ISO 9001-2015 Changes
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T h e I n t e r n a t i o n a l R e g i s t e r o f C e r t i f i c a t e d A u d i t o r s ( I R C A ) i s t h e w o r l d ’ s o r i g i n a l a n d l a r g e s t i n t e r n a t i o n a l a u d i t o r c e r t i f i c a t i o n b o d y C h a n g e L a n g u a g e H o m e | R e s o u r c e s | I N o r m | A r c h i v e | T e c h n i c a | I S O 9 0 0 1 : 2 0 1 5 – t h e c o u n d o w n b e g i n s S e a r c h S O 9 0 0 1 2 0 1 5 A P G p a p e r s T e c h n c a n o t e s O n l n e c o m m u n i t e s N f o r m A r c h v e I S O 9 0 0 1 : 2 0 1 5 – t h e c o u n t d o w n b e g i n s P e t e r L o m a s , I R C A ’ s E x e c u t i v e D i r e c t o r , p r e s e n t s I R C A ’ s s t a n d p o i n t o n t h e I S O 9 0 0 1 s t a n d a r d r e v i s i o n a n d g i v e s h i s a d v i c e o n h o w a u d i t o r s s h o u d p r e p a r e i n a d v a n c e o f t h e c h a n g e s . T h e C o m m t t e e D r a f t ( C D ) v e r s i o n o f I S O 9 0 0 1 ( S O C D 9 0 0 1 ) w a s r e l e a s e d f o r c o m m e n t a n d b a l l o a t h e b e g i n n i n g o f J u n e T h e C h a r t e r e d Q u a l i y I n s t i u t e ( C Q ) , o w h i c h I R C A s a d i v s i o n h a s C a t e g o r y A i a i s o n s t a t u s w i t h I S O / T C 1 7 6 , h e e c h n i c a l c o m m i t e e r e s p o n s i b l e o r I S O 9 0 0 1 . T h s m e a n s t h a t t h e C Q I h a s a c c e s s o a l r e e v a n t d o c u m e n t a i o n i s i n v t e d t o m e e i n g s a n d h a s n o m n a t e d i t s o w n e x p e r t s o p a r i c i p a t e i n t h e w o r k o f T C 1 7 6 a n d i n f l u e n c e t h e r e v i s i o n o f I S O 9 0 0 1 T h e C Q I s n o w a c t i v e l y f a c i l t a i n g c o n s u l t a i o n a n d w l l c o m m e n o n b e h a l o f C Q I m e m b e r s T h e c l o s i n g d a e f o r s u b m i s s o n o c o m m e n t s a n d v o t e s i s 1 0 S e p t e m b e r 2 0 1 3 . I R C A a s h e p r o e s s i o n a l b o d y o r m a n a g e m e n s y s e m a u d t o r s a n d a d i v s i o n o f h e C Q , i s e x c e p t i o n a l l y w e l p a c e d t o k e e p I R C A a u d i o r s i n f o r m e d h r o u g h o u t t h e d e v e o p m e n t p r o c e s s . A t h i s m o m e n w e e x p e c t t h e i m e t a b l e o r p u b i c a t i o n t o b e : D r a t n t e r n a i o n a S a n d a r d ( S O D S 9 0 0 1 ) – A p r i l t o A u g u s t 2 0 1 4 F n a l D r a f t I n t e r n a t i o n a l S t a n d a r d ( I S O F D I S 9 0 0 1 ) – J u l y t o A u g u s t 2 0 1 5 P u b i c a t i o n I S O 9 0 0 1 – S e p t e m b e r 2 0 1 5 . S o t h e r e s a l o n g w a y o g o b e f o r e t h e i t h e d i t o n o I S O 9 0 0 1 i s p u b l s h e d . W h a t d o w e k n o w a n d e x p e c t ? S O g a v e a p p r o v a l i n 2 0 1 2 o s t a r a m a j o r r e v i s i o n o f S O 9 0 0 1 , w h i c h w o u d b e s u i a b l e o r t h e n e x 1 0 y e a r s o r m o r e . S O 9 0 0 1 w l l a d o p t h e h i g h l e v e l s r u c u r e , d e n t c a c o r e t e x t a n d c o m m o n t e r m s a n d c o r e d e f i n t i o n s o A n n e x S L ( a p p r o x i m a e l y 3 0 % o e a c h n e w a n d r e v i s e d s t a n d a r d w i l l b e i d e n t i c a l t e x ) . T h e c u r r e n t o c u s o f I S O 9 0 0 1 2 0 0 8 o n e f e c t i v e p r o c e s s m a n a g e m e n t w i l b e m a n t a n e d , w i t h g r e a t e r e m p h a s i s o n p r o d u c i n g d e s r e d o u t p u t s a n d p r o v d i n g c o n i d e n c e n h e o r g a n s a t o n ’ s p r o d u c s . S i m p i f e d l a n g u a g e a n d w r i i n g s t y e s o a i d u n d e r s a n d i n g a n d c o n s s t e n t n t e r p r e t a t i o n s o f r e q u i r e m e n t s h a s b e e n s e t a s a r e q u r e m e n t o r t h e f i n i s h e d s t a n d a r d . U s e o f t e r m s g o o d s a n d s e r v c e s ’ r a h e r t h a n ‘ p r o d u c t , a n d ‘ m p r o v e m e n t r a t h e r t h a n c o n t i n u a l m p r o