Pengenalan Kepada ISO 9001:2000

(Sistem Pengurusan Berkualiti)

Introduction to
ISO 9001:2000
(Quality Mgmt Syst)

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 Kandungan(Contents)

1. Takrifan (Definition)
2. Pelarasan ISO9001:2000 (ISO9001:2000
Standard)

3. Sistem Dokumentasi (Documentation System)

4. Syarat2 ISO 9001 (ISO 9001 Requirements)
5. Proses Audit (Audit Process)

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 1. TAKRIFAN

1. DEFINITION

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 Takrif (Term)

Kualiti (Quality)
Syarat (Requirement)
Kebolehan (Capability)
Kepuasan Palanggan (Customer Satisfaction)

Sistem (System)
Proses (Process)
Keputusan (Result)
Prosidur (Procedure)

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 Takrif diDlm Pengurusan Kualiti
(Quality Management Terms)

Pengurus Atasan (Top management)

Polisi Kualiti (Quality Policy)
Kualiti Objektif (Quality Objective)
Sistem Pengurusan Berkualiti (QMS) (Quality
Mgmt System)
Pelan Kualiti (Quality Plan)
Kawalan Kualiti (Quality Control)
Jaminan Kualiti (Quality Assurance)

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 Takrifan Memenuhi Syarat
(Confirmity Terms)

Penuhi Syarat (Conformity)

Tak Penuhi Syarat (Non-Conformity)
Pembetulan (Correction)
Langkah Pembetulan (Corrective Action)
Langkah Pencegahan (Preventive Action)

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 Dokumen2 diDalam Siri ISO 9000
(Documents comprise the ISO 9000 Series)

ISO 9001- Syarat2 QMS (ISO 9001-Requirements)

ISO 9004- Peningkatan Prestasi (Guidance for
Performance Improvement)

ISO 9011- Audit Sistem Pengurusan (Guidelines

for Auditing Mgmt. Syst.)

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 2. PELARASAN ISO 9001:2000

2. ISO 9001:2000
STANDARD

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 ISO- Organisasi Pelarasan
Antarabangsa
(International Organization for Standardization)

Organisasi bkn kerajaan bertujuan utk

memperkenalkan pelarasan
antarabangsa. (Non-government organization
establishen to promote the dev. of standardization and related
activities worlwide)

Bermula pada1947. (Began on 1947)

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 ISO 9001:2008

Pelarasan Antarabangsa yg mengandungi

syarat2 untuk menghasilkan dan
mengekalkan Sistem Pengurusan Berkualiti
(requirements for quality assurance)

Fokus kepada proses penghasilan produk

(Focus on controlling the process)

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 4 Bahagian Sistem Pengurusan Kualiti
(Quality Management System)

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 Proses
(Process)

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 8 Prinsip Pengurusan Berkualiti
(8 Quality Mgmt Syst)

Keutamaan Pelanggan ( Customer focused organization)

Kepimpinan ( Leadership)
Penglibatan Semua (Involvement of People)
Pendekatan Proses (Process Approached)
Pendekatan Sistem Kpd Pengurusan (Syst approach to
mgmt)
Penambahbaikan Berterusan (Continual Improvement)
Pendekatan Fakta utk Membuat keputusan (Factual
Approached to decision making)
Sama Untung (mutually beneficial)

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 Penambahbaikan Berterusan PDCA
(Continual Improvement)

A P

C D
Sistem
Pengurusan Berkualiti Berterusan
(Continuous)
(Quality Mgmt Syst)

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15
 Ape Itu Berdaftar? (What Does Register
mean?)

Pendaftar berkelayakan telah

mengesahkan secara bertulis sykt
tersebut mematuhi segala syarat didlm
ISO 9001 (registrar has audited their quality system &
certified that it meet ISO 9001 requirements)

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 Kenapa RWNA Nak Berdaftar?
(Why RWNA Want to Register?)

