ISO 9001 2015 FULL DETAILED LATEST TRAINING SLIDES DANGOTE FERTILIZER.pptx

basics of quality management

1. ISO 9001 2015 FOUNDAMENTALS AND REQUREMENTS EXPLAINED DR JUSTIN B NICKAF

2. Training O b j ect i v e s  A n u nd e r s t a n d i n g o f ISO 9001:2015 r e qu i r e m e n t s & i n t er p r e t a t io n o f t he I S O cl a u s e s.  A n u nd e r s t a n d i n g o f t h e r e qu i r e m e n t s a n d app li c a t io n o f Q u a l i t y M a n a g e m e n t S y s t e m ( Q M S )  A n Un de r s t a n d i ng o n Ri sk B a s e d A p p r o a c h

3. C o u r s e C o n t e n t s  Brief on ISO O v e r v i e w of I SO 90 1  I n t r o d u c tion t o QMS & R e qu i r e m e n ts  I n t erp r e t a tion of t h e I SO 90 1:2015 c l a us es

4. Introduction of participants T h e 5 W’s ▫ W h o are you ? W h at is your preferred name in clas s? ▫ W h ere do you work? ▫ W h at is your job title, and ▫ W h at are y our main respons i b i lities? ▫ W h y are you attending this course? Please d e fine your expectat i ons

5. ke e p No smoking Punctuality P a rticipati o n Certificates Doc u men t ation Pho n es Data f o rms

6. A bou t I S O N o n - g ov e r n m e n t al o r g a ni z a t ion ( N GO) e st a b l i s h e d in 194 7 , ba s e d in G e ne v a , S w i t z e r la n d H as a m e m b e r s hip of 1 7 3 na t i o n a l s t a n d a rds in s t i t utes f r om c o u ntries in all r e g io n s of t he w o r ld 4

7. IT tools Standards development procedures Consensus building Dissemination 171 national members 98% of world GDP 97% of world population 839 active TCs 3 954 technical bodies 2 506 w ork groups experts 7 879 technical meetings Central Secretariat in Geneva 187 FTE staff Collection o over f25151 ISO Standards as at Jan 2024 25451 standards produced in 2024 The ISO System Average of 43 TC ‘s each working day somewhere in the world

8. A bou t I S O 5 D e v e lo p e d v a r io u s s t anda r d s f o r a ll d i m en s io n s o f s u s t a in a b le de v e lo p m en t : e c ono m i c , en v i ron m en t a l a n d s o c ie t a l E xa m p l es : I S O 900 1 – Q ua li ty M anage m en t S yst e m s ( Q M S ) I S O 1 4001 – E nv i r on m ent a l M anage m ent S yst e m s ( E M S ) I S O 2 7001 – I n f o r m at i on S ecu r i ty M anage m ent S yst e m s ( I S M S ) I S O 3 1000 – R i sk M anage m ent ( P r i nc i p l e s and G u i de l in e s) Standards Organisation of Nigeria is the sole r ep r e s en t a t i v e of Nigeria t o I S O

9. Cha r ac t eri s tics “Deg r ee t o w hich a s e t of inhe r e n t c ha r a c t eri s tics fulfils r equi r e m e n ts” (s o ur c e – I S O 9 1:2 1 5) Wh a t is q u ality…. Cu s t o m e r s p r ovid e s O r g ani za tion P r oducts / s er vi ces r e q ui r em e n ts su pp lies H o w was it? S a ti s fie d ? N ot s a ti s fie d ? i m p r o v e 1 2 3 4 5

10. Qua li ty Manag em e nt Sy s t em “ a s y s t em t o di r ect and c o n t r ol an o r g ani z a tion with r espe c t t o quality!!!” Wh a t is Q uality Mana g eme n t Sy st em…. P r oc e sses P oli c ies Ob je c ti v es (s o ur c e – I S O 9 1:2 1 5)

11. Establishing a QMS requires recognition of priorities

12. Quality – WHY ? Unprecedented interest in Quality both on the part of Industry & trade and Society in General. Rapid changes in technology, environment, economic aspects, trade patterns. Abundance of product variety, complexity, innovativeness.

13. ISO 9001 is a Quality Assurance tool

14. E m ph a s i s o n P r o c e s s A pp r o a c h U nde r s t and ing an d m ee t ing c u st o m e r r equ ir e m en t s H o w d o p r o c e ss e s v a lue ad d M ea s u r e p r o c e s s pe r f o r m a n c e an d e f f e c t i v ene s s C on t in u a l i m p r o v e m en t o f p r o c e ss e s ba s e d o n m ea s u r e m en t

15. Process approach Can be applied to any other process that you manage OPERATION Clause 8

16. Process approach Every process require specific inputs, resources, activities, outputs and customers What you can do now is: Define and document the inputs Define and document the kinds of resources that your process use Define and document the activities and their interactions Define and document the responsibilities Define and document the outputs You can name this document as Department Control Plan Then execute this plan, and monitor, measure, analyze and improve its performance (KPI) Thus, Plan – Do - Check – Act (Edward Demings)

17. Implementing process approach

18. Anatomy of a process Every process has an owner

19. Process Definition

20. Inputs Process (a value-adding set of activities) Outputs Resources What is a process?

21. Process management

22. W ha t is Risk? (*) Risk is t he possibili t y o f even t s or a c t ivi t ies impeding t he achievemen t o f an organiza t io n ’ s s t ra t egic and opera t ional obje c t ive s. 24 (*) Bob Deyshe r ’ s pre ferred de finition

23. Risk De f ini t ions 25 Risk can be de f ined by t wo (2) parame t ers Severi ty T his is th e Seriousness o f the harm Probabili ty T his is the Probabili ty that the harm will occur

