Xem mẫu
- TIªU CHUÈN quèc gia * national standard
TCVN
TCVN ISO 9000 : 2007
ISO 9000 : 2005
XuÊt b¶n lÇn 3
Third edition
HÖ thèng qu¶n lý chÊt l−îng −
c¬ së vµ tõ vùng
Quality management systems − Fundamentals and vocabulary
Hµ Néi - 2007
- tCVN ISO 9000 : 2007
2
- tCVN ISO 9000 : 2007
Môc lôc
Trang
Lêi nãi ®Çu ........................................................................................................................................5
Lêi giíi thiÖu......................................................................................................................................6
1 Ph¹m vi ¸p dông ............................................................................................................................9
2 C¬ së cña hÖ thèng qu¶n lý chÊt l−îng...........................................................................................9
2.1 Môc ®Ých cña hÖ thèng qu¶n lý chÊt l−îng...................................................................................9
2.2 C¸c yªu cÇu ®èi víi hÖ thèng qu¶n lý chÊt l−îng v c¸c yªu cÇu ®èi víi s¶n phÈm.....................10
2.3 C¸ch tiÕp cËn theo hÖ thèng qu¶n lý chÊt l−îng ..........................................................................11
2.4 C¸ch tiÕp cËn theo qu¸ tr×nh........................................................................................................12
2.5 ChÝnh s¸ch chÊt l−îng v môc tiªu chÊt l−îng.............................................................................12
2.6 Vai trß cña l·nh ®¹o cao nhÊt trrong hÖ thèng qu¶n lý chÊt l−îng ...............................................14
2.7 HÖ thèng t i liÖu ..........................................................................................................................14
2.8 Xem xÐt ®¸nh gi¸ hÖ thèng qu¶n lý chÊt l−îng ............................................................................16
2.9 C¶i tiÕn liªn tôc............................................................................................................................17
2.10 Vai trß cña kü thuËt thèng kª .....................................................................................................18
2.11 Träng t©m cña hÖ thèng qu¶n lý chÊt l−îng v c¸c hÖ thèng qu¶n lý kh¸c ................................19
2.12 Mèi quan hÖ gi÷a hÖ thèng qu¶n lý chÊt l−îng v c¸c m« h×nh tuyÖt h¶o ..................................19
3 ThuËt ng÷ v ®Þnh nghÜa.................................................................................................................20
3.1 C¸c thuËt ng÷ cã liªn quan ®Õn chÊt l−îng..................................................................................21
3.2 ThuËt ng÷ cã liªn quan ®Õn qu¶n lý.............................................................................................22
3.3 ThuËt ng÷ cã liªn quan ®Õn tæ chøc.............................................................................................25
3.4 ThuËt ng÷ cã liªn quan ®Õn qu¸ tr×nh v s¶n phÈm .....................................................................27
3.5 ThuËt ng÷ cã liªn quan ®Õn c¸c ®Æc tÝnh .....................................................................................30
3.6 ThuËt ng÷ liªn quan ®Õn sù phï hîp ...........................................................................................31
3.7 ThuËt ng÷ liªn quan ®Õn hÖ thèng t i liÖu...................................................................................34
3.8 ThuËt ng÷ liªn quan ®Õn xem xÐt ................................................................................................36
3.9 ThuËt ng÷ liªn quan ®Õn ®¸nh gi¸ ...............................................................................................38
3.10 ThuËt ng÷ liªn quan ®Õn ®¶m b¶o chÊt l−îng c¸c qu¸ tr×nh ®o l−êng ........................................41
Phô lôc A Ph−¬ng ph¸p luËn sö dông khi x©y dùng tõ vùng ..............................................................43
Th− môc t i liÖu tham kh¶o ...............................................................................................................61
B¶ng tra theo thø tù ch÷ c¸i...............................................................................................................62
3
- tCVN ISO 9000 : 2007
Contents
Page
Foreword ............................................................................................................................................5
Introduction.........................................................................................................................................6
1 Scope .............................................................................................................................................9
2 Fundamentals of quality management systems ..............................................................................9
2.1 Rationale for quality management systems ..................................................................................9
2.2 Requirements for quality management systems and requirements for products ...........................10
2.3 Quality management systems approach.......................................................................................11
2.4 The process approach .................................................................................................................12
2.5 Quality policy and quality objectives .............................................................................................12
2.6 Role of top management within the quality management system .................................................14
2.7 Documentation .............................................................................................................................14
2.8 Evaluating quality management systems......................................................................................16
2.9 Continual improvement ................................................................................................................17
2.10 Role of statistical techniques .....................................................................................................18
2.11 Quality management systems and other management system focuses .....................................19
2.12 Relationship between quality management systems and excellence models..............................19
3 Terms and definitions ......................................................................................................................20
3.1 Terms relating to quality ..............................................................................................................21
3.2 Terms relating to management .....................................................................................................22
3.3 Terms relating to organization ......................................................................................................25
3.4 Terms relating to process and product..........................................................................................27
3.5 Terms relating to characteristics ...................................................................................................30
3.6 Terms relating to conformity .........................................................................................................31
3.7 Terms relating to documentation ..................................................................................................34
3.8 Terms relating to examination ......................................................................................................36
3.9 Terms relating to audit .................................................................................................................38
3.10 Terms relating to quality assurance for measurement processes................................................41
Annex A: Methodology used in the development of the vocabulary ....................................................43
Bibliography .......................................................................................................................................61
Alphabetical index .............................................................................................................................65
4
- tCVN ISO 9000 : 2007
Lêi nãi ®Çu
TCVN ISO 9000 : 2007 thay thÕ TCVN ISO 9000 : 2000 (ISO 9000 : 2000);
TCVN ISO 9000 : 2007 ho n to n t−¬ng ®−¬ng víi ISO 9000 : 2005;
TCVN ISO 9000 : 2007 do Ban kü thuËt tiªu chuÈn TCVN/TC 176, Qu¶n lý
chÊt l−îng vµ ®¶m b¶o chÊt l−îng biªn so¹n, Tæng côc Tiªu chuÈn §o l−êng
ChÊt l−îng ®Ò nghÞ, Bé Khoa häc v C«ng nghÖ c«ng bè.
5
- tCVN ISO 9000 : 2007
Lêi giíi thiÖu Introduction
0.1 Kh¸i qu¸t 0.1 General
Bé tiªu chuÈn TCVN ISO 9000 liÖt kª duíi ®©y The ISO 9000 family of standards listed below has
®−îc x©y dùng nh»m trî gióp c¸c tæ chøc, thuéc been developed to assist organizations, of all
mäi lo¹i h×nh v qui m«, ¸p dông v vËn h nh c¸c types and sizes, to implement and operate
hÖ thèng qu¶n lý chÊt l−îng cã hiÖu lùc. effective quality management systems.
- TCVN ISO 9000 m« t¶ c¬ së cña c¸c hÖ thèng - ISO 9000 describes fundamentals of quality
qu¶n lý chÊt l−îng v qui ®Þnh c¸c thuËt ng÷ cho management systems and specifies the
c¸c hÖ thèng qu¶n lý chÊt l−îng. terminology for quality management systems.
- TCVN ISO 9001 qui ®Þnh c¸c yªu cÇu ®èi víi hÖ - ISO 9001 specifies requirements for a quality
thèng qu¶n lý chÊt l−îng khi mét tæ chøc cÇn management system where an organization needs
chøng tá n¨ng lùc cña m×nh trong viÖc cung cÊp to demonstrate its ability to provide products that
s¶n phÈm ®¸p øng c¸c yªu cÇu cña kh¸ch h ng fulfil customer and applicable regulatory
v c¸c yªu cÇu chÕ ®Þnh t−¬ng øng v nh»m n©ng requirements and aims to enhance customer
cao sù tho¶ m·n cña kh¸ch h ng. satisfaction
- TCVN ISO 9004 cung cÊp c¸c h−íng dÉn xem - ISO 9004 provides guidelines that consider both the
xÐt c¶ tÝnh hiÖu lùc v hiÖu qu¶ cña hÖ thèng qu¶n effectiveness and efficiency of the quality management
lý chÊt l−îng. Môc ®Ých cña tiªu chuÈn n y l c¶i system. The aim of this standard is improvement of the
tiÕn kÕt qu¶ thùc hiÖn cña mét tæ chøc v tho¶ performance of the organization and satisfaction of
m·n kh¸ch h ng v c¸c bªn quan t©m. customers and other interested parties.
