Transcript 393SYS - Microsoft Personal Web Server

Quality Management System
and ISO9000 Quality Standard
Kinnison, Chapter 17
July 15
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ISO 9001:2000
Documentation requirements
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning,
operation and control of its processes, and
e) records required by this International Standard (see 4.2.4).
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means
that the procedure is established, documented, implemented and maintained.
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Quality Management System & Quality Manuals
Quality
Manual
Quality
Programme
Corporate manual, Company level Doc.:
State & Define policy & objective
commitment. Organization Interaction
of Process
Departmental proc., Quality Plan:
Say what you do;
Do what you say;
What, Where, When, Who, Why.
Detail of how to do specific task,
work instructions, wall reference
It is a generic approach evolved throughout the years. charts,
It is anforms,
efficientspec
way sheets,
to organize an
…
Quality System and is specified in ISO9001:2000 4.2.1 blueprints,
& 5.3
Procedures/Codes
of Practice
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Quality Policy
The overall quality intentions and direction of an organization
in regard to quality, as formally expressed by top
management.
Quality Policy of CityU –
The university is committed to the pursuit of academic excellence and
service to the community … provide its students with quality higher
education and helping our students become well-rounded professionals
with the analytical, problem-solving and communication skills to meet the
needs and challenges of the workplace and society.
.
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Quality Programme example:
DCO Mission Statement
Vision
Sustained Excellence in Information Technology Education
Mission

Produce competent and responsible graduates for the socialeconomic development of Hong Kong.
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Maintain close links with IT sectors for the exchange of ideas and
transfer of technology.

Keep on top of current technological developments for the benefits
of our students and society.
Strategy
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Maintain an up-to-date curriculum supporting a variety of
disciplinary and interdisciplinary programmes at the Associate
Degree level based on societal needs, and articulation with degree
programmes; …
http://www.cityu.edu.hk/cityu/dpt-acad/col-dco.htm
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Quality procedure example:
DCO20402 Course Aims & Objectives:
… to study processes that discipline quality into software development and
provide students with the basis for managing quality in software products. It
also enables students to plan and implement software quality assurance as a
systematic pattern of actions in the software life cycle. The principles
underlying software reliability will also be introduced. On completion of this
course, students should be able to understand the need for quality assurance
in software projects; apply various metrics to measure the quality of software
process and software product; develop quality plans, conduct quality audit
and justify the need for quality assurance; and appreciate the reliability
aspect of software systems.
Note: Most procedures on a factory production line is much more
simple.
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Top-level Quality Dcmts- Company level
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2nd-level Quality Dcts- Departmental proc.,
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3rd level Quality Docts – Work
instr.
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3rd level Quality Docts –
quality records
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THE PURPOSE OF ISO 9000
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Sets out how companies can establish, document and
maintain an effective quality system
To show customers you are committed to quality
An international standard
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ISO 9000 applies to all types of organizations.
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It doesn't matter what size they are or what they do. It
can help both product and service oriented
organizations achieve standards of quality that are
recognized and respected throughout the world.
ISO does it by specify only the ‘Whats’ but not the
‘Hows’
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The ‘What’ and the ‘How’
The ‘Whats’ in
ISO9001:2000-c7.5.5 Preservation of
product: The organization shall
preserve the conformity of product
during internal processing and
delivery to the intended destination.
This preservation shall include
identification, handling, packaging,
storage and protection. Preservation
shall also apply to the constituent
parts of a product.
The ‘Hows’ in Organization:
Chickens travel to the market in stacked,
tightly packed crates. Dirt and
contamination can spread.
Temperature fluctuation and delays
during transport may cause problems…
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How does the shipper avoid the spread
of dirt and contamination during
shipment?
How does the chicken truck assure that
temperature limit do not exceed?
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Why ISO 9001Quality Management System (QMS)
ref.: ISO 9001 clause 4
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A system is a set of interrelated, mutually supporting,
and synergistic programs and activities. Synergistic
means the whole exceeds the sum of its parts.
Quality Management is not traditional quality control,
in which inspectors sort the good products from the
bad ones at the end of the assembly line. Quality
Management means planning and running a
manufacturing or service operation so it doesn’t make
bad products or deliver poor services. Its focus is on
preventing defects instead of fixing them. It also look
for ways to make the work easier and less expensive,
which increases profitability.
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ISO 9001:2000 Process approach
EFFECTIVENESS
OF PROCESS =
Ability to achieve
desired results
Input
Requirements Specified
(Includes resources)
Interrelated or interacting
activities and control
methods
Output
Requirements Satisfied
(Result of a process)
Monitoring and Measuring

