QUALITY MANAGEMENT SYSTEM MANUAL
Table of Contents
INTRODUCTION ........................................................................................................................................................... 4
1.
SCOPE .................................................................................................................................................................. 5
1.1
1.2
1.3
DESCRIPTION OF ORGANIZATION................................................................................................................................. 5
SCOPE OF CERTIFICATION .......................................................................................................................................... 5
THIRD PARTY CERTIFICATION ...................................................................................................................................... 5
2.
REFERENCES ........................................................................................................................................................ 6
3.
TERMS & DEFINITIONS ........................................................................................................................................ 7
3.1
3.2
4
DESCRIPTION .......................................................................................................................................................... 7
IMPLEMENTATION AND MAINTENANCE ........................................................................................................................ 7
QUALITY MANAGEMENT SYSTEM ........................................................................................................................ 8
4.1
GENERAL REQUIREMENTS .......................................................................................................................................... 8
4.2
DOCUMENTATION REQUIREMENTS .............................................................................................................................. 8
4.2.1
General ........................................................................................................................................................ 8
4.2.2
Quality Management System Manual ........................................................................................................ 9
4.2.3
Document and Data Control ....................................................................................................................... 9
4.2.4
Control of Records ...................................................................................................................................... 9
5.
MANAGEMENT RESPONSIBILITY ........................................................................................................................ 10
5.1
MANAGEMENT COMMITMENT ................................................................................................................................. 10
5.2
CUSTOMER FOCUS ................................................................................................................................................. 10
5.3
POLICY STATEMENT ................................................................................................................................................ 10
5.4
PLANNING ............................................................................................................................................................ 11
5.4.1
Quality Objectives ..................................................................................................................................... 11
5.4.2
Quality Management System Planning ..................................................................................................... 11
5.5
RESPONSIBILITY, AUTHORITY AND COMMUNICATION .................................................................................................... 12
5.5.1
Responsibility and Authority ..................................................................................................................... 12
5.5.2
Management Representative ................................................................................................................... 13
5.5.3
Communication & Participation ................................................................................................................ 13
5.6
MANAGEMENT REVIEW .......................................................................................................................................... 13
5.6.1
General ...................................................................................................................................................... 13
5.6.2
Review Input ............................................................................................................................................. 13
5.6.3
Review Output .......................................................................................................................................... 14
6
RESOURCE MANAGEMENT ................................................................................................................................ 15
6.1
PROVISION OF RESOURCES ....................................................................................................................................... 15
6.2
HUMAN RESOURCES ............................................................................................................................................... 15
6.2.1
General ...................................................................................................................................................... 15
6.2.2
Competence, Awareness & Training ......................................................................................................... 15
6.3
INFRASTRUCTURE ................................................................................................................................................... 15
6.4
WORK ENVIRONMENT ............................................................................................................................................ 16
7
PRODUCT REALIZATION ..................................................................................................................................... 17
7.1
PRODUCT REALIZATION PLANNING ............................................................................................................................ 17
7.2
CUSTOMER RELATED PROCESSES............................................................................................................................... 17
7.2.1
Determination of Requirements Related to Product ................................................................................ 17
7.2.2
Review of Requirements Related to Product ............................................................................................ 17
7.2.3
Customer Communication ........................................................................................................................ 17
7.3
DESIGN & DEVELOPMENT........................................................................................................................................ 18
7.3.1
Planning .................................................................................................................................................... 18
7.3.2
Input .......................................................................................................................................................... 18
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7.3.3
Output ....................................................................................................................................................... 18
7.3.4
Review ....................................................................................................................................................... 18
7.3.5
Verification ................................................................................................................................................ 18
7.3.6
Validation .................................................................................................................................................. 19
7.3.7
Control of Design & Development Changes .............................................................................................. 19
7.4
PURCHASING......................................................................................................................................................... 19
7.4.1
Purchasing Process.................................................................................................................................... 19
7.4.2
Purchasing Information ............................................................................................................................. 19
7.4.3
Verification of Purchased Product ............................................................................................................ 19
7.5
