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Itinerary

ISO 9001:2008 AWARENESS TRAINING


Sigur Ros Sdn. Bhd.
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Session 1: Background & History of ISO Session 2: Basic Structure of ISO 9001:2008 - Process Model QMS - Process Approach Session 3: ISO 9001:2000 Standard - Clause 1~3 (General, Ref, Terms & Definitions) - Clause 4 (QMS) - Clause 5 (Management Responsibility) - Clause 6 (Resource Management) - Clause 7 (Product Realization) - Clause 8 (Measurement, Analysis & Improvement)
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ISO & INTERNATIONAL STANDARD FLOW


Scheduled review & up-date present standard Scheduled review & up-date present standard

Session 1: Background & History of ISO


Background ISO
ISO = International Organization for Standardization
Countrys Reps

TC 176

75% Agreed

Countrys Reps

ISO standard

HQ: Geneva, Switzerland


Clients

ISO 9000 Standard developed by Technical Committee 176 (TC 176)


Relevant government authorities/bodies

Members of TC 176: 150 countrys representatives every country s representatives, 5 years periodic review Required minimum 75% committee agreement

ISO Cert. National standard Accreditation Bodies (UKAS, RAB, DSM etc.)

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Companies

Certification 4 Bodies (SIRIM, LRQA, BVQI etc.)

Session 1

Session 1: Background & History of ISO


History of series ISO 9000:
1st edition: 2nd edition: 3rd edition: 4th edition: 1987 1994 2000 2008 (from British Standard) (valid till Nov 2009)

Session 1: Background & History of ISO


iso = equality (Greek) ISO standard responses as a measurement point
Easier international business Basic std to generate/produce product/service

Different people, same method/system practice Same spec

Session 1

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

Session 2: Basic Structure of ISO 9001:2008

Process Model Quality Management System (QMS)

ISO 9001 2008 i a G 9001:2008 is General Std ; can b adapted l be d t d to all kind of industries/businesses & organisations Standard based on Quality Management System (QMS) WHAT to do, not HOW to do concept to fulfill the standard Organisation have to explain how they operates

Session 2:

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

Session 2: Basic Structure of ISO 9001:2008

Process Model Quality Management System (QMS)

Continual Improvement

ISO 9001:2008 elements:

consists

of

simple

approaching
CUSTOMER REQUIR REMENT

Information Flow

Management Responsibility

CUSTOMER SATISFA ACTION

Documentation Management commitment & responsibility Resources management Product / Service realization Measurement, Analysis & improvement l Continual improvement Concept of Process Model

Resource Management

Measurement, Analysis & Improvement

Information Flow

Input Value-Adding Activities

Product Realization

Product

Output

Value-Adding Activities

Session 2

Session 2: Basic Structure of ISO 9001:2008 Process Approach

Session 2: Basic Structure of ISO 9001:2008 Process Approach the Company Business Process Company Tendering Execution Company Project Execution

A process involves use of resources transformation of inputs into outputs No isolated process in the organisation Every processes/ flow inter related inter-related
(Input Action Output)

for

Session 2

Session 3: ISO 9001:2008 Standard


Clause 1~3
Scope Reference R f Terms & Definitions

Session 3: ISO 9001:2008 Standard Clause 4 (QMS) 4.1 General requirements


Organisation shall:
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

Session 3: ISO 9001:2008 Standard Clause 4 (QMS)


4.2 Documentation requirement
Document must ensure process effectiveness Paper/electronic p / Size/complexity; customised to organisation Min required documents: Quality Policy and Quality Objective

Session 3: ISO 9001:2008 Standard Clause 4 (QMS) Basic Structure of Documentation


Quality Manual

Quality Manual = Company Profile (4.2.2) 6 Mandatory Procedures

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

Procedures

Work Instructions

Control of Documents (4 2 3) (4.2.3) 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.
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Support Document

* Refer to Company Quality System Document (QSD)

Session 3

Session 3: ISO 9001:2008 Standard Clause 4 (QMS)


4.2.2 Quality Manual
Company scope of processes/activities. Explanation of documented procedures/reference A description of the interaction between processes (process mapping)

Session 3: ISO 9001:2008 Standard Clause 5 (Management Responsibility) 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)

4.2.3 Control of Documents


Ensure, review, revise, document status Identification, controlled copy

4.2.4 Control of Records


Legible, readily identifiable and retrievable Identification, storage/protection, retention disposition time and

5.2 Customer/ Client focus / l f


Determined customer requirements Aim to achieve customer satisfaction
(7.2.1 & 8.2.1)

