Product Quality Management

Project
Topic: ISO 9001:2000
Introduction to ISO 9001:2000
ISO Certificate is an international certificate, developed by ISO International
Organization on standardization which confirms presence of system of quality
management at the enterprise. resence of ISO Certificate represents your company as
competitive on home and at international level. !his certification mar" or services for
consumer is an additional guarantee of reliability and professional competence. !his
certificate operates up to # years.
!he main purpose of ISO is development of principles of standardization promoting
integration processes in different areas of business.
!o lead and operate an organization successfully requires that it be managed in a
systematic and transparent manner. Success can result from implementing and
maintaining a management system that is designed to continually improve performance
by addressing the needs of all interested parties, from customers to employees.
$anaging an organization encompasses quality management as one of the
management disciplines.
%ith the introduction of ISO &''(, the business world now has a generic model for a
quality management system that, when designed, developed and implemented, will
provide the framewor" for assuring that customer requirements are defined, quality
product or service is made or delivered on time, and that product)service and the
management system are improved on a continuing basis.
Structure of the new standard
In the ISO &''(*+''' standard, the +' elements of the (&&, standard were recognized
and streamlined to reflect a process oriented structure more in line with the brief, high
level ISO (,''( -nvironmental management system standard signed off in (&&.. !he
international organization for standardization views a process as any activity that
receives inputs and converts them in to outputs, and views an organization as a group if
numerous lin"ed process. /mong these processes, the output of one is often the input
of another. Identifying and managing these process and their interactions in an
organization is a process approach that is necessary for effective operation.
!he element of 0uman 1esources in the (&&, standard has been e2panded and
emphasized in ISO &''(*+''' along with wor" environment and the involvement of
interested parties. / greater emphasis placed on the role of top management, and a
consideration of legal and regulatory requirements is now included.
!he new standard also requires establishment of measureable ob3ectives at relevant
functions and levels, greater attention to resource availability, and determination of
training effectiveness. $easurements have been e2pended to system, products and
process. /nd finally, it is necessary to analyze collected data on the performance of
quality management system.
10 Major Revisions to the ISO 9001 Standard
ISO &''(*+''' represents a ma3or change from the (&&, standard. 4uality
professionals can debate the question of what constitutes a ma3or change, but for the
purposes of this transition
guide, let5s consider the following*
1. Three standards have been replaced by one
!here are three system standards within the (&&, ISO quality management family. !hey
are*
(. ISO 9001 64uality Systems $odel for 4uality /ssurance in 7esign, 7evelopment,
roduction, Installation and Servicing8,
+. ISO 9002 64uality Systems $odel for 4uality /ssurance in roduction, Installation,
and Servicing8, and
#. ISO 9003 64uality Systems $odel for 4uality /ssurance in 9inal Inspection and
!est8. !hese three standards are being replaced by one standard* ISO 9001, 64uality
$anagement Systems 1equirements8. ISO &''+ was used by organizations that did
not perform design or development. ISO &''# was used by organizations that only
provided final inspection and testing services. Companies that would have previously
used ISO &''+ or ISO &''# standards will now use the new ISO &''( standard and
e2clude the areas that do not apply to their business.!he (&&, revision documents will
be withdrawn 7ecember (:, +''#. ;ntil then, both the (&&, revisions and the +'''
revisions are valid for registration, although no registrars are issuing new registrations to
the (&&, versions. /lso note the term <4uality /ssurance< no longer appears in
the title of the standard. 4uality management is considered a more advanced and far=
reaching concept than quality assurance.
2. Twenty elements have been replaced with five clauses
!he (&&, version of ISO &''( required conformance with +' elements >sometimes
referred to as clauses?. !his caused problems in some organizations, not only because
of the number of clauses, but also because of the order in which they were listed and
the lac" of connection or flow between them. %hile applicable in most organization, the
way the clauses were presented really did not represent the way organizations did
business. %hile most organizations prepared their quality manuals and, hence, their
quality systems in a manner that followed strict, point=by
point conformance to the elements, many chose to develop their systems according to
their business structure. In other words, their systems were designed and implemented
the way they 6wor"ed8, not according to the order presented in the standard. !he +'
elements were embodied in these business systems, of course, but their order of
presentation was secondary to outlining the way the organization did business. Some
auditors actually preferred the element=by=element method believing that it was easier
to determine conformance. !hey could loo" at the quality manual along side the
standard and simply chec" off the elements as they appeared in the manual.
