Content:

Overview – 10 minutes

Management System – 10 minutes

Question & Answer – 10 minutes

 Overview

Requirement:
Capture Data & Document

Archive & retrieve Data & Document

Communication & exchange of information

Strength & weakness - improvement

Security of data & documents

1
 Overview

Approach:
System driven

Documenting entire activity – Process approach

Communication protocol

People’s involvement

Factual approach - decision making

2
 Overview

Realization:
Management System

Document & data management System

3
 Overview
Management System:
QMS - ISO 9001 (2000)

Document:
QSP/MR/01 Preparation & issue of documents - A
QSP/MR/02 Management review - p
QSP/MR/03 Document & data control – UA
QSP/MR/04 Control of quality records – UA
QSP/MR/05 Internal Audit - p
QSP/MR/06 Control of non conformance at KLPP – p
QSP/MR/07 Filing system and archiving of KLPP document and record – UA
QSP/MR/08 Communication – UA

4
 Overview
Document Control Centre:
System driven

Information resource – need to know

Storage, tracking, archiving & retrieval facility

Document:
QSP/MR/07 Filing system and archiving of KLPP
document and record – UA

WI-01
QSP/MR/03 Standard layout of uncontrolled documents - A
5
 Management System
ISO 9001 : 2000
4. Quality Management System - (System design, definition,
implementation and control)
5. Management Responsibility - (policy, objectives, planning,
management review)
6. Resource Management - (human resources, information,
facilities)
7. Product Realisation - (design, purchasing, production,
delivery)
8. Measurement, Analysis and Improvement - (customer
satisfaction, audit, process control, continual improvement)
7
 Management System

Training
Services Quality Management System

INTENT
POLICY

QUALITY WHAT?
MANUAL

PROCESSES WHY?
HOW?
PROCEDURES

RECORDS / FORMS PROOF

36

8
 Management System

TRAINING
Top Management
5.1
SERVICES
Regulators
Customers 5.4.1

5.2 Objectives
Quality Policy
Competitors 5.3
Plans Resources
5.4.2

Change
Management
Review management
5.5
5.6 Responsibilities
Communication

Operations

9
Quality Management System (QMS)
implementation: 15-18 months
First Phase: 7-8 months
Preparation for Quality Management System

Second Phase: 5-6 months

Implementation of ISO 9001 Quality System

Third Phase: 3-4 months

Registration and Certification of ISO 9001
Quality System
10
 Phase-First
a) Management’s Commitment to ISO 9001

b) Set up an implementation committee and appoint an

ISO 9001 co-ordinator

c) Start ISO Awareness Campaign

d) Conduct Status Review and Prepare an Action Plan

e) Develop an Organisation Structure for Quality

Management

f) Develop Quality System Documentation

g) Prepare the system to meet the requirements of

standards 11
 Phase-Second

a) Implement the Documented Quality System

b) Establish Internal Quality Audit System

c) Monitor and Stabilise the Quality System

d) Conduct Pre-registration Internal Audit

13