PELATIHAN

DESIGN, INTERPRETASI &

IMPLEMENTASI
Bagian :
SISTEM DOKUMENTASI
SISTEM MANAJEMEN MUTU - ISO 9001:2000

WHY WE NEED DOCUMENTATION?

REQUIREMENTS OF ISO 9000:2000

ISO 9001 Clause 4.1:

The organization shall establish, document,
implement and maintain a quality
management system .

ISO 9001 clause 4.2.1:

The quality management system
documentation shall include: ...

VALUE OF DOCUMENTATION
Document use contributes to:

Achievement of conformity to customer

requirements and quality improvement

Provision of appropriate training

Repeatibility and traceability

Provision of objective evidence

Evaluation of the effectiveness and continuing

suitability of the quality management system

DOCUMENT
DOCUMENT
INFORMATION AND ITS SUPPORTING
MEDIUM

FROM:______________________________________
_____________
COMPANY:___________________________________
____________
TEL:________________________________________
_____________DATE:_____________TIME:_________
_______________________

INFORMATION
MEANINGFUL DATA

The documentation medium can be:

1. Electronic or optical
computer disc

2. Magnetic

3.Paper

6. Combination there of
5. Photograph

4. Master sample

DOCUMENTATION SHALL INCLUDE:

Quality Policy & Objectives

Quality Manual
Documented Procedures required by standards
Documents required by organization to ensure the
effective planning, operation and control of its
process
Record

THE EXTENT OF DOCUMENTATION

THE EXTENT OF THE QUALITY MANAGEMENT SYSTEM DOCUMENTATION

CAN DIFFER FROM ONE ORGANIZATION TO ANOTHER

Its depends on:

The size of organization and type of activities
The complexity of their processes and their
interactions, and
The competence of personnel

QUALITY POLICY AND OBJECTIVES

Requirements for quality policy are defined in

clause 5.3 of ISO 9001:2000
Requirements for quality objectives are defined
in clause 5.4.1 of ISO 9001:2000
Quality policy and objectives must be controlled
according to requirements of clause 4.2.3

QUALITY MANUAL

ISO 9000 : 2000

DOCUMENT SPECIFYING THE QUALITY
MANAGEMENT SYSTEM OF AN
ORGANIZATION

THE CONTENT OF QUALITY MANUAL:

The scope of Quality Management System,

including details of and justification for any
exclusions

The documented procedures established for

the quality management system, or reference
to them and

A description of the interaction between the

processes of quality management system

FORMAT OF THE QUALITY MANUAL

A small organization may find it appropriate

to include the description of entire QMS
within a single manual, including all the
documented procedures required by the
standard
Large, multi-national company may need
several manuals at the global, national or
regional level, and more complex hierarchy
of documentation

SUGESTED FORMAT FOR QUALITY MANUAL

1. DOCUMENT TITLE
2. DATE OF REVISION/No. Rev.
3. DOCUMENT NUMBER
4. SIGNATORY

Prepared by Reviewed by Approved by

SUGESTED FORMAT FOR QUALITY MANUAL

5. CONTENT
6. SCOPE & PERMISSIBLE EXCLUSIONS
7. COMPANY PROFILE, QUALITY POLICY &
OBJECTIVES
8. ORGANIZATION CHART
9. DESCRIPTION OF INTER-RELATION BETWEEN
PROCESSES INCLUDED IN THE QMS OR
PROCESS MAPPING

SUGESTED FORMAT FOR QUALITY MANUAL

10. REFERENCE TO PROCEDURE OR QUALITY

PLAN
11. REFERENCE TO OTHER RELATED PROCESS
12. OVERVIEW OF ORGANIZATIONS QMS
ACCORDING TO ISO 9001:2000

13. REFERENCE TABLE

Microsoft Word
Document

DOCUMENTED PROCEDURE

DOCUMENT THAT SPECIFYING WAY

TO CARRY OUT AN ACTIVITY OR A
PROCESS

DOCUMENTED PROCEDURE

ISO 9001:2000 SPECIFICALLY REQUIRES THE

ORGANIZATION TO HAVE DOCUMENTED
PROCEDURES FOR THE FOLLOWING
ACTIVITIES:

