Introduction to ISO 9001 2015, IMS_APPRECIATION[1].ppt

introduction to integrated management system comprising ISO 9001 2015, ISO 14001 2015 and ISO 45001 2018

1. INTEGRATED MANAGEMENT SYSTEM
ISO 9001, ISO 14001 & ISO 45001
APPRECIATION COURSE

3. BetterunderstandingofIMScomponents
requirements.
Applicationoftherequirementsinmonosystems
Applicationoftherequirementsinmultisystem
Integrationoftherequirementsintoasingle
system(IMS)
Auditingknowledge&skills
Auditingofsingle,multisystems&IMS

4. 1.What are single and mult-systems
2.What is IMS?
3.What is the benefit of IMS?
4.What is the difference between consultation and
participation?
5.What is the difference between hazard and aspect?
6.What is the difference between monitoring and
measurement?
7.What is organisational knowledge?
8.Define competence?
9.Differentiate between correction and corrective action?
10.Differentiate between nonconformity and
nonconforming output?

5. PROCESS APPROACH
a systematic management of processes, and their
interactions, so as to achieve intended results
RISK BASED THINKING
assessing a situation by looking for the potential for success
and failure. “Taking a proactive approach”
PLAN-DO-CHECK-ACT
continuous improvement methodology guiding
organizations in planning, implementing, monitoring, and
improving their processes.

6. 6

7. Summary of the Requirements
of the Management System Standards
(OHSMS,QMS, EMS)

8. INTEGRATED MANAGEMENT SYSTEM PROCESS MAP

9. The new standard
adopts the
HARMONISED
STRUCTURE and
terminology of Annex
SL (used for the
development of all new
ISO Management
System Standards)
HarmonisedStructure
-identical core text and
common terms and core
definitions for use in all
Management System
Standards:
purpose -enhance the
consistency and alignment of
different management system
standardsorganisations that
integrate multiple standards
(e.g. EMS,QMS,FSMS) will see
the most benefit uses simplified
language and writing styles to
aid understanding and
consistent interpretations of
requirements.
Benefits of
implementing
morethanone
MSS:
•Seamless
integration.
•Shorterlearning
curve.
•Less
cumbersome
documentation.

10. Annex SL : high level structure
Benefits
same Harmonized Structure for all
ISO MS standards
More efficient to address multiple
management system requirements
(e.g. QMS, EMS, OH&S)
Provides the option of integrated
management systems
Standardized core definitions
Provides a common language and structure for ISO MS
Standards

11. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
1 SCOPE 1 SCOPE 1 SCOPE
2 NORMATIVE
REFERENCES
2 NORMATIVE
REFERENCES
2 NORMATIVE
REFERENCES
3 TERMS AND
DEFINITIONS
3 TERMS AND
DEFINITIONS
3 TERMS AND
DEFINITIONS
SIMILARITIES DIFFERENCES
•Generic requirements
•Performance
improvement
•All can be used for
certification
•No exclusion in EMS &
OHSMS Scope
•EMS and OHSMS can be
used in parts
•EMS & OHSMS no
normative references
•All have different focuses

12. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
4.1Understanding
theorganization&
itscontext
4.1Understanding
theorganization&
itscontext
4.1Understanding
theorganization&
itscontext
SIMILARITIES DIFFERENCES
•Determination of relevant
internal issues
•Determination of relevant
external issues
•Climate change
•EMS emphasize actual and
potential environmental
issues.
•QMS is specific on
monitoring and reviewing
•QMS (notes) listed the
possible internal and
external issues
•The focuses are different

13. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
4.2Understanding
theneedsand
expectations of
workersandother
interestedparties
4.2Understanding
theneedsand
expectations of
interestedparties
4.2Understanding
theneedsand
expectations of
interestedparties
SIMILARITIES DIFFERENCES
•Determination of relevant
interested parties
•Determination of relevant
requirements of the
interested parties
•Climate change
•QMS is specific on
monitoring and reviewing
•Determining EMS and
OHSMS compliance/legal
rqts.
•The focuses are different

14. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
4.3Determiningthe
scopeoftheOHS
mgtsystem
4.3Determining
thescopeofthe
QMS
4.3Determiningthe
scopeoftheEMS
SIMILARITIES DIFFERENCES
•Determine boundaries
and applicability
•Consider 4.1 and 4.2
•Document scope
•OHS considers planned and
performed works
•EMS considers units, functions
and physical boundaries
•EMS requires scope to be
available to interested parties
•EMS considers controls and
influence
•QMS requires justification for
exclusion

15. ISO 45001:2018ISO 9001:2015 ISO 14001:2015
4.4 OH & S
management
system
4.4QMS&itsprocesses
(Title)-
4.4.1(aboutQMSandits
processes)
4.4.2(aboutdocumented
information)
4.4 Env.
management
system
SIMILARITIES DIFFERENCES
•Establish, implement,
maintain & improve MS
•Establishing processes and
their interactions
•QMS is detailed
•EMS requires usage of
knowledge gained in 4,1
and 4,2

16. ISO 45001:2018ISO 9001:2015 ISO 14001:2015
5.1 Leadership
and commitment
5.1 Leadership and
commitment (Title)
5.1.1 General
5.1.2 Customer focus
5.1 Leadership
and commitment
SIMILARITIES DIFFERENCES
•Taking responsibilities for
commitments of the MS
•Ensuring assigned
responsibilities
•OHS requires
•establishing OHS culture
•process for preventing
reprisal attack
•Process for consultation
and participation
•Supporting safety
committees

17. ISO 45001:2018ISO 9001:2015 ISO 14001:2015
5.2 OH & S policy5.2 Policy (Title)
5.2.1 Establishing the
quality policy
5.2.2 Communicating the
quality policy
5.2 Environmental
policy
SIMILARITIES DIFFERENCES
•Appropriateness of
purpose
•Compliance to
requirements
•Continual improvement
•Documented
•Framework for objectives
•EMS requires commitment
to protect environment
•EMS insist on comm. to
interested parties
•OHS requires commitment
to eliminate hazards &
risks and consultation &
participation

18. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
5.3 Organizational
roles, responsibilities,
accountabilitiesand
authorities
5.3 Organizational
roles, responsibilities
and authorities
5.3 Organizational
roles,
responsibilities
and authorities
SIMILARITIES DIFFERENCES
•Assigning responsibilities
for MS
Establishing
Reporting
•OHSMS specifically requires
that responsibilities be
documented
•QMS requires promotion of
customer focus and
protection of QMS integrity

19. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
5.4 Consultation
and participation of
workers
--- ---
SIMILARITIES DIFFERENCES
•NA •OHS requires
•Processes for consultation and
participation of all staff.
•Remove barriers and obstacles
•Specific consultation and
participation requirements for
non managerial staff

20. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
6.1 Actions to address
risks & opportunities
6.1 Actions to address
risks & opportunities
6.1 Actions to address
risks & opportunities
6.1.1 General 6.1.1(about
requirements when
planning QMS)
6.1.1 General
SIMILARITIES DIFFERENCES
•Consider 4.1 and 4.2
•Requires assurance,
prevention of undesirable
effect and improvement
•OHS & EMS considers 4.3
•EMS requires considering
potential emergencies and
documentation of risks/opportunity
and processes
•OHS requires-Account of hazards,
risks & opportunities, legal, risk
assessment, changes

21. ISO 45001:2018 ISO 9001:2015 ISO
14001:2015
6.1.2 Hazard
Identification and
assessment of risks
and opportunities
6.1.2(about
addressing risks &
opportunities)
6.1.2
Environmental
aspects
SIMILARITIES DIFFERENCES
•Identification/determine
•Assessment
(methodology & Criteria)
•OHS & EMS all have varying
requirements for determination
/identification and assessment
•QMS did not have these
requirements in 6.1.2