24. W ha t is “Risk-Based T hinking”? 27 AS Q Reliability and Risk Division Webin ar Janu ary 14, 2021 Risk-based thinking is some thing we all do au tomatically and o ften sub-consciously The concep t o f risk has always been implici t in ISO 9001 – the 2015 revision makes i t more explici t and builds i t in to the whole managemen t system Risk-based thinking is already pa rt o f the process approach Risk-based thinking makes preven tive action pa rt o f the rou tine Risk is often thought o f only in the negative sense. Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk

25. Where is risk addressed in ISO 9001:2015? 28

26. Risk-based thinking is in: Introduction - the concept of risk-based thinking is explained Clause 4 - organization is required to determine its QMS processes and address its risks and opportunities Clause 5 – top management is required to Promote awareness of risk-based thinking Determine and address risks and opportunities that can affect product /service conformity Clause 6 - organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them 29

27. Risk-based thinking is in: Clause 7 – organization is required to determine and provide necessary resources C lause 8 - organization is required to manage its operational processes Clause 9 - organization is required to monitor, measure, analyse and evaluate the effectiveness of actions taken to address risks and opportunities Clause 10 - organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities Note, risk is implicit whenever suitable or appropriate is mentioned (clause 7 and 8) 30

28. Why use risk-based thinking? Successful organizations intuitively apply risk-based thinking because it brings benefits that: improve governance establish a proactive culture of improvement assist with compliance assure consistency of quality of products and services improve customer confidence and satisfaction 31

29. Why Ri sk - ba s e d M ana g e m e n t ? T o i m p r o v e c u st o m er c o n f ide n c e an d s a t i s f a c t ion T o a ss u r e c on s i s t en c y o f qua li t y o f p r odu ct s an d s e r v i c e s T o e s t ab li s h a p r oa c t i v e c u l t ur e o f p r e v en t ion an d i m p r o v e m en t S u cc e ss f u l c o m pan ies intui t i v e ly t a k e a r i s k - ba s e d app r oa c h I m p r o v e go v e r nan c e R i s ks O pp o rt uniti e s

30. How do I do it? I dentify what your risks are – it depends on context Use risk-based thinking to prioritize the way you manage your processes ISO 9001:2015 does not require formal risk management ISO 31000 Risk management — Principles and guidelines may be a useful reference for organizations that want or need a more formal approach to risk (but its use is not obligatory) 33

31. How do I do it? Balance risks and opportunities Analyse and prioritize your risks what is acceptable? what is unacceptable ? Plan actions to address the risks how can I avoid, eliminate or mitigate risks? Implement the plan; take action C heck the effectiveness of the action; does it work? Learn from experience; improve 34

32. I SO 9001 : 2015 Risk & O ppo rt uni t ies 35 W hen planning for the quali ty managemen t syste m, the organiza tion shall consider the issues re ferred to in 4 .1(Conte xt o f the Organiza tion) and the requirements re ferred to in 4 .2 ( I n tere sted Pa r t ies) and de termine the risks and oppo r t uni ties that need to be addressed to: give assurance that the quali ty managemen t system can achieve i ts in tended resul t(s); preven t, or reduce , undesired e f fe cts; achieve con tinual improvemen t.

33. I SO 9001 : 2015 Risk & O ppo rt uni t ies 36 T he organiza tion shall plan : a ctions to address these risks and oppo r t uni tie s; how to: in tegrate and implemen t the a ctions in to i ts quali ty managemen t system processes (see 4 .4); evalua te the e f fe ctiveness o f these a ctions. Actions taken to address risks and oppo r t uni ties shall be propo r t iona te to the po tential impa ct on the conformity o f produ cts and service s.

34. I SO 9001 : 2015 Risk & O ppo rt uni t ies 37 I SO 9001 : 2015 is a li st o f requiremen t s Bu t Does no t prescribe how t o do an y t hing I ncluding Risk & O ppo rt uni t ies Bu t Mo st Clien t s rely on Risk Ma t rices and Risk Regi s t ers

35. Risk in I ndu s t ry Speci f ic Clien t s 38 Indust ry Standa rd Risk Definition Sou rce Ge n er ic ISO 9001:2015 Effect of uncertainty on objectives ISO 31000:2018 Aerospace A S 9100:2016 An undesirable situation that has both the likelihood of occurring and a potentially negative consequences IAQG Risk Management Guidance Material Automotive IATF 16949:2016 Same as Generic Medical Device ISO 13485:2016 Combination of the probability of occurrence of harm and the severity of that harm ISO 14971:2019 ISO 24971:2020

36. Conclusions Risk-based thinking: is not new is something you probably do already is ongoing ensures greater knowledge of risks and improves preparedness increases the probability of reaching objectives reduces the probability of negative results makes prevention a habit 39

37. W ha t is I S O 9001? 6 IS O 9 01 is t he w o r ld ’ s m o s t popu lar an d m o s t c o mm on ly u s e d s t andar d f o r Q u a l i t y M anage m en t S y s t e m s ( Q M S ) I n t e r n a t ion a l c o n s e n s us on g o od m a n a g e m e n t p r a ct i c e Fo c u s e s o n m ee t ing c u s t o m e r r equ i re m en t s an d o t he r in t ere s t e d par t ies C o v er s an y o r gan i z a t ion – w ha t e v e r t h e s i ze , in du s t r y o r c u l t ur e

38. W o rl d ’ s fi r s t c er ti fiab l e QMS s t anda r d “ Quality Mana g eme n t S y s t em - R equ i r eme n ts” ISO 90 1 : 20 1 5…. P r o p ri e t ary a n d c onfi d e n tial. All rig hts r ese r v ed I n t ern a t i onal S t and a r d publ i sh ed by ISO P r e s c r i b e s set of r e q ui r em e n ts r el a t ed t o a qua li ty mana g eme n t s y s t em Co n f orm i ty c an be ass e s s ed i n t ernal l y as w ell as b y e x t ernal part i es

39. I SO 9001 : 2015 43 AS Q Reliability and Risk Division Webin ar Janu ary 14, 2021 ISO 9001 is a standard that se ts ou t the requirements for a quali ty managemen t syste m. ISO 9001 is a “ G eneric Standard ” . Generic means that the same standards can be applied: to any organiza tion, large or small , wha tever its produ ct or service , in any se ctor o f a ctivi t y , and whe ther i t is a business en terprise, a public admini stra tion, or a governmen t depa r t men t.