4.2.3
4.2.4
8.2.2
8.5.2
8.5.2
8.5.3

CONTROL OF DOCUMENTS
CONTROL OF QUALITY RECORDS
INTERNAL AUDIT
CONTROL OF NONCONFORMITY
CORRECTIVE ACTION
PREVENTIVE ACTION

Microsoft Word
Document

DOCUMENTED PROCEDURES

SOME ORGANIZATIONS MAY REQUIRE

ADDITIONAL DOCUMENTED PROCEDURES
IN ORDER TO IMPLEMENT AN EFFECTIVE
QMS

Microsoft Word
Document

OTHERS DOCUMENT
IN ORDER FOR AN ORGANIZATION TO
DEMONSTRATE THE EFFECTIVE
IMPLEMENTATION OF ITS QMS, IT MAY BE
NECESSARY TO DEVELOP DOCUMENTS
OTHER THAN DOCUMENTED PROCEDURES

THERE ARE SEVERAL REQUIREMENT OF ISO 9001:2000

WHERE ORGANIZATION COULD ADD VALUE TO ITS
QMS AND DEMONSTRATE CONFORMITY BY PREPARATION
OF OTHER DOCUMENTS

OTHERS DOCUMENT

EXAMPLES MAY INCLUDE:

PROCESS MAPS
ORGANIZATION CHARTS
INTERNAL COMMUNICATIONS
PRODUCTION SCHEDULES
APPROVED SUPPLIER LISTS
QUALITY PLAN S
SPECIFICATIONS
GUIDELINES

QUALITY PLANNING

PART OF QUALITY MANAGEMENT

FOCUSED ON SETTING QUALITY
OBJECTIVES AND SPECIFYING NECESSARY
OPERATIONAL PROCESSES AND RELATED
RESOURCES TO FULFIL
THE QUALITY OBJECTIVES

QUALITY PLAN

DOCUMENT SPECIFYING AND ASSOCIATEDRESOURCES

SHALL BE APPLIEDBY WHOM AND WHEN TO A SPESIFIC
PROJECT, PRODUCT, PROCESS OR CONTRACT
ISO 9000:2000, 3.7.2

A QUALITY PLAN OFTEN MAKES REFERENCE TO CHARTS OF

THE QUALITY MANUAL OR TO PROCEDURE DOCUMENTS

TYPE OF QUALITY PLAN

1.

2.

Long term Quality Plan : Describe long term strategy

Specific Quality Plan

New product
DESIGN PLAN

3.

New service
SERVICE QUALITY
PLAN

Operational Quality Plan

New contract
Contractual Quality
Plan

LONG TERM QUALITY PLAN

EXAMPLE OF A LONG TERM STRATEGIC PLAN

1996 Budgets by dept
This years critical
success factors
5 years goals

Vision statement
1996 Business Plan
Company XXX
pg 1

pg.4
pg.3

pg.2

pg. 5-10

STEPS TO DEVELOP LONG TERM QUALITY PLAN

SCAN EXTERNAL
ENVIRONMENTAL

DISCOVER BUSINESS
MISSION GOALS
STRATEGIES

SCAN INTERNAL
ENVIRONMENTAL

IDENTIFY
OPPORTUNITIES
THREATS

DECIDE OBJECTIVES
LONGTERM QP

IDENTIFY
STRENGTHS
WEAKNESSES

SPESIFIC QUALITY PLAN

ENSURE SPECIFIC QUALITY REQUIREMENTS ARE:

PROPERLY PLANNED
CLEARLY DEFINED
AGREED BY BOTH PARTIES
COMMUNICATED TO ALL CONCERNED

SPESIFIC QUALITY PLAN

I. SERVICE QUALITY PLAN
Minimum content:
Service specification (what required)
Delivery specification (how achieved, what
method)
Constraints (company aims, policy, costs)
Control specification (measures, feedback)
Design review including risk analysis
Responsibilities
Change control

SERVICE QUALITY PLAN contd...

SERVICE SPECIFICATION
Example : New carpet cleaning service being offered

Customer Need

Standard of
acceptability

Company
constraints

Quick service

Within one
week

Three trained
cleaners, three
machines

Guarantees

Fully insured

Rp.50m cover

SERVICE QUALITY PLAN contd...