Session 3: ISO 9001:2008 Standard Clause 5 (Management Responsibility)


5.3 Quality Policy
Must appropriate to the purpose/target of the organization Provide framework & review of quality objectives Communicated within organization Commitment for continually improve the QMS Company Quality Policy

Session 3: ISO 9001:2008 Standard Clause 5 (Management Responsibility) 5.5 Responsibility, authority and communication
5.5.1 5.5.2 Responsibility & authority Management representative
Responsibilities defined and communicated (Jobs Description) Responsible for implementing/maintaining & reporting the QMS Report on needs of improvement Promote awareness of customer needs

5.4.1 Quality Objectives


Measurable and in line with Quality Policy Use as one of the factors to facilitating continual improvement Company Quality Objective Departmental Quality Objective

5.5.3

Internal communication

Communication between various level (processes & effectiveness of QMS) Organization Chart
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Session 3

Session 3: ISO 9001:2008 Standard Clause 5 (Management Responsibility) 5.6 Management Review
Review input
Reactive (i.e. problem trends) R ti (i bl t d ) Proactive (i.e. opportunities)

Session 3: ISO 9001:2008 Standard Clause 6 (Resource management) 6.1, 6.2 Human resources
Must ensure staff:
Competent C t t Provide training Aware of importance of their activities

Review output
Improvement of QMS, customer requirement Resources needs

Maintained records (Training Procedure)

Record shall be maintained (Management Review Procedure)

6.3 Infrastructure
Must have correct infrastructure to achieve aims
buildings, hardware, software, transportation etc.) ( (i.e.

6.4 Work environment


Must be right environment to achieve conforming product (i.e. Food industry; humidity & temperature etc.)
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Session 3: ISO 9001:2008 Standard Clause 7 (Product Realization)


7.1 Planning of product realization
Determine following, as appropriate:
Q Quality requirement for the products y q p The need to establish project specific process, documents, resources (4M method) Inspection & testing requirement & criteria required Records (Project Planning Procedure)

Session 3: ISO 9001:2008 Standard Clause 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 Design Cont ol Procedure Control P oced e

7.2 Customer-related process


Must be method:
To identify customer requirements To make sure requirements (regulatory/legal) understood and met For communicating with customer For controlling changes to requirements Tendering Planning Procedure
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Session 3

Session 3: ISO 9001:2008 Standard Clause 7 (Product Realization) 7.4 Purchasing


Must ensure that any purchased goods/services are to an acceptable standard & criteria Purchase document & information must be precise Supplier must be evaluated Verification of purchased products Procurement Procedure, Subcontracting Procedure

Session 3: ISO 9001:2008 Standard Clause 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 can be 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


For some processes the resulting output cannot be verified processes, (i.e. proof of good welding). Special process validation required
Review criteria, equipments, competency, procedures, records

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Session 3: ISO 9001:2008 Standard Clause 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

Session 3: ISO 9001:2008 Standard Clause 7 (Product Realization) 7.6 Control of monitoring & measuring equipment ( (Calibration) )
To ensure any device used for accurate measurement is itself accurate Device is routinely checked/calibrated Protected from damage Control of Monitoring & Measuring Devices Procedure

7.5.4 Customer property


Information/data/hardware belong to customer must be looked after ft Control of Client Property Procedure

7.5.5 Preservation of product


Ensure product/service is not damaged
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Session 3

Session 3: ISO 9001:2008 Standard 8.1 General 8.2 Monitoring & measurement
8.2.1 8 2 1 Customer satisfaction 8.2.2 Internal Audit

Clause 8 (Measurement, Analysis & Improvement)

Session 3: ISO 9001:2008 Standard 8.3 Control of nonconforming product

Clause 8 (Measurement, Analysis & Improvement)

Key measures must be defined (survey/project feedback form etc.) QMS is audited to check: Internal Audit Procedure

To ensure faulty product/service is not accidentally used including those detected after delivery Control of Nonconformities Procedure

The system followed, effective? Meets ISO9001 requirement?

8.4 Analysis of Data


Data from Internal Audit, customer complaint, processed, suppliers must be analyzed so as to find ways of i f improving business i b i Analysis of Data Procedure

8.2.3, 8 2 4 M it i 8 2 3 8.2.4 Monitoring & measurement of t f processes/product

To defined that processes/products meet customer requirement? Inspection & Test Plan (ITP) Inspection & Testing Procedure
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Session 3: ISO 9001:2008 Standard


Clause 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

8.5.3 Preventive action


Take action to avoid occurrence of potential nonconformities/problems Corrective & Preventive Action Procedure
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Session 3