ISO &''(*+''' replaces the +' clauses of the (&&, standard with five*
Clause ,* 4uality $anagement System
Clause :* $anagement 1esponsibility
Clause .* 1esource $anagement
Clause @* roduct 1ealization
Clause A* $easurement, /nalysis, and Improvement
Clauses (, + and # are Scope, Bormative reference, and !erms and definitions,
respectively, and are not part the standard that describes requirements for
implementation.
3. ustomer Satisfaction
Customer satisfaction is the principal objective of the ISO &''(*+''' quality
management system. Organizations must determine customer needs and e2pectations,
ensure awareness of those customer requirements throughout organization, and
consider these requirements in establishing ob3ectives for improvement. !o ensure this
focus on the customer, there is also a significant new emphasis >and associated
requirements? for customer communication.
!. "mphasis is placed on the #$rocess%
If you loo" at the (&&, standard5s +' clauses and compare them to the five main
elements of the new standard, it will become readily apparent that the emphasis now is
on the 6process8 or, more specifically*
C ;nderstanding and meeting >customer? requirements
C Considering processes in terms of value added >from the customer5s perspective?
C -valuate processes in terms of performance and effectiveness, and
C ;sing ob3ective measurements of process as the basis for continual improvement.
&. 'ana(ement Involvement and )esponsibility
$anagement involvement was required in the (&&, standard, but in the +''' version
the requirements have been broadened and significantly strengthened. !op
management need not participate in the daily operation of the quality management
system, but these individuals are required to establish the quality policy and the quality
ob3ectives, conduct management reviews, ensure availability of resources, and
communicate the importance of meeting customer requirements and any applicable
regulatory mandates. It is certainly debatable, but many quality professionals consider
management involvement to be the most important consideration for success of a
quality management system.
*. ontinual Improvement
Continual improvement was a part of the (&&, standard, being most evident in the
internal auditing, corrective action, and preventive action clauses. Bow, however,
continual improvement must be a 6planned process8 and must be demonstrated.
Continual improvement is further facilitated in the new standard by the requirement to
establish, communicate, monitor, and measure quality ob3ectives. 9or clarification, as"
your registrar what they will be loo"ing for.
+. ,ata ollection and -nalysis
Organizations are now required to analyze data to obtain information about customer
satisfaction, the organization5s conformance to customer requirements, characteristics
and trends of processes and products, and supplier performance.
.. /ess $rescriptive and 'ore 0le1ible ,ocumentation
7ocumented procedures are now required in only si2 areas*
Control of documents >,.+.#?
Control of quality records >,.+.,?
Internal audits >A.+.+?
Control of nonconforming product >A.#?
Corrective action >A.:.+?
reventive action >A.:.#?
Organizations must be careful here, however. It could be a serious error to assume that
the only documentation requirements are a quality manual and these si2 procedures.
%hile these si2 are required, the organization must determine the family of documents
needed to ensure effective planning, operating, and control of processes.
;ltimately, the need for procedures, or, additionally, wor" instructions, must be based on
the organization5s size, the type of activities that the organization performs, the
comple2ity of these processes and their interactions with other processes, and the
competency of personnel. Small organizations may be able to develop quality systems
where the required si2 procedures are included in the quality manual and few others are
needed for effective operation of the business. !his is probably not wor"able for larger,
more comple2 organizations.
9. 2ew ,efinitions
In addition to the ma3or changes, consider these new definitions*
(. !he (&&, standard defined product as, 6!he result of activities or processes.8 In the
+''' standard, product is the 6result of a system of activities that use resources to
transform inputs to outputs >i.e., result of a 6process8?8.
+. In the (&&, standard, quality was defined as the 6totality of characteristics of an entity
that bear on its ability to satisfy stated and implied needs8. In the +''' standard,
quality is the, 6ability of a set of inherent characteristics of a product, system, or
process to fulfill requirements of customers and other interested parties8.
#. Bote also that the (&&, terms supplier, sub=supplier, and customer have been
replaced
with organization, supplier, customer, respectively in the +''' standard.