40. B en e f i t s o f t h e N e w I S O 9001 : 2 1 5 P u t s g r ea t e r e m pha s is o n le a de r s h ip e n g a g e m e n t H e lps add r e s s o r gan i z a t io n a l r i s k s an d oppo r t un i t ies in a st r u ct u r e d m anne r U s e s s i m p li f ied la n guag e an d a c o mm o n s t r u c t u r e an d t e r m s A dd r e ss e s s upp ly c ha in m anage m en t m o r e e f f e ct i v e ly I s m o r e u s er - f r ie n d ly f o r s e r v i c e an d k no w le d g e - ba s e d o r gan i z a t io n s

41. A d v an t age s o f C e r t i f i c a t i o n Co m p lian ce w i t h c u s t o m e r r equi r e m en t s s p e c i f y in g c e r t i f i c a t io n I ndependen t c he ck o f c o n f o rm i t y I ndi c a t e s a n e f f e c t i ve Q uali t y S y s t e m Na t ional /I n t e r na t iona l r e c o gni t io n Pr o v ide s c o m pe t i t i ve ad v an t ag e I m p r o v e s c o m p an y i m ag e 8

42. ISO 9001 Certification reduces the 8 waste in an organization

43. W h y W a s I S O 900 1 R e v i s ed ? 9 A d a pt t o a c hang ing w o r ld E nhan c e a n organ i z a t io n ’ s ab ili t y t o s a t i s f y c u s t o m er s M a in t a in re le v an c e , p r o v ide inte gr a t e d app r oa c h t o organ i z a t io n a l m anage m en t , an d in t egra t e w i t h o t he r m anage m en t s y s t e m s R ef l e c t n e e d s of a ll u s e r g r oup s an d in c r ea s in g ly c o m p lex opera t ing en v ir o n m en t s S e t a c on s i s t en t f ounda t ion f o r t h e ne x t 1 y ea r s

44. K e y I m p r o v e m en t s t o I S O 9001 : 20 1 5 10 I n c r ea s e d e m pha s is o n a c h ie v ing v a lue f o r t h e o r g a ni z at i on a n d i t s c u st o m e r s A g r ea t e r e m pha s is o n le a de r s h ip an d organ i za t io na l c on t e x t The f o c u s o n r i s k - ba s e d t hi n k ing E m pha s is o n ob je ct i v e s , m ea s u r e m en t s an d c hang e St a k eho ld e r - f o c u s e d c o m mu n i c a t ion an d a w a r ene s s D e c r ea s e d e m pha s is o n do c u m en t a t ion

45. P DC A an d I S O 900 1 C l au s e St r u c t u r e A C T P L A N DO CH E C K 9 . P e rf o r m a n c e E v a l u a t i o n 4 . C ont ex t of th e O r g a n i z a t i o n 5 . L ea d e r s h i p 6. P l a nn i n g 7 . S upport 8 . O p e r a t i on s 10 . I m p r o v e m e n t . I n t r o du c t i o n S c o pe N o r m a t i v e R e f e r e n ce s 3. T e r m s & D e f i n i t i o ns

46. QMS Model…. Cu s t omer s a t is f ac t i on R e s u lts of the QMS P r oduct and se r vi c es Qua li ty Management Sy s t em ( 4 ) O rg ani z a t i on and i ts c o n t e xt ( 4 ) Cu s t om e r r e qui r eme n ts Ne e ds and e xpec t a t i ons of r el e v a nt i n t e r e s t ed L eaders h ip ( 5) Impr o v e me n t (10) S uppo rt a n d O p e r a t i o n (7,8) Perf o rma n c e E v a l u a t i o n (9) Pl a nn i n g (6) P LAN DO CH E CK A C T part ies (4)

47. Quali t y P olicy…. P a r t of Q u ality Manual Publish e d on I n t r an et Ex p r ess e s T op Mana g e m e n t ’ s c ommit m e n t t o w a r ds qu a lity All e m pl o y e e s MU S T unde r s t and and apply the qu a lity poli c y

48. “ Q ua li t y i s n e v e r a n a c c i d e n t; i t i s a l w a y s t h e r e s u l t o f h i g h i n t e n t i o n , s i n c e r e e ff o r t , i n t e lli g e n t d i r e c t i o n and s k ill f u l e x e c u t i o n ; i t r e p r e s e n t s t h e w i s e c h o i c e o f ma n y a l t e r na t i ve s . ” - W I L L I A M A . F O S T E R

49. Q u a l i t y M a n a g e m e n t P r i n c i p l e s  C u s t o m er f ocus  Leade r s hip  En g a g e m e n t of people  P r oce s s a pp r o a ch  I m p r o v e m e n t  E v idenc e -b a s ed d e ci s ion ma k ing  R el a tion s hip ma n a g eme n t

50. Wh a t is ISO 9001? This s y s t em has 5 c o m pone n ts or e l eme n ts and th e y a r e appli e d w ith i n y our business m a na geme n t: Leade r ship Planning Support and ope r a tion P er f ormance e v alu a tion Imp r o v eme n t B e f o r e w e e xp l o r e these e l em e n ts, w h y is ISO 9001 necessa r y f or o ur o r g ani z a tion?