Kehendak pelanggan (Cient demand)

Kelebihan berbanding pesaing (Competitive advantage in marketing)
Imej Sykt yg berkualiti(Quality Image)
Menjalankan kerja dengan lebih baik- kurang produk yg cacat
(Better performance)
Kualiti produk yang lebih baik (Better quality)
Kepuasan pelanggan & penambahbaikan berterusan (Client
satisfaction & continual improvement)
Komunikasi dalaman yg lebih baik (Better company-wide comm.)
Kurangkan Kos (Quality Mgmt Syst)

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 3. SISTEM DOKUMENTASI

3. DOCUMENTATION
SYSTEM

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 Peringkat Dokumen
(Levels of Documentation)

Manual

Procedures

Work Instruction

Records

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 Common Document Format

Policy/QualityManual/Quality Plan- document

specifying the quality mgmt system with policy and
objectives information
Documented rocedures/Diagram/Flowchart/Position
Description- control documents with specified ways
to perform activities, including instruction, diagrams,
software applications, and position description.

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 Common Document Format

External documents- instruction guidelines,

standards, specifications, legislation,
statutory requirements
Forms/software- format for gathering and
controlling information, results or evidence.
Records- documents showing results
achieved or evidence of activities performed.

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 6 Prosidur Wajib
(6 Mandatory Procedure)

4.2.3 Pengawalan Dokumen (Control of

Documents)
4.2.4 Pengawalan Rekod (Control of Records)
8.2.2 Audit Dalaman (Internal Audit)
8.3 Pengawalan Produk tak Menepati Syarat
(Control of Non-conforming Product)
8.5.2 Langkah Pembetulan (Corrective Action)
8.5.3 Langkah Pencegahan (Preventive Action)
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 4. SYARAT2 ISO 9001:2000

4. THE
REQUIREMENTS OF
ISO 9001:2000

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 Struktur ISO 9001
(Structure of ISO 9001)

No. 4. Sistem Pengurusan Berkualiti (Quality

Mgmt Syst)
No. 5. Tanggungjawab Pihak Pengurusan
(Mgmt Responsibility)
No. 6. Pengurusan Pekerja (Resource Mgmt)
No. 7. Kesedaran Produk (Product Realization)
No. 8. Pemeriksaan, Analisis &
Penambahbaikan (Measurement, analysis, and
improvement)

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 4.1 General Requirements

A quality system needs to be established, documented,

implemented, maintained, and its effectiveness continually
improved. To do this means.
Identifying the process needed for the QMS.
Determining the sequence and interaction of these
processes.
Determining criteria and methods required to ensure that
both operation and control of these processes is effective.
Ensuring the availability of resources and info necessary to
support the operation and monitoring of these processes.
Monitoring, measuring , and analysing these processes.
Implementing actions necessary to achieve planned results
25 and continual improvement.
 4.2 Documentation Requirements
4.2.1 general

Policy and objectives, a quality manual, and

certain mandatory documented procedures
and records are required. Additional
documentation is required to ensure effective
planning operation and control processes.

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 4.2.2 Quality Manual

A quality manual that includes: scope of

QMS, exclusion, documented procedures or
a cross-reference to them and a description
of the interaction between the processes
needs to be established and maintained.

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 4.2.3 Control of Documents

Documentation and data including external

documents must be kept current and
available to ensure everyone is working off
the latest versions. A documented procedure
is required to define the controls needed
such as approval, review, update,
identification of changes, legibility,
identification, distribution and removal.