- TCVN ISO 19011 cung cÊp h−íng dÉn vÒ ®¸nh - ISO 19011 provides guidance on auditing quality
gi¸ c¸c hÖ thèng qu¶n lý chÊt l−îng v m«i tr−êng. and environmental management systems.
TÊt c¶ c¸c tiªu chuÈn n y t¹o th nh mét bé tiªu chuÈn Together they form a coherent set of quality
vÒ hÖ thèng qu¶n lý chÊt l−îng t¹o ®iÒu kiÖn thuËn lîi management system standards facilitating mutual
cho viÖc th«ng hiÓu lÉn nhau trong th−¬ng m¹i quèc gia understanding in national and international trade.
v quèc tÕ.
0.2 Quality management principles
0.2 C¸c nguyªn t¾c cña qu¶n lý chÊt l−îng
§Ó l·nh ®¹o v ®iÒu h nh th nh c«ng mét tæ chøc, To lead and operate an organization successfully,
cÇn ®Þnh h−íng v kiÓm so¸t tæ chøc mét c¸ch hÖ it is necessary to direct and control it in a
thèng v râ r ng. Cã thÓ ®¹t ®−îc th nh c«ng nhê systematic and transparent manner. Success can
duy tr× mét hÖ thèng qu¶n lý chÊt result from implementing and maintaining a
¸p dông v
l−îng ®−îc thiÕt kÕ ®Ó c¶i tiÕn liªn tôc kÕt qu¶ thùc management system that is designed to
hiÖn trong khi vÉn l−u ý ®Õn c¸c nhu cÇu cña c¸c continually improve performance while addressing
bªn quan t©m. ViÖc qu¶n lý mét tæ chøc bao gåm the needs of all interested parties. Managing an
c¸c qui t¾c cña qu¶n lý chÊt l−îng, trong sè c¸c organization encompasses quality management
6
- tCVN ISO 9000 : 2007
lÜnh vùc qu¶n lý kh¸c. amongst other management disciplines.
T¸m nguyªn t¾c cña qu¶n lý chÊt l−îng ®−îc nhËn Eight quality management principles have been
biÕt ®Ó l·nh ®¹o cao nhÊt cã thÓ sö dông nh»m identified that can be used by top management in order
dÉn d¾t tæ chøc ®¹t ®−îc kÕt qu¶ cao h¬n. to lead the organization towards improved performance.
a) H−íng v o kh¸ch h ng a) Customer focus
Mäi tæ chøc ®Òu phô thuéc v o kh¸ch h ng cña m×nh v Organizations depend on their customers and therefore
v× thÕ cÇn hiÓu c¸c nhu cÇu hiÖn t¹i v t−¬ng lai cña should understand current and future customer needs,
kh¸ch h ng, cÇn ®¸p øng c¸c yªu cÇu cña kh¸ch h ng should meet customer requirements and strive to
v cè g¾ng vuît cao h¬n sù mong ®îi cña hä. exceed customer expectations.
b) Sù l nh ®¹o b) Leadership
L·nh ®¹o thiÕt lËp sù thèng nhÊt gi÷a môc ®Ých v Leaders establish unity of purpose and direction of the
ph−¬ng h−íng cña tæ chøc. L·nh ®¹o cÇn t¹o ra v duy organization. They should create and maintain the
tr× m«i tr−êng néi bé ®Ó cã thÓ ho n to n l«i cuèn mäi internal environment in which people can become fully
ng−êi tham gia ®Ó ®¹t ®−îc c¸c môc tiªu cña tæ chøc. involved in achieving the organization's objectives.
c) Sù tham gia cña mäi ng−êi c) Involvement of people
Mäi ng−êi ë tÊt c¶ c¸c cÊp l yÕu tè cña mét tæ chøc v People at all levels are the essence of an organization
viÖc huy ®éng hä tham gia ®Çy ®ñ sÏ gióp cho viÖc sö and their full involvement enables their abilities to be
dông ®−îc n¨ng lùc cña hä v× lîi Ých cña tæ chøc. used for the organization's benefit.
d) C¸ch tiÕp cËn theo qu¸ tr×nh d) Process approach
KÕt qu¶ mong muèn sÏ ®¹t ®−îc mét c¸ch hiÖu qu¶ khi A desired result is achieved more efficiently when
c¸c nguån lùc v c¸c ho¹t ®éng cã liªn quan ®−îc qu¶n activities and related resources are managed as a
lý nh− mét qu¸ tr×nh. process.
e) C¸ch tiÕp cËn theo hÖ thèng ®èi víi qu¶n lý e) System approach to management
ViÖc x¸c ®Þnh, hiÓu v qu¶n lý c¸c qu¸ tr×nh cã liªn quan Identifying, understanding and managing interrelated
lÉn nhau nh− mét hÖ thèng sÏ ®em l¹i hiÖu lùc v hiÖu processes as a system contributes to the organization's
qu¶ cña tæ chøc nh»m ®¹t ®−îc c¸c môc tiªu ®Ò ra. effectiveness and efficiency in achieving its objectives.
f) C¶i tiÕn liªn tôc f) Continual Improvement
C¶i tiÕn liªn tôc c¸c kÕt qu¶ thùc hiÖn ph¶i l môc Continual improvement of the organization's overall
tiªu th−êng trùc cña tæ chøc. performance should be a permanent objective of the
organization.
g) Factual approach to decision making
g) QuyÕt ®Þnh dùa trªn sù kiÖn
Mäi quyÕt ®Þnh cã hiÖu lùc ®−îc dùa trªn viÖc Effective decisions are based on the analysis of data
and information.
ph©n tÝch d÷ liÖu v th«ng tin.
7
- tCVN ISO 9000 : 2007
h) Quan hÖ hîp t¸c cïng cã lîi víi ng−êi cung øng h) Mutually beneficial supplier relationships
Tæ chøc v ng−êi cung øng phô thuéc lÉn nhau v An organization and its suppliers are interdependent
mèi quan hÖ cïng cã lîi sÏ n©ng cao n¨ng lùc cña and a mutually beneficial relationship enhances the
c¶ hai bªn ®Ó t¹o ra gi¸ trÞ. ability of both to create value.
T¸m nguyªn t¾c qu¶n lý chÊt l−îng n y t¹o th nh These eight quality management principles form the
c¬ së cho c¸c tiªu chuÈn vÒ hÖ thèng qu¶n lý chÊt basis for the quality management system standards
within the ISO 9000 family.
l−îng trong bé TCVN ISO 9000.
8
- tCVN ISO 9000 : 2007
Tiªu chuÈn quèc gia * national standard TCVN ISO 9000:2007
XuÊt b¶n lÇn 3
Third edition
HÖ thèng qu¶n lý chÊt l−îng − C¬ së v tõ vùng
Quality management − Fundamentals and vocabulary
1 Ph¹m vi ¸p dông 1 Scope
Tiªu chuÈn n y m« t¶ c¬ së cña c¸c hÖ thèng qu¶n lý This standard describes fundamentals of quality
chÊt l−îng, mét ®èi t−îng cña bé tiªu chuÈn TCVN ISO management systems, which form the subject of
9000, v x¸c ®Þnh c¸c thuËt ng÷ cã liªn quan. the ISO 9000 family, and defines related terms.
