Lecture -8 Step by Step Implementation of ISO-9001:2008

Presented by Dr. Ali Nesar Khan

ISO 9000:2008Family
Annexes A & B for information only

ISO ISO 10012 Measurement 10012

Audits

Quality management systems Fundamentals & vocabulary

ISO 9000: 2005

ISO 19011

Guidelines Quality management systems Guidelines for performance improvement Technical Reports

ISO 9004: 2009

ISO 9001: 2008

Quality management systems Requirements

Quality Management System Documentation

Standard ISO 9000
Quality Manual
LEVEL 1

Policy Statement, Commitment, Organisation, Responsibilities

Quality System Procedures

LEVEL 2

Company Practices, Interfaces

Work Instructions
LEVEL 3

Written Instructions to Control Tasks

Forms
LEVEL 4

Quality Records

Sales

Design

Purchasing

Manufacturing

Accounts

Personnel

After Sales

ISO 9001:2008 can be simplified by breaking the project down into 8 manageable steps.

Step-1 :Learn About ISO 9001

Buy a Copy of the Standard Free ISO 9000 Tutorial Requirements of ISO 9001

Step-2. Perform a Gap Analysis

Schedule the Gap Analysis Conducting an ISO 9001 Gap Analysis Gap Analysis Report Buy Gap Analysis Checklist You know where you are (Current Quality Management System). You want to be ISO 9001 Compliant. The difference between these is your gap. Anytime they differ you need to change your processes to bridge the gap. If are going to implement first time ISO 9000?

Step-3. Prepare Your Document

ISO 9001 Step-by-Step Workbook (Documentation: All about 8 Elements of ISO 9001:2008 i.e., 1. Scope, 2. Normative references, 3. Terms and definitions, 4. Quality management system 5. Management Responsibility, 6.Resource management, 7.Product realization, 8.Measurement, analysis and improvement and ISO 9001 QMS Templates

Step-4
Form a Project Plan (TQM Team Formation and Train Employees on ISO 9001

The Team Approach

Steering Team Task Teams by departments and by assignments

Management Orientation Employee Awareness Keeping them informed

Step-5 Implement the ISO QMS in Your Organization

Starting of ISO Quality Management System Practice Training on New Procedures Formation of Internal Auditors (IA) Team Training of IA Team

Step-6 Audit Your QMS by Yourself

Trained Internal Auditors are ready to work Conduct Internal Audits Corrective/Preventive Action

Step-7 Early Stage of ISO 9001:2008 Third Party Registration

Select a Registrar i.e., a Third Party Auditor (Independent Auditor) Let Third Party Auditor to Conduct Desk Audit Let Third Party Auditor to conduct Compliance Audit

Step-8
Final Stage of Third Party Registration and Completion of Your Document System

Pass Surveillance audit (each six months; 2-3 times before certification) Pass Sampling Audit (Every 2 to 4 weeks; at least 3 times before certification) Certification, if all are complied with

Schematic Diagram of ISO 9001 Implementation and certification process

1,2,3
Basic Document Preparation

Management Orientation
Employ ee Aware ness Trainin g

Implementation

5, 5 6

Formation of TQM Team

TQM Team Training

TQM Trial Practice + training for all

employees

Internal Auditing + IA Staff Training

5

Desk audit and Compliance audit

7

Not OK

OK

Surveillance Audit for six months

8
Sample Audit Certification
8

Assignment Write a paper describing as how you will be implementing ISO-9001:2008 in one of the following types of industry.

Type of Industry: Knitting Mill (Medium & Large), Weaving Mill (Medium & Large), Woven Dyeing-Finishing (large), Knit Dyeing (large), Yarn Dyeing Large, Garments (Medium & Large), Garments Washing and Dyeing (large) Step Q1 Year-1 Q2 Q3 Q4 Time in Quarter Year-2 Q1 Q2 Q3 Q4

Q1

Year-3 Q2 Q3 Q4

Step-1 Step-2 Step-3 Step-4 Step-5 Step-6 Step-7 Step-8 Description of every step should be elaborated

WISH YOU A GOOD START

ISO 9001:2008 lists requirements, while ISO 9000:2000 and ISO 9004:2009 are Quality Guidelines. People often say "ISO 9000 certified", but what they mean is they have met the requirements of the ISO 9001 standard.

ISO 9001:2000 Process Approach

PROCESS EFFECTIVENESS

CONTROLS

Extent to which planned activities are realized and planned results achieved

PROCESS INPUT
set of interrelated or interacting activities which transforms inputs into outputs

OUTPUT

PRODUCT

PROCESS EFFICIENCY

RESOURCES

Relationship between the result achieved and the resources used

A desired result is achieved more efficiently when activities and related resources are managed as a process

ISO 9001:2000 System approach to management

Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives

R I Process A O I C I I O R C = = = = Process C I R

R Process B I C O I Process D O O R

INPUT OUTPUT RESOURCES CONTROLS

Concept of integration
ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 standards

based on PDCA concept, therefore having similar structure:

Policy & Planning Implementation and operation Performance assessment Improvement through Management review