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Session 1 1

AWARENESSAWARENESSTRAININGTRAINING

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Sigur Ros Sdn. Bhd.

Session 1: Background & History of ISOSession 1: Background & History of ISO

ItineraryItinerary

Session 2: Basic Structure of ISO 9001:2008Session 2: Basic Structure of ISO 9001:2008-- Process Model QMSProcess Model QMS

-- Process ApproachProcess Approach

Session 3: ISO 9001:2000 StandardSession 3: ISO 9001:2000 Standard-- Clause 1~3 (General, Ref, Terms & Definitions)Clause 1~3 (General, Ref, Terms & Definitions)

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---- Clause 5 (Management Responsibility)Clause 5 (Management Responsibility)-- Clause 6 (Resource Management)Clause 6 (Resource Management)-- Clause 7 (Product Realization)Clause 7 (Product Realization)-- Clause 8 (Measurement, Analysis & Improvement)Clause 8 (Measurement, Analysis & Improvement)

Background ISO=

Session 1: Background & History of ISOSession 1: Background & History of ISO

HQ: Geneva, Switzerland

ISO 9000 Standard developed by Technical Committee176 (TC 176)

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,5 years periodic review

Required minimum 75% committee agreement

Scheduled review & up-datepresent standard

Countrys Reps Countrys Reps

Scheduled review & up-datepresent standard

ISO & INTERNATIONAL STANDARD FLOWISO & INTERNATIONAL STANDARD FLOW

75% Agreed

TC 176

Relevant government authorities/bodies

Clients

ISO standard

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AccreditationBodies

(UKAS, RAB, DSMetc.)

Certification

Bodies (SIRIM,LRQA, BVQI etc.)Companies

National standard

ISO Cert.

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Session 1 2

History of series ISO 9000:Session 1: Background & History of ISOSession 1: Background & History of ISO

e on: rom r s an ar

2nd edition: 1994

3rd edition: 2000 (valid til l Nov 2009)

4th edition: 2008

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iso = equality (Greek)

Session 1: Background & History of ISOSession 1: Background & History of ISO

ISO standard responses as a measurement point

Easier international business

Basic std to generate/produce product/service

Different people, same method/system practice

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Session 2 1

Session 2: Basic Structure of ISO 9001:2008

Process Model Quality Management System (QMS)

Process Approach

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Session 2: Basic Structure of ISO 9001 :2008

Process Model Quality Management System (QMS)

ISO 9001:2008 is a Genera St ; can e a apteto all kind of industries/businesses & organisations

Standard based on Quality Management System(QMS)

WHAT to do, not HOW to do concept to fulfillthe standard

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Organisation have to explain how they operates

Session 2: Basic Structure of ISO 9001:2008Process Model Quality Management System (QMS)

ISO 9001:2008 consists of simple approachingelements:

Documentation Management commitment & responsibility

Resources management

Product / Service realization

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Measurement, Ana ysis & improvement

Continual improvement

Concept of Process Model

Continual Improvement

Session 2: Basic Structure of ISO 9001:2008

Process Model Quality Management System (QMS)

ManagementResponsibility

ResourceManagement

Measurement,Analysis &

Improvement

CUSTOMERREQUI

CUSTOMERSATISF

Information Flow

InformationFlow

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ProductInput OutputProduct

Realization

EMENT

CTION

Value-Adding Activities

Value-Adding Activities

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Session 2: Basic Structure of ISO 9001:2008

Process Approach

A process involves use of resources for thetransformation of inputs into outputs

No isolated process in the organisation

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- (Input Action Output)

Session 2: Basic Structure of ISO 9001 :2008

Process Approach

Company Business Process

Company Tendering Execution

Company Project Execution

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Session 3: ISO 9001:2008 Standard

Clause 1~3 Scope

Reference

Terms & Definitions

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4.1 General requirements

Organisation shall:

Session 3: ISO 9001 :2008 StandardClause 4 (QMS)

Establish, document, implement & maintain a QMS

Identify the sequence & interaction of processes

Control & ensure the processes are effective

Resource & info to be available

Monitor, measure, analyse & improve the processes

Control process that are outsource

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4.2 Documentation requirement

Document must ensure process effectiveness Paper/electronic

Session 3: ISO 9001 :2008 StandardClause 4 (QMS)

Size/complexity; customised to organisation Min required documents:

Quality Policy and Quality Objective Quality Policy = Company Motto (5.3) Quality Objective = Company/Dept Target (5.4.1)

Quality Manual = Company Profile (4.2.2) 6 Mandatory Procedures

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. . Control of Records (4.2.4) Internal Audit (8.2.2) Control of Nonconforming Product (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) Records & Others (document to ensure effective operation,

any defined method/format: flowchart, diagram, picture etc.

Session 3: ISO 9001 :2008 StandardClause 4 (QMS)

Basic Structure of Documentation

Quality Manual

Procedures

Work Instructions

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Support Document

* Refer to Company Quality System Document (QSD)

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4.2.2 Quality Manual Company scope of processes/activities.

