Iso9001 Overview

8/14/2019 Iso9001 Overview

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What is ISO9001:2000?

ISO 9001:2000 is aninternationalstandard for implementing aquality management system



ISO 9001:2000 sets out

how a company canestablish an effectivequality management

system to meet itsstakeholders’ needs

ISO 9001:2000 sets out

how a company canestablish an effectivequality management

system to meet itsstakeholders’ needs

Why Use ISO9001:2000?



ISO 9000:2000 - Fundamentals andVocabulary

Provides an introduction to Quality

Management Systems (QMS) and vocabularyISO 9001:2000 - Requirements

Specifies requirements for a QMS wherecapability to provide product that meets

customer and regulatory requirements needsto be demonstrated

ISO 9004:2000 - Guidelines forPerformance Improvement

Provides guidance on using an establishedQMS to further enhance customer satisfaction

IS0 9000:2000 Series of Standards



1. Customer focus

2. Leadership

3. Involvement of people4. Process approach

5. System approach to management

6. Continual improvement7. Factual approach to decision making

8. Mutually beneficial supplierrelationship

Eight Quality ManagementPrinciples



CONTINUAL IMPROVEMENT OF THE QUALITY

MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF THE QUALITY

MANAGEMENT SYSTEM

Measurement,analysis and improvement

Measurement,analysis and improvement

Product Product Input Output

Management responsibility

Resourcemanagement

Resourcemanagement

Clause 5

Clause 6 Clause8

Clause 7

Customers

Requirements

Product

realization

Customers

Satisfaction

Value adding activitiesInformation flow

Introduction to ISO 9000:2000



1. Scope

1.1 General

1.2 Application

2. Normative reference

3. Terms and definitione.g., Supplier OrganizationCustomer

ISO 9001:2000Requirements



Possibility to reduce scope

No 9002 or 9003

Can reduce the scope of requirementsrelated to “product realization”

May not exclude any requirement thataffects ability to provide product and/orservice that meets customer andregulatory requirements

Permissible Exclusions



To meet the requirements you must: Document

Implement Maintain Continually improve effectiveness

4 Quality ManagementSystem



4 Quality ManagementSystem

4.1 General requirements Processes, interaction, improvement

4.2 Documentation requirements General Quality manual Control of document Control of records



5 Management Responsibility

5.1 Managementcommitment

5.2 Customer focus5.3 Quality policy

5.4 Planning Objectives

Management system



5.5 Responsibility, authority andcommunication Top management emphasis

Management representative Includes promotion of customer

requirements throughout the organization Internal communication

5.6 Management review Lists of inputs and outputs Recommendation for improvement Action items expected Records

5 Management Responsibility



6 Resource Management

6.1 Provision of resources to improveprocesses and enhance customersatisfaction

6.2 Human resource Determine competence Provide training or other action Evaluate effectiveness of action

6.3 Infrastructure

Buildings, workspace, utilities Process equipment Support services

6.4 Work environment Manage conditions of environment to

achieve product requirement conformance



7 Product Realization

7.1 Plan and develop the processes

Include product objectives, relevantprocesses and resource, appropriate testand validation

7.2 Customer related processes

Customer requirement - stated andimplied

Statutory and regulatory

Product requirements and changes Organization ability Communication with customers

7.3 Design and development

Planning, inputs, outputs, systematicreviews, verification and validation,




7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product

7.5 Production and service provision Controlled conditions including product

characteristics, work instructions, suitableequipment, measuring devices, andsystem

Release, delivery and post deliveryactivities Validation of processes when no other

method Identification and traceability of product

and it’s status Care of customer property




7.6 Control of monitoring and measuringdevices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration



8 Measurement, Analysis,and Improvement

8.1 General Plan and implement Measurement and monitoring processes

To demonstrate product conformity,

system conformity and continuallyimprove the QMS

8.2 Monitoring and measurement Customer satisfaction

Perception of fulfillment

Internal planned audit, etc. Auditors independent of their own work

Processes Demonstrate achievement of planned results

Product

Monitor and measure characteristics Conformity with acceptance criteria



8 Measurement, Analysis,and Improvement

8.3 Control of nonconforming product Elimination, concession, preclude

intended use

8.4 Analysis of data Customer satisfaction Product and process requirements and

trends Suppliers

8.5 Improvement Continually improve effectiveness

of the system Corrective action

Preventive action



Next Steps

Phase I: Assess the present situation

Phase II: Plan the implementation /transition

Phase III: Implement plan

Phase IV: Assess and review

Phase V: Consolidate and improve

Phase VI: External assessment



Next Steps

I mplementation Transition

Assess existing Business

System

Review:

ScopeI.D. Steering Team andImplementation Team

Existing documentation Assessment system Management review

Prepare and coach

teams

Corrective and Preventive

Action Systems Senior management focus Performance since

registration For compliance gaps

Phase I: Assess the PresentSituation



Next Steps


Develop: Project Plan

Develop: Overall transition plan

Documentation plan Training plan Communication plan Process mapping plan Calibration plan Assessment plan Management review

plan

Plan for those topics

needing attention as aresult of the review

- Documentation(especially if existing

system is not processfocused)

- Transition Measurement and

Improvement plan Registrar selection plan

Plan to implement

processes to fulfill anysystem gaps

Phase II: Plan theImplementation/Transition



Next Steps


Maintain project plan Provide training identified Process map the business

processes

Gather metrics data I.D. improvement issues Publish improvement

Map processes is notalready Measure processes Train assessors to assess

for business effectiveness Gather metrics data I.D. improvement issues Publish improvement

Phase III: Implement the Plan



Next Steps

Assess Review

Use internal assessmentto verify compliance andI.D. businesseffectiveness issues

Use internal assessmentto verify compliance andI.D. business effectivenessissues

Share information to gain

improvement momentum

Share information to gain

improvement momentum Start management

reviews

Continue managementreviews (revised)

Phase IV: Assess and Review



Next Steps


$ Improvement issues(process mapping,assessments, customersatisfaction)

$ Improvement issues(process mapping,assessments, customersatisfaction)

Change the processes Change the processes

Publish gains andsuccess

Publish gains andsuccess

Close gaps withcompliance

Close gaps withcompliance

Phase V: Consolidate and Improve



Next Steps


Optional pre-assessment

On goingsurveillance(increase scope)

Registrationassessment

Upgrading theexisting registration

Business focus Business focus

Phase VI: External Assessment



Summary

ISO 9001:2000 is much more project driven

Top management have greater accountability

The organization is required to measurebusiness performance against objectives

If implemented correctly, it will help theorganization to: Be more competitive Improve cycle times Reduce costs Improve morale

Iso9001 Overview

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