v e m e n t i s p r o p o s e d . P u r c h a s n g ’ a n d ‘ o u t s o u r c i n g a r e r e p a c e d b y ‘ e x e r n a l p r o v i s i o n o f g o o d s a n d s e r v i c e s ’ . T h e C D v e r s i o n m a k e s e x p i c i t r e e r e n c e s t o r i s k , d e n t f y n g r i s k s a n d o p p o r u n i i e s a n d p a n n i n g a c t o n s o a d d r e s s r i s k s a n d o p p o r t u n i t e s i d e n t i i e d T h e s e r e p l a c e p r e v e n t i v e a c i o n n h e c u r r e n t s a n d a r d . T h e C D a l s o i d e n i f e s a n d a d d r e s s e s r i s k s w h c h c a n a f e c t c o n f o r m i t y o f g o o d s a n d s e r v c e s a n d c u s t o m e r s a i s f a c i o n , i n c l u d n g a k n g a r i s k - b a s e d a p p r o a c h o d e e r m n e h e y p e a n d e x e n t o f c o n r o l s a p p r o p r a t e t o e a c h e x t e r n a p r o v i d e r a n d a l l e x t e r n a p r o v s i o n o f g o o d s a n d s e r v i c e s . T h e r e i s n o w a g r e a t e r b u s i n e s s f o c u s E x t e r n a l a s w e l a s i n e r n a l i s s u e s r e l a t e d t o t h e o r g a n i s a i o n ’ s s t r a e g i c p u r p o s e , n t e r e s t e d p a r t e s a n d t h e r r e q u i r e m e n s m u s t a l b e d e t e r m i n e d Q u a i t y p o l c e s a n d o b j e c i v e s m u s t b e c o m p a t b l e w t h t h e s t r a t e g c d r e c i o n o f h e o r g a n s a t o n . S u b s e q u e n t y , t h e o r g a n i s a i o n m u s t c o n s d e r t h e s e i n d e t e r m i n n g t h e s c o p e o f t h e Q M S . S e n o r m a n a g e m e n n o w h a s a g r e a t e r a c t v e n v o l v e m e n t . T h e r e a r e e s s e x p l i c i r e q u r e m e n t s o r d o c u m e n t a i o n n o r e e r e n c e t o d o c u m e n t e d q u a l i y m a n u a l a n d d o c u m e n t e d p r o c e d u r e s , a n d n o r e f e r e n c e o q u a i t y r e c o r d s . n s t e a d , h e C D v e r s i o n r e e r s t o d o c u m e n t e d i n o r m a t i o n , e i n o r m a t i o n r e q u i r e d t o b e c o n r o l e d a n d m a n t a n e d b y a n o r g a n i s a i o n a n d t h e m e d u m o n w h i c h i i s c o n t a i n e d . E x p e c m o r e d e t a i e d r e v e w s a n d a n a l y s i s b y R C A a s t h e s t a n d a r d p r o g r e s s e s o w a r d s t h e f i n a l v e r s o n . I R C A o p i n i o n A u d i t o r S e r v i c e s P e a s e o g n o a c c e s s R C A m e m b e r s e r v c e s , u p d a t e y o u r d e t a s a n d p a y s u b s c r p t o n s , o r r e g s t e r f y o u h a v e n o t d o n e s o a r e a d y . S e e A l s o I N f o r m d i r e c t t o y o u r i n b o x P r n p a g e L o g i n R e g s t e r H o m e A u d t o r c e r t i f c a t i o n A u d i t o r t r a i n i n g O r g a n i s a t o n s F n d a n a u d t o r R e s o u r c e s A b o u t I R C A A u d t o r S e r v i c e s
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The Committee Draft (CD) version of ISO 9001 (ISO CD 9001) was released for commentand ballot at the beginning of June.
Transcript of ISO 9001-2015 Changes
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ISO 9001:2015 – the countdownbeginsPeter Lomas, IRCA’s Executive Director, presents IRCA’s standpointon the ISO 9001 standard revision and gives his advice on howauditors should prepare in advance of the changes.
The Committee Draft (CD) version of ISO 9001 (ISO CD 9001) was released for commentand ballot at the beginning of June. The Chartered Quality Institute (CQI), of which IRCA is adivision, has Category A liaison status with ISO/TC 176, the technical committeeresponsible for ISO 9001. This means that the CQI has access to all relevantdocumentation, is invited to meetings and has nominated its own experts to participate inthe work of TC 176 and influence the revision of ISO 9001. The CQI is now activelyfacilitating consultation and will comment on behalf of CQI members. The closing date forsubmission of comments and votes is 10 September 2013.