PRODUCTION & SERVICE PROVISION.......................................................................................................................... 19
7.5.1
Control of Production & Service Provision ................................................................................................ 19
7.5.2
Validation of Processes for Production & Service Provision ..................................................................... 20
7.5.3
Identification & Traceability ...................................................................................................................... 20
7.5.4
Customer Property .................................................................................................................................... 20
7.5.5
Preservation of Product ............................................................................................................................ 20
7.6
CONTROL OF MONITORING & MEASURING EQUIPMENT................................................................................................ 21
8
MEASUREMENT, ANALYSIS & IMPROVEMENT ................................................................................................... 22
8.1
GENERAL .............................................................................................................................................................. 22
8.2
MONITORING & MEASUREMENT .............................................................................................................................. 22
8.2.1
Customer Satisfaction ............................................................................................................................... 22
8.2.2
Internal Audit ............................................................................................................................................ 22
8.2.3
Process Monitoring & Measurement ........................................................................................................ 23
8.2.4
Product Monitoring & Measurement ....................................................................................................... 23
8.3
CONTROL OF NON-CONFORMANCES .......................................................................................................................... 23
8.4
ANALYSIS OF DATA ................................................................................................................................................. 24
8.5
IMPROVEMENT ...................................................................................................................................................... 24
8.5.1
Continual Improvement ............................................................................................................................ 24
8.5.2
Corrective Action ...................................................................................................................................... 24
8.5.3
Preventive Action ...................................................................................................................................... 25
APPENDICES .............................................................................................................................................................. 26
A.1
ABBREVIATIONS & ACRONYMS ................................................................................................................................. 26
A.2
SEQUENCE & INTERACTION OF QMS PROCESSES ......................................................................................................... 27
A.3
LIST OF KEY MANAGEMENT SYSTEM DOCUMENTS ........................................................................................................ 28
Operational Procedures ............................................................................................................................................ 28
Forms & Records ....................................................................................................................................................... 28
A.4
ORGANIZATION CHART............................................................................................................................................ 29
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QUALITY MANAGEMENT SYSTEM MANUAL
Introduction
Your Company has developed and implemented a quality management system (QMS) in order to document the
company’s best business practices, to better satisfy the requirements and expectations of its customers and to
improve the overall performance of the company. The quality management system of Your Company meets the
requirements of international standard ISO 9001:2008. This system addresses the design, development, production,
installation and servicing of the company’s products.
This document describes the quality management system, delineates authorities, inter-relationships and
responsibilities of process owners and personnel that perform within the system. This manual also provides
procedures or references for all activities that comprise the system to ensure compliance to the necessary
requirements of the standard.
This document is also used, externally, to introduce our quality management system to our customers, suppliers and
other external organizations or individuals. This document is used to familiarize them with the controls that have been
implemented and to assure them that the integrity of our system is maintained and is focused on delivering customer
satisfaction and continuous improvement.
Outline Structure of the Quality Management System in Terms of the PDCA Process
Q
Quality Management System
Resources & infrastructure
System Data
Trends
Performance
ACT
PLAN
Customer Feedback
Customer Requirements
Process & Product Design
Corrective Action
Nonconforming Products
Quality Performance
Quality Requirements
Stakeholder Requirements
Continual Improvement
Preventive Action
Policies, Objectives/Targets
CHECK
DO
Purchasing & Suppliers
Design & Developement
Calibration
The model above illustrates that organizational effectiveness and improvement can be represented as a cyclical; plan,
do, check and act process that uses components of the quality management system to analyze data to then direct
appropriate changes and initiatives that ensure the system’s continual improvement. This also ensures a proactive
approach to meeting management system objectives, as well as customer and stakeholder requirements.
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QUALITY MANAGEMENT SYSTEM MANUAL
4
Quality Management System
4.1 General Requirements
Your Company has implemented a quality management system that exists as part of a larger, overall management
system which has established, documented and implemented our policies and related processes for providing
products and services which meet or exceed customer requirements, whilst satisfying the requirements of ISO
9001:2008.
Your Company has adopted the process approach advocated by ISO 9000:2005. By defining four key process-groups
and by managing their inputs, activities, controls, outputs and interfaces; we ensure that system effectiveness is
maintained. Your Company monitors, measures and analyzes relevant processes and takes action to achieve planned
results and to deliver the continual improvement of our products, services and to our management system.
Four Key QMS Process Groups:
Management
Orientated
Processes
Customer
Orientated
Processes
Support
Orientated
Processes
Assessment
Orientated
Processes
Specific responsibilities for, and the sequence and interaction of key quality management system processes are
detailed in the management system procedures, some of which contain or make reference to deployment flow charts
depicting the process which is also described in the text based narrative of the procedure. Appendix A.2 describes the
sequence and interaction of our quality management system.
Where Your Company identifies the requirement to outsource any process, or part thereof, that affects conformity
with requirements; Your Company identifies control requirements such as; the competence of personnel, the
provision of product conformity certificates, contract documentation, specific job files, etc. The controls identified do
not absolve us of the responsibility to conform to client, statutory and regulatory requirements but instead they
enhance our capacity to manage the supply chain. The controls adopted are influenced by the potential impact of
outsourcing on meeting requirements and the degree to which control of the process is shared. Outsourced processes
are controlled by internal audits and process performance data review as well as purchasing process and contractual
agreements.
4.2 Documentation Requirements
4.2.1 General
This document contains documented statements concerning our corporate policies, targets and objectives and
references the documented procedures required by ISO 9001:2008 and other documents needed to ensure effective
planning, operation and control of our key processes. The quality management system documentation includes:

