MRUTUNJAY JENAMRUTUNJAY JENA

Joint Director, QCI/NABCBJoint Director, QCI/NABCB

03 Nov 201803 Nov 201803 Nov 201803 Nov 2018

Coverage

ISO 45001:2018 – The Changes� ISO 45001:2018 – The Changes

� Migration to ISO 45001:2018 Certification

� About QCI/NABCB

� Benefits of Accredited OHSMS Certification

Current Scenario

According to the latest estimates released by the International LabourAccording to the latest estimates released by the International LabourOrganization (ILO),

�� 22..7878 millionmillion workers die every year due to occupational accidents andwork-related diseases.

�Some 2.4 million (8686..33 perper centcent) of these deaths are due to workwork--relatedrelated diseasesdiseases

�while over 380,000 (1313..77 perper centcent) result from an occupationaloccupational accidentsaccidents.�while over 380,000 (1313..77 perper centcent) result from an occupationaloccupational accidentsaccidents.

Strategies to Improve Safety� Psychological factors linked to poor workplace relations & management

� Mental & physical consequences of repetitive, highly technical tasks � Mental & physical consequences of repetitive, highly technical tasks

� Information on handling new technologies and substances

� Improving safety and health practices

� Preventing traditional accidents and diseases,

� Improve safety and health information

Improved policies and measurable targets for improving OH&S� Improved policies and measurable targets for improving OH&S

� Improved infrastructure and manpower

� Better recording and notification systems

� Improved safety culture & dealing with evolving dangers/risks

International Efforts ��ILOILO--OSHOSH 20012001, also titled "Guidelines on occupational safety and

health management systems (OSHMS)" to assist organizations withintroducing it - encourage continual improvement in employee healthintroducing it - encourage continual improvement in employee healthand safety, through a policy, organization, planning & implementation,evaluation, and action for improvement, and auditing to determine thesuccess of OSH actions.

�� OHSASOHSAS 1800118001 ((19991999--20072007--20182018)) was widely used internationally -developed by a selection of leading trade bodies, internationaldeveloped by a selection of leading trade bodies, internationalstandards and certification bodies to address a gap where no third-party certifiable international standard existed. In India, BIS publishedIS 18001

�� ISOISO 4500145001 was published in March 2018.

How is ISO 45001 a better option� The burden of occupational injuries & diseases is significant for economies

due to losses from early retirements, staff absence and rising insurancepremiums.premiums.

� OHSAS 18001 widely used internationally, but not by an InternationalStandards Body

� ISO has developed ISO 45001, Occupational health and safety managementsystems – Requirements with guidance for use, to help organizations reducethis burden by providing a framework to improve employee safety, reduceworkplace risks and create better, safer working conditions, all over the worldworkplace risks and create better, safer working conditions, all over the world

� It was developed by a committee of OHS experts, and follows other genericmanagement system approaches such as ISO 14001 and ISO 9001. It takesinto account OHSAS 18001, the ILO-OSH Guidelines, various nationalstandards and the ILO's international labour standards and conventions.

Cultural Change – Reactive to ProactiveISO 45001 can help organizations mitigate risk by:

� Identifying regulatory requirements before they become � Identifying regulatory requirements before they become compliance issues.

� Educating all employees at all organizational levels.

� Encouraging employee ownership of the safety management system.

� Lowering the rate of OH&S incidents and disruption of � Lowering the rate of OH&S incidents and disruption of operations.

� Resolving OH&S issues through checking and CAPA.

� Changing an OH&S culture from reactive to proactive.

Differences in approach

�� ISOISO 4500145001 takestakes aa proactiveproactive approachapproach to risk control, by incorporationISOISO 4500145001 takestakes aa proactiveproactive approachapproach to risk control, by incorporationof H & S in the overall management, driving top management to have astronger leadership role in the safety and health program.

�� OHSASOHSAS 1800118001 takestakes aa reactivereactive approachapproach of hazard control by delegationof hazard control responsibilities to safety management personnel,rather than integrating the responsibilities into the overallmanagement system of the organization.management system of the organization.

Main differences that make the world safer� Increased Management commitment, managerial ownership,

building safety culture by the engagement of both management and workers� building safety culture by the engagement of both management and workersdemonstrated by a top-down emphasis.

� Instead of providing oversight, management should be true safety leaders.

� employees training and education to identify risks.

