Tài liệu ISO 9000 _ AN INTRODUCTION ppt

ISO 9001 contains requirements and is often used for certification purposes while ISO 9004 presents a set of guidelines and is used to develop quality management systems that go beyon

ISO 9000

AN INTRODUCTION

I S O 9 0 0 0 is rapidly becoming the most important quality management standard in the world Thousands of companies in over 100 countries have already adopted it, and many more are

in the process of doing so Why? Because it controls quality

It saves money Customers expect it And competitors use it ISO 9000 applies to all types of organizations 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.

I S O is the International Organization for Standardization.

It is located in Switzerland and was established in 1947 to develop common international standards in many areas Its members come from over 150 national standards bodies

What is ISO 9000?

The term ISO 9000 unfortunately has two different meanings:

it refers to a single standard (ISO 9000) and it refers to a set

of three standards (ISO 9000, ISO 9001, and ISO 9004) All three

are referred to as quality management system standards

ISO 9000 discusses definitions and terminology and is used

to clarify the concepts used by the ISO 9001 and ISO 9004

standards ISO 9001 contains requirements and is often used

for certification purposes while ISO 9004 presents a set of

guidelines and is used to develop quality management

systems that go beyond ISO 9001

ISO's purpose is to facilitate international trade by

providing a single set of standards that people

everywhere would recognize and respect.

The ISO 9000 standards apply to all kinds of organizations in all kinds of areas Some of these areas include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace,

construction, exploration, textiles, pharmaceuticals, oil and gas, pulp and paper, petrochemicals, publishing, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, transportation, software development, consumer products, product design, instrumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, consulting, insurance, and so on.

How does ISO 9000 Work?

Here's how it works You decide that you need to develop a quality management system that complies with the ISO 9001 requirements That's your mission You choose to follow this path because you feel the need to control or improve the quality of your products and services, to r e d u c e the costs associated with poor quality, or to become more competitive

Or, you choose this path simply because your customers expect you to do so or because a governmental body has made it mandatory You then develop a quality management

system that meets the requirements specified by ISO 9001

In the course of doing so, you may also wish to consult the ISO 9000 definitions and the ISO 9004 guidelines.

But how do you develop such a q u a l i t y management

system? There are at least two approaches You can either

do a gap analysis or follow a detailed quality management

system development plan.

If you've already got a functioning quality management

system, we suggest that you carry out a gap analysis

A gap analysis will tell you exactly what you need to do to meet the ISO 9001 standard It will help you to identify the gaps that exist between the ISO 9001 standard and your organization's processes Once you know where the gaps are, you can take steps to fill your gaps By following this incremental approach, you will not only comply with the ISO 9001 standard, but you will also improve the overall effectiveness of your organization's quality management system A gap analysis will also help you to figure out how much time it will take and how much it will cost to bring your QMS into compliance with the ISO 9001 standard

However, if you don't have a quality management system

or you're starting from scratch, we suggest that you use an

ISO 9001 process-based QMS development plan to develop your quality management system

Once your QMS has been fully developed and implemented, you may wish to carry out an internal compliance audit to ensure that it complies with the ISO 9001 2008 requirements Once you're sure that your QMS is fully compliant, you're ready

to ask a registrar (certification body) to audit the effectiveness

of your QMS If your auditors like what they see, they will

certify that your QMS has met ISO's requirements.

While ISO 9001 is specifically designed to be used for

certification purposes, you don't have to become certified ISO does not require formal certification (registration) You can simply establish a compliant QMS and then announce

to the world that it complies with the ISO 9001 standard Of course, your compliance claim may have more credibility

in the marketplace if an independent registrar has

audited your QMS and agrees with your claim

Why is ISO 9000 Important?

ISO 9000 is important because of its orientation While

the content itself is useful and important, the content

alone does not account for its widespread appeal.

ISO 9000 is important because of its international orientation

Currently, ISO 9000 is supported by national standards bodies from more than 150 countries This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard

of excellence.

ISO is also important because of its systemic orientation

We think this is crucial Many people wrongly emphasize

motivational and attitudinal factors The assumption is that quality can only be created if workers are motivated and have the right attitude This is fine, but it doesn't go far enough Unless you institutionalize the right attitude by supporting

it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards

of quality that other organizations seem to be able to achieve

Unless you establish a quality attitude by creating a quality

management system, you will never achieve a world-class

standard of quality.

Simply put, if you want to have a quality attitude you must

have a quality system This is what ISO recognizes, and

this is why ISO 9000 is important

ISO 9000 2005 Quality Management

Principles Translated into Plain English

According to ISO 9000, the ISO 9001 and 9004 standards are based on

eight quality management principles These principles were chosen

because they can be used to improve performance and achieve success

But how can you ensure that your organization applies these principles? The answer is to establish a quality management system that meets the

ISO 9001 2008 standard If you do so, your organization will automatically apply these principles This is because they permeate the ISO 9001 standard and will therefore be built into any quality system that is based on this standard So if you want to improve the performance

of your organization, you need to develop and implement an

ISO 9001 2008 quality management system that applies the eight principles listed below

1 Focus

on your

customers

Organizations rely on customers Therefore:

• Organizations must understand customer needs.

• Organizations must meet customer requirements.

• Organizations must exceed customer expectations.

2 Provide

leadership

Organizations rely on leaders Therefore:

• Leaders must establish a unity of purpose and

set the direction the organization should take.

• Leaders must create an environment that encourages

people to achieve the organization's objectives.

3 Involve

your

people

Organizations rely on people Therefore:

• Organizations must encourage the

involvement of people at all levels.

• Organizations must help people to

develop and use their abilities.

• Organizations must use a process approach

to manage activities and related resources.

