Professional Documents
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Quality Management System Manual
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.
DESCRIPTION .......................................................................................................................................................... 7
IMPLEMENTATION AND MAINTENANCE ........................................................................................................................ 7
5.
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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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Introduction
Your Company has developed and implemented a quality management system (QMS) in order to document the
companys 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 companys 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
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
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 systems continual improvement. This also ensures a proactive
approach to meeting management system objectives, as well as customer and stakeholder requirements.
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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.
Documents required or the effective planning, operation and control our processes
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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Document Type
Purpose
Policies
Key system driver of process inputs and objectives; statement of corporate vision
System manual
Procedures
Work instructions
Key system outputs; data, records, proof of conformance and evidence of verification
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 of external origin are identified and their distribution controlled
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:
Documented procedures
Controlled documents are identified with a document name and document number:
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
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