51. Th e s t r u ct u r e o f I S O 900 1 : 20 1 5 S c o pe N or m a t i v e re f e r e n c e T er m s a n d d e fi n i t io ns C o n t e xt o f t he o r g a ni s a t io n L e a de r s h i p P l a n n i ng S upp or t O p e r a t io n P er f or m a nc e e v a l u a t io n I m p r o v e m e n t

52. 4 C o n t e xt o f t h e O r g a ni z a t i o n 4 .1 Un d e r st a n d ing the O r g a ni z a tion a nd its c o n t e xt  C ons i d er the e x t ern a l a nd i n t ern a l i s s u e s of the o r g a n i za t i on  D e t erm i ne the i s s u e s r e l e v a n t t o i ts p u rpose  D e t erm i ne the i s s u e s e f f e c t i ng i ts a b i li ty t o ac h i e v e t he Q MS i n t e n d e d r esu l ts

53. The context of the organization will be multi-layered, for example; external and internal issues - e.g. those that directly affect the organization and its products and services. relevant to its purpose - e.g. the QMS exists to supply products and / or services efficiently and effectively to its intended market strategic direction - e.g. grow the business, increase product lines, increase market share intended result - e.g. for example: hit targets, goals, objectives

54. Internal Issues Typical internal issues my include, but not limited to: relevant legislation (e.g. Acts, Regulations, Statutory Instruments, etc ) industry specific requirements standards, guidelines and models adopted by the organisation resources (e.g. staff, capital, assets and technologies) products and / or services culture, social and workforce influence competency, knowledge and relationship with workforce

55. Typical External issues my include, but not limited to ( PESTEL): economics and financial factors government regulations and changes in legislation business competitors cultural , social and economic environments changes in technology  Political External issues

56. External issues

57. GROUP ASSIGNMENT 1 Determine the internal and external issues applicable to Dangote Fertilizer with their associated risk, control measures and responsible management in compliance with ISO 9001 2015 clause 4.1

58. 4 C o n t e xt o f t h e O r g a ni z a t i o n 4 .2 Unde r s t a nding the ne e ds a nd e x p e c t a t i ons of the i nt e r e s t e d p a r t ie s  De t er m ine the i n t e r e s t ed p a r ties th a t a r e r el e v a n t t o the quality ma n a g eme n t s y s t em  De t er m ine the r equi r e m e n ts of the s e i n t e r e s t ed p ar ties th a t a r e r el e v a n t t o the quality ma n a g eme n t s y s t em what are needs and expectations? • Needs - a requirement, necessary duty, or obligation that is essential or very important to the quality management system. • Expectations - a strong belief that something will happen or be the case.

59. Interested Parties

60. Some examples of needs and expectations might be Interested Parties Needs Expectations Shareholders profit a return on their investment / organizational influence (major shareholders) Suppliers orders timely payments / a mutually beneficial relationship  Employees work security workplace wellbeing / career opportunities Customers fit for purpose value for money / delivery times met Regulatory bodies compliance co-operation, openness and of course evidence  

61. Group Assignment 2 Determine the needs and expectatios of interested parties to Dangote Fertilizer with their associated risk, control measures and responsible management in compliance with ISO 9001 2015 clause 4.2

62. 4 C o n t e xt o f t h e O r g a ni z a t i o n 4.3 De t e r m i n i ng t he s cope of t he Q M S S c o p e s t o b e c o n si d e r e d a r e as f ollo w: e x t er n al a n d i n t er n al i ssu e s r e qu i r e m e n t s o f r ele v a n t i n t e r e s t e d p a rt ie s p r o du c t s a n d se r vice s c o v e r e d S c o p e s t o b e doc u m e n t e d s t a t i n g p r o du c t / s e r vic e c o v e r e d b y Q M S j u s t i f i c a t io n f o r a p p li c a bili t y

63. 4 C o n t e xt o f t h e O r g a ni z a t i o n 4.4 Q M S and i t s p r oce s se s T h e o r g a ni z a t io n sh a l l  D e t er m i ne In p u t s, o u t p u t s, s e q ue n c e a n d i n t e r a c t io n o f p r oce s se s  E n s u r e ef f ec t i v e o p e r a t io n o f p r oce ss  E n s u r e av a i l a bili t y o f r e s o u r ce s  P l an a c t io n t o a d d r e ss ri sk a nd o p por t u ni t ie s  D e t er m i ne m e t h o ds t o m o n i t o r , m e a s u r e a nd e v a l u a t e p r oce ss  D e t er m i n e o pp or t un i t ie s t o i m p r o v e p r oce s s an d QM S

64. 5 L e a d e r s hi p 5 . 1 L e ad e r s h i p and co mm i t m e n t T o p ma n a g e m e n t t o d e m o n s t r at e l e a d e r s h i p a n d c o mmit m e n t.  A cc o u n t a b i l i t y  Q u a l i t y po li cy a n d qu a l it y obj e ct iv e s  I n t e g r a t i o n o f t h e qu a l i t y m a n a g e m e n t s y s t em  P r o m o t i n g a w a r e n ess o f t h e pr o c ess a p pr o a c h  E n s u r i n g r es o ur c es a r e a v a i l a b le  C o mm un i c a t i n g t h e i m p o r t a n c e  En s u r i n g r e s u l t s a r e a c h i e v ed  En g a g i n g , d i r e c t i n g a n d s upp o r t i n g  P r o m o t i n g i m pr o v e m e n t  S upp or t i n g o t h er m a n a g e r s

65. 5 L e a d e r s hi p Qua li t y P o li cy Doc u m e n t e d S u i t a bl e a n d app r o p ri a t e C o mm i t m e n t t o m ee t r e q ui r e m e n t s a n d c o n t i n u al i m p r o v e m e n t F r a m e w or k f o r qu a l i t y o b j ec t i v e s C o mm un i c a t e d & und e r s t oo d A v a i l a bl e t o r ele v a n t i n t e r e s t e d p ar t ie s

66. 5 L e a d e r s hi p 5.3 O r g an iz a t i on a l r o l es , r es pons i b ili t i e s a nd au t hor i t i e s T o p m a n a g e m e n t s h a l l a s si g n t he r e s p o n s i b i li t y a n d a u t h o ri t y t o  E n s u r e Q M S c o n f or m s t o r e q ui r e m e n t s  P r oce ss e s deli v eri n g i n t e nd e d o u t pu t  R e p or t i n g o n per f or m a nc e o f Q M S  E nsu r e c u s t o m e r f oc u s  E nsu r e i n t e g ri t y o f Q M S m a i n t a i n e d wh e n QM S c h a n g e

