ISO 9000: 2000 SeriesAwareness & Internal Auditor Certification CourseInstructorMohamed GhorabNovember 2008

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Audience Acquaintance / Ice Breaker:

Introduce yourself

What Company do you work for?

Any previous Quality Management or auditing experience?

Define a process in your company which has a direct impact on the customer (External)

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BasicsSwitch mobile phones to the silent mode.

Toilets.

Break.

Material provided.

A written open book final exam

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Is THE Global GroupEstablished in 1878 - Head Office in Geneva, Switzerland.

42000 employees -1000 Offices and 320 Laboratories in more than 120 Countries.

SGS is recognized as the global benchmark for the highest standards of expertise, quality and integrity.

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We provide leading & innovative services to all industriesCertificationInspection & VerificationOutsourcingRisk ManagementTechnical ConsultingTesting & Analysis Trainings :

In the areas of:ISO 9000: 2000 SeriesAwareness & Internal Auditor Certification Course

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Course Objectives:Understand and apply the process approach to auditing.Understand the structure and content of ISO 9001: 2000 and the support documents.

Who should attend?

A person who has the competence to conduct an audit.Demonstrated personnel attributes and demonstrated ability to apply knowledge and skills.

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Goal of ISO 9001: 2000The goal of this Technical Specification is the development of a quality management system that provides for:

Continual improvementEmphasizing defect prevention andThe reduction of variation and waste in the supply chain.

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Course Outline:Introduction to ISO 9000: 2000 family of standards ISO 9001: 2000 overview & Clause 4

ISO 9001: 2000: Clause 5, 6ISO 9001: 2000: Clause 7, 8

Internal Auditor QualificationDay 1Day 2Day 3Session 1Session 3Session 4Session 5Session 2

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Session 1: Introduction to ISO 9000: 2000 Family of standards

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The benefits of a quality management systemISO 9000 family of StandardsThe process approachThe quality management principles

Introduction to the ISO 9000 series of Standards

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Evolution of QMS Standards

MIL - Q - 9858 USA ~ 1958BS 5750 Part I , II ,III UK ~ 1979ISO 9001 , 9002 & 9003 1987ISO 9001 , 9002 & 9003 1994ISO 9001 : 2000 2000

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ISO 9000 familyISO 9000 -- Quality management systems - Fundamentals and vocabulary

ISO 9001 - Quality management systems - Requirements

ISO 9004 - Quality management systems - Guidelines for performance improvements

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ISO 9000:2005Replaces ISO 8402Comprises:

2.0Fundamentals of quality management systems

3.0Terms and definitions

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2.0 Fundamentals ofquality management systemsrationale for quality management systemsprocess approachquality policy and quality objectivesrole of top managementdocumentationrole of statistical techniques

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3.0 Terms and definitionsterms having a special meaningWritten definitions

Cross references to other defined terms

Terms may be replaced by its definition in other definitions

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Example definitionSpecification:document (3.7.2) stating requirements (3.1.2)

or by replacing the terms in bold:

information and its support medium stating need or expectation that is stated, generally implied or obligatory

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Relationship between ISO 9001 & 9004consistent pair for use together or independently

ISO 9001 sets out requirements

ISO 9004 provides guidance for improvementnot for implementation of ISO 9001 or certification/contractual use

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Compatibility with other StandardsIS0 14001 - Environmental management systems - specification with guidance for use

OHSAS 18001 Occupational health and safety management systems - specification

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ISO 19011contains information on:Terms and definitionsPrinciples of auditingManaging an audit programmeAudit activitiesCompetence and evaluation of auditorsGuidelines for quality and/or environmental management systems auditing

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Identification of processes

ISO 9001: 2000 requires:The organization shall identify processes needed for the quality management system and their application throughout the organization.Determine the sequence and interaction of these processes.Measure, monitor and improve these processes.

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Process

Any Activity or set of activities that uses resources to transform inputs to outputs

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A process

A process has a start and an end defined by two limits.