IRCA, as the professional body for management system auditors and a division of the CQI,is exceptionally well placed to keep IRCA auditors informed throughout the developmentprocess. At this moment we expect the timetable for publication to be:
Draft International Standard (ISO DIS 9001) – April to August 2014Final Draft International Standard (ISO FDIS 9001) – July to August 2015Publication ISO 9001 – September 2015.
So there is a long way to go before the fifth edition of ISO 9001 is published.
What do we know and expect?
ISO gave approval in 2012 to start a major revision of ISO 9001, which would be suitablefor the next 10 years or more.ISO 9001 will adopt the high level structure, identical core text and common terms andcore definitions of Annex SL (approximately 30% of each new and revised standard willbe identical text).The current focus of ISO 9001:2008 on effective process management will bemaintained, with greater emphasis on producing desired outputs and providingconfidence in the organisation’s products.Simplified language and writing styles to aid understanding and consistentinterpretations of requirements has been set as a requirement for the finished standard.Use of terms ‘goods and services’ rather than ‘product’, and ‘improvement’ rather than‘continual improvement’ is proposed.‘Purchasing’ and ‘outsourcing’ are replaced by ‘external provision of goods andservices’.The CD version makes explicit references to risk, identifying risks and opportunities andplanning actions to address risks and opportunities identified. These replace preventiveaction in the current standard. The CD also identifies and addresses risks which canaffect conformity of goods and services and customer satisfaction, including taking arisk-based approach to determine the type and extent of controls appropriate to eachexternal provider and all external provision of goods and services.There is now a greater business focus. External as well as internal issues related to theorganisation’s strategic purpose, interested parties and their requirements must all bedetermined. Quality policies and objectives must be compatible with the strategicdirection of the organisation. Subsequently, the organisation must consider these indetermining the scope of the QMS.Senior management now has a greater active involvement.There are less explicit requirements for documentation, no reference to documentedquality manual and documented procedures, and no reference to quality records.Instead, the CD version refers to documented information, ie information required to becontrolled and maintained by an organisation and the medium on which it is contained.
Expect more detailed reviews and analysis by IRCA as the standard progresses towardsthe final version.
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To say that we can expect a lot of debate, speculation and comment is an understatement.We anticipate the debate to continue long after publication in 2015.
The direction being taken was apparent when Annex SL was published and is even clearernow we have ISO/CD 9001. Some will not like it and may seek to block publication orchoose to develop industry standards independent of ISO 9001. A second Committee Draftwould indicate slow progress.
The aim of ISO 9001 is to assist organisations in improving the quality component of theirbusiness management system, in the same way that ISO 14001 aims to assistorganisations in improving the environmental component of their business managementsystem.
Annex SL helps us to think in terms of organisations having a single businessmanagement system, built on the organisational core activities and processes which arecovered by the common text of Annex SL. With the adoption of Annex SL, the potential forradical change is significant – think in terms of a single business management systemaudit and certification, and in terms of audits following the principle of a generic audit of theorganisational core, prior to bringing in experts to audit the organisational specialisms andcomponent parts of the business management system. I’d also envisage an increase inremote auditing as it will be too expensive to amass the required team in one location.These concepts are for the future, beyond 2015, but are made possible by Annex SL.
ISO management system requirements are not written for the express purpose of audit andcertification. However, an important part of the development process is to ensure we end upwith an auditable standard. At the IRCA Forum on 23 June there was discussion aroundauditability of ISO 9001:2015. The requirements need to be capable of being audited, whichis the responsibility of standard developers.
Auditors also need to be capable of auditing the requirements, which is the responsibility oforganisations employing auditors. The discussion, led by experienced and well informedpeople, proposes that a significant number of organisations and auditors never quiteunderstood the process approach, and that some requirements of ISO 9001:2000 and ISO9001:2008 have been totally disregarded by a large percentage of organisations andcertifiers for the last 13 years. If so, there is an urgent need to start addressing this now,before the next version of ISO 9001 is released.
What should IRCA auditors do now?
Many of the significant changes that will be in ISO 9001:2015 originate from Annex SL. AllIRCA auditors must familiarise themselves with this document. If you have not already readIRCA’s guide to Annex SL , do so now. You will find it under ‘Technical Notes’ on ourwebsite. If you have read it, have another look.
ISO 9001 will not be the first standard to adopt Annex SL. ISO 22301:2012 – BusinessContinuity management systems requirements adopted ISO Guide 83 an early version ofAnnex SL and there are IRCA briefing notes on ISO 22301:2012 available on the IRCAwebsite.
The next issue of ISO 27001 – Information Security management system requirements isdue to be published in November 2013. And the next issue of ISO 14001 – Environmentalmanagement system requirements is due to be published in March 2015. So, by the timeISO 9001:2015 is published, there should already be a degree of experience ofimplementing and auditing many of the new and enhanced requirements originating fromAnnex SL.
To keep you informed and to support your continuing professional development, IRCA willbe publishing briefing notes and technical guidance on all of these standards at each stagein their development. All information will be available on our ISO 9001:2015 section of thewebsite.
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