67. Schematics of accountability in an organization

68. ISO 9001-2015 Clause 6 Planning

69. 6 P l a nnin g A c t i ons t o a dd r es s r i s k and o ppo r t un i t i e s O r g a ni z a t io n s h a l l de t er m i ne t he ri sk a n d o p por t u ni t ie s t o A s s u r e Q M S a c h i e v e i n t e n de d r e s ult s P r e v e n t o r r e d uc e u n d e s i r e d r e s ult s A c h i e v e c o n ti n u al i m p r o v e m e n t O r g a ni z a t io n sh a l l pl an h o w t o i n t e g r a t e a n d i m p l e m e n t a c tio ns i n t o Q M S e v a l u a t e e f f ecti v e n e ss o f a ctio n t a k e n

70. Q uali t y Sys t em Planning 78 AS Q Reliability and Risk Division Webin ar Janu ary 14, 2021 Risk & Oppo rtunities Con text External Issue Con text Internal Issue (ISO 9001 Clause 6 .1) (ISO 9001 Clause 4 .1) (ISO 9001 Clause 4 .2) Interested Parties’ Needs

71. Q uali t y Sys t em Planning(con t. ) AS Q Reliability and Risk Division Webin ar Janu ary 14, 2021 79 Ris k & Opp o rtuniti es (ISO 9001 Clause 6 .1) Pla n: De termine Action Plans to address Risks and Oppo rtuni ties (Clause 6 .1.2) D o: Integrate and implemen t a ctions in to i ts quali ty management system processes (Clause 4 .4) C heck: Evalua te e f fe ctiveness o f a ctions taken (Clause 9 .3) Act: Learn from resul ts and reassess Con te xt and Intere sted Pa rties (Clause 10 .3)

72. Risk-based thinking approach Need to identify / demonstrate:- Identify what your risks are – it depends on context, interested parties prioritize the way you manage your processes balance risks and opportunities Analyse and prioritize your risks what is acceptable? what is unacceptable? Evaluate - Plan actions to address the risks how can I avoid, eliminate or mitigate risks? Treat / Address - Implement the plan; take action reduce the probability Monitor / Review check the effectiveness; does it work? learn from experience; improve

73. Risk Assessment - Quantitative ASQ Consequence Likelihood Insignificant 1 Minor 2 Moderate Major 4 Catastrophic 5 3 Almost Certain 5 5 10 Likely 4 4 8 Possible 3 6 12 Unlikely 2 8 10 Rare 1 4 5 Division

74. Risk Assessment - Qualitative L M H Probability H M

75. 6 P l a nnin g 6.2 Qua l i t y o bject i v e and p l ann i ng t o ach i e v e t h e m Q u a l i t y o b j ec t i v e s sh a l l b e  E s t a bli sh e d a t r ele v a n t f un c t io ns , le v el s a n d p r oce ss e s  C o n s i s t e n t w i t h q u a l i t y p o lic y  R ele v a n t t o a p p l i c a bl e r e q ui r e m e n t s & c o n f or m i t y o f p r o d uc t s & s e r vice s t o e nh a nc e c u s t o m e r s a t i s f a ct io n  M o n i t o r e d , c o mm un i c a t e d & u pd a t e d

76. 6 P l a nnin g 6.2 Qua li t y ob j e c t i v e and p l ann i ng t o a ch i e v e t h e m De t er m i n e  W h a t t o b e d o ne  W h a t r e s o u r ce s w il l b e r e q ui r e d  W ho w il l be r e s p o n si b l e  W h e n i t w i l l be c o m p l e t e d  H o w t he r e s u lt s w il l b e e v a l u a t e d

77. QMS Objectives and Planning Action QMS Objectives What is an Objective? A Specific Result that a person or system aims to achieve with a time frame and with available recourse.

78. 6 P l a nnin g 6.3 P l ann i ng of ch a n g e s O r g a ni z a t io n d e t er m i n e n ee d f o r c h a n g e an d c o ns i d e r  P u r p o s e o f c h a n g e  Q M S i n t e g ri t y  A v a i l a bl e r e s o u r ce s  R e sp o ns i b ili t y / a u t h ori t y

79. ISO 9001:2015 Clause 7 Support

80. 7 S upp o r t 7.1 R es ou r c e s O r g a n i z a tio n d e t er m i n e , p r o v i de a n d m a i n t a i n i n f r a s tr u c t u r e f o r o p e r a tio n o f it s p r o ce s s e s  P eo p l e  In f r a s t r u c t u r e  E n vi r o n m e n t f o r t h e o p e r a t io n o f p r oce ss e s  Mo n i t ori n g a n d m e a s u ri n g r e s o u r ce s  O r g a ni z a t io n al k n o w le d g e

81. 7 S upp o r t 7.1.2 P e op l e  S u f f icie n t m a n p o w e r  C o m p e t e n t pe r s o nn e l F o r t he ef f ec t i v e i m p l e m e n t a t io n o f Q M S a nd f o r t he o p e r a t io n a n d c o n t r o l o f i t s p r oce ss e s .