Tiªu chuÈn n y ®−îc ¸p dông cho nh÷ng ®èi t−îng sau: This standard is applicable to the following:
a) c¸c tæ chøc muèn cã nh÷ng lîi Ých th«ng qua viÖc ¸p a) organizations seeking advantage through the
implementation of a quality management system;
dông mét hÖ thèng qu¶n lý chÊt l−îng;
b) c¸c tæ chøc muèn cã sù tin t−ëng ®èi víi ng−êi cung b) organizations seeking confidence from their
øng r»ng c¸c yªu cÇu ®èi víi s¶n phÈm cña hä sÏ ®−îc suppliers that their product requirements will be
satisfied;
®¸p øng;
c) users of the products;
c) ng−êi sö dông s¶n phÈm;
d) nh÷ng ng−êi quan t©m ®Õn sù th«ng hiÓu lÉn nhau d) those concerned with a mutual understanding
c¸c thuËt ng÷ dïng trong viÖc qu¶n lý chÊt l−îng (vÝ dô of the terminology used in quality management
(e.g. suppliers, customers, regulators);
nh−: ng−êi cung øng, kh¸ch h ng, c¬ quan ®Þnh chÕ)
e) nh÷ng ng−êi thuéc néi bé hay bªn ngo i tæ chøc cã e) those internal or external to the organization
nhiÖm vô ®¸nh gi¸ hÖ thèng qu¶n lý chÊt l−îng hay who assess the quality management system or
®¸nh gi¸ sù phï hîp cña hÖ thèng ®ã theo c¸c yªu cÇu audit it for conformity with the requirements of ISO
cña TCVN ISO 9001 (vÝ dô nh−: chuyªn gia ®¸nh gi¸, 9001 (e.g. auditors, regulators, certification /
registration bodies);
c¬ quan ®Þnh chÕ, c¸c tæ chøc chøng nhËn/®¨ng ký);
f) nh÷ng ng−êi thuéc néi bé hay bªn ngo i tæ chøc cã f) those internal or external to the organization who give
nhiÖm vô t− vÊn hoÆc ® o t¹o vÒ hÖ thèng qu¶n lý chÊt advice or training on -the quality management system
appropriate to that organization;
l−îng cho thÝch hîp víi tæ chøc ®ã;
g) developers of related standards.
g) tæ chøc x©y dùng c¸c tiªu chuÈn liªn quan.
2 Fundamentals of quality management systems
2 C¬ së cña hÖ thèng qu¶n lý chÊt l−îng
2.1 Rationale for quality management systems
2.1 Môc ®Ých cña hÖ thèng qu¶n lý chÊt l−îng
9
- tCVN ISO 9000 : 2007
HÖ thèng qu¶n lý chÊt l−îng cã thÓ gióp c¸c tæ chøc Quality management systems can, assist organizations
n©ng cao sù tho¶ m·n cña kh¸ch h ng. in enhancing customer satisfaction.
Kh¸ch h ng ®ßi hái s¶n phÈm cã nh÷ng ®Æc tÝnh tho¶ Customers rsequire products with characteristics that
m·n nhu cÇu v mong ®îi cña hä. Nhu cÇu v mong satisfy their needs and expectations. These need'; and
®îi n y ®−îc thÓ hiÖn ë c¸c qui ®Þnh cho s¶n phÈm v expectations are expressed in product specifications
®−îc gäi chung l c¸c yªu cÇu cña kh¸ch h ng. Yªu and collectively referred to as customer requirements.
cÇu cña kh¸ch h ng cã thÓ ®−îc qui ®Þnh d−íi d¹ng hîp Customer requirements may be specified contractually
®ång hoÆc do chÝnh tæ chøc x¸c ®Þnh. Trong mäi tr−êng by the customer or may be determined by the
hîp, kh¸ch h ng ®Òu l ng−êi quyÕt ®Þnh cuèi cïng vÒ organization itself. In either case, the customer
viÖc chÊp nhËn s¶n phÈm. Do nhu cÇu v mong ®îi cña ultimately determines the acceptability of the product.
kh¸ch h ng thay ®æi, do ¸p lùc c¹nh tranh v tiÕn bé kü Because customer needs and-expectations are
thuËt nªn c¸c tæ chøc còng ph¶i liªn tôc c¶i tiÕn s¶n changing, organizations are driven to improve
phÈm v c¸c qu¸ tr×nh cña hä. continually their products and processes.
Ph−¬ng ph¸p hÖ thèng trong qu¶n lý chÊt l−îng khuyÕn The quality management system approach encourages
khÝch c¸c tæ chøc ph©n tÝch c¸c yªu cÇu cña kh¸ch organizations to analyse customer requirements, define the
h ng, x¸c ®Þnh ®−îc c¸c qu¸ tr×nh gióp cho s¶n phÈm processes that contribute to the achievement of a product
®−îc kh¸ch h ng chÊp nhËn v gi÷ c¸c qu¸ tr×nh n y which is acceptable to the customer, and to keep these
trong tÇm kiÓm so¸t. Mét hÖ thèng qu¶n lý chÊt l−îng cã processes under control. A quality management system can
thÓ cung cÊp c¬ së cho viÖc c¶i tiÕn kh«ng ngõng nh»m provide the framework for continual improvement to increase
t¨ng kh¶ n¨ng tháa m·n kh¸ch h ng v c¸c bªn cã liªn the probability of enhancing customer satisfaction and the
quan kh¸c. Nã t¹o ra sù tin t−ëng cho tæ chøc v kh¸ch satisfaction of other interested parties. It provides confidence
h ng vÒ kh¶ n¨ng cung cÊp s¶n phÈm lu«n ®¸p øng to the organization and its customers that it is able to provide
c¸c yªu cÇu products that consistently fulfil requirements.
2.2 C¸c yªu cÇu cña hÖ thèng qu¶n lý chÊt l−îng 2.2 Requirements for quality management systems
v c¸c yªu cÇu ®èi víi s¶n phÈm and requirements for products
Bé tiªu chuÈn TCVN ISO 9000 ph©n biÖt c¸c yªu cÇu The ISO 9000 family distinguishes between
®èi víi hÖ thèng qu¶n lý chÊt l−îng víi c¸c yªu cÇu ®èi requirements for quality management systems and
víi s¶n phÈm. requirements for products.
Yªu cÇu ®èi víi hÖ thèng qu¶n lý chÊt l−îng ®−îc qui Requirements for quality management systems are
®Þnh trong TCVN ISO 9001. C¸c yªu cÇu ®èi víi hÖ specified in ISO 9001. Requirements for quality
thèng qu¶n lý chÊt l−îng mang tÝnh tæng qu¸t v cã thÓ management systems are generic and applicable to
¸p dông cho c¸c tæ chøc trong mäi ng nh c«ng nghiÖp organizations in any industry or economic sector
hay c¸c khu vùc kinh tÕ bÊt kÓ lo¹i h×nh s¶n phÈm ®−îc regardless of the offered product category. ISO 9001
cung cÊp. Tiªu chuÈn TCVN ISO 9001 kh«ng qui ®Þnh itself does not establish requirements for products.
yªu cÇu cho s¶n phÈm.
C¸c yªu cÇu cho s¶n phÈm cã thÓ do kh¸ch h ng hay Requirements for products can be specified by customers
10
- tCVN ISO 9000 : 2007
tæ chøc qui ®Þnh cã tÝnh ®Õn c¸c yªu cÇu cña kh¸ch or by the organization in anticipation of customer
h ng hay c¸c chÕ ®Þnh. C¸c yªu cÇu ®èi víi s¶n phÈm requirements, or by regulation. The requirements for
v , trong mét sè tr−êng hîp, c¸c qu¸ tr×nh kÌm theo cã products and in some cases associated processes can be
thÓ n»m trong c¸c t i liÖu nh− qui ®Þnh ký thuËt, tiªu contained in, for example, technical specifications, product
chuÈn cho s¶n phÈm, c¸c tiªu chuÈn cho qu¸ tr×nh, c¸c standards, process standards, contractual agreements
tho¶ thuËn trong hîp ®ång v c¸c yªu cÇu chÕ ®Þnh and regulatory requirements.
