lecture-8 step by step iso(1)

7/29/2019 Lecture-8 Step by Step ISO(1)

1/20

Lecture -8

Step by Step Implementation ofISO-9001:2008

Presented by Dr. Ali Nesar Khan


2/20

ISO

10012

ISO 9000:2008Family

ISO

9000:

2005

Quality management

systems -

Fundamentals &

vocabulary

ISO

9004:

2009

Quality management

systems -

Guidelines for

performance

improvement

ISO

9001:

2008

Quality management

systems -

Requirements

Technical

Reports

ISO

10012MeasurementISO

19011Audits

Guidelines

Annexes A & B for

information only


3/20

Quality Management System

DocumentationStandard

ISO 9000

Quality Manual

Quality System Procedures

Work Instructions

Forms

LEVEL 1

LEVEL 2

LEVEL 3

LEVEL 4

Policy Statement, Commitment,

Organisation, Responsibilities

Company Practices, Interfaces

Written Instructions

to Control Tasks

Quality

Records

Sales Design Purchasing Manufacturing Accounts Personnel After Sales


4/20

ISO 9001:2008 can be simplified by

breaking the project down into 8

manageable steps.
http://the9000store.com/Step1-what-is-iso-9001.aspx


5/20

Step-1

:Learn About ISO 9001

Buy a Copy of the Standard

Free ISO 9000 Tutorial

Requirements of ISO 9001
http://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/buy-standards.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspxhttp://the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/buy-standards.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspx


6/20

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 QualityManagement System).

You want to be ISO 9001 Compliant.

The difference between these is your gap.

Anytime they differ you need to change yourprocesses to bridge the gap.

If are going to implement first time ISO 9000?
http://the9000store.com/Step2-perform-gap-analysis.aspxhttp://the9000store.com/Step2a-schedule-iso-9001-gap-analysis.aspxhttp://the9000store.com/Step2b-Conduct-ISO-9001-Gap-Analysis.aspxhttp://the9000store.com/Step2c-iso-9001-gap-analysis-report.aspxhttp://the9000store.com/iso-9001-Gap-Analysis-Checklist.aspxhttp://the9000store.com/iso-9001-Gap-Analysis-Checklist.aspxhttp://the9000store.com/Step2c-iso-9001-gap-analysis-report.aspxhttp://the9000store.com/Step2b-Conduct-ISO-9001-Gap-Analysis.aspxhttp://the9000store.com/Step2a-schedule-iso-9001-gap-analysis.aspxhttp://the9000store.com/Step2-perform-gap-analysis.aspx


7/20

Step-3. Prepare Your Document

ISO 9001 Step-by-Step Workbook

(Documentation: All about 8 Elements ofISO 9001:2008 i.e., 1. Scope, 2.

Normative references, 3. Terms anddefinitions, 4. Quality managementsystem 5. Management Responsibility,6.Resource management, 7.Product

realization, 8.Measurement, analysis andimprovement and ISO 9001 QMSTemplates
http://the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://the9000store.com/iso-9001-workbook-training.aspxhttp://the9000store.com/ISO-9000-Tips-Documentation-Requirements.aspxhttp://the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://the9000store.com/ISO-9000-Tips-Documentation-Requirements.aspxhttp://the9000store.com/iso-9001-workbook-training.aspxhttp://the9000store.com/iso-9001-workbook-training.aspxhttp://the9000store.com/iso-9001-workbook-training.aspxhttp://the9000store.com/iso-9001-workbook-training.aspxhttp://the9000store.com/iso-9001-workbook-training.aspxhttp://the9000store.com/Step3-ISO-9001-implementation-plan.aspx


8/20

Step-4Form a Project Plan

(TQM Team Formation and Train Employees on

ISO 9001

The Team Approach Steering Team

Task Teamsby departments and byassignments

Management Orientation Employee Awareness

Keeping them informed

St 5
http://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step3a-ISO-9001-implementation-teams.aspxhttp://the9000store.com/Step3b-ISO-9001-steering-team.aspxhttp://the9000store.com/Step3c-ISO-9001-task-team.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/iso-9001-Employee-Training.aspxhttp://the9000store.com/iso-9001-Employee-Flyers.aspxhttp://the9000store.com/iso-9001-Employee-Flyers.aspxhttp://the9000store.com/iso-9001-Employee-Training.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/Step1-what-is-iso-9001.aspxhttp://the9000store.com/Step3c-ISO-9001-task-team.aspxhttp://the9000store.com/Step3b-ISO-9001-steering-team.aspxhttp://the9000store.com/Step3a-ISO-9001-implementation-teams.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step4-ISO-9001-Training.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspx


9/20

Step-5

Implement the ISO QMS in Your

Organization

Starting of ISO Quality Management

System Practice Training on New Procedures

Formation ofInternal Auditors (IA)Team

Training of IA Team
http://the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://the9000store.com/Step6-Implement-ISO-9001-QMS.aspx


10/20

Step-6

Audit Your QMS by Yourself

Trained Internal Auditors are ready

to work Conduct Internal Audits

Corrective/Preventive Action

St 7
http://the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/ISO-9000-Tips-Internal-Audit-to-the-Standard.aspxhttp://the9000store.com/ISO-9000-Tips-Corrective-and-Preventive-Action.aspxhttp://the9000store.com/ISO-9000-Tips-Corrective-and-Preventive-Action.aspxhttp://the9000store.com/ISO-9000-Tips-Internal-Audit-to-the-Standard.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspx


11/20

Step-7

Early Stage of ISO 9001:2008 Third

Party Registration

Select a Registrar i.e., a Third PartyAuditor (Independent Auditor)

Let Third Party Auditor to ConductDesk Audit

Let Third Party Auditor to conductCompliance Audit
http://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspx


12/20

- Final Stage of Third Party Registration

and Completion of Your Document System

Pass Surveillance audit (each sixmonths; 2-3 times beforecertification)

Pass Sampling Audit (Every 2 to 4weeks; at least 3 times beforecertification)

Certification, if all are complied with
http://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspxhttp://the9000store.com/Step5-document-iso-9001.aspx


13/20

Schematic Diagram of ISO 9001 Implementation

and certification process

Employ ee

Awareness

TrainingTQM Team

Training

Internal

Auditing +

IA Staff

Training

Desk audit and

Compliance audit

Surveillance Audit for six

months

Sample Audit

Certification

TQM Trial

Practice +

training for allemployees

OK

Not OK

ManagementOrientation

Implementation1,2,3

BasicDocument

Preparation

Formationof TQM

Team

4 4

7

7

7

8

5

5

5,

6

8

8


14/20

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), WovenDyeing-Finishing (large), Knit Dyeing (large), Yarn Dyeing Large, Garments (Medium &

Large), Garments Washing and Dyeing (large)

Time in QuarterStep

Year-1 Year-2 Year-3

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Step-1

Step-2

Step-3

Step-4

Step-5Step-6

Step-7

Step-8

Description of every step should be elaborated


15/20

WISH YOU A GOOD START


16/20

ISO 9001:2008 lists requirements,

while ISO 9000:2000 and ISO 9004:2009 are QualityGuidelines.

People often say "ISO 9000 certified", but what they

mean is they have met the requirements of the ISO

9001 standard.


17/20


18/20

A desired result is achieved more efficiently

when activities and related resources are

managed as a process

PROCESS

set of interrelated orinteracting activities

which transforms

inputs into outputs

INPUT OUTPUT

RESOURCES

CONTROLS

PRODUCT

PROCESS

EFFECTIVENESS

Extent to which p lanned

activi t ies are r eal ized and

planned resul ts achieved

PROCESS EFFICIENCY

Relat ionship b etween the

resul t achieved and th eresources used

ISO 9001:2000 Process Approach


19/20

Identifying,understanding and

managinginterrelated

processesas a

systemcontributes tothe organizations

effectiveness and

efficiency in

achieving its

objectives

Process

A

Process

B

Process

C

Process

D

R R

R R

I

I

I

CC

C C

I O

I

I

O

O

OI = INPUT

O = OUTPUT

R = RESOURCESC = CONTROLS

ISO 9001:2000 System approach to management


20/20

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

lecture-8 step by step iso(1)

Documents