82. 7 S upp o r t 7.1.3 Inf r a s t ructu r e P r e v e n t i v e m a i n t e n a nc e p r o g r am f o r  B u il d i n g & a s s oci a t e d u t ili t ie s  E q ui p m e n t ( h a r d w a r e & sof t w a r e )  T r a n s p or t a t io n r e s o u r ce s  In f or m a t io n & c o mm u ni c a t io n t ec h nolo g y

83. 7 S upp o r t 7.1.4 E n v i r on m e n t f or t he ope r a t i on of p r oce s se s P r ovi d e an d m a i n t a i n e n vi r o n m e n t n ece ss a r y wh i c h c an i n cl ud e :  S oc i al ( n on - d i scr i m ina t o r y , c al m, n o n - c o nf r o nt at io n a l )  P sy cho l o g i cal ( s t res s - re du c i ng , bu r n o u t p reve n t io n , em ot io na ll y p r o t ec ti ve)  P h y s i cal ( t em p er atu re, h e at , h u m i d i t y , li g h t , a i r flo w , h y g i e n e, n oi se)

84. 7 S upp o r t 7.1.5 M on i t or i ng and m e asu r i ng r es ou r ces  C a l i b r a t io n s c h e du l e  P l a n n e d i n t e r v a l s  T r a c e a bl e t o i n t er n a t io n al o r n a t io n al s t a n d a r d s  L a b e l c a l i b r a t io n s t a t us  S a f e g u a r d e d f r o m u n a u t h o ri z e d a d ju s t m e n t  P r o t ec t e d f r o m d a m a g e a n d d e t erio r a t io n  M a i n t a i n c a l i b r a t io n r e c o r ds

85. 7 S upp o r t 7.1 . 6 O rg an i z a t i onal k now l e d g e D e t er m i n e , m a i n t a i n a n d m a d e a v a i l a bl e t he k n o w l e d g e n ece ss a r y :  S p eci f i c k n o w le d g e g a i n e d b y e x perie n c e / i n f or m a t io n u s e d a n d s h a r e d t o a c h i e v e o bj e cti v e s  B a se d o n i n t er n al s o u r ce s an d e x t er n al s o u r ce s

86. 7 S upp o r t 7 . 2 C o m p e t e nce T he o r g a n i z a tio n s h a l l  De t er m i n e n ece ss a r y c o m p e t e n c e o f p e r s o nn e l  T a k e a c t io ns t o a c q ui r e n e ce s s a r y c o m p e t e n c e , a nd e v a l u a t e e f f ec t i v e n e s s o f a c t io n s t a k e n  M a i n t a i n t r a i n i n g r e c o r d f o r a l l t r a i n i n g s

87. 7 S upp o r t 7.3 A w a r e n es s E m p lo y ee s t o b e a w a r e o f  Q u a l i t y p olic y  R ele v a n t q u a l i t y o bj e c t i v e s  T h e i r c o n t ri b u t io n t o Q M S  I m p l i c a t io ns o f no t c o n f or m i ng t o Q M S

88. 7 S upp o r t 7 . 4 C o mm un i c a t i on O r g an i z a tio n s h a l l d e t e r m i ne w h a t, w he n, w i th who m , how t o c o mm u ni c a t e a n d who c o mm u ni c a t e s t o i n t er n a l a n d e x t er n a l p e o p l e .

89. 7 S upp o r t 7.5 D ocu m e n t e d i n f or m a t i on In g e n e r a l , QM S s h a l l i n c l u d e  D oc u m e n t e d i n f or m a t io n r e q ui r e d by s t a n d a r d  D oc u m e n t e d i n f or m a t io n f o r e f f ec t i v e Q M S

90. E xtent of documented information The extent of documented information for a quality management system can differ from one organization to another due to:   the size of organization and its type of activities, processes, products and services; t he complexity of processes and their interactions; the competence of persons. (ability to apply knowledge and skills to achieve intended results)

91. OMS DOCUMENTATION HEIRACHY

92. Quality Policy   A policy represents a declarative statement by an organization. A Quality Policy should state the commitment of the organization to quality and continual improvement. Usually, this policy is used for promotional purposes and should be displayed in the organization’s premises and posted on websites, so a clear and short Quality Policy is convenient and is the general practice. The  Quality Policy  defines the quality objectives to which the organization strives. The quality goals of organizations are defined by quantifying the  quality objectives .

93. QUALITY MANUAL The manual should fit your organization. The structure and the content of the manual can vary depending on the size of the organization, the complexity of its operations, and the competence of the personnel. Small organizations can document the entire QMS in one manual. On the other side, large international organizations may have several different quality manuals. Generally, the manual includes the QMS scope, exclusions from the standard, references to relevant documents, and the business process model. The Quality Policy and the objectives can be part of the manual as well. The Quality Manual should include most of the following elements: title and table of contents; scope of the QMS; exclusions from ISO 9001, versioning information, and approval; Quality Policy and objectives; QMS description, the business process model of the organization; definition of responsibilities for all personnel; and references to relevant documents and relevant appendices, policies with respect to the requirements of the standard

94. QMS DOCUMENTATION Procedure : A specified way to perform an activity  Quality procedures formats.   Quality procedures can have different formats and structures. They can be narrative, i.e., described through text; they can be more structured by using tables; they can be more illustrative, i.e., flow charts; or they can be any combination of the above.

95. STRUCTURE OF QMS PROCEDURES Quality procedures should include the following elements: Title – for identification of the procedure Purpose – describing the rationale behind the procedure Scope – to explain what aspects will be covered in the procedure, and which aspects will not be covered Responsibilities and authorities of all people/functions included in any part the procedure Definitions and lists of all records that result from the activities described in the procedure Document control – identification of changes, date of review, and approval and version of the document should be included in accordance with the established practice for document control Description of activities – this is the main section of the procedure; it relates all the other elements of the procedure and describes what should be done, by whom and how, when and where. In some cases, “why” should be clarified as well. Additionally, the inputs and the outputs of the activities should be explained, including the needed resources. Appendices may be included, if needed.

96. Managing SOPs

97. Work instructions Work instructions can be part of a procedure, or they can be referenced in a procedure. Generally, work instructions have a similar structure to the procedures and cover the same elements; however, the work instructions include details of activities that need to be realized, focusing on the sequencing of the steps, tools, and methods to be used and required accuracy.