Documented policies and objectives regarding quality performance

This quality management system manual

Documented procedures (refer to Appendix A.3)

Documents required or the effective planning, operation and control our processes

Quality records and data
The level and type of management system documentation established for our business is continually reviewed to
ensure it remains appropriate for the complexity of the interactions of our key processes and the competence of our
employees. Quality management system documents and data exist in hard copy and electronic format and include
internal and external documents and data needed to manage, perform and verify work that affects product quality. All
quality management system documentation that is utilized or generated is categorized by the following hierarchy:
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QUALITY MANAGEMENT SYSTEM MANUAL
Quality Management System Documentation Hierarchy:
Tier
Document Type
Purpose
1
Policies
Key system driver of process inputs and objectives; statement of corporate vision
2
System manual
Describes the corporate approach and responsibilities
3
Procedures
Describes the methods required for process implementation
4
Work instructions
Describes the operating practices and controls of each process
5
Forms and records
Key system outputs; data, records, proof of conformance and evidence of verification
4.2.2 Quality Management System Manual
This document has been prepared to describe Your Company’s quality management system and to introduce the
associated procedures and processes that are required to implement our policies and processes in order to achieve
our targets and objectives. Each section of the manual makes reference to various procedures, forms and process
maps relating to the requirements outlined in that section. A list of key quality management system documents;
including all procedures, forms and other key management system documents is located in Appendix A.3.
4.2.3 Document and Data Control
All quality management system documents are controlled according to the Document and Data Control Procedure
which defines the process for:

Approving documents for adequacy prior to issue

Reviewing and revising as necessary and re-approving documents

Ensuring that changes and current revision status of documents are identified

Ensuring that relevant versions of applicable documents are available at points of use

Ensuring that documents remain legible and readily identifiable

Ensuring that documents of external origin are identified and their distribution controlled

Preventing the unintended use of obsolete documents

Ensuring that documents of external origin are identified and their distribution controlled
The company uses standard forms and a local area network computer system with an electronic document
management system which is backed up and updated as required <amend as appropriate>. Documents which are
controlled include, but not limited to the followings examples:

Management system manuals

Documented procedures

Forms and records (outputs)

Customer specifications (inputs)
Controlled documents are identified with a document name and document number:

Mandatory and operational procedures are prefixed ‘OP and numbered 01 to 20’

Forms and records are prefixed ‘F and numbered according to the procedure they relate to’

Checklists are prefixed ‘CL and numbered according to the procedure they relate to’
4.2.4 Control of Records
Records are established to provide evidence of conformity to the requirements specified by the standards, customer
requirements and of the effective operation of the quality management system. Records are formally controlled
through the application of the Control of Records Procedure. Records which are controlled include, but not limited to
the list of documents that are referenced Appendix A.3.
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QUALITY MANAGEMENT SYSTEM MANUAL
A.3 List of Key Management System Documents
Operational Procedures
Title & Description
Document & Data Control Procedure
Control of Records Procedure
Internal Audit Procedure
Non-conforming Product Procedure
Corrective & Preventive Action Procedure
Objective, Targets & Programmes Procedure
Communication & Participation Procedure
Management Review Procedure
Competence, Awareness & Training Procedure
Calibration Procedure
Forms & Records
Title & Description
Master Document Index
Document Issue Sheet
Document Change Request
Master Quality Record Index
Internal Audit Schedule
Internal Audit Assignment
Internal Audit Report
Internal Audit Feedback
Internal Audit & Gap Analysis Checklist
Nonconformity Report
Nonconformity Report Log
Corrective Action Request
Preventive Action Request
CAPA Request Log
Objectives, Targets & Management Programme
Management Review Agenda & Minutes
Competency Review Form
Training Attendance Form
Training Evaluation Form
Controlled Equipment Log
Calibration Log
Software Validation Log
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