• Organizations must identify interrelated

processes and treat them as a system

• Organizations must use a systems approach

to manage their interrelated processes.

• Organizations must make a permanent commitment

to continually improve their overall performance.

7 Get the facts

before you

decide

Organizations perform better when their decisions are based on facts Therefore:

• Organizations must base decisions on the

analysis of factual information and data.

8 Work

with your

suppliers

Organizations depend on their suppliers

to help them create value Therefore:

• Organizations must maintain a mutually

beneficial relationship with their suppliers.

ISO 9001 2008 vs ISO 9001 2000

ISO 9001 2008 and ISO 9001 2000 use the same numbering system

to organize the ISO 9001 2008 and ISO 9001 2000 use the same numbering

system

to organize the standard As a result, the new standard looks much like the old standard However, some important clarifications and modifications were made These changes are summarized below

Outsourced Processes

The process approach continues to be of central importance to

ISO 9001 And since outsourcing has become increasingly common during the last few years, the new ISO 9001 standard has expanded its discussion of outsourced processes (see ISO 9001 Part 4.1)

The new standard makes it clear that an outsourced process is

still part of your QMS even though it is performed by a party that

is external to your organization The new standard emphasizes

the need to ensure that outsourced processes comply with all

customer and legal requirements While the responsibility for

a process may have been outsourced, your organization is,

nevertheless, still responsible for ensuring that it meets all

customer, regulatory, and statutory requirements

While the old standard said that outsourced processes must be

controlled, the new standard goes further by expecting you also

to specify the type, nature, and extent of control ISO 9001 2008

also wants you to think carefully about how you’re going to control outsourced processes How you choose to control an outsourced

process should be influenced by the potential impact it could have

on your products, whether or not process control will be shared

with the process supplier, and whether or not adequate controls

can be contractually established using your purchasing process

Documentation

ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentation

includes not only the records required by the standard but also the records that your organization needs to have in order to be able to plan, operate, and control its QMS processes So the new standard has expanded the definition of documentation to include all QMS process records

Part 4.2.1 makes it clear that a single document may contain several procedures or several documents may be used to describe a single procedure While this has always been an option, the new standard makes this possibility explicit

ISO 9001 2000 Part 4.2.3 gave the impression that all external

documents needed to be identified and controlled This has now been clarified The new standard says that you need to identify and control the distribution of only those external documents that you need in order to be able to plan and operate your QMS In other

words, only relevant external QMS documents need to be

controlled, not all of them

Management Representative

ISO 9001 2000, Part 5.5.2, allowed you to appoint any member

of management to oversee the organization’s QMS Since the old standard did not explicitly say that the management representative must be a member of the organization’s own management, outsiders were sometimes appointed, instead This loophole has now

been closed

ISO 9001 2008 now makes it clear that the management representative must be a member of the organization’s own management Outsiders may no longer perform this important function

Competence

While both old and new standards stress the importance of

competence, the old standard wasn’t very clear about who they

were talking about Now it’s pretty clear that all QMS personnel must

be competent ISO 9001 2008, Part 6.2.1, makes it clear that any task within the QMS may directly or indirectly affect the organization’s ability or willingness to meet product requirements Since any

QMS task could directly or indirectly influence product quality,

the competence of anyone and everyone who carries out

any QMS task must be assured

For ISO 9001 2000 (Part 6.3) the term infrastructure includes

buildings, workspaces, equipment, software, utilities, and support services like transportation and communications ISO 9001 2008 has now added information systems to the previous list of support services Both old and new standards expect you to provide the infrastructure (including information systems) that your

organization needs in order to ensure that product

requirements are being met

Work Environment

According to ISO 9001 2000, Part 6.4, you are expected to

manage the work environment that your organization needs

in order to be able to ensure that all product requirements are being met However, it failed to indicate exactly what they were talking about This problem has now been solved ISO 9001 2008

says that the term work environment refers to working conditions

These working conditions include physical and environmental conditions, as well as things like noise, temperature, humidity, lighting, and weather According to the new standard, all of

these conditions need to be managed in order to help

ensure that product requirements are being met

Customer Requirements

According to ISO 9001 2000, Part 7.2.1, you are expected to identify your customers’ specific delivery and post delivery requirements Since some people weren’t sure about what post delivery meant, the new standard has tried to clarify this

According to ISO 9001 2008, post delivery requirements include things like warranty provisions, contractual obligations (such as maintenance), and supplementary services (such as recycling and final disposal)

Design and Development Planning

Both old and new standards expect organizations to plan and perform product design and development review, verification,

and validation activities (Part 7.3.1)

While each of these three activities serves a different purpose, ISO 9001 2008 makes it clear that these three activities can be carried out and recorded separately or in any combination as long as it makes sense for the product and the organization

Design and Development Outputs

Part 7.3.3 of ISO 9001 2000 wants you to make sure that the design and development process generates information

(outputs) that your purchasing, production, and service

provision processes need to have

ISO 9001 2008 now also says that design and development outputs could include information that explains how products can be preserved during production and service provision

Monitoring and Measuring Equipment

While ISO 9001 2008, Part 7.6, refers to the need to control

monitoring and measuring equipment, the old standard talked about controlling devices Since the term device can refer to

almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear The new ISO 9001 standard

has removed this ambiguity by using the term equipment

Both the old and the new standard wants you to confirm that monitoring and measuring software is capable of doing the job you want it to do In addition to this requirement, the new standard suggests (in a note) that configuration management and well established verification methods can be used to ensure the ongoing suitability of monitoring and measuring software However, this is not a requirement, just a statement that

explains how the ongoing suitability of software can

be maintained

Customer Satisfaction

Both old and new standards want you to monitor and

measure customer satisfaction (perceptions) A new note to