The World of Management Systems Standards Their Content ...health.bmz.de/events/Events_2015/A_Retreat_on_Health__Social... · Ishikawa/Fishbone Diagram various steps when implementing

The World of Management Systems Standards

Their Content, Meaning and Certification

Potential meaning for social programs

Dr. Herfried Kohl

A Zoo of Management Systems Standards:

What are they good for?

13.09.2016 Dr. Herfried Kohl 3

Quality Management

ISO 9001

Environmental Management ISO 14001

Work Safety OHSAS, SCC, (ISO 45001)

Information Security

ISO 27001

Energy Efficiency ISO 50001

Anti-Bribery Management ISO 37001

Business Continuity ISO 22301

...and many others

WHAT’S THE DRIVING FORCE BEHIND THESE THINGS?

There’s JUST ONE DRIVING FORCE for dealing with the mentioned standards for

management systems and their potential certification:

THE SUPPLY CHAIN


Supplier 1 Supplier 2 Supplier 3

What’s a Process?


Process

Step 1

Process

Step 1

Process

Step 2

Process

Step 2 ….. ….. Input Output

Process

Step n

Process

Step n

Process

Step 4

Process

Step 4 Process

Step 3

Process

Step 3

Stop Stop

Roughly speaking a process is a sequence of individual steps processing an INPUT into an

OUTPUT. A process my be arbitrarily complex. Processing may involve material goods,

resources, information and others.


Step 1 P1 = 5%

Step 1 P1 = 5%

Step 2 P2 = 2%

Step 2 P2 = 2%

Step 3 P3 = 5%

Step 3 P3 = 5%

Step 4 P4 =

10%

Step 4 P4 =

10%

Step 5 P5 = 5%

Step 5 P5 = 5%

Stop Stop

This is to illustrate that deficiencies multiply along a process.

(1 −

𝑝𝑘

100)5

𝑘=1 = 0.7562

Means: only 75,62 % success

In this process the pk show the failure rates in each step.

As a result with the figures given, the process shows only about 75 % of reliability.

This setting would be a nightmare in production. However, it is reality in some service processes.

Illustration with high school math…..

Why processes matter…..

ISO 9001, ISO 14001, …..

They all are process oriented

Processes are at the very heart of the mentioned ISO-Standards for Management

Systems.

The organization is required to identify those processes which have a serious impact on

quality, environmental and other respective aspects.

It is expected that continuous improvement programs for those processes are

implemented and kept alive.

Risk based thinking is the essential part of these Management Systems Standards.

This leads automatically to the need to implement adequate KPIs (Key Performance

Indicators).

- ”We can manage what we measure.”

- However, avoid meaningless “cemeteries of numbers”.

…


Established Quality Tools and Techniques may help…

Qualit

y T

ools

Ishikawa/Fishbone

Diagram

FMEA - Failure Mode and Effects Analysis

Control Charts

Root Cause Analysis

Value Stream Mapping

Gamba Walks

+ An infinity of others

Many of the obstacles faced during the

various steps when implementing a QMS

or other module of a management system

my be treated with standard and well

established tools.

There is a continuum of tools and

approaches to choose from.

One should make a tailor-made selection

for one’s own needs.


PDCA-Cycle is a driving force

Plan

Do

Check

Act

The old PDCA-Cycle still describes the

main building blocks of process

management:

1. Plan the process properly

2. Implement the process and run it

3. Check the process adequately

(is it like it should?)

4. Initiate the change of a process if

you’re convinced it must be

changed


Tool: PDCA Cycle in Practice


The PDCA cycle is a fundamental way

how to look at processes: their

planning, controlling and their

improvement.

Note:

Although seemingly trivial, the art is to

really live it.

Homework:

Try to implement it in your private life!

PLAN

Define processes and

objectives to achieve

the expected output.

DO

Implement processes.

Produce output.

Measure performance.