10. $ermissible "1clusions
-2clusions were handled somewhat differently under the (&&, version of the standard
than they are in the +''' standard. 9or e2ample, if your organization did not design
products or services, it sought registration under ISO &''+. Or, if the organization did
not service products >Clause ,.(& of the (&&, standard?, it simply stated this in the
quality manual. Di"ewise for other clauses of the (&&, standard that may not have
applied. In the +''' version of the standard, e2clusions are only allowed for Section @
>roduct 1ealization? requirements, and only if it can be demonstrated those
requirements do not apply. Some typical e2clusions
might relate to*
C 7esign and)or developmentE
C Customer property, >that is, the organization never handles customer property?E
C Identification and traceability of productE or
C Control of monitoring and measuring devices.
%hatever the e2clusion, it must be fully e2plained and 3ustified in the quality manual.
!he many organizations that actually did design, but chose to register to &''+, will not
be allowed to e2clude design under the +''' revision.
Elements of ISO 9001:2000
!he lan 7o Chec" /ct >7C/? cycle is the foundation of all ISO management
system standards. !he cycle ensures development, continuous improvement and
control of the management system in question. It is a simple tool that ensures constant
monitoring of your organization5s effectiveness. It consists of thefollowing*
lan establishing the architecture of your quality management system is covered in
clause ,.( of the standard where it requires the identification of the processes, their
success criteria, the inter=relationship between processes and the system for chec"ing
your results
7o implementing the plans and using the quality management system Chec"
reviewing whether the results are satisfactory at appropriate intervals against the ISO
&''( requirements
/ct improving the quality management system or acting on the challenges and issues
found in the reviews.
It is most li"ely that an organization already has an effective quality management
system but it is probably informal and not well documented. ISO &''( provides a more
systematic approach to achieving organization5s ob3ectives. It should not result in
e2cessive bureaucracy or paperwor" and lac" of fle2ibility. Bor should it be a financial
burden. 4uality management systems should be considered an investment as the
return on investment will be in terms of the previously mentioned benefits and
improvements.
$lan $anagement responsibility
!he 7C/ cycle starts with management as it is up to them to identify appropriate
processes and relevant
areas of focus.
rocess identification*
/ppropriate process identification is essential to a practical system and the "ey is to
start with two processes
>$anagement and Operations? and then decide if sub=processes are necessary rather
than wor"ing 6bottom
up8. -ach process has to also have an 6owner8 that is responsible for the activities that
relate to the success
criteria of the process.
$lannin( and review3
In order to successfully plan your quality system before implementation a quality manual
and a number of documents outlining procedures are required. !he areas of
documentation are*
FFG 7ocument control
FFG 1ecords control
FFG Internal audits
FFG Bon conforming product
FFG Corrective action
FFG reventative action
/dditional procedures may be required if, without them, the process might end up
having variable or
unpredictable results such as those caused by ine2perienced staff, complicated
parameters or other ris"s.
!he 4$S is, after all, a system for minimizing business ris"s.
9undamental direction*
Owners or managers of your organization should establish the fundamental direction of
the 4$S using the 4uality olicy. !here are several aspects that have to be thought
through while designing the 4uality olicy*
FFG Strategy should follow from the 4uality olicy and the business environment
FFG rocess criteria should be aligned to the strategy
FFG Customer focus system processes have to be designed to ensure customer
satisfaction
FFG 1esources human, technological and environmental resources have to be put in
place. !he 4$S
requires that each company establish a way that their staff are competent
,o 4 implementation and use
0aving established the system, it has to be used to see that it wor"s in the way it was
intended. It will be necessary to use the procedures, forms, equipment and instructions
in the way it was planned
!he direction from your management and the assigned resources should ma"e this part
of the process fairly easy to implement. It is important to plan and define the processes
all along the supply chain, this mightinclude*
FFG Sales
FFG urchasing
FFG 1esearch and 7evelopment
FFG $anufacturing
FFG 7elivery
7on5t worry if some of the steps don5t apply to you. ISO &''( certification is designed
for every type of organization, 3ust wor" on the aspects that are relevant to you.
Chec" review of results
/t appropriate intervals, the results of 4$S should be reviewed. !he intervals will be
short when the system is new but can be longer once the 4$S becomes mature. !he
reporting of results against the process success criteria should be regular and be used
by management to ensure that the business is on trac".
