iso 9001:2015 addresses products and...
TRANSCRIPT
05.10.2015
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CHANCES BY ISO 9001:2015 AND ISO 14001:2015 - REVISION PROCESS HAS SUCCESSFULLY BEEN CLOSED, LET´S START!
Mr. Friedrich Khuen-Belasi, MSc
ISO 9001:2015 addresses products andservices
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Chance 1: Service providers are better adressed.
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Slide Nr. 3
High Level Structure of MS-Standards
1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization
• Understanding the organization and its context
• Needs and requirements of interested parties
• Scope • XXX-management system
5. Leadership • Leadership and commitment• Policy • Roles, responsibilities and authorites
6. Planning • Actions to address risks and
opportunities • XXX-objectives and planning to
achieve them
7. Support • Resources
• Competence
• Awareness
• Communication
• Documented information
8. Operation • Operational planning and control
9. Performance evaluation • Monitoring, measurement, analysis
and evaluation
• Internal audit
• Management review
10. Improvement • Nonconformity and corrective action
• Continual improvement
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Chance 2: HLS facilitates Integration ofdifferent MS requirements
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P
D
C
A
Overview on Changes
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Scope
Context of the organization
LeadershipResponsibility
Risks&Opportunities
Quality objectives and planning
Changes
Organizational knowledge
Competence
Documented information
Operational planning
Design and Development
External processes, products and services
Production and
service provision
Monitoring and measurement
Performance and Effectiveness
Processes
Interested Parties
Model of the standard
Slide Nr. 6Note: Numbers in brackets refer to the clauses in this International Standard.
Support & Operation
(7,8)
Quality Management System (4)
Act
Do
Check
Plan
Organization and its context
(4)
Needs and expectations of
relevant interested parties (4)
Results of the QMSPlanning
(6)
Leadership(5)
Improvement(10)
Performanceevaluation
(9)
Customers requirements
Customer satisfaction
Products and services
Chance 3:
a clear Plan–
Do–Check-
Act-Cycle2015-10-02
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TailoredManagement Systems
System, processes,
objectives,
action planning
Risks andopportunities
Stake-holder
Context
Slide Nr. 7
• Which surrounding
issues are relevant?
(market, sector,
laws, issues)
• Which internal
issues are relevant?
(strategies,
competence,
culture, systems)
• Who is being
affected by
my
performance
in this field?
• Who can
influence my
performance
in this field?
• Which risks and
opportunities result from
the above for achieving
the intended goals?
• How do I deal with that?
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Implementation: process of strategicManagement
The process of strategic management includes three phases. Analysis, development of strategy and realization (includingstrategic control)
Slide Nr. 82015-10-02
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Chance 4: better comprehensiveunderstanding of the organisation
Leadership ISO 9001:2015
Top management shall demonstrate leadership andcommitment with respect to the quality managementsystem by:
New
taking accountability for the effectiveness of the QMS
ensuring establishment of quality objectives and quality policy(compatible with context, strategic direction)
ensuring the integration of QM-system requirements into thebusiness processes
ensuring the resources needed
ensuring achievement of intended results by the QM-system
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Leadership ISO 9001:2015
Top management shall demonstrate leadersip andcommitment with respect to the quality managementsystem by:
New
Promoting the use of the process approach and risk-basedthinking
communicating the importance of effective QM and ofconforming to the QMS requirements
engaging, directing and supporting persons to contribute theeffectiveness of the QMS
supporting other relevant management roles to demonstratetheir leadership as it applies to their areas of responsibility
promoting improvement
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Chance 5: Leadership is more than management and leads to the success of tomorrow.
Folie Nr. 122015-10-02
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Consequent process-approach
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Sources of Input Inputs Activities OutputsReceivers of
Output
PredecessorProcesses
e.g. at providers(internal or external)
at customers, at other relevant
interested parties
Matter, energy,
information, e.g. in form of
materials, resources,
requirements
Matter, energy,
information, e.g. in form of
product, service, decision
subsequent processes e.g. at
cutomers (internal or external), at other relevant
interested parties
decide ... where to monitor and measure performance
„Schematic representation of a single process“, cp. ISO 9001:2015, section 0.3
IMS Kalibrierung 2013 / zusammengestellt von Joseph B. GARSCHA - Folie6 -
Valuable and helpfulkey questions: Whatare relevant system
boundaries (including the
relevant „context of theorganization“)
What strategy is valid for the identified
system?
What processes arenecessary in order to
implement thestrategy for this system
What structure ishelpful for this?