� Sharing of results of IA and risk assessment with workers to allow for employee input.

� following a preventative (proactive) process, so that hazard risks are evaluated and� following a preventative (proactive) process, so that hazard risks are evaluated andremedied, as opposed to hazard control (reactive), under OHSAS 18001.

� Its structure is based on common structure of management systems based onsystems such as ISO 9001 and ISO 14001

In Short………………

� ISO 45001 is a whole-organization, proactive approach to incorporating� ISO 45001 is a whole-organization, proactive approach to incorporatinga safety culture.

� Provides a framework to take organizations to the next higher level insafety and health.

� NABCB grants accreditation to certification bodies who certify theorganizations as per requirements of ISO 45001.organizations as per requirements of ISO 45001.

Changes & Shift in Business Model

OHSAS 18001:2007 ISO 45001:2018

New & Changes: Contents / ClausesOHSAS 18001OHSAS 18001 ISO 45001ISO 45001

1. Scope 1. Scope

2. Reference Publications 2. Normative References

3. Terms and definitions (23 terms) 3. Terms and Definitions (3737 termsterms)3. Terms and definitions (23 terms) 3. Terms and Definitions (3737 termsterms)

4. OHSMS Requirements

4.1 General Requirements

4.2 OH&S Policy

4.3 Planning

4.4 Implementation and Operations

4.5 Checking

4.6 Management Review

4. Context of the Organization

5. Leadership and Worker Participation

Not in Alphabetical

Order

5. Leadership and Worker Participation

6. Planning

7. Support

8. Operations

9. Performance Evaluation

9. Improvements

New and Changes : COTO� 4. Context Of The Organization (COTO)

� 4.1 Understanding the organization and its context� 4.1 Understanding the organization and its context

� 4.2 Understanding the needs and expectations of workers and other interested parties

� 4.3 Determining the scope of the OH&S management system

4.1 Internal & External

4.3 + Legal and Other

4.2Interested Parties Internal & External

relevant IssuesE.g. PESTLE

+ Legal and OtherRequirements

Interested Parties other than

workers

New and Changes : Leadership-Worker� 5. Leadership and Worker Participation

� 5.1 Leadership and Commitment � 5.1 Leadership and Commitment

� 5.2 OH&S Policy

� 5.3 Organizational Roles, Responsibilities and Authorities

� 5.4 Consultation and Participation of workers

Policy to include commitment to

Specific Requirements for: Key Success Factor

commitment to consultation & participation

Requirements for: Consultation & Participation

Key Success Factor – Consultation &

Participation

New and Changes: Planning� 6 Planning

� 6.1 Actions to address risks and opportunities� 6.1.1 General� 6.1.1 General� 6.1.2 Hazard identification and assessment of risks and opportunities

� 6.1.2.1 Hazard Identification� 6.1.2.2 Assessment of OH&S risks and other risks to the OH&S

management system� 6.1.2.3 Assessment of OH&S opportunities and other opportunities for

OH&S MSOH&S MS� 6.1.3 Determination of legal requirements and other requirements� 6.1.4 Planning action� 6.2 OH&S objectives and planning to achieve them� 6.2.1 OH&S objectives� 6.2.2 Planning to achieve OH&S objectives

Social factors (including workload,

work hours, victimization,

harassment, and bullying,), leadership, culture in organization

New and Changes : Support� Support

� 7.1 Resources

� 7.2 Competence � 7.2 Competence

� 7.3 Awareness

� 7.4 Communication

� 7.4.1 General

� 7.4.2 Internal Communication

� 7.4.3 External Communication

Additional and specific requirements of Awareness

are given to improve effectiveness of OHSMS

� 7.4.3 External Communication

� 7.5 Documented Information

� 7.5.1 General

� 7.5.2 Creating and Updating

� 7.5.2 Control of documented information

New and Changes : Operations � 8 Operation� 8.1 Operational planning and control

� 8.1.1 General. � 8.1.1 General. � 8.1.2 Eliminating hazards and reducing OH&S risks� 8.1.3 Management of change� 8.1.4 Procurement

� 8.1.4.1 General� 8.1.4.2 Contractors� 8.1.4.3 Outsourcing � 8.1.4.3 Outsourcing

� 8.2 Emergency preparedness and response

Management of Change

Control on outsource of

functions and processes

Processes for Control on

procurement of products, services

& contractors

New and Changes : Performance Evaluation� 9 Performance evaluation

� 9.1 Monitoring, measurement, analysis and performance evaluation� 9.1 Monitoring, measurement, analysis and performance evaluation

� 9.1.1 General

� 9.1.2 Evaluation of compliance

� 9.2 Internal audit

� 9.2.1 General.