1ecords should be designed to facilitate prompt recording as well as the early detection
of problems.
7on5t worry if your organization has some problems >or 6challenges8 as we call them?,
every organization has them but a successful one will identify these at an early stage
and deal with them in an effective manner.
1eviewing perceived customer satisfaction is a "ey metric that has to be reviewed. It is
recognised that the handling of complaints is not enoughE customers may 3ust move
their business to a competitor.
robably the most important characteristic of a successful quality management system
is internal audits.
It is e2pected that an organization that does not do internal audits is very li"ely to have
their certification
revo"ed as their system is probably out of control.
-ct continuous improvement
Improvement is another name for dealing with challenges of the organization.
Challenges can be tac"led either with corrective action or, preferably, with preventative
action. /ll corrective actions need to be recorded and preventative actions designed for
recurring problems.
ISO 9001
Implementation and Certification
!he ISO &''( implementation and the ISO &''( certification process will not only result
in the desired ISO &''( registration but prove to be one of the most valuable e2ercises
we can do to improve virtually all aspects of your company.
$ost people seem to be primarily interested in how to get ISO &''( certification = the
quic"er the better. Hefore we e2plain how small and mid=size companies can achieve
ISO &''( certification easily and ine2pensively, we would li"e to point out that the ISO
&''( implementation and certification process itself will provide numerous valuable
benefits.
!he ISO &''( implementation is a process that, if done correctly, will unify all
employees and managers in improving wor" processes. -verybody will have a chance
to identify processes that are inefficient or otherwise inadequate. ;nder the umbrella of
ISO &''( implementation, employees and management will be able to improve cross=
functional cooperation and fine=tune business processes.
he !est time for
ISO 9001 implementation and certification
Ideally we should begin our ISO 9001 implementation when we first
start up our company.
If we are in the position of starting up a new company, we should be setting
up your business processes according to ISO 9001:2000 reuirements and
start implementing ISO 9001 before hiring your employees. !his is the most
efficient approach as your company not only immediately reaps the benefits
of ISO 9001 but you also don"t ha#e to o#ercome resistance to change when
ad$usting wor% processes later to meet the reuirements of the ISO
9001:2000 standard.
&owe#er, most companies ha#e been long established before they start their
ISO 9001 implementation. Since a complete ISO 9001 uality management
system brings many benefits to a company, it"s always better to start the
ISO 9001 implementation sooner rather than later.
"o# do I start #ith ISO 9001$
/s a first step, you should ma"e yourself familiar with the ISO &''(*+''' standard and
its requirements.
It is important that you get a good understanding of the ISO &''( requirements, how
they will affect your company, and how much is involved in the ISO &''( certification
process before you ma"e the final decision on starting the ISO &''( implementation.
Iou can find some important information on ISO &''(*+''' and lin"s to organizations
selling the standard and ISO &''( training courses in our 1eviews section.
Once you have a wor"ing "nowledge of ISO &''( and its implementation, you will need
to decide on which approach to ta"e* use a consultant or implement ISO &''( in=house.
ISO 9000 as a consultant
%e found that ISO &''' consultants can be of great help, and they can also cause
great damage, depending on the ISO &''' consultant and depending on how you use
them.
Jood ISO &''' consultants can add value as trainers. It may be beneficial if an e2pert
in ISO &''( requirements is used to train the ISO &''( $anagement 1epresentative, or
to 6sell8 the benefits of ISO &''( certification to top management. 0owever, since most
consultants try to sell their consulting services, pure ISO &''( instructors are generally
a better choice. %e have heard of countless cases in which ISO &''' consultants
purposely made the ISO &''( requirements appear overly complicated and restrictive
only in order to 3ustify the high price of their consulting services.
!he most common and also most severe problems that we routinely encounter are
inefficient and bureaucratic ISO &''( quality management systems. !hese are typically
the result of an ISO &''' consultant writing an overly complicated and convoluted ISO
&''( quality manual and quality procedures.
ISO 9001 documentation
7eveloping the ISO &''( documentation is a significant part of any ISO &''(
implementation process. !he ISO &''( standard contains specific requirements on the
nature and content of several documents.
