ISO 9001 :2008

ISO 9001:2008 is the International Standard for Quality Management Systems (QMS).
It ro!ides your "omany #ith a set of rin"iles that ensure a "ommon sense aroa"h to the
management of your $usiness a"ti!ities to "onsistently a"hie!e "ustomer satisfa"tion.
Who is ISO 9001:2008 applicable to?
%ny organisation "an $enefit from imlementing ISO 9001:2008 as its re&uirements are
underinned $y eight management rin"iles:
o a "ustomer fo"used organisation
o leadershi
o the in!ol!ement of eole
o ensuring a ro"ess aroa"h
o a systemati" aroa"h to management
o a fa"tual aroa"h to de"ision ma'ing
o mutually $enefi"ial sulier relations
o "ontinuous imro!ement
What are the benefits of registration?
o (ustomer satisfa"tion ) through deli!ery of rodu"ts that "onsistently meet "ustomer
re&uirements
o *edu"ed oerating "osts ) through "ontinual imro!ement of ro"esses and resulting
oerational effi"ien"ies
o Imro!ed sta'eholder relationshis ) in"luding staff+ "ustomers and suliers
o ,egal "omlian"e ) $y understanding ho# statutory and regulatory re&uirements
ima"t on the organi-ation and its your "ustomers
o Imro!ed ris' management ) through greater "onsisten"y and tra"ea$ility of rodu"ts
and ser!i"es
o .ro!en $usiness "redentials ) through indeendent !erifi"ation against re"ogni-ed
standards
o %$ility to #in more $usiness ) arti"ularly #here ro"urement se"ifi"ations re&uire
"ertifi"ation as a "ondition to suly
How to gain registration?
/he ro"ess of registration follo#s three simle stes:
o %li"ation for registration is made $y "omleting the QMS &uestionnaire
o %ssessment to ISO 9001:2008 is underta'en $y 0Q% ) the organisation must $e a$le
to demonstrate that its &uality management system has $een fully oerati!e for a
minimum of three months and has $een su$1e"t of a full "y"le of internal audits
o *egistration is granted $y 0Q% and maintained $y the organisation. Maintenan"e is
"onfirmed through a rogramme of annual sur!eillan"e !isits and a three yearly re)
"ertifi"ation audit.
Initial Certification A!it
/he assessment ro"ess for a"hie!ing "ertifi"ation "onsists of a t#o stage Initial (ertifi"ation
%udit as follo#s:
Stage 1 ) the urose of this !isit is to "onfirm the readiness of the organisation for full
assessment. /he assessor #ill:
o "onfirm that the &uality manual "onforms to the re&uirements of ISO 9001:2008
o "onfirm its imlementation status
o "onfirm the s"oe of "ertifi"ation
o "he"' legislati!e "omlian"e
o rodu"e a reort that identifies any non)"omlian"e or otential for non)"omlian"e
and agree a "orre"ti!e a"tion lan if re&uired.
o rodu"e an assessment lan and "onfirm a date for the Stage 2 assessment !isit.
Stage 2 ) the urose of this !isit is to "onfirm that the &uality management system fully
"onforms to the re&uirements of ISO 9001:2008 in ra"ti"e. /he assessor #ill:
o underta'e samle audits of the ro"esses and a"ti!ities defined in the s"oe of
assessment
o do"ument ho# the system "omlies #ith the standard
o reort any non)"omlian"es or otential for non)"omlian"e
o rodu"e a sur!eillan"e lan and "onfirm a date for the first sur!eillan"e !isit
o If the assessor identifies any ma1or non)"onforman"e+ the organisation "annot $e
"ertified until "orre"ti!e a"tion is ta'en and !erified.
A!"antages
It is #idely a"'no#ledged that roer &uality management imro!es $usiness+ often ha!ing a
ositi!e effe"t on in!estment+ mar'et share+ sales gro#th+ sales margins+ "ometiti!e ad!antage+
and a!oidan"e of litigation. /he &uality rin"iles in ISO 9000:2000 are also sound+ a""ording to
2ade and also to 3arnes+ #ho says that 4ISO 9000 guidelines ro!ide a "omrehensi!e model
for &uality management systems that "an ma'e any "omany "ometiti!e.4Imlementing ISO
often gi!es the follo#ing ad!antages:
1. "reates a more effi"ient+ effe"ti!e oeration
2. in"reases "ustomer satisfa"tion and retention
5. redu"es audits
6. enhan"es mar'eting
7. imro!es emloyee moti!ation+ a#areness+ and morale
8. romotes international trade
9. in"reases rofit
8. redu"es #aste and in"reases rodu"ti!ity
9. "ommon tool for standardi-ation.
Criticis#s of ISO 9000
% "ommon "riti"ism of ISO 9000 and 9001 is the amount of money+ time+ and aer#or'
re&uired for registration. :algleish "ites the 4inordinate and often unne"essary aer#or'
$urden4 of ISO+ and says that 4&uality managers feel that ISO;s o!erhead and aer#or' are
e<"essi!e and e<tremely ineffi"ient.4
%""ording to 3arnes+ 4Oonents "laim that it is only for do"umentation. .roonents $elie!e that
if a "omany has do"umented its &uality systems+ then most of the aer#or' has already $een
"omleted.4 2ilson suggests that ISO standards 4... ele!ate inse"tion of the "orre"t ro"edures
o!er $roader ase"ts of &uality+4 and therefore+ 4the #or'la"e $e"omes oressi!e and &uality is
not imro!ed.4
%""ording to =ohn Seddon+ ISO 9001 romotes se"ifi"ation+ "ontrol+ and ro"edures rather than
understanding and imro!ement. 2ade argues that ISO 9000 is effe"ti!e as a guideline+ $ut that
romoting it as a standard 4hels to mislead "omanies into thin'ing that "ertifi"ation means
$etter &uality+ >undermining? the need for an organi-ation to set its o#n &uality
standards.4 .arahrased+ 2ade;s argument is that relian"e on the se"ifi"ations of ISO 9001 does
not guarantee a su""essful &uality system.
/he standard is seen as ese"ially rone to failure #hen a "omany is interested in "ertifi"ation
$efore &uality. (ertifi"ations are in fa"t often $ased on "ustomer "ontra"tual re&uirements rather
than a desire to a"tually imro!e &uality. 4If you 1ust #ant the "ertifi"ate on the #all+ "han"es are
you #ill "reate a aer system that doesn;t ha!e mu"h to do #ith the #ay you a"tually run your
$usiness+4 said ISO;s *oger @rost. (ertifi"ation $y an indeendent auditor is often seen as the
ro$lem area+ and a""ording to 3arnes+ 4has $e"ome a !ehi"le to in"rease "onsulting ser!i"es.4
:alglesh argues that #hile 4&uality has a ositi!e effe"t on return on in!estment+ mar'et share+
sales gro#th+ $etter sales margins and "ometiti!e ad!antage+4 that 4ta'ing a &uality aroa"h is
unrelated to ISO 9000 registration.4 In fa"t+ ISO itself ad!ises that ISO 9001 "an $e imlemented
#ithout "ertifi"ation+ simly for the &uality $enefits that "an $e a"hie!ed.