1qms concept

QUALITY MANAGEMENT SYSTEMS,

CONCEPTS & DEFINITIONS

Section 1 – Quality Management System (QMS)Concepts and Definitions

Definition of Quality –

• Degree to which a set of inherent characteristics of a product or service fulfill the needs or expectations of our customer.

• Quality can be used with such adjectives as:

• Poor• Good• Excellent


QUALITY MANAGEMENT SYSTEM (QMS)

A Management system to direct and control an organization with regards to quality.

MANAGEMENT SYSTEM

A system to establish policy and objectives and to achieve these objectives.

DIRECTION AND CONTROL GENERAL INCLUDES ESTABLISHMENT OF:

• Quality Policy

• Quality Objectives

• Quality Planning

• Quality Control

• Quality Assurance

• Quality Improvement


Quality Management System Benefits

• Help organizations to enhance customer satisfaction• Encourages organizations to:

• Analyze customer requirement • Define processes that contribute to achieving quality product or service• Keep these processes under control

• Provides:• A framework for continual improvement• Confidence in ability to consistently fulfill customer requirements


ISO 9000: 2000 SERIES

• ISO 9000 – Quality Management Systems: Fundamentals and Vocabulary

• ISO 9001 – Quality Management Systems: Requirements

• ISO 9004 – Quality Management Systems: Guidance for Performance Improvements

• ISO 19011 – Guidelines on Quality and Environmental Auditing


8 Quality Management Principles –

• Customer focus• Leadership• Involvement of people• Process approach• Systems approach to management• Continual improvement• Factual approach to decision making• Mutually beneficial supplier relationships


HOW DOES ISO 9001 WORK?

• It is a strategic, stakeholder focused, performance driven mechanism for delivering business quality objectives.

• Requires business processes to be defined and controlled to achieve quality policy and objectives.

• Requires continual improvement of the QMS to ensure changing customer needs and expectations are met.


ISO 9001 gives high level principles, e.g. to paraphrase the document Control clause:

“ You must have the right document, at the right issue level, in the right place, at the right time “.

This holds true for any business (whether service or manufacture), and for any media (e.g. paper, electronic or optical). In principle, ISO 9001 requires nothing that a reputable organization should not want to do anyway.


DEVELOPING/IMPLEMENTING THE QMS

• Consists of several steps, structured around the PDCA cycle.• The same approach is also applicable to maintaining and improving an

established quality management system.

PLAN

DO

CHECK

ACT


QUALITY MANAGEMENT SYSTEM APPROACH involves thefollowing:• Determining needs and expectations of customers and other interested parties.• Establishing the quality policy and objectives.• Determining the processes and responsibilities necessary to attain the quality objectives.• Determining and providing the resources necessary to attain the quality objectives.• Establishing methods to measure the effectiveness and efficiency of each process.• Applying these measures to determine the effectiveness and efficiency of each process.• Determining means of preventing nonconformities and eliminating their causes.• Establishing and applying a process for continual improvement.


ISO 9001: 20004.2.1 Documentation RequirementsThe QMS shall include:

Documented statements of quality policy and objectives A quality manual, documented procedures required Documents needed by the organization to ensure effective planning, operation and control of its processes Quality records required


Documenting The QMS

• Each organization determines: Extent of documentation required. Media to be used.

• Emphasis is on controlling processes and meeting quality objectives, not on generating unnecessary documentation.

• Documentation can be in any type or form of media.


Objectives of Documenting the System

To communicate the company’s policy procedures and requirements.

To train personnel in the quality system requirements & methods of compliance.

To demonstrate, for external purposes, compliance with required quality standards.

To provide continuity of the quality system.


Value of Documentation• Enables:

Communication of intent. Consistency of action.

• Contributes to: Conformity to customer requirements. Continual improvement. Provision of appropriate training. Repeatability and traceability. Provision of objective evidence. Evaluation of effectiveness and suitability of QMS.

• Generation of documents should add value, if not, don’t document it!


Extent of Documentation• Depends on factors such as:

Type and size of organization. Complexity and interaction of processes. Complexity of products. Customer requirements. Regulatory requirements. Demonstrated ability of personnel. Extent to which it’s necessary to demonstrate QMS requirements is met.


Documentation of a System

Quality Manual

Company Procedures

Work Instructions/Plans of work

Forms, Records, Documents, etc.


Types of Documents Used in a QMS

• Documented statements of quality policy and objectives.• Quality manual.• Procedures.• Work instructions.• Quality Plans.• Specifications, drawings, standards.• Guidelines.• Records.