality policy:
a.Is appropriate to the business needs of the organization.
b.Includes a commitment to comply with requirements and continually improve
QMS effectiveness.
c.Provides a framework for establishing and reviewing quality objectives.
d.Is communicated and understood within the organization.
e.Is reviewed for continued suitability.
QMS Process Manual References:
5.1 QMS Planning
Title: Management Planning
Approved By: Revision Date: Oct. 2, 2001
Page 1 5.4 Management Planning
Policy:
Management planning provides the roadmap for implementing, controlling, directing, and improving the QMS.
Responsibility:
The company President, General Manager, is responsible for defining and maintaining management planning policy, requirements, and process.
Requirements:
5.4.1 Quality Objectives
The organization shall:
5.4.1.1Ensure that quality objectives, including those needed to meet product
requirements, are established at relevant functions and levels within the
organization.
5.4.1.2Ensure quality objectives are measurable and consistent with the quality policy.
5.4.2 QMS planning
The organization shall:
5.4.2.1Ensure QMS planning is carried out in order to meeting quality requirements as
well as the quality objectives.
5.4.2.2Maintain the integrity of the QMS when changes to the QMS are planned and
implemented.
QMS Process Manual References:
5.1 QMS Planning
Title: Responsibility and Communication
Approved By: Revision Date: Oct. 2, 2001
Page 1 5.5 Responsibility and Communication
Policy:
QMS roles are defined and status communicated.
Responsibility:
The company President, General Manager, is responsible for defining and maintaining responsibility and communication policy, requirements, and process. Requirements:
5.5.1 Responsibility and Authority
The organization shall:
5.5.1.1Ensure QMS responsibilities and authorities are defined and communicated.
5.5.2 Management Representative
The organization shall:
5.5.2.1Appoint a member of management who, irrespective of other responsibilities, has
responsibility and authority to:
a.Ensure QMS processes are established, implemented, and maintained
b.Report to senior management on QMS performance and any need for
improvement
c.Ensure the promotion of awareness of customer requirements throughout the
organization.
5.5.3 Internal Communication
The organization shall:
5.5.3.1Ensure that appropriate communication processes are established and
implemented regarding QMS effectiveness.
QMS Process Manual References:
5.2 Communications
Page 1 5.6 Management Review
Policy:
Senior management provides QMS oversight and direction.
Responsibility:
The company President, General Manager, is responsible for defining and maintaining management review policy, requirements, and processes.
Requirements:
5.6.1 General Requirements
The organization shall:
5.6.1.1Perform management reviews of the QMS at planned intervals to ensure
continuing suitability, adequacy, and effectiveness.
5.6.1.2Assess opportunities for improvement and QMS change need including the
quality policy and objectives during management reviews.
5.6.1.3Maintain records of management reviews.
5.6.2 Review Input
The organization shall:
5.6.2.1Use the following information to support management review:
a.Audit results
b.Customer feedback
c.Process performance and product conformity
d.Corrective and preventive action status
e.Previous management review follow-up actions
f.Changes that could impact the QMS
g.Recommendations for improvement.
5.6.3 Review Output
5.6.3.1 Ensure management review outputs include decisions and actions relating to:
Page 2
a.Improvement of QMS effectiveness and its processes
b.Improvement of product related to customer requirements
c.Resource needs.
QMS Process Manual References:
? 5.4 Risk Management
? 5.5 Management Review
Page 1 6. Resource Management
The quality management system (QMS) defines the mechanisms and methods for managing its resources, environment, and infrastructure. Specific QMS requirements for resource management are specified in the following sections.