ACT

Optimize processes

and implement other

optimizations where

necessary.

Change of the PDCA

cycle may be needed:

change its scope.

CHECK

Analyze performance

data collected in “DO”.

Statistical process

analysis may be used.

Tool: Root-Cause Analysis with ISHIKAWA-Diagrams


Evolution and Specialization of Standards for Management

Systems

ISO 9001

ISO 14001

OHSAS/SCC

ISO 27001

ISO 50001

TS 16949

TL 9000

AS 9100

. . . .


The first edition of ISO 9001 back in 1987 wasn‘t received with welcome everywhere.

Meanwhile, however, there is a global acceptance of the standard.

The need was felt to supplement it with:

Industry specific QMS like for

Automotive, aerospace, telecommunications

Healthcare industry

Food, agriculture, forestry

Other modules for

Environmental management and work safety

Energy efficiency

Information security

History Path of ISO 9001


ISO 9001:1987

ISO 9001:1994

ISO 9001:2000

ISO 9001:2008

ISO 9001:2015

The “architecture” of the ISO 9001 changed fundamentally from version to version.

Since its edition in the year 2000 a process oriented thinking has been implemented.

The current edition (2015) shows in addition the “high level structure”.

This will be the common structure for all Management Systems standards.

High Level Structure (1)

Context of the organization

• Understanding the organization and its context

• Needs and expectations of interested parties

• Scope of the QMS

• QMS and its processes

• Understanding the organization and its context

• Needs and expectations of interested parties

• Scope of the QMS

• QMS and its processes

Leadership

• Leadership and commitment

• Policy

• Organizational roles, responsibilities and authorities

• Leadership and commitment

• Policy

• Organizational roles, responsibilities and authorities

Planning

• Actions to address risks and opportunities

• Quality objectives and planning to achieve them

• Planning of changes

• Actions to address risks and opportunities

• Quality objectives and planning to achieve them

• Planning of changes

Support

• Resources

• Competence

• Awareness

• Communication

• Documented information

• Resources

• Competence

• Awareness

• Communication

• Documented information


High Level Structure (2)

Operation

• Operational planning and control

• Requirements for products and services

• Design and development of products and services

• Control of externally provided processes, products and services

• Production and service provision

• Release of products and services

• Control of nonconforming outputs

• Operational planning and control

• Requirements for products and services

• Design and development of products and services

• Control of externally provided processes, products and services

• Production and service provision

• Release of products and services

• Control of nonconforming outputs

Performance evaluation

• Monitoring, measurement, analysis and evaluation

• Internal audits

• Management review

• Monitoring, measurement, analysis and evaluation

• Internal audits

• Management review

Improvement

• General

• Nonconformity and corrective action

• Continual improvement

• General

• Nonconformity and corrective action

• Continual improvement


Advantages of the New High Level Structure

Harmonization of structure and requirements of the ISO Management Systems

Standards

User friendliness for those who want to implement integrated management systems

Even greater emphasis on processes and their control

Focused on risk relevant topics

Stricter requirements on performance evaluation and control

Explicit requirement of knowledge management

Emphasis on change management

…..


Case Study: Cleaning Company

Client Reqiurements

Client Reqiurements

Industry Requirements

Industry Requirements

Overall Management

Overall Management

Central management

Central management

Industry sector 1 Industry sector 1

Clients and objects

Clients and objects

Clients and objects

Clients and objects

Industry sector 2 Industry sector 2

Clients and objects

Clients and objects

Clients and objects

Clients and objects

Industry sector n Industry sector n

Clients and objects

Clients and objects

Company profile:

The company offers cleaning services for

very different industries and in very

different environments:

- Public areas like metro stations

- Offices and hotels

- Hospitals (all departments)

- Industrial facilities

- Building industry

No. of employees: 5000 with a yearly stuff

turnover of about 60 %.

Operation in Germany only.