!he required documents are* a quality manual, quality procedures, a quality policy and
quality ob3ectivesE in addition, ISO &''( requires wor" instructions that provide detailed
guidelines to employees on how to perform their wor".
0owever, the ISO &''(*+''' standard is very clear that wor" instructions need only be
created where they add business value >for e2ample, a trained painter will not find value
in instructions on how to paintE on the other hand, brief instructions = possibly in form of
pictures = and displayed right on a machine, e2plaining how to replace a filter could be a
great time=saver?. 9orms, which must be "ept on file after they are filled=in, are also part
of any ISO &''( quality management system. Some of the most typical forms are the
Corrective /ction 1eport 9orm, the -mployee 1eview 9orm, and the Customer Survey.
It is important to note that ISO &''( does not directly require these formsE however, ISO
&''( calls for recording certain information and a well=designed form not only requires
the information but it also guides the user through the process. Since the ISO &''(
documentation is the bac"bone of your ISO &''( quality management system, this
website has a dedicated section on using !emplates for ISO &''( 7ocumentation.
ISO 9001 certification process
!he ISO &''( certificate is issued by an independent registrar after successful
verification that you company has implemented an ISO &''( quality management
system and follows all its requirements in daily operations.
Once the company has completed all ISO &''( documentation >including the all=
important quality manual and quality procedures?, the company may apply for ISO &''(
certification. !he certification is issued by an independent and accredited ISO &''(
registrar. !here are many such ISO &''( registrars, so you can choose the one that fits
your companyKs circumstances the best. %e recommend that you choose your ISO
&''( registrar early during the ISO &''( implementation process as some registrars
offer free support materials that help you implement ISO &''(.
Steps to ISO 9001 Certification
In order to achieve ISO &''( certification, your company needs to have the entire ISO
&''( quality management system implementedE this includes having written the entire
ISO &''( documentation and following all the requirements stipulated in your
documentation. Hefore the certification audit can be performed and the ISO &''(
certification be issued, your company needs to meet two conditions*
a? erform one complete internal ISO &''( audit. Such an internal audit is performed
internally by one or more company employees who verify that their company in fact
follows the requirements described in the ISO &''( documentation.
b? Secondly, your company needs to have a trac" record of operating according to ISO
&''( requirementsE most registrars require about + months of trac" record.
ISO 9001 Certificate
If no significant gaps to the ISO &''(*+''' requirements are discovered >or if any
discovered gaps have been corrected?, the ISO &''( registrar issues the prestigious
ISO &''( certification. !he ISO &''( certificate is typically valid for three years and can
then be easily renewed. / condition for continued validity of the ISO &''( certification is
that periodic so=called surveillance audits are conducted by the ISO &''( registrar, and
that those surveillance audits show continued ISO &''( compliance >again, the
company has an opportunity to correct any non=conformities?. Surveillance audits are
usually conducted every . = (+ monthsE they are much smaller in scope, time and cost
than the initial certification audit.
"o# lon% does the ISO 9001 implementation
ta&e$
!he time to implement ISO &''( and reach certification depends very much on you and
your company. !he fastest is +=# months because most ISO &''( registrars require at
least + months ISO &''( trac" record before the certification audit.
/ more realistic estimate may be this = but there are many 6ifKs8*
i. if you have a relatively small company 5say6 less than 20 employees76
ii. if your employees are motivated and if they don8t oppose chan(e
5employee buy9in is crucial6 and employees must be involved from the
be(innin(: consider an ISO 9001 introduction video presentation76
iii. if you have the bac;in( of all senior e1ecutives 5which you will li;ely only
(et if they understand ISO 9001 and its benefits to the company: consider a
trainin( course76
iv. if you and other mana(ers are ready to put si(nificant time and efforts into
the ISO 9001 implementation endeavor6 and
v. if you use a really (ood pre9written template for your ISO 9001 <uality
manual and <uality procedures6 as well as (ood pre9written forms and
chec;lists6
then you may be able to get your organization certified in as short as #=, months.
Some companies are significantly slower, with .=(+ months not being unusual.
0owever, companies that write their quality manual and quality procedures from
scratch, rather than base them on a good template, often ta"e as long as + years and
longer.