98. Relationship between Procedure and Work Instruction

99. Records and forms.     In order to demonstrate that your processes met their requirements, you will want to keep some evidence; this is where forms and records are used. A record is what has been chosen by the process owner to demonstrate that the process and activities have been conducted in the way prescribed in the procedures and work instructions. Forms are the blank templates to be filled in with information that will become these records. Make your records and forms practical by being concise and simply recording the information required; do not make employees write essays to complete the form and create the record.

100. Requirements for Registration/Certification Documented quality policy and objectives Documented quality management system scope Documented Information & retained Information required by ISO 9001:2015 Other procedures & records required for the effective operation and control of organizations processes Registration /certification body conditions Internal policies and procedures/work instructions Applicable regulatory/statutory requirements Industry standards & contractual agreements

101. Mandatory documents and records required by ISO 9001:2015 Documented information : Scope of the QMS (clause 4.3) Quality policy (clause 5.2) Quality objectives (clause 6.2) Criteria for evaluation and selection of suppliers (clause 8.4.1)

102. Retained information : Monitoring and measuring equipment calibration records* (clause 7.1.5.1) Records of training, skills, experience and qualifications (clause 7.2) Product/service requirements review records (clause 8.2.3.2) Record about design and development outputs review* (clause 8.3.2) Records about design and development inputs* (clause 8.3.3) Records of design and development controls* (clause 8.3.4) Records of design and development outputs *(clause 8.3.5) Design and development changes records* (clause 8.3.6) Characteristics of product to be produced and service to be provided (clause 8.5.1)

103. Retained information : Records about customer property (clause 8.5.3) Production/service provision change control records (clause 8.5.6) Record of conformity of product/service with acceptance criteria (clause 8.6) Record of nonconforming outputs (clause 8.7.2) Monitoring and measurement results (clause 9.1.1) Internal audit program (clause 9.2) Results of internal audits (clause 9.2) Results of the management review (clause 9.3) Results of corrective actions (clause 10.1)

104. Non-mandatory documents Non-mandatory documents but most commonly used: Procedure for determining context of the organization and interested parties (clauses 4.1 and 4.2) Procedure for addressing risks and opportunities (clause 6.1) Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3) Procedure for equipment maintenance and measuring equipment (clause 7.1.5) Procedure for document and record control (clause 7.5) Sales procedure (clause 8.2) Procedure for design and development (clause 8.3) Procedure for production and service provision (clause 8.5) Warehousing procedure (clause 8.5.4) Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2) Procedure for monitoring customer satisfaction (clause 9.1.2) Procedure for internal audit (clause 9.2) Procedure for management review (clause 9.3)

105. AFTER CERTICATION , WHAT NEXT? The system is subjected to surveillance audits twice a year for the first three years After three years the system is revalidated and surveillance scaled down to once a year

106. 7 S upp o r t 7.5 Docu m e n t e d i n f o r m a t i on C r e a t i ng a nd upd a t i ng W h e n c r e a ti ng a n d u p d a ti n g , e n s u r e  Id e n t i f i c a t io n a n d de s cri p t io n  F or m a t  R evie w an d app r o v al D o c u m e n t e d i n f or m a tio n h a s t o be c o n t r olle d t o  B e av a i l a bl e a n d s u i t a bl e f o r u se  A d e q u a t el y p r o t ec t e d

107. 7 S upp o r t 7.5 D o cu m e n t e d i n f or m a t i on C o n t r ol of docu m e n t e d i n f or m a t i on D o c u m e n t e d i n f or m a t io n i s c o n t r olle d by a d d r e s si ng  D i s t ri b u t io n, a cce s s , r e t rie v al a n d u s e  S t o r a g e an d p r e s e r v a t io n  C o n t r o l o f c h a n g e s  R e t e n t io n a n d di sp o s i t io n  C o n t r o l e x t er n al ori g i n doc u m e n t

108. Control of documents used to run the system

109. 8 O p e r a t i o n 8.1 O p e r a t i onal p l ann i ng a nd co n t r ol T h e o r g a ni z a t io n sh a l l  D e t er m i n e r e qu i r e m e n t s  E s t a bli s h cri t eri a  D e t er m i n e r e s o u r ce s  I m p le m e n t c o n t r o l  R e t a i n d oc u m e n t e d i n f or m a t io n

110. 8 O p e r a t i o n 8 .2 D e t e r m in a t i on of r e qui r e m e n ts f or p r odu c ts a nd s e r vi c e s T h e o r g a ni z a t io n sh a l l  E s t a bli s h p r oce s s t o c o mm un i c a t e w i t h c u s t o m e r s - P r o d uc t / s e r v ic e i n f or m a t io n, e n q u i rie s/ c o n t r a c t s/ o r d e r s, c u s t o m e r f ee db a ck / c o m p l a i n t s , c u s t o m e r p r o p er t y , r e qu i r e m e n t s f o r c o n t i n g e n c y a ct io n s  De t er m i n e p r o du c t a n d se r vic e r el a t e d r e qu i r e m e n t s  R evie w p r o du c t a n d se r vic e r el a t e d r e qu i r e m e n t s

111. 8.3 Design and Development in Summary Design planning 8.3.1 8.3.2 8.3.3 8.3.5 8.3.4 8.3.6 8.3.7 Control of D&D changes

112. 8 O p e r a t i o n 8 . 4 C o n t r ol of e x t er na l l y p r o v i d e d p r odu c t and se r v i c e s O r g ani z a t ion s hall e s t ablish c r i t e r ia f or  E v a lu a t ion  S e l e c t ion  P e r f o r m a nce moni t o r ing  R e - e v alu a t ion O r g ani z a t ion s hall  D e t e r m ine t y pe a nd e x t e nd of c o n t r ol  C om muni c a t e t o e x t e r n a l p r o v id e r s t he r e qui r e m e n t s f or Q C , c omp e t e nc e , Q M S, c o n t r ol a nd ve r i f i c a t i o n