2.3 C¸ch tiÕp cËn theo hÖ thèng qu¶n lý chÊt l−îng 2.3 Quality management systems approach
Ph−¬ng ph¸p x©y dùng v ¸p dông mét hÖ thèng qu¶n An approach to developing and implementing a
lý chÊt l−îng bao gåm mét sè b−íc, trong ®ã cã c¸c quality management system consists of several
b−íc sau ®©y: steps including the following:
a) x¸c ®Þnh nhu cÇu v mong ®îi cña kh¸ch h ng v a) determining the needs and expectations of
c¸c bªn quan t©m kh¸c; customers and other interested parties;
b) thiÕt lËp chÝnh s¸ch chÊt l−îng v môc tiªu chÊt l−îng b) establishing the quality policy and quality
cña tæ chøc; objectives of the organization;
c) x¸c ®Þnh c¸c qu¸ tr×nh v tr¸ch nhiÖm cÇn thiÕt ®Ó ®¹t c) determining the processes and responsibilities
®−îc c¸c môc tiªu chÊt l−îng; necessary to attain the quality objectives;
d) X¸c ®Þnh v cung cÊp nguån lùc cÇn thiÕt ®Ó ®¹t ®−îc d) determining and providing the resources
c¸c môc tiªu chÊt l−îng; necessary to attain the quality objectives;
e) thiÕt lËp c¸c ph−¬ng ph¸p ®o hiÖu lùc v hiÖu qu¶ e) establishing methods to measure the effectiveness
cña mçi qu¸ tr×nh; and efficiency of each process:
f) ¸p dông c¸c ph−¬ng ph¸p ®o n y ®Ó x¸c ®Þnh hiÖu lùc f) applying these measures to determine the
v hiÖu qu¶ cña mçi qu¸ tr×nh; effectiveness and efficiency of each process;
g) x¸c ®Þnh c¸c biÖn ph¸p ng¨n ngõa sù kh«ng phï hîp g) determining means of preventing nonconformities
v lo¹i bá c¸c nguyªn nh©n g©y ra chóng; and eliminating their causes;
h) thiÕt lËp v ¸p dông mét qu¸ tr×nh ®Ó c¶i tiÕn liªn tôc h) establishing and applying a process for continual
hÖ thèng qu¶n lý chÊt l−îng improvement of the quality management system.
Cã thÓ ¸p dông ph−¬ng ph¸p nh− vËy ®Ó duy tr× v c¶i Such an approach is also applicable to maintaining and
tiÕn hÖ thèng chÊt l−îng hiÖn t¹i. improving an existing quality management system.
B»ng c¸ch ¸p dông c¸ch tiÕp cËn nh− vËy, tæ chøc t¹o An organization that adopts the above approach creates
ra sù tin t−ëng v o kh¶ n¨ng cña c¸c qu¸ tr×nh v chÊt confidence in the capability of its processes and the
l−îng cña s¶n phÈm, v cung cÊp c¬ së cho c¶i tiÕn liªn quality of its products, and provides a basis for continual
tôc. §iÒu n y cã thÓ dÉn ®Õn t¨ng sù tho¶ m·n cña improvement. This can lead to increased satisfaction of
kh¸ch h ng v c¸c bªn quan t©m kh¸c v th nh c«ng customers and other interested parties and to the
cña c¶ tæ chøc. success of the organization.
11
- tCVN ISO 9000 : 2007
2.4 C¸ch tiÕp cËn theo qu¸ tr×nh 2.4 The process approach
Mäi ho¹t ®éng, hay tËp hîp c¸c ho¹t ®éng sö dông c¸c Any activity, or set of activities, that uses
nguån lùc ®Ó biÕn ®Çu v o th nh ®Çu ra cã thÓ xem nh− resources to transform inputs to outputs can be
mét qu¸ tr×nh. considered as a process.
§Ó c¸c tæ chøc ho¹t ®éng cã hiÖu qu¶, hä ph¶i x¸c ®Þnh For organizations to function effectively, they have to
v qu¶n lý nhiÒu qu¸ tr×nh cã liªn quan v t−¬ng t¸c lÉn identify and manage numerous interrelated and
nhau. Th«ng th−êng, ®Çu ra cña mét qu¸ tr×nh sÏ trùc interacting processes. Often, the output from one
tiÕp t¹o th nh ®Çu v o qu¸ tr×nh tiÕp theo. ViÖc x¸c ®Þnh process will directly form the input into the next process.
mét c¸ch hÖ thèng v qu¶n lý c¸c qu¸ tr×nh ®−îc triÓn The systematic identification and management of the
khai trong tæ chøc v ®Æc biÖt qu¶n lý sù t−¬ng t¸c gi÷a processes employed within an organization and
c¸c qu¸ tr×nh ®ã ®−îc goi l "c¸ch tiÕp cËn theo qu¸ particularly the interactions between such processes is
tr×nh". referred to as the "process approach".
Tiªu chuÈn n y khuyÕn khÝch ¸p dông c¸ch tiÕp cËn The intent of this standard is to encourage the adoption
theo qu¸ tr×nh ®Ó qu¶n lý mét tæ chøc. of the process approach to manage an organization.
H×nh 1 minh ho¹ hÖ thèng qu¶n lý chÊt l−îng dùa trªn Figure 1 illustrates the process-based quality management
qu¸ tr×nh ®−îc m« t¶ trong bé tiªu chuÈn TCVN ISO system described the ISO 9000 family of standards. This
9000. Minh ho¹ n y chØ râ c¸c bªn quan t©m ®ãng vai illustration shows that interested parties play a significant
trß cã ý nghÜa trong viÖc cung cÊp ®Çu v o cho tæ chøc. role in providing inputs to the organization. Monitoring the
ViÖc theo dâi sù tho¶ m·n cña c¸c bªn quan t©m ®ßi satisfaction of interested parties requires the evaluation of
hái viÖc xem xÐt ®¸nh gi¸ th«ng tin cã liªn quan ®Õn sù information relating to the perception of interested parties
c¶m nhËn cña c¸c bªn cã quan t©m vÒ møc ®é ®¸p øng as to the extent to which their needs and expectations
nhu cÇu v mäng ®îi cña hä. M« h×nh biÓu thÞ trong have been met. The model shown in Figure 1 does not
H×nh 1 kh«ng chØ râ c¸c qu¸ tr×nh ë møc ®é chi tiÕt. show processes at a detailed level.
2.5 ChÝnh s¸ch v môc tiªu chÊt l−îng 2.5 Quality policy and quality objectives
ChÝnh s¸ch chÊt l−îng v môc tiªu chÊt l−îng ®−îc thiÕt Quality policy and quality objectives are established to
lËp nh»m ®−a ra träng t©m ®Ó ®Þnh h−íng tæ chøc. C¶ hai provide a focus to direct the organization. Both determine
®Òu nh»m x¸c ®Þnh nh÷ng kÕt qu¶ cÇn ®¹t v gióp tæ chøc the desired results and assist the organization to apply its
sö dông nguån lùc nh»m ®¹t ®−îc c¸c kÕt qu¶ n y. ChÝnh resources to achieve these results. The quality policy
s¸ch chÊt l−îng cung cÊp c¬ së thiÕt lËp v xem xÐt c¸c provides a framework for establishing and reviewing quality
môc tiªu chÊt l−îng. Môc tiªu chÊt l−îng cÇn ph¶i nhÊt objectives. The quality objectives need to be consistent
qu¸n víi chÝnh s¸ch chÊt l−îng v cam kÕt c¶i tiÕn liªn tôc, with the quality policy and the commitment to continual
v c¸c kÕt qu¶ ®¹t ®−îc cÇn ph¶i ®o ®−îc. ViÖc ®¹t ®−îc improvement, and their achievement needs to be
môc tiªu chÊt l−îng cã thÓ cã t¸c ®éng tÝch cùc ®Õn chÊt measurable. The achievement of quality objectives can
l−îng s¶n phÈm, hiÖu lùc t¸c nghiÖp v c¸c kÕt qu¶ ho¹t have a positive impact on product quality, operational
®éng t i chÝnh v nh− vËy t¸c ®éng ®Õn sù tho¶ m·n v tin effectiveness and financial performance and thus on the
t−ëng cña c¸c bªn quan t©m. satisfaction and confidence of interested parties.