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4.2.4 Control of Record

Records are required to be established and

maintained in an appropriate environment to
provide evidence of conformity to
requirements and demonstrate effectiveness
of the QMS. A documented procedure is
required to define the controls needed
including retention times, legibility,
identification, and retrievability.
Management Responsibility
5.1 Management Commitment

Commitment to development, and

implementation of the QMS and to
continually improving its effectiveness needs
to be demonstrated by Top Management
through communication, establishing policy,
conducting management reviews and
ensuring the availability of resources.
5.2 Customer Focus

Customers needs and expectations need to

be determined and met the aim of enhancing
customer satisfaction.
5.3 Quality Policy

A policy must be established that is appropriate to

the purpose of the organization and includes a
commitment to meeting requirement and to continual
improvement in effectiveness. It must provide a
framework for establishing and reviewing quality
objectives, be communicated and understood within
the organization and it needs to be reviewed for
continuing suitability.
5.4 Planning
5.4.1 Quality Objectives

Measurable quality objectives consistent with

policy need to be for relevant functions and
levels of the organization.
5.4.2 Quality Management System
Planning

Management needs to take responsibility for

planning in order to define the processes
needed to effectively and efficiently meet
objectives and requirements, and to ensure
the integrity of the systems is maintained
when changes to the QMS are planned and
implemented.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority

Responsibilities and authorities need to be

defined and communicated within the
organization.
5.5.2 Management Representative

A representative needs to be appointed to

ensure that the processes needed for the
QMS are established, implemented,
maintained, reported and the awareness of
customer requirements are promoted.
5.5.3 Internal Communication

Channels for internal communications need

to be established within the organization and
communication regarding QMS processes
and effectiveness needs to take place.
Management Responsibility
5.6 Management Review
5.6.1 General

Top management needs to review the QMS

at planned intervals to ensure its continuing
adequacy and effectiveness.
5.6.2 Review Input

Inputs into the review need to include

information on audits, customer, feedback,
process performance, product conformity,
preventive and corrective action status,
follow-up, effect of changes and
recommendations for improvement.
5.6.3 Review Output

Review output needs to include decisions

and actions related to improvement of the
effectiveness of the QMS and its processes
and products and services related to
customer requirements.
Resource Management
6.1 Provision of Resources

Resources needed to implement and

improve the quality management system and
to enhance customer satisfaction need to be
determined and provided.
6.2 Human Resources
6.2.1 General

Any personnel performing work affecting

product service requirements need to be
competent.
6.2.2 competence, Awareness and Training

The necessary competence for personnel

performing work affecting quality must be
determined. Training or other actions must
be provided and the effectiveness of such
training or actions evaluated. Employees
need to be aware of the relevance and
importance of their roles and activities and
records of education, training, skills and
experience need to be retained.
6.3 Infrastructure

Infrastructure needed to achieve conforming

product/service must be determined,
provided and maintained. This includes as
applicable: buildings, workspace, utilities,
process equipment (hardware/software) and
supporting service
(transport/communication).
Resource Management
6.4 Work Environment

The work environment ( human and physical

factors) needed to achieve conforming
product or service must be determined and
managed.
Product Realization
7.1 Planning of Realization Processes

Processes needed for product realization (

core activities, products or services) need to
be planned and developed. This is includes
objectives, processes, documentations,
resources, facilities, verification, validation,
monitoring activities, inspection and testing,
and the records required to provide evidence
of outcome.
Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirement
Related to The Product

Customer and other stakeholder

requirements whether stated or inherent
need to be determined. Structures and
processes need to be established to do this.
7.2.2 Review of Requirements Related
to The Product

Before commitment to supply a product or service to

a customer, organizations need to review their
capability and capacity to do so. Records of actions
arising from the review need to be maintained and
updated with the changes variations between
previously expressed and contract requirement need
to be resolved. Where the customer provides no
documented statement of requirement, the customer
requirement shall be confirmed by the organization
before acceptance.
7.2.3 Customer Communication

Effective arrangements for communicating

with customers in relation to product
information, enquiries order, amendments,
customer feedback and complaints need to
be established.
Product Realization
7.3 Design and Development
7.3.1 Design and Development Planning

Organizations involved in design need to

establish processes and organizational
structures for undertaking design and need
to be capable of undertaking all aspect of
design including identifying risks, life-cycles,
usability. Dependability durability,
environment and disposal.
7.3.2 Design and Developments Inputs