9.2.2 Internal audit programme

Need Knowledge & Understanding of

Compliance Status� 9.2.2 Internal audit programme

� 9.3 Management review

Compliance Statuso Maintain:

New and Changes : Improvements

� 10. Improvement� 10. Improvement

� 10.1 General

� 10.2 Incident , nonconformity and corrective action

� 10.3 Continual Improvement

Preventive ActionReplaced by :

Reoccur or OccurElsewhere

Maintain Evidenceof CONTINUAL IMPROVMENT

Participation of worker &

Involvement of Interested Parties in

CA

Migration to ISO 45001:2018As per IAF MD 21

� ISO 45001:2018 was Published on 12 Mar 2018� ISO 45001:2018 was Published on 12 Mar 2018

� IAF Resolution 2016-15 was passed by the IAF General Assembly in Delhi, India on 4th November 2016 endorsing a 3-year migration period to ISO 45001:2018 from the date of publication

� OHSAS 18001:2007 certifications will not be valid after 3- years from publication of ISO 45001:2018 (12 Mar 2021)from publication of ISO 45001:2018 (12 Mar 2021)

� Based on local regulation, the validity of accredited certification to BS OHSAS 18001 (or national equivalent standard) may be extended.

Migration to ISO 45001:2018As per IAF MD 21

(For Industry)

� Obtain a copy of ISO 45001 � Obtain a copy of ISO 45001

� Identify the gaps in the OHSMS which need to be addressed to meet any new requirements.

� Develop an implementation plan.

� Ensure that any new competence needs are met and create awareness for all parties that have an impact on the effectiveness of the OHSMS.for all parties that have an impact on the effectiveness of the OHSMS.

� Update the existing OHSMS to meet the new requirements and provide verification of its effectiveness.

� Where applicable, liaise with their Certification Body for migration arrangements

ISO/IEC TS 17021-10

About QCI� Established in 1997 by a Cabinet decision

– in partnership with CII, FICCI, ASSOCHAM

� Autonomous body – regd as society - Chairman appointed by PM-� Autonomous body – regd as society - Chairman appointed by PM-

Current Chair: Adil Zainulbhai; DIPP - Nodal Min.

Objectives:Objectives:

� Provide accreditation structure in the country

� Spread quality movement in India – assigned National Quality Campaign funded by GovtCampaign funded by Govt

� Provide right and unbiased information on quality & related standards

� Represent India’s interest in international fora

� Help establish brand equity of Indian products and services

Structure of QCIStructure of QCI

QUALITY COUNCIL OF INDIA

NATIONAL

ACCREDITATION

BOARD FOR

CERTIFICATION

BODIES

NATIONAL

ACCREDITATION

BOARD FOR TESTING

AND CALIBRATION

LABORATORIES

(NABL)

NATIONAL

AACREDITATION

BOARD FOR

EDUCATION AND

TRAINING (NABET)

(NABCB)

NATIONAL BOARD

FOR QUALITY

PROMOTION (NBQP)

(NABL)

NATIONAL ACCREDITATION

BOARD FOR HOSPITALS

AND HEALTHCARE

PROVIDERS (NABH)

NABCB Mandate

� Accreditation of Certification and Inspection Bodies as perinternational standards, generally ISO Standardsinternational standards, generally ISO Standards

� NABCB along with NABL, is part of international system ofaccreditation and equivalence operated under the aegis of theInternational Accreditation Forum (for Certification Bodies) andInternational Laboratory Accreditation Cooperation (forInternational Laboratory Accreditation Cooperation (forInspection Bodies and Labs)

International Accreditation System� International Bodies - Association of accreditation bodies –

International Accreditation Forum (IAF) for CBs, InternationalLaboratory Accreditation Cooperation (ILAC) for Labs and IBsLaboratory Accreditation Cooperation (ILAC) for Labs and IBs

� Regional Bodies – Pacific Accreditation Cooperation (PAC) for CBsand Asia Pacific Laboratory Accreditation (APLAC) for IBs and Labs