And a chain of activities between these two limitsINPUTCustomer who has a needOUTPUTCustomer who has a need metInputStep1Step2StepNOutput

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Plan-Do-Check-Act cycle & continual improvement

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Management responsibilityResource managementMeasurement analysis and improvementContinual improvement of the quality management systemCustomersCustomersProduct realisationSatisfactionRequirementsProductInputOutputProcess approach

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Process Approach48765

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8 Quality Management Principles

Customer FocusLeadershipInvolvement of PeopleProcess ApproachSystem Approach to managementContinual ImprovementFactual Approach to decision makingMutually beneficial supplier relationship

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8 Quality Management Principles

Customer Focus (1, 5.1, 5.2, 5.6.1, 8.2.1, 8.3)Leadership (5.3, 5.4.1)Involvement of People (5.5.3, 6.2.2)Process Approach (4.1, 5.1)System Approach to management (4.1, 5.1, 5.4.1, 5.6.1)Continual Improvement (Goal, 1, 5.1, 5.3, 8.5.1)Factual Approach to decision making (5.6.1, 8.2.2, 8.4)Mutually beneficial supplier relationship (7.4)

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Process Improvement (Shewart Cycle)

PlanWhat and why? DoHow, when, and how much? CheckHow will you know it worked? ActHow do you plan to fully adopt?ActPlanCheckDo

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The Dilbert Cycle Blame someone else for catastropheAdopt unproven process or technologyMake wild guess at what is wrongACT

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Plan-Do-Check-Act diagram

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Audit Tool: Turtle DiagramOutputs

Conforming product delivered to customer schedule (8.2.1)Inputs

Customer schedule (7.5.1)Raw materials (7.4)How? Control plans (7.5.1)Work instructions (7.5.1)Preventive maintenance (7.5.1)SPC (8.1.1)Nonconforming product procedure (8.3)Dispatch process (7.5.1)Contingency plan (6.3.2)Document control/ records (4.2.3/4)What Results?Analysis of data (8.4.1)Customer satisfaction (8.2.1)Other Organizational objectives (5.4.1)Maintenance objectives (7.5.1)Cost of poor quality (5.6.1)Process capability (8.2.3)Management review (5.6.1)Continual improvement results (8.5)Audit records (8.2.2)With Who? Competence criteria (6.2.1)Induction/ training records (6.2.2)Agency/ Contract labour (6.2.2.3)Job responsibilities/ authorities (5.5)Training effectiveness (6.2.2)SPC awareness (8.1.2)Personnel safety (6.4.1)Awareness of policy/ objectives (6.2.2)With What? Plant and machinery (6.3) Process equipment (6.3)Measuring equipment (7.6)Tooling (7.5.1)Maintenance (7.5.1)Packaging/labeling (7.5.5)Customer property (7.5.4)Transportation (6.3)(Support Processes)ITHuman resourceLogisticsSalesQualityPreventive maintenanceProcess:

Manufacturing Process (7.5)

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Session 2: ISO 9001: 2000 Overview

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ISO 9001:2000 overviewThe structure of ISO 9001:2000Scope and application of ISO 9001:2000ISO 9001:2000 Clause 4: Quality management systemGeneral requirementsDocumentation requirements

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The structure of ISO 9001:2000ScopeNormative referenceTerms and definitionsQuality management systemManagement responsibilityResource managementProduct realizationMeasure, analysis and improvementComprises 8 clauses:

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ISO 9001 - ScopeThe requirements are:for those who need to:demonstrate ability to provide consistently product that meets customer and regulatory requirements

enhance customer satisfaction and continual improvement

applicable to all organisations

generic

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Application of the StandardExclusions:may be due to:-nature of the product-customer requirements-applicable regulatory requirementslimited to Section 7 only

must be justifiedmay not be requirements which affect the ability or responsibility to provide product that meets customer and regulatory requirements

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ISO 9001; clause 4

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The End of Day 1Mohamed GhorabMohamed.ghorab@sgs.com

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Session 3: ISO 9001: 2000: Clause 5, 6

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ISO 9001:2000 clause 5, Management responsibilityManagement commitmentCustomer focusQuality PolicyPlanningResponsibility, authority and communicationManagement review

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ISO 9001; clause 5 (1)

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ISO 9001; clause 5 (2)

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SMART

The more the goals reflects the customers needs and expectations, the more successful the project will be.