Vision – missionwhere to why
strategyhow
Operative implementation
P1 P2 P3 P4 P5customer customer
Raising awareness
which process„feeds“ whichkey indicator interaction
Process
performance
indicators (e. g.
with BSC)
Effective Process Management
Slide Nr. 14
Chance 6:
Increase
effectiveness
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Planning: Actions to addressRisks and Opportunities (6.1)
When planning for the QMS, the organization shall
Consider „the context“ (4.1, 4.2) and
determine the Risks and opportunities that need to
be adressed to:
give assurance that the QMS can achieve its intended result(s)
enhance desirable effects
prevent, or reduce, undesired effects
achieve improvement
Slide Nr. 152015-10-02
„Risks based thinking“
business
strategy / objectives
business processes
personnel /
organization
technology
buying market supplier
(market power)
competitiveness
image of a technology
personnel / organization
change in technology / substitution
dependency of suppliers
variety of suppliers
material quality
reliability of suppliers
competition
new competitors
price competition
product competition
customer retention
natural events
windstorm
flood
earthquake
volcanic eruption
product quality
warranty
guarantee
product liability
goodwill
capital market
sales market customers
(market power)
trend of interest rates
refinancing risk
capital market provision
speculations
risk of order
change in demand
dependency on customer
economic situation
legal / political
environment
new regulations
new customs regulations
change of government
civil unrest / war Slide Nr. 162015-10-02
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Chance 7:Larger perspectivemanagement system is in itself a preventive actionseize chances
Document Management today
Slide Nr. 18
Documented procedures
RecordsQuality manual
Documented procedure for document control
Documented procedure for control of records
DoCuments
4 additional documented procedures
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Chance 8:More flexibility inmeeting business requirements
Folie Nr. 192015-10-02
PDCA
Lif
e c
ycle
persp
ecti
ve
Leadership
Busin
ess p
rocess
Ris
k b
ased t
hin
kin
g
Compliance obligations
Environmentalaspects
Context
Communication
Competence
Documented information
Environmental performance
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Objectives of the ISO 14001 revision
Following High Level Structure (Harmonization)
Risk based approach
Environmental management as a part of strategic management
Increasing integration of environmental management into business processes
Evidence of increased environmental performance through KPIs
Life cycle approach
External communication/reporting:restoration of trust through publication of environmental achievements
Slide No. 212015-10-02
Success factors
Slide No. 22
… commitment from all levels and functions of the organization, led by top management.
They can leverage opportunities to prevent or mitigate adverse environmental impacts, particularly those with strategic and competitive implications.
Top management can effectively address its risks and opportunities by integrating environmental management into its business processes, strategic direction and decision making, aligning them with other business priorities, …
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Slide No. 23
Who are the interested parties being relevant to the EMS?
4.2 Interested parties
Relevant interested party Needs Expectations Compliance
obligations
Owner
Management
Employees, labour union
Competitors
Banks, investors, insurance
Regulation (Law,…)
Media
NGO, citizens' action committee,
customer
Supplier, partner, retailers, distributers
Science
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Slide No. 24
7.4 Communication
The organization shall establish, implement and maintain processes for internal and external communications relevant to the environmental management system, including:
What When With whom How
External
communication
Internal
Communication
Compliance obligations
Consistent and reliable information
Response (feedbacks, complaints,
reports)
Evidence of its
communications:
Retain
documented
information
New requirement in
ISO 14001:2015
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Chance 9restoration of trust through publication of environmental achievements
Chance 10Satisfy compliance obligations
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Design has been
mentioned in ISO
14001:2004, but only
in A.3.1
(environmental
aspects)
8.1.a) determine environmental requirements for the procurement of products and services, …
LCA: Which stages can be controlled or influenced?
Raw material Design Production Transport Use End-of-life treatment
8.1.a) establish controls to ensure that its environmental requirements are
addressed in the design and development process for the product or
service, considering each stage of its life cycle;
8.1.c) communicate relevant environmental requirement(s) to
external providers, including contractors;
consider the need to provide
information about potential
significant environmental impacts
associated with the transportation or
delivery, use, end-of-life treatment
and final disposal of its products or
services
The organization shall ensure that (an) outsourced process(es) is (are)
controlled or influenced. The type and degree of control or influence to be
applied to the process(es) shall be defined within the environmental
management system.Slide No. 27
Chance 11 and 12Optimize the product footprintandthe supply chain
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At least 12 chances – so let´s start
Succeed with quality!