ISO 9001 – QUALITY MANAGEMENT SYSTEM

A BRIEF OVERVIEW

MUHAMMAD REHAN KHAN

MAINTENANCE ENGINEER

This summary has been developed as a key to internal auditors who have gone through the complete ISO9001 standard once. It will serve as a guide to revise key points and develop an audit checklist quickly

QUALITY MANAGEMENT SYSTEM (QMS) m rehan khan

CONTROL OF RECORDSIDENTIFICATIONSTORAGEPROTECTIONRETRIEVABLERETENTIONDISPOSITION

CONTROL OF DOCUMENT• APPROVED• REVIEWED, UPDATED & RE-APPROVED• CHANGES ARE IDENTIFIED• REVISION NUMBER• LEGIBLE & IDENTIFIABLE• PROVIDE REFERENCE OF VENDOR DOCUMENTS• SEPARATE OBOLETE ONE

ISO 9001

CONTROLLED

ONLY IF RED

MANAGEMENT RESPONSIBILITY m rehan khan

MANAGEMENT COMMITTMENT

RESOURCES CUSTOMER FOCUS

QUALITY POLICY

QUALITY OBJECTIVES

REVIEWS COMMUNICATIONS

QMR

ESTABLISHED DOCUMENTED

IMPLEMENTED MAINTAINED

LIASION WITH EXTERNAL PARTIES

REPORT PERFORMANCE

REPORT NEED FOR IMPROVEMENT TO

MANAGEMENT

PROMOTE AWARENESS OF CUSTOMER REQUIREMENT

QMS

INTERNAL

RESOURCE MANAGEMENT m rehan khan

QUALITY MANAGEMENT SYSTEM

IMPLEMENT MAINTAIN CONTINUOUS IMPROVEMENT

PROVISION OF RESOURCES COMPETENCY

-EDUCATION-TRAINING-SKILLS-EXPERIENCE

PRODUCT REALIZATION m rehan khan

DESIGN AND DEVELOPMENT

PLANNINGDetermine stagesDetermine review, verification and validationResponsibilities and authorities

INPUTS

Functional and performance requirementsStatutory and regulatory requirementsInformation from previous designOther essential requirementsMaintain records

OUTPUTS

Meet the input requirementsProvide information for purchasing, production & servicesContain product acceptance criteriaSpecify the essential characteristics for intended use

REVIEWEvaluate the ability of resultsIdentify problem and propose actionMaintain records

VERIFICATION Ensure requirements are metMaintain records

VALIDATION Ensure product is capable of meeting the requirementDone before delivery and maintain records

CONTROL OF CHANGES

Identify changes and maintain recordsChanges shall be verified, validated and approvedEvaluate effect of changes

PRODUCTION & SERVICES PROVISION

CONTROL

Availability of information that describe characteristicAvailability of work instructionsUse of suitable equipmentAvailability & use of Monitoring & measuring equipmentImplementation of monitoring & measurementImplementation of product release, delivery & post-delivery

VALIDATION OF PROCESSES

Defined criteria for review & approval of processesApproval of equipment & qualification of personnelUse of specific methods & proceduresRequirements for recordsRevalidation

IDENTIFICATION & TRACEABILITY

Identify the productIdentify the product status If required, give unique identification and record it

CUSTOMER PROPERTY

Identify, verify, protect & safeguard customer propertyIn case of damaged, report customer and record

PRESERVATION OF PRODUCT

Preserve product during internal processing & deliveryPreservation include identification, handling, packing, storage and delivery

PURCHASINGPURCHASING PROCESS- Purchased product must

conform to Purchase requirement

- Control on supplier- Establish criteria for

supplier selection, evaluation & re-evaluation

PURCHASING INFORMATION- Requirements for approval- Requirements for

qualification of personnel- QMS requirements

VERIFICATION- Establish & implement

inspection of purchased product

- State verification arrangements in purchasing information

MONITORING AND MANAGEMENT m rehan khan

MONITORING & MEASUREMENTS

QMS PROCESS PRODUCT

Apply suitable methods

Define Corrective and Preventive actions in case of deviation

Measure and monitor characteristics at appropriate stages

Maintain evidence of conformity with acceptance criteria

Release of product by relevant authority

ANALYSIS OF DATA

Determine, collect and analyze data to demonstrate suitability and effectiveness and evaluate need of continuous improvement

Data includes:a. Customer Satisfactionb. Conformity to product

requirementc. Trends of process and productd. Opportunities for preventive

actionse. suppliers

CONTINUOUS IMPROVEMENT

• Use of Quality Policy• Use of Quality

Objectives• Audit results• Analysis of Data• Corrective Action• Preventive Actions• Management Reviews

CPD

A