22. ISO 45001:2018 ISO 9001:2015 ISO
14001:2015
6.1.3 Determination of
legal requirements and
other requirements
- 6.1.3
Compliance
obligations
SIMILARITIES DIFFERENCES
•Determination of CO
•Establish how to access
CO
•Maintain Doc Info
•OHS equally requires retaining Dc
Info
•QMS did not have these
requirements in 6.1.3

23. ISO 45001:2018 ISO 9001:2015 ISO
14001:2015
6.1.4 Planning action - 6.1.4 Planning
action
SIMILARITIES DIFFERENCES
•Have action plan in place
•Integrate with other plans
•Maintain Doc Info
•Consider tech, finance,
operation and bus rqts
•OHS added best practices and
hierarchy of control
•QMS addressed requirements of
this clause in 6.1.2

24. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
6.2 OH & S objectives
and planning to
achieve them (Title)
6.2 Quality objectives
and planning to
achieve them (Title)
6.2 Environmental
objectives and planning
to achieve them (Title)
6.2.1 OH & S
objectives
6.2.1(about quality
objectives)
6.2.1 Environmental
objectives
SIMILARITIES DIFFERENCES
•To be established
functions and levels
•To meet specifics
•To be documented
•OHS & EMS measurement is
based on practicability
•OHS requires consideration of
consultation results.

25. ISO 45001:2018ISO 9001:2015 ISO 14001:2015
6.2.2 Planning
actions to achieve
OH & S objectives
6.2.2(about
achievement planning)
6.2.2 Planning actions to
achieve environmental
objectives
-- 6.3 Planning of changes --
SIMILARITIES DIFFERENCES
•Specified elements of
action plan
•OHS & EMS emphasis integration
of action plan into business
process
•OHS emphasis maintaining and
retaining documented information
•Only QMS has 6.3

26. ISO 45001:2018ISO 9001:2015 ISO 14001:2015
7.1 Resources 7.1 Resources 7.1 Resources
-- 7.1.1 to 7.1.6 --
SIMILARITIES DIFFERENCES
•Determining and
providing required
resources
•Only QMS detailed the required
resources as in 7.1.1 to 7.1.6

27. ISO 45001:2018ISO 9001:2015 ISO 14001:2015
7.2 Competence7.2 Competence 7.2 Competence
7.3 Awareness 7.3 Awareness 7.3 Awareness
SIMILARITIES DIFFERENCES
•Determine competence
•Acquire competence and evaluate
effectiveness & maintain record
•Awareness on policy, objectives,
responsibilities and failure
---
EMS added aspects
OHS added hazards,
incident investigation,
removing themselves
from danger

28. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
7.5 Documented
information
7.5 Documented
information
7.5 Documented
information
SIMILARITIES DIFFERENCES
•Same requirements

29. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
8.1 Operational planning
and control
8.1 Operational
planning and control
8.1 Operational planning
and control
SIMILARITIES DIFFERENCES
•Establish processes & criteria
•Implement the controls
•Control changes
•Review consequences of
unintended changes
/emergencies
•Maintaining and retaining
documentation
•Control of outsourced
processes
•EMS and OHS recommends
hierarchy of controls
•EMS considers lifecycle
perspective.
OHS emphasise
Work adaptation
Procurement control
Hazard elimination
Outsource control
Control of contractors

30. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
8.2 Emergency
preparedness and
response
8.2 Requirements
for products &
services
8.2 Emergency
preparedness and
response
--- 8.3 to 8.7 ----
SIMILARITIES DIFFERENCES
•EMS & OHS addresses emergency
preparedness and response
•QMS addresses
product and service requirements
Control of external provisions
Control of production & service provision
Product release
Control of NC outputs

31. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
9.1 Monitoring,
measuring, analysis
and evaluation
9.1 Monitoring,
measuring,
analysis and
evaluation
9.1 Monitoring,
measuring, analysis
and evaluation
SIMILARITIES DIFFERENCES
•Determine what to monitor
and measure
•Establish monitoring and
measuring process (criteria,
method, frequency, etc)
•Mtce of records
•EMS & OHS requires calibration
and compliance evaluation
•QMS requires customer
satisfaction monitoring and data
analysis & evaluation

32. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
9.2 Internal audit 9.2 Internal audit 9.2 Internal audit
SIMILARITIES DIFFERENCES
•Establish frequency
•Have programme
•Implement and report
•OHS requires reporting audit
results to workers

33. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
9.3 Management
review
9.3 Management
review
9.3 Management
review
SIMILARITIES DIFFERENCES
•Establish frequency
•Consider all inputs
•Retain record of output
•OHS requires communication of
review output to workers

34. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
10.1 General 10.1 General 10.1 General
SIMILARITIES DIFFERENCES
•Determine opportunities for
improvement
•Implement the required
action
•QMS gave specific examples of
possible improvements in the note

35. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
10.2 Incident,
Nonconformity &
corrective action
10.2
Nonconformity
and corrective
action
10.2 Nonconformity
& corrective action
SIMILARITIES DIFFERENCES
•NC Correction
•NC Corrective action
•Retain records
•OHS included incidents and
incidents investigation
•OHS requires participation of, and
communication to workers.

36. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015
10.3 Continual
improvement
10.3 Continual
improvement
10.3 Continual
improvement
SIMILARITIES DIFFERENCES
•Establish frequency
•Consider all inputs
•Retain record of output
•OHS requires communication of
review output to workers

38. AUDITEVIDENCE
Records,statementsoffactsorotherinformation,
whicharerelevanttotheauditcriteriaand
verifiable.
AUDITCRITERIA
Setofrequirementsusedasareferenceagainst
whichobjectiveevidenceiscompared

39. Principles of
Auditing
2.Fair Presentationthe obligation to report
truthfully and accurately
3.Due Professional Carethe application of
diligence and judgment
in auditing
1.Integrity Trust, perform work
ethically and in an
impartial manner.
4. ConfidentialitySecurity of Information
6. Evidence-Based Approach
The basis for the
impartiality of the audit
and objectivity of the
audit conclusion.
5. Independence
7. Risk Based Approach
An audit approach that
considers risks and
opportunities.
The rational method for reaching reliable and
reproducible audit conclusions

40. Audit programme
Showsauditspreadforaperiodoftimeindicating
thefrequency
Audit plan
Showsadetailedauditplannedforaspecified
time,dateandlocationincludingdetailsofnames
ofauditors,auditeeetc.Basedonstatusand
importanceofactivity

41. ObjectiveRecording:
Auditfindingsmustberecordedsothattheycanbe
investigatedbyanotherauditorandauditedorganisationand
shouldincludeobjectiveevidencetosupportfindings.
RecordingNonConformance
1.Factualobservation(What)
2.Identifiedlocation(Where)
3.Establishedcriteria(Why&how)
4.Personinvolved(whereunavoidable)Who?

42. Factual Observation (Audit
evidence ) +Identified location by
Person involved as against
Established criteria

43. Nonfulfilmentofrequirement
Managementsystemstandard
Establishedmanagementsystem-Procedure,
processetc
Failuretomeetanestablishedobjectiveisnota
nonconformitybyitself

44. Content of Audit Report
Report reference
Date of Audit
Organization audited
Department (s) / Unit (s) visited
Audit scope
Audit basis
Personnel seen
Summary of major findings

45. ContentofAuditReport
Recommendations
Correctiveactionschedule
Follow-uprecommendations
Auditmethod
Reportdistributionlist
Signatureofauditor(s)/TeamLeaderwithdate

46. Ensurecorrectiveactiontaken
Evaluateeffectiveness
Closeoutrecords
Permitsatisfactoryconclusion
Limitedre-audit
Reviewofdocumentation
Verification

47. Review NC and take correction (auditee)
Determine and justify if any need for CA(auditee)
Identify root cause/prepare CAP(auditee)
Prepare and propose CA (auditee)
Agree CA plan (auditor)
Implement CA based on CA plan accepted (auditee)
Retain documented info. On CA taken (auditee)
Review CA effectiveness and revise if not ok (auditee)
Verify CA effectiveness (auditor)
NC closed (CA is effective)