Case Study: Hotel

Ho

tel M

an

ag

em

ent

Ho

tel M

an

ag

em

ent

Reception Reception

Sales Sales

Rooms Rooms

Banquet Banquet

Restaurants and Bars

Restaurants and Bars

Housekeeping Housekeeping

Facility Management

Facility Management

..... .....

Company profile:

Hotel category: 5 Stars

600 rooms, several banquet areas

What is a quality management good for and

what are potential main targets?

Where do targets for a QMS derive from? Who

defines them?

What would be targets for an environmental

management system according to ISO 14001?


Myths and Facts About an ISO 9001 Quality Management

System


Myth 1

It’s mainly about the documentation of

things. And that documentation is not really

reflecting the real world.

Myth 2

Although the upper management initiated

the implementation of the QMS, many of

their daily decisions and doings are

contradicting the principles of that QMS.

Myth 3

QMS was implemented to get a certificate.

This has nothing to do with the real life in

the company.

Distinguish clearly:

Certification of Management Systems, Products and Personnel

It is important to distinguish clearly

between the different forms of

certification.

A certification of the quality management

system of a company doesn’t include the

certification of its products or its

personnel.

The different modules of certification

may be combined in some cases.


Certification of Management Systems

• Quality

• Environment

• Work safety

• .....

Certification of Products

• Safety

• Usability

• Environmental aspects

• .....

Certification of Personnel

• Auditors

• Technical skills (e.g. welding)

• .....

Combinations of the other three modules

• Quality management system and product aspects

…..

In General: What Makes an Audit or Certification Scheme?

Auditor qualification and experience should be

fixed in detail.

Auditors should undergo sort of a calibration to

make audit results comparable.

In most schemes auditing time is correlated to

the number of employees of the organization to

be audited. However, the number of headcounts

is not a measure for the complexity of an

organization.

Schemes should contain measurable

requirements, as only then they may be used to

measure status quo and improvements as well

as deviations from defined requirements. Where

this is lacking, the range of interpreting the

standards is too wide.

To fix an adequate design of the audit scheme

is an art and must be done with great care.

Specific customer focused selection and

preparation of the audit team may help in

complex cases (client together with certification

organization.


Auditing and certification

scheme

Auditor proficiency

Design of the audit scheme

Requirements of the

audit/certification standard

Relationship between

Accreditation and certification body and owner of certificates

Accreditation Body

• Grants accreditation to certification body and conducts surveys of the certification body

Certification Body

• Issues certificates and surveys the owner of certificates

Owner of Certificates

• Complies with the requirements of certifications during the period of validity of the certificates.


Certification Body for Management Systems

Requirements of ISO 17021-1:2015 and Beyond

Impartiality Impartiality Competence Competence Responsibility Responsibility

Openness and Confidentiality Openness and Confidentiality

Legal Responsibility

and Certification Agreement

Legal Responsibility

and Certification Agreement

Human Resources:

Auditors and Others

Human Resources:

Auditors and Others

Information Management Information

Management

Processes Application

Review

Processes Application

Review

Processes Plaining and

Conduction of Audit

Processes Plaining and

Conduction of Audit

Processes Certification

Decision

Processes Certification

Decision

Processes Surveillance

Audits

Processes Surveillance

Audits

Internal Management

System

Internal Management

System

ISO 17021-1:2015 defines general

requirements for organizations auditing

and certifying management systems.

These requirements are concretized by

accreditation bodies, the IAF

(International Accreditation Forum) and

scheme owners.

Several industry specific auditing and

certification schemes define specific

requirements on auditors and processes.