Cost of an ISO 9001 'ualit( mana%ement s(stem
!he cost of ISO &''( implementation and achieving ISO &''( certification varies
significantly depending on the size of your company and the implementation approach
you ta"e.
%hile operating a good ISO &''( quality management system >4$S? typically results in
significant cost savings >even after paying the periodic audit fees of about ;SL(,''' =
;SL+,''' per auditor day?, the ISO &''( implementation and ISO &''( certification
process can be rather e2pensive. Darge companies often spend in e2cess of hundred
thousand dollars in consultant fees, while small companies can get by with a thousand
dollars = if they ta"e the right approach.
)*+),)-ES
It is widely ac"nowledged that proper quality management improves business, often
having a positive effect on investment, mar"et share, sales growth, sales margins,
competitive advantage, and avoidance of litigation. !he quality principles in ISO
&'''*+''' are also sound, according to %ade

and Harnes, who says that <ISO &'''
guidelines provide a comprehensive model for quality management systems that can
ma"e any company competitive<.

Sroufe and Cur"ovic, >+''A? found benefits ranging
from registration required to remain part of a supply base, better documentation, to cost
benefits, and improved involvement and communication with
management. Implementing ISO often gives the following advantages*
1. Creates a more efficient, effective operation
2. Increases customer satisfaction and retention
3. 1educes audits
4. -nhances mar"eting
5. Improves employee motivation, awareness, and morale
6. romotes international trade
7. Increases profit
8. 1educes waste and increases productivity
9. Common tool for standardization
ME"O*O.O-/
Once the processes needed for the 4$S and their sequences and interactions have
been identified. It is necessary to establish management responsibilities and
accountabilities for the performance of these processes. $any methodologies are
available for managing and improving processes, but all share some simple basic
elements. / simple process management and improvement methodology organized in a
series of steps is described in the following*
Step one3 "stablish the responsibilities for mana(in( the process. It is critical to
have an overall process manager or process owner with end to end responsibility and
accountability for all aspects of process performance. !he process manager needs to
understand the entire process and have the authority to effect changes in any part of it.
!he process manager is responsible for the following*
9orming the process management team, which includes representatives from
each ma3or part of the process.
-nsuring the process operates in a controlled state of predictable performance.
-stablishing process performance measures that adequately characterize the
efficiency and effectiveness of the process in meeting the needs of all customers
and other interested parties.
-nsuring all aspects of process management and improvement are performed.
!his includes creating documentation, trac"ing performance, and securing and
allocating resources.
Step two3 ,efine the process. !he process manager and process management team
need to carefully define the process so everyone wor"ing within the process has a
shared understanding of how it operates. 0ow much documentation is required
depends on such attributes as the stability and education of the wor"force and the
comple2ity and criticality of the process.
/ll process inputs and outputs are identified, along with the suppliers and customers,
who may be internal or e2ternal. !he team also identifies process steps and flows.
$any quality tools, such as bloc" diagrams and flowcharts, are available to support
these activities.
Step three3 Identify customer re<uirements. Carefully gather, analyze and document
customer needs, including how customers use the outputs of the process.
Communicate frequently with customers to understand needs from their viewpoint.
!o the e2tent possible, define measurable customer needs and ran" them in order of
importance. 7irectly validate needs and requirements with customers.
Step four3 "stablish measures of process performance. !ranslate customer needs
and requirements into measures of process performance. !his is one of the most
important and difficult steps in process management.
Include customer satisfaction, in=process measures and measures of supplier
performance in process measures. 1elate all important customer needs, such as on
time performance, defect or error rates, tolerance intervals, product reusability, and
wor"er health and safety, to performance measures.
!he process approach is therefore one of the strongest approaches for integrating
management system standards because each process must be managed and improved
simultaneously for all process performance measures. 7irectly lin"ing process
performance measures with customer needs is one of the most powerful aspects of
process management.
Step five3 ompare process performance with customer re<uirements. ;se the
process performance measures to ensure your process is operating in a stable and
predictable manner.
Compare the process performance measures with the needs and requirements of the
customers. ;se a variety of statistical tools for analyzing process measurement data to
help quantify process performance. Identify critical process improvement opportunities
through gaps in process performance.
!hese first five steps provide a basic methodology for process management. Hut the
responsibilities of the process manager and process management team do not end
there. / significant benefit of process management is its natural fit with process
improvement. Once process performance has been compared with customer
requirements, process improvement is the natural ne2t step.