Process need to be established to determine

customer and other stakeholder
requirements whether stated or inherent.
This includes functional and performance
requirements, applicable statutory, and
regulatory requirements, information derived
from previous similar designs, and other
requirements essential for design and
development.
7.3.3 Design and Development
Outputs( paperwork)

Design outputs need to be in a form that

enables verification against input
requirement and designs need to be
approved before they released.
7.3.4 Design and Development Review

At suitable stages, systematic design and

development reviews need ti be undertaken
to identify their ability to meet requirements
and to identify any problems and necessary
resulting actions.
7.3.5 Design and Development
Verification

Verification is required of design and

development outputs to ensure that design
will meet all the input requirements,
7.3.6 Design and Development
Validation ( product/service)

Validation is required to ensure that the

resulting product/service is capable of
meeting requirements for specified
application or intended use.
7.3.7 Control of Design and/or
Development Changes.

Design and development changes need to

be identified and records maintained.
Changes need to be reviewed and records of
the results and any necessary actions
maintained.
 7.4.3 Design Review

User 7.3.2 Design 7.3.3 Product

Needs Design Design Service
Input Output

7.3.5 Verification

7.3.6 Validation
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Product Realization
7.4 Purchasing
7.4.1 Purchasing Control

Criteria for selection, evaluation and re-

evaluation of suppliers based on their ability
to support product in accordance with the
organizations requirements need to be
established.
7.4.2 Purchasing Information

Purchasing documentation needs to

adequately describe the product/service to
be purchased, including where appropriate:
requirements for approval, requirements for
qualification of personnel and quality system
requirements.
7.4.3 Verification of Purchased
Products

Inspection or other activities necessary for

ensuring that purchased products or services
meets specified purchase requirements need
to be established and implemented, this may
include verification at suppliers premises.
Product Realization
7.5 Product and Service Provision
7.5.1 Control of Production and service
Provision

Production and service activities need to be

controlled. This includes management and
supervision activities and as applicable; the
availability of information, procedures, work
instructions, suitable equipment, the use of
monitoring and measuring devices,
monitoring, measurement and release, as
well as delivery and post-delivery activities.
7.5.2 Validation of Processes for
Production and Service Provision

Any unusual production or service provision

processes where the resulting output cannot
be verified by subsequent monitoring or
measurement need appropriate validation.
This includes processes where deficiencies
become apparent only after the product is in
use or the service has been delivered.
7.5.3 Identification and Traceability

Products and services need to be

appropriate identified by suitable means
throughout product realization. This includes
the project status with respect to monitoring
and measurement requirements. Where
traceability is a requirement, unique
identification shall be controlled and
recorded.
7.5.4 Customer Property

Customer property while it is under

organizations control or being used by the
organization needs to be looked after. If any
customer property is lost, damaged or
otherwise found to be unsuitable for use, this
shall be reported to the customer and
records maintained.
7.5.5 Preservative of Product

The conformity of product/service and their

constituent parts need to be preserved
during internal processing and during
delivery to the intended destination. This
includes identification, handling, packaging,
storage and protection.
7.6 Control of Monitoring and
Measuring Devices

Monitoring and measuring devices needed to

provide evidence of conformity of product to
determined requirements need to be
calibrated at specified intervals to
appropriate tolerances. Calibrations must be
traceable to international or national
measurement standard unless no such
standards exist and the equipment also
needs to be safeguarded and protected.
8 Measurement, Analysis and
Improvement
8.1 General

Monitoring, measurement, analysis and

improvement processes need to be planned
and implemented to ensure product/service
or system conformity and improvement. This
shall include, where applicable, the need for
statistical techniques.
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction

Customer satisfaction measures and

methods need to be established to determine
customer perceptions as to whether the
organization has fulfilled their requirements.
8.2.2 Internal Audit

An internal audit programme needs to be

determine whether the quality management
system is effectively implemented and
maintained.
8.2.3 Monitoring and Measurement
of Processes