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EFFICIENCY OF
PROCESS =
Results achieved
vs. resources used
A “Process” can be defined as a “Set of interrelated or interacting activities, which
transforms inputs into outputs”. These activities require allocation of resources such
as people and materials.
A process approach is a powerful way of organizing and managing how work
activities create value for the customer and other interested parties.
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ISO 9001:2000 Process approach
ref. ISO/TC 176/SC 2/N 544R2(r)
ISO 9001 0.2 Process approach
This International Standard promotes the adoption of a process
approach when developing, implementing and improving the
effectiveness of a quality management system, to enhance
customer satisfaction by meeting customer requirements.
A major advantage of the process approach, when compared
to other approaches, is in the management and control of
the interactions between these processes and the
interfaces between the functional hierarchy of the
organization
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ISO 9001:2000 Process approach
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Organizations are often structured vertically into a hierarchy of functional units. with
responsibility for the intended outputs being divided. The end customer or other
interested party is not always visible to all involved. Consequently, problems that occur
at the interface boundaries are often given less priority than the short-term goals of the
units. This leads to little or no improvement to the interested party, as actions are
usually focused on the functions, rather than overall benefit to the organization.
The process approach introduces horizontal management between different functional
units and unifying their focus to the main goals of the organization.
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Example of Process linkages across departments in an organization.
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The outputs from one process may be inputs to other processes and interlinked into the overall
network or system.
Note: The consistent operation of this network is often referred to as the "system approach" to
management.
Outputs from
other processes
Inputs
to A
PROCESS A
Inputs to B
Outputs
from A
Outputs from
other processes
PROCESS B
Outputs
from B
Inputs to D
Outputs
from D
PROCESS D
Outputs
from C
Inputs to C
PROCESS C
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Example of a process sequence and its interactions
Management Processes
O
Process Design
I
O
I
I
Production
Product Design
I
I
O
I
O
I
O
O
O
Project Planning
O
Measurement, Analysis, and Improvement
I
Resource Processes
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ISO 9001: 0.2 Process approach
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Corrective action and improvement
of the process (PDCA)
Act
Plan
•How to improve
next time?
•What to do?
•How to do it?
Check
Do
• Did things happen
according to plan?
•Do what was
planned
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In addition, the methodology known
as “Plan-Do-Check-Act” (PDCA)
can be applied to all processes.
PDCA can be briefly described as
follows.
1.
Plan: establish the objectives and
processes necessary to deliver
results in accordance with
customer requirements and the
organization's policies.
2.
Do: implement the processes.
3.
Check: monitor and measure
processes and product against
policies, objectives and
requirements for the product and
report the results.
4.
Act: take actions to continually
improve process performance.
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Entities on ISO9001: 1994 vs. 2000
ref.: c 3
subcontractor
Supplier
Contract
Purchaser
Customer
Supplier
Organization:
Product / Service
shall do,
should do,
May do …
Supply Chain
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ISO 9000 language of Standards
ref.: ISO 9000 Introduction and Support Package:
Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000
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“shall” or “ shall not” is used to express a provision that is binding
between two or more parties, means ‘it is necessary’, ‘ it is required
to’
“should” or “should not” express a recommendation among several
possibilities without mentioning or excluding others.
“may” or “need not” indicate a course of action permissible within the
limits of ISO 9001
“can” or “cannot” refers to the ability of the user of the standard.
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