CONTROL SPECIFICATION
For each critical customer need
Example of cleaning business:

Key activity = 1 week response

Key constraint = number machines

Key measure = maintenance checks

Back-up plan = contact where extra

machines can be rented

SPESIFIC QUALITY PLAN

II. DESIGN PLAN
Minimum content
Service quality plan (previous page) plus:

Standardization, use as a policy at QP

Reliability, probability of failure over specified
length of time, can use FMEA, Taguchi
Safety of employees during manufacturing
Maintenance
Value Engineering (design review)
Trials
Transfer to production, suppliers

SPESIFIC QUALITY PLAN

III. CONTRACTUAL QUALITY PLAN
Minimum content:

Introduction - project description, issue

control, ammendment approval, distribution
Related documents
Project organisation and responsibilities
Quality control procedures
Quality milestones
Critical or unusual features
Document management - change control

SPESIFIC QUALITY PLAN

CONTRACTUAL QUALITY PLAN contd...

Procured items
Installation and service
Transfer to production
Security

OPERATIONAL QUALITY PLAN

Quality plan that use for the routine

operational
in organization to produce product
Minimum content:

Process (can be describe by flowchart or

word)
Reference document
Responsible person, including
competence required
Process parameter

Product specification (if required)

OPERATIONAL QUALITY PLAN

Usually begin with the order receiving

and finish at product delivery or after
sales (if it is required by the customer)

OTHERS DOCUMENT

SPECIFICATIONS:
DOCUMENTS STATING REQUIREMENTS

GUIDELINES:
DOCUMENTS STATING RECOMMENDATIONS

RECORDS

DOCUMENT STATING RESULTS ACHIEVED

OR PROVIDING EVIDENCE OF
ACTIVITIES PERFORMED

RECORDS

Organizations are free to develop records that

may be needed to demonstrate conformity of
their processes, products and Quality
Management System
Quality records must be controlled according to
clause 4.2.4 ISO 9001:2000

RECORDS

Examples of Records specifically required by

ISO 9001:2000 are presented in next page.
Organizations are free to develop other records
that may be needed to demonstrate conformity
of their processes, products and Quality
Management System
Records must be controlled according to clause
4.2.4 ISO 9001:2000

ANNEX 1:RECORDS REQUIRED BY ISO 9001:2000

Clause 5.6.1 : Management Review

Clause 6.2.2.e : Education, training, skills and experience
Clause 7.1.d : Evidence that the realization processes and
resulting product fulfill requirements
Clause 7.2.2 : Result of the review of requirements relating to
the product and actions arising from the review
Clause 7.3.2 : Design and development inputs
Clause 7.3.4 : Results of design and development reviews and
any necessary actions
Clause 7.3.5 : Results of design and development reviews and any
necessary actions
Clause7.3.6 : Results of design and development validation and
any necessary actions
Clause 7.3.7 : Results of the review of design and development
changes and any necessary actions

RECORDS REQUIRED BY ISO 9001:2000

Clause 7.4.1
arising

: Results of supplier evaluations and actions

from the evaluations

Clause 7.5.2.d : As required by the organization to demonstrate
the validation of processes where the resulting
output cannot be verified by subsequent
monitoring or measurement
Clause 7.5.3
: The unique identification of the product, where
traceability is a requirement
Clause 7.5.4 : Customer property that is lost, damaged or
otherwise found to be unsuitable for use
Clause 7.6 a : Standards used for calibration and verification of
measuring equipment where no international or
national measurement standard exist
Clause 7.6
: Validity previous results when measuring
equipment is found not to conform with its
requirements
Clause 7.6
: Results of calibration and verification of
measuring

RECORDS REQUIRED BY ISO 9001:2000

Clause 8.2.2
Clause 8.2.4
Clause 8.3
Clause 8.5.2
Clause 8.5.3

: Internal audit results

: Evidence of product conformity with the acceptance
criteria and indication of the authority responsible for
the release of the product
: Nature of the product nonconformities and any
subsequent action taken, including concessions
obtained
: Results of corrective action
: Results of preventive action