113. 8 O p e r a t i o n 8.5 P r oduc t i on and se r v i ce p r ov i s i on F or p r o d uc t i o n and s e r v ice p r o v ision o r g a ni z a t i o n sh a ll  I mpl e m e n t c o n t r o l l e d c o n di t i o n  P r a c t ice id e n t i f i c a t i o n a nd t r a c ea bil i t y t o e nsu r e c o n f o r mit y  E x e r ci s e c a r e w i t h p r o pe r t y b e l onging t o cu s t om e r / e x t e r n a l p r o v id e r  Ensu r e p r e s e r v a t i o n of p r oc e ss o ut pu t s  Mee t r e qui r e m e n t s on p o s t - d e li v e r y  C o n t r ol unp l a nn e d c h a n g e s

114. 8 O p e r a t i o n 8.6 R e l e a s e of p r oduct and se r v i c e s O r g a n i z a tio n s h a l l i m p l e m e n t p l a n n e d a r r a n g e m e n t s f o r v erifi c a tio n o f c o n f or m it y 8.7 C o n t r ol of noncon f o r m i ng outpu t s O r g a n i z a tio n s h a l l  E nsu r e no n c o n f or m a nc e i s i d e n t i f ie d a n d c o n t r olle d  T a k e app r o p ri a t e c or r ec t i v e a ct io n

115. 9 P er f o r m a n c e e v a lu a t i o n 9.1 M on i t or i n g , m e asu r e m e n t , an a l ys i s and e v a l u a t i on T he o r g a ni z a t i o n sh a ll  D e t e r mine w h a t , w h e n a nd m et h o ds f or mo n i t o r ing a nd m e a su r e m e n t  M o n i t or cu s t om e r s a t i sf a c t i o n  A n a l y z e a nd e v a lu at e t he a pp r o p r i a t e d at a

116. Why monitor and measure as insisted by ISO 9001:2015? If you cannot measure it, you cannot improve it. Lord Kelvin Measurements provide you with a baseline to improve upon.

117. 9 P er f o r m a n c e e v a lu a t i o n 9.2 I n t e rnal a ud i t I n t e r n a l a udit c o n duc t e d a t pl a nn e d i n t e r v a ls Q M S m u s t  M e e t o r g a ni z a t ions a nd QMS r e qui r e m e n t s  M e e t s t a nda r d r e qui r e m e n t s  E f f e c t i ve ly i mpl e m e n t e d a nd m a i n t a in e d

118. Audit defined Audit is a systematic and documented process for gathering audit evidence and evaluating it against the audit criteria to determine whether it has been fulfilled Audit criteria is a set of policies, procedures or requirements Audit evidence is records, statements of fact or other information which are relevant to the audit criteria and verifiable Audit conclusion is the outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings

119. Internal audit process Purpose is to verify whether your QMS Conforms to your Quality Plan, Conforms to ISO 9001 requirements, Conforms to your QMS requirements, and is effectively implemented and maintained.

120. Audit process Model

121. Internal Audit process

122. For effective corrective actions

123. 9 P er f o r m a n c e e v a lu a t i o n 9 . 3 M ana g e m e n t r e vi e w s h a l l be pl a n n e d a nd c on s i d e r  S t a t us of p r e v i ous mee t i ng a c t i ons  C h a ng e s i n i n t e r n a l / e x t e r n a l i ss u e s  P e r f o r ma n c e & e ff ec t i v e n e s s of Q M S - C u st o m e r s a t i s f ac t i on & f ee db ac k, qu a li t y o bj ec t i v e s ac h i e v eme nt , n o n c o n f o r m i t y & c o r r ec t i v e ac t i o n , m o n i t o r i ng & mea s u r eme nt r e s u l ts , a ud i t r e s u l ts , e x t e r n a l p r ovid e r s p e r f o r m a n c e  R e s ou r ce s a d e q u a c y  P r o c e s s p e r f o r m a n c e  E ff ec t i v e n e s s of a c t i on t a k e n f or r i s k a nd o p po r t un i t i e s  N e w o ppo r t un i t i e s f or c o nt i nu a l i m p r o v eme nt

124. 1 I m p r o v e m e n t 10.1 Ge n e r al O r g a ni z a t io n s h a l l selec t o p por t u ni t y f o r i m p r o v e m e n t t o  P r e v e n t n o n c o n f or m a nc e  M ee t k n o wn a nd p r e d i c t e d p r o d uc t a n d s e r v ic e r e q ui r e m e n t s  I m p r o v e QM S r e su l t s

125. 1 I m p r o v e m e n t 10.2 N o ncon f or mi t y and cor r e c t i v e ac ti on W h e n no n c o n f or m i t y o cc u r s , o r g a ni z a t io n sh a l l  R e a c t t o n o n c o n f or m i t y  E v a l u a t e n e e d f o r a c t io n t o eli m i n a t e c a u se  I m p l e m e n t a c t io n n e e d e d  R e v ie w e f f ec t i v e n e ss o f c or r ec t i v e a c t io n t a k e n

126. Corrective action process

127. Corrective action using PDCA

128. 1 I m p r o v e m e n t 10 . 3 C o n t i nual I m p r o v e m e n t O r g an i z a t io n s h a l l  c o n t i n u a l l y i m p r o v e s u i t a bili t y , a de q u a c y a nd ef f ec t i v e n e ss o f Q M S  c o n s i d e r o u t p u t f r o m a n al y s i s, e v a l u a t io n a n d M R t o c o n f ir m u n d e r p e r f or m a n c e o r o p port u nitie s f o r c o n ti n u al i m p r o v e m e n t s  S elec t a n d u t ili z e t ool s a n d m e t h o d s t o i n v e s t i g a t e c a u s e o f u n d e r p e r f or m a n c e f o r c o n ti n u al i m p r o v e m e n t

129. CONTINUAL IMPROVEMENT

130. Q u e s t i o n s

131. • • • + + • + , ,. , \ ' ' , , , ' + • •