lecture-8 step by step iso(1)
TRANSCRIPT
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Lecture -8
Step by Step Implementation ofISO-9001:2008
Presented by Dr. Ali Nesar Khan
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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
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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
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ISO 9001:2008 can be simplified by
breaking the project down into 8
manageable steps.
http://the9000store.com/Step1-what-is-iso-9001.aspx -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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- 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 -
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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
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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
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WISH YOU A GOOD START
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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.
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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
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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
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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