Ex lanation of documented rocedures reference

Session 3: ISO 9001 :2008 StandardClause 4 (QMS)

A description of the interaction between processes (processmapping)

4.2.3 Control of Documents Ensure, review, revise, document status

Identification, controlled copy

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4.2.4 Control of Records Legible, readily identifiable and retrievable

Identification, storage/protection, retention time anddisposition

Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)

5.1 Management Commitment Management must demonstrate its commitment

Must meet customer needs & requirements

Must meet regulatory & legal requirements

QMS must be driven by top management

Establish quality policy & objectives (5.3 & 5.4.1)

Conduct management review (5.6)

Ensure availability of resources (6)

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5.2 Customer/ Client focus Determined customer requirements

Aim to achieve customer satisfaction (7.2.1 & 8.2.1)

Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)

5.3 Quality Policy Must appropriate to the purpose/target of the organization

Communicated within organization

Commitment for continually improve the QMS

Company Quality Policy

5.4.1 Quality Objectives Measurable and in line with Quality Policy

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Use as one of the factors to facilitating continual improvement

Company Quality Objective

Departmental Quality Objective

Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)

5.5 Responsibility, authority and communication

5.5.1 Res onsibilit & authorit

Responsibilities defined and communicated (Jobs Description)

5.5.2 Management representative

Responsible for implementing/maintaining & reporting theQMS

Report on needs of improvement

Promote awareness of customer needs

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5.5.3 Internal communication Communication between various level (processes &

effectiveness of QMS)

Organization Chart

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Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)

5.6 Management Review Review input

eac ve .e. pro em ren s

Proactive (i.e. opportunities)

Review output Improvement of QMS, customer requirement

Resources needs

Record shall be maintained (Management Review

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Procedure

Session 3: ISO 9001 :2008 StandardClause 6 (Resource management)

6.1, 6.2 Human resources Must ensure staff:

ompe en

Provide training

Aware of importance of their activities

Maintained records (Training Procedure)

6.3 Infrastructure

Must have correct infrastructure to achieve aims (i.e.

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buildings, hardware, software, transportation etc.)

6.4 Work environment

Must be right environment to achieve conformingproduct (i.e. Food industry; humidity & temperature etc.)

Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)

7.1 Planning of product realization Determine following, as appropriate:

ualit re uirement for the roducts

The need to establish project specific process, documents, resources(4M method)

Inspection & testing requirement & criteria required Records (Project Planning Procedure)

7.2 Customer-related process Must be method:

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To make sure requirements (regulatory/legal) understood and met

For communicating with customer

For controlling changes to requirements

Tendering Planning Procedure

Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)

7.3 Design & Development (D&D)

Establish design & development route with:

D&D Planning (Design Plan)

D&D inputs (from clients, supplier)

D&D outputs D&D review

D&D validation (performance test etc.)

D&D changes

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es gn on ro roce ure

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Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)

7.4 Purchasing

Must ensure that an urchased oods services are toan acceptable standard & criteria

Purchase document & information must be precise

Supplier must be evaluated

Verification of purchased products

Procurement Procedure, Subcontracting Procedure

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Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)

7.5 Production/Construction and service provision 7.5.1 Control of Construction & service provision

Summaries the core activities on how the product/service canbe provided in a controlled and consistent way, i.e.:

Clear instructions (WP, PP, DPP etc.)

Suitable equipments, monitoring activities, test equipments

Construction procedures, WP, PP etc.

7.5.2 Validation of processes

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,

(i.e. proof of good welding). Special process validation required Review criteria, equipments, competency, procedures, records

Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)

7.5 Production/Construction and service provision

7.5.3 Identification & traceability

Identification: what the product/service is?

Traceability: where the product/service gone/come from?

Identification, Traceability & Preservation of Material,Equipment & Work Procedure

7.5.4 Customer property Information/data/hardware belong to customer must be looked

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a er

Control of Client Property Procedure

7.5.5 Preservation of product

Ensure product/service is not damaged

Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)

7.6 Control of monitoring & measuring equipmentCalibration

To ensure any device used for accurate measurement isitself accurate

Device is routinely checked/calibrated

Protected from damage

Control of Monitoring & Measuring Devices Procedure

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Session 3: ISO 9001 :2008 StandardClause 8 (Measurement, Analysis & Improvement)

8.1 General 8.2 Monitoring & measurement

. . Key measures must be defined (survey/project feedback form

etc.)

8.2.2 Internal Audit QMS is audited to check:

The system followed, effective? Meets ISO9001 requirement?

Internal Audit Procedure

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8.2.3, 8.2.4 Monitoring & measurement oprocesses/product To defined that processes/products meet customer

requirement? Inspection & Test Plan (ITP) Inspection & Testing Procedure

Session 3: ISO 9001 :2008 StandardClause 8 (Measurement, Analysis & Improvement)

8.3 Control of nonconforming product

o ensure fault roduct service is not accidentallused including those detected after delivery

Control of Nonconformities Procedure

8.4 Analysis of Data

Data from Internal Audit, customer complaint,processed, suppliers must be analyzed so as to find

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ways o improving usiness Analysis of Data Procedure

Session 3: ISO 9001 :2008 StandardClause 8 (Improvement)

8.5 Improvement

8.5.1 Continual improvement

Improve QMS effectiveness through the use of quality policy &objective, audit result, analysis of data, management review

etc. 8.5.2 Corrective action

Take action to avoid recurrence of nonconformities/problems

Corrective & Preventive Action Procedure

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8.5.3 Preventive action Take action to avoid occurrence of potential

nonconformities/problems

Corrective & Preventive Action Procedure