Step si13 Identify process improvement opportunities. ;se gaps in process
performance vs. customer needs to determine critical process improvement
opportunities. /nalyze process performance measures for improvement opportunities
related to sources of such attributes as errors and defects, process simplification
opportunities, process bottlenec"s and lac" of adequate process controls.
Hoth process effectiveness and efficiency can improve as a result of process
improvement activities. $any tools e2ist to identify process improvement opportunities.
Once process improvement opportunities are identified, any of the many quality
improvement methods can be used to improve process performance. !hese quality
improvement methods fit naturally into step seven of the process management and
improvement methodology.
One quality improvement method that can be used at this step is the plan, do, chec",
act >7C/? cycle.
Step seven3 Improve process performance. Select the process improvement
opportunity to pursue. !his selection should ta"e into account such attributes as the
criticality of certain improvement needs, difficulty of improvement opportunities, and
resources and e2pertise available.
-stablish quality improvement teams to pursue specific improvement opportunities.
!hese teams are established by the process manager and process management team.
!he quality improvement teams report to the process manager or the process
management team and are typically disbanded once their improvement pro3ect is
completed.
!he quality improvement teams complete the following activities*
Clarify the improvement opportunity problem statement, schedule and budget.
7etermine the root causes of problems.
7evelop and implement countermeasures to reduce or eliminate the occurrence
of root causes.
Stabilize the process at the new level of performance.
1eturn to step si2 or seven.
Support for the system approach
!he process approach is an important part of the system approach to management. !he
process approach assumes understanding and managing interrelated processes as a
system can contribute to an organizationKs effectiveness and efficiency in achieving
ob3ectives.
;sing the process approach, a 4$S is comprised of the following four categories of
interrelated processes *
$anagement responsibility.
1esource management.
roduct realization.
$easurement, analysis and improvement.
-ach process can be managed and improved using process management and
improvement methodology, but managing the interrelated processes as a system
introduces additional improvement opportunities.
9irst, processes can be analyzed and improved together as mega=processes,
increasing the opportunities for improvement. Hut you can also directly pursue
improvement of the entire 4$S using audit and self=assessment >using &'',*+''' or
quality award criteria? results and the 7C/ cycle.
!he multiple levels at which continual improvement occurs ma"e 4$Ss based on the
process approach a powerful way to manage organizations toward achieving
performance e2cellence.
0enefits of ISO 9001:2000
Internal =enefits39
(. Hetter management of core business processes.
+. Increased awareness of quality among staff.
#. Improved productivity and quality .
,. Improved internal communications .
:. 1educed wastage and cost per unit)service
"1ternal =enefits39
(. Competitive /dvantage* @+.#M of corporations with ISO &''(*+''' report a
ma3or competitive advantage. !his means they are winning more business.
>Source 7un and Hradstreet Survey?
+. Improves Customer 7emand* ##.,M of corporations with ISO &''(*+''' report
improved customer demand. !his means they are winning more business.
>Source 7un and Hradstreet Survey?
#. rotect Iour Husiness* .&.#M of surveyed businesses that do not have ISO
&''(*+''' say they have lost a customer bid or proposal to an ISO &''(*+'''
certified competitor. $any of these companies said they didn5t "now why they
were losing the business until it was too late.
,. Iour Competitors /re 7oing It* In many industries, #: to ,'M of your competitors
are ISO &''(*+''' 1egistered or in the process. !he longer you wait to start,
the greater is their competitive advantage.
:. -asy N Cost -ffective * Jetting ISO &''(*+''' is no longer the costly, time
consuming proposition that it once was. ;sing our system to become ISO
&''(*+''' compliant is very simple and ine2pensive. It will put you way ahead of
your competition and will enable you to improve your systems and operations.
.. 4ualify for Jovernment Contracts * !he 7epartment of 7efense, 9ood and 7rug
/dministration, 1ailways, 7epartment of -nergy and the Jeneral Services
/dministration have all approved the use of ISO &''(*+''' in contracts and bids.
Increased Credibility * Iou can generate a significant increase in business, as many
corporations will only deal with ISO &''(*+''' 1egistered or Complaint companies.