Methods for monitoring and where applicable

measuring management system processes
need to be established. These methods need
to demonstrate the ability of the processes to
achieve planned results. When planned
results are not achieve, correction and as
appropriate corrective shall be taken to
ensure conformity of the product.
8.2.4 Monitoring and Measurement
of Product

Monitoring and measurement needs to be carried

out at appropriate stages of the product realization (
core activity) process to verify that product/service
requirements have been met. Evidence of conformity
to acceptance criteria and records of persons
authorizing product/service release are required.
Release should not proceed until all planned
arrangements are satisfactory completed or
otherwise approved b a relevant authority.
8.3 Control of Nonconforming Product

Product that does not confirm to product

requirements needs to be identified and controlled to
prevent its unintended use or delivery. Options
include eliminating the defected non-conformity,
authorizing its use, release, or acceptance under
concession, or precluding its use for original
intended use or application. The controls and related
responsibilities and authorities for dealing for dealing
with nonconforming product shall be defined in a
documented procedure.
Measurement Analysis and
Improvement
8.4 Analysis of Data

Decision need to be on facts. Organizations need to

collect and analyze appropriate data to demonstrate
the suitability and effectiveness of the quality
management system, and to evaluate where
continual improvement can be made. Customer
satisfaction, product conformity, characteristics and
trends of processes/products and suppliers are all
appropriate area to review data.
8.5 Improvement
8.5.1 Continual Improvement

Processes and structures need to be

established to continually improve the
effectiveness of the quality management
system through the use of the quality policy,
quality objectives, audit results, analysis of
data, corrective and preventive actions and
management review.
8.5.2 Corrective Action

Corrective actions appropriate to the effects of

nonconformities encountered need to be taken to
eliminate their cause and to prevent recurrence. A
documented procedure needs to be established to
define requirements for: reviewing nonconformities (
including customer complaints), determining the
causes of nonconformities, evaluating the need for
action to ensure that nonconformities do not recur,
determining and implementing action needed, and
recording the results of action taken.
8.5.3 Preventive Action

Processes and structures need to be established to

eliminate the causes of potential nonconformities in
order to prevent their occurrence. Preventive actions
should be appropriate to the effects or risks of the
potential problems. A documented procedure needs
to be established to define: requirements for:
determining potential nonconformities and their
causes, evaluation of the need for action to prevent
occurrence of nonconformities, determining and
implementing action needed, records of results of
action taken and reviewing preventive action taken.
 5. PROSES AUDIT

5. AUDIT PROCESS

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 Jenis2 Audit (Audit Types)

Pihak pertama (First Party)

Pihak kedua (Second Party)
Pihak ketiga (Third Party)
Persijilan (Certification)
Penyiasatan (Surveillance)

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 Apakah Tujuan Audit?
(Whats the Purpose of Audit?)

ISO 9001 mensyaratkan 2 jenis audit (ISO 9001

requires your company go through 2 types of audit)
Audit dalaman (Internal Audit)
Audit oleh pihak ketiga (Third party audit)
Memastikan RWNA sudah mempunyai &
mengamalkan (Determine whether RWNA has developed and
implement QMS thats)
Memenuhi syarat ISO 9001 (Meets the req. Of ISO 9001)
Efektif dlm menghasilkan produk yang berkualiti
(Effective in providing quality product)

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 Apa yg Auditor Cari?
(Whats the Auditor Looking For?)

Bukti sistem (dokumentasi) RWNA memenuhi syarat

ISO 9001 (Evidence that the system (as documented) meets the
requirements stated in ISO 9001.)
Bukti semua pekerja faham dokumentasi yg
berkaitannya (Evidence that all employees understand the
documentation that affects them)
Bukti aktiviti kerja mengikut prosidur (Evidence that the
system (as implemented) works according to planned arrangements (such as
the instructions stated in your quality management system documentation or in
agreements with customers)
Bukti sistem adalah berkesan menhasilkan produk
berkualiti (Evidence that the system is effective in providing quality
products)

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