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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.

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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

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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!