12
- tCVN ISO 9000 : 2007
13
- tCVN ISO 9000 : 2007
2.6 Vai trß cña l nh ®¹o cao nhÊt trong hÖ thèng 2.6 Role of top management within the quality
qu¶n lý chÊt l−îng management system
Th«ng qua sù l·nh ®¹o v c¸c h nh ®éng, l·nh ®¹o cao Through leadership and actions, top management can
nhÊt t¹o ra m«i tr−êng ®Ó huy ®éng mäi ng−êi tham gia create an environment where people are fully involved
v ®Ó hÖ thèng qu¶n lý chÊt l−îng ho¹t ®éng cã hiÖu and in which a quality management system can operate
lùc. L·nh ®¹o cÊp cao nhÊt cã thÓ sö dông c¸c nguyªn effectively. The quality management principles (see 0.2)
t¾c cña qu¶n lý chÊt l−îng (xem 0.2) l m c¬ së cho vai can be used by top management as the basis of its role,
trß cña hä , ®ã l : which is as follows:
a) thiÕt lËp v duy tr× chÝnh s¸ch v môc tiªu chÊt l−îng a) to establish and maintain the quality policy and quality
cña tæ chøc; objectives of the organization;
b) phæ biÕn chÝnh s¸ch chÊt l−îng v môc tiªu chÊt b) to promote the quality policy and quality objectives
l−îng trong to n bé tæ chøc ®Ó n©ng cao nhËn thøc, throughout the organization to increase awareness,
®éng viªn v huy ®éng tham gia; motivation and involvement
c) ®¶m b¶o to n bé tæ chøc h−íng v o c¸c yªu cÇu cña c) to ensure focus on customer requirements
kh¸ch h ng; throughout the organization;
d) ®¶m b¶o c¸c qu¸ tr×nh thÝch hîp ®−îc thùc hiÖn ®Ó d) to ensure that appropriate processes are implemented
t¹o kh¶ n¨ng ®¸p øng ®−îc yªu cÇu cña kh¸ch h ng v to enable requirements of customers and other interested
c¸c bªn quan t©m v ®¹t ®−îc môc tiªu chÊt l−îng; parties to be fulfilled and quality objectives to be achieved;
e) ®¶m b¶o thiÕt lËp, thùc thi v duy tr× mét hÖ thèng e) to ensure that an effective and efficient quality
qu¶n lý chÊt l−îng cã hiÖu lùc v hiÖu qu¶, ®Ó ®¹t ®−îc management system is established, implemented and
c¸c môc tiªu chÊt l−îng ®ã; maintained to achieve these quality objectives;
f) ®¶m b¶o cã s½n c¸c nguån lùc cÇn thiÕt; f) to ensure the availability of necessary resources;
g) xem xÐt ®Þnh kú hÖ thèng qu¶n lý chÊt l−îng; g) to review the quality management system periodically;
h) quyÕt ®Þnh c¸c h nh ®éng ®èi víi chÝnh s¸ch chÊt h) to decide on actions regarding the quality policy and
l−îng v môc tiªu chÊt l−îng; quality objectives;
j) quyÕt ®Þnh c¸c h nh ®éng c¶i tiÕn hÖ thèng qu¶n lý k) to decide on actions for improvement of the quality
chÊt l−îng. management system.
2.7 HÖ thèng t i liÖu 2.7 Documentation
2.7.1 Gi¸ trÞ cña hÖ thèng t i liÖu 2.7.1 Value of documentation
HÖ thèng t i liÖu t¹o kh¶ n¨ng th«ng b¸o c¸c ý ®Þnh v sù Documentation enables communication of intent and
nhÊt qu¸n c¸c h nh ®éng. ViÖc sö hÖ thèng t i liÖu gióp: consistency of action. Its use contributes to
a) ®¹t ®−îc sù phï hîp víi c¸c yªu cÇu cña kh¸ch h ng a) achievement of conformity to customer requirements
v c¶i tiÕn chÊt l−îng; and quality improvement;
14
- tCVN ISO 9000 : 2007
b) cung cÊp viÖc ® o t¹o thÝch hîp; b) provision of appropriate training;
c) lÆp l¹i v x¸c ®Þnh nguån gèc; c) repeatability and traceability;
d) cung cÊp b»ng chøng kh¸ch quan; v d) provision of objective evidence, and
e) ®¸nh gi¸ tÝnh hiÖu lùc v sù lu«n thÝch hîp cña hÖ e) evaluation of the effectiveness and continuing
thèng qu¶n lý chÊt l−îng. suitability of the quality management system.
B¶n th©n viÖc t¹o th nh hÖ thèng t i liÖu kh«ng ph¶i l Generation of documentation should not be an end in
môc ®Ých m cÇn ph¶i l mét ho¹t ®éng gia t¨ng gi¸ trÞ itself but should be a value-adding activity.
2.7.2 C¸c lo¹i t i liÖu ®−îc sö dông trong hÖ thèng 2.7.2 Types of document used in quality management
qu¶n lý chÊt l−îng systems
C¸c lo¹i t i liÖu sau ®−îc sö dông trong hÖ thèng qu¶n The following types of document are used in quality
lý chÊt l−îng: management systems:
a) t i liÖu cung cÊp nh÷ng th«ng tin nhÊt qu¸n, c¶ cho a) documents that provide consistent information, both
néi bé v bªn ngo i, vÒ hÖ thèng qu¶n lý chÊt l−îng cña internally and externally, about the organization's quality
tæ chøc; nh÷ng t i liÖu n y ®−îc gäi l sæ tay chÊt l−îng management system; such documents are referred to
as quality manuals;
b) t i liÖu miªu t¶ c¸ch thøc ¸p dông hÖ thèng qu¶n lý b) documents that describe how the quality management
chÊt l−îng ®èi víi mét s¶n phÈm, dù ¸n, hîp ®ång cô system is applied to a specific product, project or contract;
thÓ; nh÷ng t i liÖu n y ®−îc gäi l kÕ ho¹ch chÊt l−îng; such documents are referred to as quality plans;
c) t i liÖu c«ng bè c¸c yªu cÇu; nh÷ng t i liÖu n y ®−îc c) documents stating requirements; such documents
gäii l c¸c qui ®Þnh; are referred to as specifications;
d) t i liÖu cung cÊp c¸c khuyÕn nghÞ hay gîi ý; nh÷ng t i d) documents stating recommendations or sugge; such
liÖu n y gäi l h−íng dÉn; documents are referred to as guidelines;
e) t i liÖu cung cÊp c¸c th«ng tin vÒ c¸ch thøc tiÕn h nh e) documents that provide information about how to
c¸c ho¹t ®éng v qu¸ tr×nh mét c¸ch nhÊt qu¸n; nh÷ng perform activities and processes consistently; such
t i liÖu n y cã thÓ bao gåm c¸c thñ tôc, h−íng dÉn c«ng documents can include documented procedures, work
viÖc v b¶n vÏ; instructions and drawings;
f) t i liÖu cung cÊp nh÷ng b»ng chøng kh¸ch quan vÒ f) documents that provide objective evidence of activities
c¸c ho¹t ®éng ®· ®−îc thùc hiÖn hay kÕt qu¶ ®¹t ®−îc; performed or results achieved; such documents are
nh÷ng t i liÖu n y gäi l hå s¬. referred to as records.