� Similar bodies in other Continents – recognized by IAF/ILAC -European Accreditation Cooperation (EA), Inter AmericanAccreditation Cooperation (IAAC), - African AccreditationCooperation (AFRAC), Arab Accreditation Cooperation (ARAC)Cooperation (AFRAC), Arab Accreditation Cooperation (ARAC)

� Multilateral Mutual Recognition Arrangement – MLAs in IAF, MRAsin ILAC

� National ABs in India - NABCB for Certification & Inspection Bodies,NABL for Laboratories, PTPs, RMPs

International EquivalenceNABCBNABCB -- SignedSigned MLAMLA� QMS – PAC Aug 2002/ IAF Sept 2002� EMS – PAC July 2007/IAF Oct 2007� PCB – PAC May 2013/IAF August 2013� PCB – PAC May 2013/IAF August 2013� Inspection – APLAC in Sept. 2013/ ILAC in Sept. 2013� FSMS – PAC in June 2014/IAF in Oct 2015� PAC GlobalG.A.P in Oct 2014 /IAF in Oct 2015� ISMS – PAC in June 2015/IAF in Oct 2015� GlobalG.A.P - PAC in Oct 2015� EnMS - PAC in June 2017/ IAF in Apr 2018

NABLNABL – signatory to ILAC/APLAC MRAsNABLNABL – signatory to ILAC/APLAC MRAs� for Testing and Calibration Labs since 2000� ILAC/APLAC MRA on ISO 15189 for Medical Labs since 2008� PTP & RMP: Recommended during Peer Evaluation in July 2016

•• ToTo SumSum UpUp –– IndiaIndia hashas worldworld classclass accreditationaccreditation infrastructureinfrastructure

STATISTICS ( OCT 2018)Accreditation Programmes Accreditations Applications

Quality Management Systems (QMS) 37 09

Environmental Management Systems (EMS) 09 04

Inspection Bodies (IB) 46 22

14 08Food Safety Management Systems (FSMS) 14 08

Occupational Health and Safety Management Systems

(OHSMS)

06 02

Product Certification (PCB) 11 06

Information Security Management Systems (ISMS) 05 -

Energy Management Systems (EnMS) 05 -

Information Technology Service Management Systems 01 -Information Technology Service Management Systems

(ITSMS)

01 -

Personnel Certification (PrCB) 01 04

Road Traffic Safety Management Systems (RTSMS) - -

Trustworthy Digital Repositories Management Systems

(TDRMS)

01 -

Medical Devices Quality Management System (MDQMS) 07 10

NABCB AccreditationSchemes Planned

� Business Continuity Management System as per ISO 22301� Business Continuity Management System as per ISO 22301

� Green House Gases (GHG) Validation and Verification Bodies as ISO14065

� QMS for Aerospace Industry as per AS 9100 standard

� Asset Development Management System as per ISO 55001

Equivalence Framework

IAF / ILAC

PACIFIC ACCREDITATION COOPERATION / ASIA PACIFIC LABORATOY ACCREDITATION

COOPERATION

(PAC / APLAC)

EUROPEAN ACCREDITATION COOPERATION

(EA)

INTER AMERICAN ACCREDITATION

COOPERATION (IAAC)

ACCREDITATION BODY ISO 17011

ISO 17020ISO 17025

CB/IB/LAB

ORGANIZATION / ITEM UNDER INSPECTION /

CERTIFICATION / TESTING

ISO 17025ISO 17021ISO 17065

Standards againstwhich certified –

ISO/IEC StandardsISO 9001 / ISO14001

� Recognition of Technical Competence

� Customer confidence & satisfaction

Benefits of Accreditation

� Customer confidence & satisfaction

� Minimizes risks

� Avoids re-testing/inspection & Reduces costs

� Increased efficiency

� Marketing advantage & Increased business� Marketing advantage & Increased business

� International Recognition

www.qcin.org/nabcb

INFORMATION

National Accreditation Board for Certification Bodies (NABCB)(NABCB)

Quality Council of India

2nd Floor, Institution of Engineers Building2, Bahadur Shah Zafar Marg

New Delhi - 110002

Telefax : +91-11-23379321/9260/0567/8057Telefax : +91-11-23379321/9260/0567/8057

Email: nabcb@qcin.org, ceo.nabcb@qcin.org

Website : www.qcin.org/nabcb

THANK YOU

FOR YOUR ATTENTION!

Any Questions ?Any Questions ?