13.09.2016

4. Principles

4.1 General

4.2 Impartiality

4.3 Competence

4.4 Responsibility

4.5 Openness

4.6 Confidentiality

4.7 Responsiveness to complaints

4.8 Risk-based approach

5. General requirements

5.1 Legal and contractual matters

•Legal responsibility

•Certification agreement

•Responsibility for certification decisions

5.2 Management of impartiality

5.3 Liability and financing

6. Structural requirements

6.1 Organizational structure and top management

6.2 Operational control

7. Resource requirements

7.1 Competence of personnel

•General considerations

•Determination of competence criteria

•Evaluation processes

•Other considerations

7.2 Personnel involved in the certification activities

7.3 Use of individual external auditors and external technical experts

7.4 Personnel records

7.5 Outsourcing

8. Information requirements

8.1 Public information

8.2 Certification documents

8.3 Reference to certification and use of marks

8.4 Confidentiality

8.5 Information exchange between a certification body and its clients

•Information in the certification activity and requirements

•Notice if changes by a certification body

•Notice of changes by a certified client

9. Process requirements

9.1 Pre-certification activities

•Application

•Application review

•Audit program

•Determining audit time

•Multi-site sampling

•Multiple management systems standard

9.2 Planning audits

•Determining audit objectives, scope and criteria

•Audit team selection and assignment

•Audit plan

9.3 Initial certification

•Initial certification audit

9.4 Conducting audits

•General

•Conducting the opening meeting

•Communication during the audit

•Obtaining and verifying information

•Identifying and recording audit findings

•Preparing audit conclusions

•Conducting the closing meeting

•Audit report

•Cause analysis of nonconformities

•Effectiveness of corrections and corrective actions

9.5 Certification decision

•General

•Actions prior to making a decision

•Information for granting initial certification

The Modules of ISO 17021-1:2015

Dr. Herfried Kohl 24

International network of accreditation bodies....

IAF IAF

EA EA

DAkkS DAkkS

UKAS UKAS

... ...

IAAC IAAC

ANAB ANAB

OAA OAA

... ...

PAC PAC

CNAS CNAS

JAB JAB

... ...


The international network of accreditation bodies bundled by regional

surveillance organizations and IAF is designed to create harmonization

of accreditation approaches.

Recall: Accreditation = Assign competence to an organization.

This is a prerequisite for the mutual recognition of certificates.

In practice, however, this goal isn‘t reached thoroughly and differences

exist between the approaches of the individual accreditation bodies.

Therefore, the full equivalence of certificates and the market may be

questioned.

Popular recent example: Requirements for the upgrade of auditors for

ISO 9001:2015 are not really harmonized.

Some Critical Remarks.....

Even after 25 years of history of systems

certification, by far not all users of the

management standards deploy them as a

real practical working tool in their daily

business.

Due to high degree of variance in the level of

implementation of standards and in the

auditing processes of certification bodies,

reliance on certified management systems is

often limited.

The development of industry specific

standards have the potential to improve this

development by

- Defining specific measurable means for

the user of a management system and

- Directly controlling the activities and

performance of the certification bodies.

Almost all industries with high requirements

on their supply chains follow exactly this

path.

Certifications like ISO 9001 being considered as

old products on the market, show the tendency

to decreasing prices.

This almost inevitably leads to a decrease in

quality and reliability of auditing and certification

processes.

Auditing and certification organizations show

different policies how to adapt to this

development.

Growing requirements from industry specific

high level standards will lead to a concentration

process in the auditing and certification industry.


Case Study Peru Project

Background- Quality Management in Peruvian Public

administration

In 2013 by means of Supreme Decree No. 004-2013 of Prime Minister Office was

defined the Implementation of Process Management in whole Peruvian public

administration.

The Guidelines defined for this process is according with PDCA cycle and according

with the spirit of International Standard ISO 9001:2008.

The principles of the Peruvian Public process management considered :

Leadership

Citizen Focus

Public Ethics and transparency

Process approach and continual improvement

Mutualy beneficial supplier relationships


2002- It is created 27658 National Law of Modernization of Peruvian state

management

Background- Quality Management in Peruvian Public

administration


Stages of Management Process Methodology

PRECONDITIONS: • Leaders establish unity of purpose and direction of the organization.