Mçi tæ chøc x¸c ®Þnh møc ®é cña hÖ thèng t i liÖu cÇn Each organization determines the extent of documentation
thiÕt v ph−¬ng tiÖn th«ng tin ®−îc sö dông. §iÒu n y required and the media to be used. This depends on
phô thuéc v o c¸c yÕu tè nh− quy m« v lo¹i h×nh tæ factors such as the type and size of the organization, the
chøc, sù phøc t¹p cña s¶n phÈm, yªu cÇu cña kh¸ch complexity and interaction of processes, the complexity of
h ng, c¸c yªu cÇu chÕ ®Þnh t−¬ng øng, n¨ng lùc cña products, customer requirements, the applicable regulatory
15
- tCVN ISO 9000 : 2007
nh©n viªn ®· ®−îc chøng minh, v møc ®é cÇn thiÕt ®Ó requirements, the demonstrated ability of personnel, and
chøng tá viÖc thùc hiÖn c¸c yªu cÇu cña hÖ thèng qu¶n the extent to which it is necessary to demonstrate
lý chÊt l−îng. fulfillment of quality management system requirements.
2.8 Xem xÐt ®¸nh gi¸ hÖ thèng qu¶n lý chÊt l−îng 2.8 Evaluating quality management systems
2.8.1 Xem xÐt ®¸nh gi¸ c¸c qu¸ tr×nh trong hÖ 2.8.1 Evaluating processes within the quality
thèng qu¶n lý chÊt l−îng management system
Khi xem xÐt ®¸nh gi¸ hÖ thèng qu¶n lý chÊt l−îng, cã When evaluating quality management systems, there
bèn c©u hái c¬ b¶n cÇn ®Æt ra liªn quan ®Õn mäi qu¸ are four basic questions that should be asked in relation
tr×nh ®−îc ®¸nh gi¸: to every process being evaluated.
a) c¸c qu¸ tr×nh cã ®−îc nhËn biÕt v c¸c x¸c ®Þnh tho¶ ®¸ng? a) Is the process identified and appropriately defined?
b) cã ph©n c«ng tr¸ch nhiÖm? b) Are responsibilities assigned?
c) c¸c thñ tôc cã ®−îc ¸p dông v duy tr×? c) Are the procedures implemented and maintained?
d) qu¸ tr×nh n y cã hiÖu lùc ®Ó ®¹t ®−îc kÕt qu¶ ®Æt ra? d) Is the process effective in achieving the required results?
TËp hîp c¸c cÇu tr¶ lêi cho nh÷ng cÇu hái trªn cã thÓ The collective answers to the above questions can
x¸c ®Þnh ®−îc kÕt qu¶ cña viÖc xem xÐt ®¸nh gi¸. Xem determine the result of the evaluation. Evaluation of a
xÐt ®¸nh gi¸ mét hÖ thèng qu¶n lý chÊt l−îng cã thÓ quality management system can vary in scope and
thay ®æi tuú thuéc v o ph¹m vi v bao gåm nhiÒu d¹ng encompass a range of activities, such as auditing and
ho¹t ®éng, nh− ®¸nh gi¸ v xem xÐt hÖ thèng qu¶n lý reviewing the quality management system, and self-
chÊt l−îng v tù xem xÐt ®¸nh gi¸. assessments.
2.8.2 §¸nh gi¸ hÖ thèng qu¶n lý chÊt l−îng 2.8.2 Auditing the quality management system
§¸nh gi¸ ®−îc sö dông ®Ó xem xÐt møc ®é thùc hiÖn Audits are used to determine the extent to which the
c¸c yªu cÇu cña hÖ thèng qu¶n lý chÊt l−îng. C¸c kÕt quality management system requirements are fulfilled.
qu¶ ®¸nh gi¸ ®−îc sö dông ®Ó x¸c ®Þnh hiÖu lùc cña hÖ Audit findings are used to assess the effectiveness of
thèng qu¶n lý chÊt l−îng v c¸c c¬ héi c¶i tiÕn. the quality management system and to identify
opportunities for improvement.
§¸nh gi¸ cña bªn thø nhÊt ®−îc chÝnh tæ chøc, hay First-party audits are conducted by, or on behalf of, the
ng−êi ®¹i diÖn cña tæ chøc ®ã tiÕn h nh, v× môc ®Ých néi organization itself for internal purposes and can form the
bé v cã thÓ dïng l m c¬ së cho viÖc tù c«ng bè cña tæ basis for an organization's self -declaration of
chøc vÒ sù phï hîp. conformity.
§¸nh gi¸ cña bªn thø hai ®−îc thùc hiÖn bëi kh¸ch Second-party audits are conducted by customers of the
h ng cña tæ chøc hay ®¹i diÖn cña kh¸ch h ng. organization or by other persons on behalf of the customer.
§¸nh gi¸ cña bªn thø ba ®−îc thùc hiÖn bëi c¸c tæ chøc Third-party audits are conducted by external independent
®éc lËp bªn ngo i. Nh÷ng tæ chøc nh− vËy, th−êng ®−îc audit service organizations. Such organizations, usually
c«ng nhËn, sÏ chøng nhËn sù phï hîp víi c¸c yªu cÇu accredited, provide certification or registration of conformity
16
- tCVN ISO 9000 : 2007
vÝ dô nh− yªu cÇu cña TCVN ISO 9001. with equirements such as those of ISO 9001.
TCVN ISO 19011 cung cÊp h−íng dÉn cho viÖc ®¸nh gi¸. ISO 19011 provides guidance on auditing.
2.8.3 Xem xÐt hÖ thèng qu¶n lý chÊt l−îng 2.8.3 Reviewing the quality management system
Mét vai trß cña l·nh ®¹o cao nhÊt l xem xÐt ®¸nh gi¸ One role of top management is to carry out regular
®Þnh kú hÖ thèng qu¶n lý chÊt l−îng vÒ sù thÝch hîp, phï systematic evaluations of the suitability, adequacy,
hîp, hiÖu lùc v hiÖu qu¶ cña hÖ thèng qu¶n lý chÊt effectiveness and efficiency of the quality management
l−îng theo chÝnh s¸ch chÊt l−îng v môc tiªu chÊt system with respect to the quality policy and quality
l−îng. ViÖc xem xÐt n y cã thÓ bao gåm nghiªn cøu objectives. This review can include consideration of the
nhu cÇu thay ®æi chÝnh s¸ch v môc tiªu chÊt l−îng cho need to adapt the quality policy and objectives in
phï hîp víi c¸c nhu cÇu v sù mong ®îi lu«n thay ®æi response to changing needs and expectations of
cña c¸c bªn quan t©m. ViÖc xem xÐt bao gåm c¶ x¸c interested parties. The review includes determination of
®Þnh sù cÇn thiÕt ph¶i cã c¸c h nh ®éng. the need for actions.
Trong sè c¸c nguån th«ng tin kh¸c, c¸c b¸o c¸o ®¸nh gi¸ Amongst other sources of information, audit reports are
®−îc sö dông ®Ó xem xÐt hÖ thèng qu¶n lý chÊt l−îng. used for review of the quality management system.