An effective quality planning goal has five characteristics (SMART):Specific.Measurable.Agreed upon/Achievable.RealisticTime-phased.

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ISO 9001:2000 clause 6, Resource managementProvision of resourcesHuman resourcesInfrastructureWork environment

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ISO 9001; clause 6

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Session 4: ISO 9001: 2000: Clause 7, 8

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ISO 9001:2000 clause 7, Product realization

Planning of product realizationCustomer-related processesDesign and developmentPurchasingProduction and service provisionControl of monitoring and measuring devices

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ISO 9001; clause 7 (1)

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ISO 9001; clause 7 (2)

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ISO 9001; clause 7 (3)

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ISO 9001; clause 7 (3)

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ISO 9001:2000 clause 8Measurement, analysis and improvement

GeneralMonitoring and measurementControl on nonconforming productAnalysis of dataContinual improvement

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ISO 9001; clause 8 (1)

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ISO 9001; clause 8 (2)

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The End of Day 2Mohamed GhorabMohamed.ghorab@sgs.com

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Session 5: Internal Auditor Qualification

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Internal Auditor QualificationISO 19011

Auditor: a person who has the competence to conduct an audit.

Competence: Demonstrated personal attributes and demonstrated ability to apply knowledge and skills.

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Auditor Competence defined in ISO 19011Quality system knowledgePersonnel attributesEnvironmentSystemknowledgeGenericKnowledgeEducationWork ExperienceAuditor trainingAudit Experience

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Current techniques

What is your organizations current process for qualifying internal auditors?

How is competence maintained?

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Personnel AttributesEthical: Fair, truthful, sincere, honest, discreetOpen minded: Willing to consider other points of viewDiplomatic: Tactful in dealing with peopleObservant: Actively aware of physical surroundings and activitiesPerceptive: Instinctively aware of and able to understand situationsVersatile: Adjusts readily to different situationsTenacious: Persistent, focused on achieving objectivesDecisive: Reaches timely conclusions based upon logical reasoning and analysisSelf reliant: Acts and functions independently while interacting effectively with others

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Auditor Qualification Criteria

EducationTraining in ISO 9001: 2000Work ExperienceQuality management experienceDemonstrated ability to apply knowledge and skills

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Audits parties levelsAccreditation BodyCertification BodyORGANIZATIONCUSTUMERSUPPLIER3rd p3rd p3rd p1st p1st p1st p2nd p2nd p4th p2nd p

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Why conduct Internal Audits?

To comply with quality management system standards!To help facilitate continuous improvement of the quality management systemHelp in sharing best practices between departmentsProvides management information about the state of the businessHelps focus attention on need for system compliance.

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Phases of an audit

Audit planning and scopePreparationDocumentationChecklist (your own)Executing the auditOpening meetingCollecting evidenceClosing meetingAudit report preparation / distributionCorrective action follow up / Close out.

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Audit PlanningThe audit program shall be planned taking into consideration:Status and importance of the processes and areas to be audited.Results of previous audits.When internal / external non conformities or customer complaints occur, the audit frequency shall be appropriately increased.Cover all processes & activities (Procedures) in accordance with an annual plan.

Prepare an audit plan to satisfy the system and process audit requirements in 9001: 2000

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Process Approach to auditing methodologyWhat are the objective(s) for the process?How do they link to business objective?What activities are carried out in the process?What are the applicable support processes?How is achievement measured?What results are actually being achieved?What actions are planned to ensure achievement of defined objectives?What improvement efforts are being made?

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ISO 9000: 2000 definitions

Conformity:Fulfillment of requirement

Nonconformity:Non fulfillment of a requirement

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Reporting Findings

Evidence gathered should be evaluated against requirements defined in ISO 9001: 2000, customer requirements, and organizations management systemConfirm decisions:(Conformity, Non conformity or Observation)Where found, prepare written nonconformities / Observation.

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Corrective action follow up

Auditee is responsible for determining root cause, and initiating corrective and preventive action needed to address nonconformities

Auditors responsibility is to verify corrective and preventive action is effectively implemented within the agreed timescale

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The End of Day 3 & the CourseMohamed GhorabMohamed.ghorab@sgs.com

THANKS

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