• Organization objective's clearly define

• Assure resources for the implementation

• Defined and create organizational structure for this purpose

•

Present- Quality Management in Peruvian Public

administration


Implementation and certification of Quality Management Systems in Peruvian

Public Administration

At the end of July 2016 in more than 60 public institutions and certain state driven

projects in Peru has been implemented and certified a Quality management system of

their core process.

Due to the benefits and improvements of the performance of Public Sector, the last

National Quality Award, granted by Private associations, was awarded in their most

part to public administration.

As a part of these the Ministry of Social Inclusion and Development (MIDIS) already

has certified two of their most important social programs of which main beneficiaries

are the poorest citizens.

Programa Nacional de Apoyo a los mas Pobres JUNTOS

Programa Nacional de Alimentacion Escolar QALIWARMA

PERUVIAN STATE PROGRAMS

AND THEIR CERTIFICATION PROCESS

Quality Management System Certification

Programa Nacional de Apoyo a los Mas Pobres- JUNTOS

The main objective of this program is to promote

and dinamize in the poorest regions of Peru the

use of social services as health, nutrition and

education through an economic incentive in order

to brake the poverty intergenerational transfer.

The scope of their certification involve their

process of transfer and delivery of economic

incentive and the verification of compliance

responsibilities of the beneficiaries.

It include a Central Head Office in Lima and

18 Regional sites in whole country.

The beneficiaries are about 768,000 families

and about 1,925 employees are involved in

the operative process


Brief Description


Programa Nacional de Apoyo a los Mas Pobres- JUNTOS


Benefits of certification process according with Client experience

Standartisation of operative processes

Transparency

Validation by an independent third party

of the veracity of beneficiaries information

Improve the performance of payment

process

Improve the quality of beneficiaries

attention


Programa Nacional de Alimentacion escolar- QALIWARMA

The main objective of this program is to provide

quality and balanced food services to Children's

during the whole school year as complement of

the Public educational services in order to reduce

school dropout and promote better feeding habits

The scope of their certification involve their

process of transfer of financial resources to

purchase committees ( formed by civilians and

public and private stakeholders) and verification

of payments to suppliers of food services.

It include a Central Head Office in Lima

The beneficiaries are about 3,600,000

children's and about 2,000 employees are

involved in the operative process


Brief Description


Programa Nacional de Alimentacion escolar- QALIWARMA


Benefits of certification process according with Client experience

Standartisation of operative process

Transparency

Validation by an independent third part

of the payments to suppliers

Improve the development of purchase

committees

Improve the performance of payment

process

Improve the quality of Beneficiaries

attention


On a certificate you’ll typically find two

legal entities:

• The certified organization and

• The certification organization

A certificate is typically valid three

years. The date of expiration of the

certificate is mentioned on the

certificate.

Within that period two surveillance

audits take place.

A certificate contains the “Scope of

Certification”. This is important, as a

legal entity may be certified for a part of

its organization or activities only.

Certification of a Management System:

That’s the way it goes


Quotation from your registrar

Quotation from your registrar

Contract with your registrar

Contract with your registrar

Planning of audit

Planning of audit

Audit on spot

Audit on spot

Certification Certification

Yearly surveillance

Yearly surveillance

How to Select an Auditing and Certification Organization

Demonstrate the relevant accreditations where needed.

Demonstrate its ability to deliver at the quality and service level needed.

In some cases these requirements should be fixed individually.

Demonstrate its organization and actions to achieve independence, objectivity and

integrity.

...be given the chance to demonstrate to the professionals of the client that prices

for its services are adequate.

The auditing and certification company

should....


Thanks for your attention!

[email protected]


Documents

The World of Management Systems Standards Their Content ...health.bmz.de/events/Events_2015/A_Retreat_on_Health__Social... · Ishikawa/Fishbone Diagram various steps when implementing