2.8.4 Tù xem xÐt ®¸nh gi¸ 2.8.4 Self-assessment
ViÖc tù xem xÐt ®¸nh gi¸ cña mét tæ chøc l sù xem xÐt An organization's self-assessment is a comprehensive
mét c¸ch to n diÖn v hÖ thèng c¸c ho¹t ®éng v kÕt and systematic review of the organization's activities
qu¶ cña tæ chøc so víi hÖ thèng qu¶n lý chÊt l−îng hay and results referenced against the quality management
m« h×nh tuyÖt h¶o. system or a model of excellence.
ViÖc tù xem xÐt ®¸nh gi¸ cã thÓ cung cÊp mét c¸ch nh×n Self -assessment can provide an overall view of the
tæng qu¸t vÒ kÕt qu¶ thùc hiÖn cña tæ chøc v møc ®é performance of the organization and the degree of
ho n thiÖn hÖ thèng qu¶n lý chÊt l−îng. Nã còng gióp maturity of the quality management system. It can also
®Ó x¸c ®Þnh lÜnh vùc cÇn c¶i tiÕn trong tæ chøc v x¸c help to identify areas requiring improvement in the
®Þnh sù −u tiªn. organization and to determine priorities.
2.9 C¶i tiÕn liªn tôc 2.9 Continual improvement
Môc ®Ých c¶i tiÕn liªn tôc mét hÖ thèng qu¶n lý chÊt The aim of continual improvement of a quality management
l−îng l ®Ó t¨ng c−êng kh¶ n¨ng n©ng cao sù tho¶ m·n system is to increase the probability of enhancing the
cña kh¸ch h ng v c¸c bªn quan t©m kh¸c. C¸c h nh satisfaction of customers and other interested parties.
®éng c¶i tiÕn bao gåm c¶ nh÷ng ho¹t ®éng sau: Actions for improvement include the following:
a) ph©n tÝch v xem xÐt ®¸nh gi¸ t×nh tr¹ng hiÖn t¹i ®Ó a) analysing and evaluating the existing situation to
x¸c ®Þnh lÜnh vùc c¶i tiÕn; identify areas for improvement';
b) thiÕt lËp môc tiªu c¶i tiÕn; b) establishing the objectives for improvement;
c) t×m kiÕm gi¶i ph¸p cã thÓ ®¹t c¸c môc tiªu n y; c) searching for possible solutions to achieve the objectives;
17
- tCVN ISO 9000 : 2007
d) xem xÐt ®¸nh gi¸ c¸c gi¶i ph¸p n y v lùa chän; d) evaluating these solutions and making a selection;
e) thùc hiÖn c¸c gi¶i ph¸p ®−îc lùa chän; e) implementing the selected solution;
f) ®o l−êng, kiÓm tra x¸c nhËn, ph©n tÝch v xem xÐt f) measuring, verifying, analysing and evaluating results
®¸nh gi¸ c¸c kÕt qu¶ thùc hiÖn ®Ó x¸c ®Þnh viÖc ®¹t c¸c of the implementation to determine that the objectives
môc tiªu; have been met;
g) chÝnh thøc ho¸ nh÷ng thay ®æi. g) formalizing changes.
Khi cÇn thiÕt, c¸c kÕt qu¶ ®−îc xem xÐt ®Ó x¸c ®Þnh c¬ Results are reviewed, as necessary, to determine
héi c¶i tiÕn tiÕp theo. Theo c¸ch thøc n y, c¶i tiÕn l mét further opportunities for improvement. In this way,
ho¹t ®éng kh«ng ngõng. C¸c ph¶n håi cña kh¸ch h ng improvement is a continual activity. Feedback from
v c¸c bªn quan t©m kh¸c, c¸c cuéc ®¸nh gi¸, xem xÐt customers and other interested parties, audits and
hÖ thèng qu¶n lý chÊt l−îng còng cã thÓ ®−îc sö dông review of the quality management system can also be
®Ó x¸c ®Þnh c¬ héi c¶i tiÕn. used to identify opportunities for improvement.
2.10 Vai trß cña kü thuËt thèng kª 2.10 Role of statistical techniques
ViÖc sö dông kü thuËt thèng kª gióp cho hiÓu biÕt ®−îc The use of statistical techniques can help in understanding
sù biÕn ®éng, bëi vËy sÏ gióp tæ chøc gi¶i quyÕt ®−îc variability, and thereby can help organizations to solve
c¸c vÊn ®Ò x¶y ra v n©ng cao hiÖu lùc v hiÖu qu¶. Kü problems and improve effectiveness and efficiency. These
thuËt n y còng cã thÓ t¹o ®iÒu kiÖn sö dông tèt h¬n c¸c techniques also facilitate better use of available data to
d÷ liÖu s½n cã ®Ó trî gióp viÖc ®−a ra c¸c quyÕt ®Þnh. assist in decision making.
Sù biÕn ®éng cã thÓ ®−îc quan s¸t dùa trªn c¸ch thøc Variability can be observed in the behaviour and
v kÕt qu¶ cña nhiÒu ho¹t ®éng, thËm chÝ d−íi ®iÒu kiÖn outcome of many activities, even under conditions of
æn ®Þnh râ r ng. Sù biÕn ®éng ®ã cã thÓ ®−îc quan s¸t apparent stability. Such variability can be observed in
dùa trªn c¸c ®Æc tÝnh ®o ®−îc cña s¶n phÈm v qu¸ measurable characteristics of products and processes.
tr×nh, v cã thÓ tån t¹i ë c¸c giai ®o¹n kh¸c nhau xuyªn and may be seen to exist at various stages over the life
suèt chu kú sèng cña s¶n phÈm tõ nghiªn cøu thÞ tr−êng cycle of products from market research to customer
®Õn dÞch vô kh¸ch h ng v viÖc xö lý cuèi cïng. service and final disposal.
Kü thuËt thèng kª gióp cho viÖc ®o l−êng, m« t¶, ph©n Statistical techniques can help to measure, describe,
tÝch, gi¶i thÝch v lËp m« h×nh nh÷ng biÕn ®éng nh− vËy, analyse, interpret and model such variability, even with a
thËm chÝ víi mét khèi l−îng d÷ liÖu kh¸ h¹n chÕ. Ph©n relatively limited amount of data. Statistical analysis of
tÝch thèng kª ®èi víi nh÷ng d÷ liÖu nh− vËy cã thÓ gióp such data can help to provide a better understanding of
hiÓu tèt h¬n b¶n chÊt, møc ®é v nguyªn nh©n cña sù the nature, extent and causes of variability, thus helping
biÕn ®éng. §iÒu n y gióp cho viÖc gi¶i quyÕt, thËm chÝ to solve and even prevent problems that may result
ng¨n ngõa nh÷ng vÊn ®Ò cã thÓ x¶y ra tõ sù biÕn ®éng from such variability, and to promote continual
®ã, v thóc ®Èy c¶i tiÕn liªn tôc. improvement.
H−íng dÉn vÒ c¸c kü thuËt thèng kª trong hÖ thèng Guidance on statistical techniques in a quality
qu¶n lý chÊt l−îng ®−îc tr×nh b y trong b¸o c¸o kü thuËt management system is given in ISO/TR 10017.
18
- tCVN ISO 9000 : 2007
ISO/TR 10017.
