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Swit zerland,


21 May 2014



ISO 9001:2015 UPDATE


ISO/DIS 9001 ENCOURAGES MORE EXTERNAL FOCUS IN QUALITY MANAGEMENT AS
PART OF RISK-BASED APPROACH

The lat est st age in t he ISO 9001 revision process arrived wit h t he issue of ISO/DIS 9001 on
8t h
t h
May 2014. This f irst f ormal draf t describes t he pot ent ial requirement s of t he revised
version of ISO 9001; t his is not t he f inal version. However, it does at least give an indicat ion
on what might be included and we need t o be aware of it s cont ent . Furt her changes are, of
course, possible bef ore f inal publicat ion of ISO 9001:2015 current ly scheduled t o be released
in Q4 2015.

The main areas of changes proposed in ISO/DIS 9001 are:
1. St ruct ure and t erminology, including incorporat ion of Annex SL f ramework;
2. The wider int ernal and ext ernal cont ext of a organisat ion s Qualit y Management Syst ems
(QMS) (Clauses 4 and 6);
3. Det ailed Qualit y Management Syst em (QMS) requirement s (broadly clauses 5 & 7 10).


1. STRUCTURE AND TERMINOLOGY: DIS ADOPTS ANNEX SL, NOTABLE CHANGES IN
TERMINOLOGY


ISO/DIS 9001 adopt s t he clause st ruct ure specif ied in Annex SL which is now t he required
f ramework f or all new and revised ISO St andards. The st at ed reason f or t his is t o ensure t hat
t he f inal version of ISO 9001 is aligned wit h ot her management syst ems st andards. Ut ilizing
t he Annex SL st ruct ure will present QMS requirement s in a more consist ent , rat ional manner
and not simply of f er a t emplat e f or element s of an organisat ion s QMS.

ISO/DIS 9001 cont ains some not able changes in t he t erminology used in ISO 9001:2008:

ISO 9001:2008 ISO 9001:2015 (DIS version)
Product s Product s and services
Document at ion Records Document ed inf ormat ion
Work environment Environment f or t he operat ion of
processes
Purchased product Ext ernally provided product s and
services
Supplier Ext ernal provider



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In addit ion, t here would no longer be any requirement t o ident if y any Exclusions , i.e. QMS
requirement s t hat could not be applied due t o t he nat ure of t he organisat ions business (clause
1.2 in ISO 9001:2008).


2. ORGANIZATIONAL CONTEXT: QUALITY MANAGEMENT SYSTEMS TO BE MORE
EXTERNALLY ORIENTED


ISO/ DIS 9001 requires any organisat ion est ablishing a QMS t o det ermine relevant int ernal
and ext ernal issues, underst and t he need and expect at ions of int erest ed part ies, specif y t he
scope of applicabilit y of t he Qualit y Syst em and consider t hese aspect s t oget her in order t o
properly underst and t he opport unit ies and risks t hey represent .

The proposed change in met hodology requires a move away f rom a purely inward-f ocusing
approach t o QMS development and implement at ion t o one where ext ernal or out side f act ors
have a great er inf luence on t he way in which t he QMS is f ocussed and priorit ised; t o be as
ef f ect ive as possible in meet ing key int ernal and ext ernal object ives. An organizat ion seeking
t o implement a QMS would need t o det ermine t he int erest ed part ies relevant t o it s QMS and
t heir requirement s.

Closely aligned t o t he cont ext of an organizat ion is t he adopt ion of a risk-based approach
when developing and implement ing it s QMS. An organisat ion would have t o ident if y t he risks
and opport unit ies t hat need t o be addressed t o ensure t hat t he QMS can achieve it s int ended
out come(s) including t hose relevant t o or det ermined by it s organizat ional cont ext . The
organizat ion would have t o plan act ions t o address t hese risks and opport unit ies, int egrat e
and implement t hem int o it s QMS processes and evaluat e t he ef f ect iveness of t hese act ions.


3. NUMEROUS CHANGES TO QMS REQUIREMENTS


Besides t he adopt ion of a risk-based approach, t here are a f ew ot her new requirement s:

Any organizat ion implement ing a QMS would have t o ident if y t he compet ence necessary f or
personnel doing work t hat af f ect s it s qualit y perf ormance, as well as ensuring t hat t hose
personnel are compet ent t o do so.

There remains a requirement t o ident if y and maint ain t he knowledge needed t o ensure t hat it
can achieve conf ormit y of product s and services.

Prevent ive act ion is no longer a specif ic clause in ISO/DIS 9001 as it is a primary object ive
of a QMS in addit ion t he risk-based approach.

ISO/ DIS 9001 more direct ly expect s organisat ions t o apply a process approach when
planning, implement ing and developing t heir QMS. The version also includes a list of
requirement s ident if ying t he essent ial element s of such an approach. The int ent ion is t o
ensure t hat organisat ions syst emat ically def ine and manage not just t heir processes, but


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also t he int eract ion bet ween t hem.


HOW CAN SGS HELP?

SGS can provide awareness t raining t o help our prospect s and client s underst and t he
requirement s of ISO/DIS 9001. We will also publish a whit e paper about t he subject during
Q3 2014. A checklist will be developed t o be able t o of f er gap assessment s against t he
requirement s of ISO/DIS 9001. An overview on Annex SL could be f ound on
www.sgs.com/ISO9001. A t raining course relat ed t o risk-based t hinking will also be made
available by June.


FUTURE UPDATES

A copy of t he ISO/DIS 9001 st andard can be purchased
ht t p://www.iso.org/iso/home/st ore/cat alogue_t c/cat alogue_det ail.ht m?csnumber= 62085.

The of f icial ISO 9001:2015 working group (ISO/TC 176/SC 2) responsible f or t he
development and publishing of t he ISO 9001:2015 st andard will develop a mat rix showing a
correlat ion bet ween t he clauses of ISO9001:2008 and ISO/DIS 9001:2015, which will be
available short ly at www.iso.org/t c176/sc02/public.

Furt her inf ormat ion and updat es on t he development of ISO 9001:2015 and it s publicat ion
schedule will be issued by SGS as t hey become available.


For more det ails, please cont act :

Outi Helena Armstrong
SGS SA, 1 place des Alpes
CH-1211 Geneva, Swit zerland
T: + 41 22 739 9161
M: + 41 79 251 8218
E: out i.armst rong@sgs.com



About SGS
SGS is t he world s leading inspect ion, verif icat ion, t est ing and cert if icat ion company. SGS is
recognized as t he global benchmark f or qualit y and int egrit y. Wit h more t han 80,000
employees, SGS operat es a net work of over 1,650 of f ices and laborat ories around t he world.