2.11 Quality management systems and other
2.11 Träng t©m cña hÖ thèng qu¶n lý chÊt l−îng v
management system focuses
c¸c hÖ thèng kh¸c
HÖ thèng qu¶n lý chÊt l−îng l mét phÇn cña hÖ thèng The quality management system is that part of the
qu¶n lý cña tæ chøc tËp trung v o viÖc ®¹t ®−îc ®Çu ra organization's management system that focuses on the
(kÕt qu¶), cã liªn quan ®Õn môc tiªu chÊt l−îng, nh»m achievement of results, in relation to the quality
tho¶ m·n nhu cÇu, mong ®îi v yªu cÇu cña kh¸ch objectives, to satisfy the needs, expectations and
h ng v c¸c bªn quan t©m mét c¸ch thÝch hîp. C¸c requirements of interested parties, as appropriate. The
môc tiªu chÊt l−îng bæ sung cho c¸c môc tiªu kh¸c cña quality objectives complement other objectives of the
tæ chøc nh− nh÷ng môc tiªu liªn quan ®Õn t¨ng tr−ëng, organization such as those related to growth, funding,
ng©n quü, lîi nhuËn, m«i tr−êng, søc khoÎ v an to n profitability, the environment and occupational health and
nghÒ nghiÖp. C¸c phÇn kh¸c nhau cña hÖ thèng qu¶n lý safety. The various parts of an organization's
cña tæ chøc cã thÓ ®−îc hîp nhÊt ho¸ víi hÖ thèng management system might be integrated, together with
qu¶n lý chÊt l−îng th nh mét hÖ thèng qu¶n lý duy nhÊt the quality management system, into a single
sö dông c¸c yÕu tè chung. §iÒu n y t¹o thuËn lîi cho management system using common elements. This can
viÖc ho¹ch ®Þnh, ph©n bæ nguån lùc, x¸c ®Þnh c¸c môc facilitate planning, allocation of resources, definition of
tiªu bæ sung v xem xÐt ®¸nh gi¸ hiÖu lùc chung cña tæ complementary objectives and evaluation of the overall
chøc. HÖ thèng qu¶n lý cña tæ chøc cã thÓ ®−îc ®¸nh effectiveness of the organization. The organization's
gi¸ theo nh÷ng yªu cÇu vÒ hÖ thèng qu¶n lý cña tæ chøc management system can be assessed against the
®ã. HÖ thèng qu¶n lý n y còng cã thÓ ®−îc ®¸nh gi¸ organization's management system requirements. The
management system can also be audited against the
theo nh÷ng yªu cÇu tiªu chuÈn nh− TCVN ISO 9001 v
TCVN ISO 14001. ViÖc ®¸nh gi¸ hÖ thèng qu¶n lý n y requirements of International Standards such as ISO
9001 and ISO14001. These management system audits
cã thÓ ®−îc thùc hiÖn mét c¸ch riªng rÏ hoÆc kÕt hîp .
can be carried out separately or in combination.
2.12 Mèi quan hÖ gi÷a c¸c hÖ th«ng qu¶n lý chÊt 2.12 Relationship between quality management
systems and excellence models
l−îng v c¸c m« h×nh tuyÖt h¶o
C¸c c¸ch tiÕp cËn cña hÖ thèng qu¶n lý chÊt l−îng The approaches of quality management systems given
trong bé tiªu chuÈn TCVN ISO 9000 v trong c¸c m« in the ISO 9000 family of standards and in
h×nh tuyÖt h¶o vÒ tæ chøc dùa trªn nh÷ng nguyªn t¾c organizational excellence models are based on
common principles. Both approaches
chung. C¶ hai ®Òu:
a) enable an organization to identify its strengths and
a) t¹o ®iÒu kiÖn cho tæ chøc x¸c ®Þnh c¸c ®iÓm m¹nh v
weaknesses;
®iÓm yÕu;
b) cã c¸c ®iÒu kho¶n ®Ó xem xÐt ®¸nh gi¸ theo c¸c m« b) contain provision for evaluation against generic
models;
h×nh tæng qu¸t;
c) provide a basis for continual improvement, and
c) cung cÊp c¬ së ®Ó c¶i tiÕn liªn tôc, v
19
- tCVN ISO 9000 : 2007
d) cã c¸c ®iÒu kho¶n ®Ó ®−îc sù thõa nhËn tõ bªn ngo i. d) contain provision for external recognition.
Sù kh¸c nhau gi÷a bé tiªu chuÈn TCVN ISO 9000 v The difference between the approaches of the quality
c¸c m« h×nh tuyÖt h¶o l ë ph¹m vi ¸p dông. Bé TCVN management systems in the ISO 9000 family of the
ISO 9000 cung cÊp c¸c yªu cÇu ®èi víi hÖ thèng qu¶n excellence models lies in their scope of application. The
lý chÊt l−îng v h−íng dÉn ®Ó c¶i tiÕn kÕt qu¶ thùc hiÖn; ISO 9000 family of standards provides requirements for
viÖc xem xÐt ®¸nh gi¸ hÖ thèng qu¶n lý chÊt l−îng x¸c quality management systems and guidance for
®Þnh møc ®é thùc hiÖn c¸c yªu cÇu ®ã. C¸c m« h×nh performance improvement; evaluation of quality
tuyÖt h¶o cã c¸c chuÈn mùc gióp cho viÖc xem xÐt ®¸nh management systems determines fulfilment of those
gi¸ mang tÝnh so s¸nh kÕt qu¶ thùc hiÖn cña tæ chøc v requirements. The excellence models contain criteria that
cã thÓ ¸p dông cho mäi ho¹t ®éng v c¸c bªn cã quan enable comparative evaluation of organizational
t©m cña tæ chøc. C¸c chuÈn mùc ®¸nh gi¸ trong m« performance and this is applicable to all activities and all
h×nh tuyÖt h¶o cung cÊp c¬ së ®Ó mét tæ chøc so s¸nh interested parties of an organization. Assessment criteria in
kÕt qu¶ thùc hiÖn cña tæ chøc víi ho¹t ®éng cña c¸c tæ excellence models provide a basis for an organization to
chøc kh¸c. compare its performance with the performance of other
organizations.
3 ThuËt ng÷ v ®Þnh nghÜa 3 Terms and definitions
Mét thuËt ng÷ trong mét ®Þnh nghÜa hay trong chó thÝch, A term in a definition or note which is defined elsewhere
®−îc ®Þnh nghÜa ë môc n o ®ã trong ®iÒu n y sÏ ®−îc biÓu in this clause is indicated by boldface followed by its
thÞ b»ng ch÷ ®Ëm kÌm theo l sè môc trong dÊu ngoÆc. entry number in parentheses. Such a boldface term
Mét thuËt ng÷ d−íi d¹ng ch÷ ®Ëm nh− vËy cã thÓ ®−îc may be replaced in the definition by its complete
thay thÕ trong ®Þnh nghÜa b»ng ®Þnh nghÜa ®Çy ®ñ cña nã. definition.
VÝ dô: For example:
s¶n phÈm (3.4.2) ®−îc ®Þnh nghÜa l "kÕt qu¶ cña mét product (3.4.2) is defined as "result of a process
qu¸ tr×nh (3.4.1)". (3.4.1)";
qu¸ tr×nh (3.4.1) ®−îc ®Þnh nghÜa l "tËp hîp c¸c ho¹t process (3.4.1) is defined as "set of interrelated or
®éng cã quan hÖ lÉn nhau v t−¬ng t¸c ®Ó biÕn ®Çu v o interacting activities which transforms inputs into
th nh ®Çu ra" outputs".
NÕu thuËt ng÷ "qu¸ tr×nh" ®−îc thay thÕ bëi ®Þnh nghÜa if the term "process" is replaced by its definition, as
n y th×: follows:
s¶n phÈm trë th nh "kÕt qu¶ cña mét tËp hîp c¸c ho¹t product then becomes "result of a set of interrelated or
®éng cã quan hÖ lÉn nhau v t−¬ng t¸c ®Ó biÕn ®Çu v o interacting activities which transforms inputs into
th nh ®Çu ra" outputs".
Mét kh¸i niÖm ®−îc giíi h¹n ë mét nghÜa cô thÓ trong mét A concept limited to a special meaning in a particular
t×nh huèng nhÊt ®Þnh sÏ ®−îc chØ ra b»ng c¸ch nªu lÜnh vùc context is indicated by designating the subject field in
cña ®èi t−îng ®ã trong dÊu < > tr−íc ®Þnh nghÜa n y. angle brackets, < >, before the definition.
20
nguon tai.lieu . vn
