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TUV Middle East

Member of TÜV NORD Group

Exchange of Experience
IMS requiremens based on ISO 9001:2015, ISO 14001:2015 &
OHSAS 18991:2007, 16 – 18 October 2016, Dubai, UAE
Ravi Sankar Gomatam – Auditor / Trainer
Aim of EoE:

 To Understand
- the requirements related to the ISO 9001, ISO 14001 & OHSAS 18001
standard elements

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Contents

 Introduction
 Benefit of the Management Systems
 Structure of the Management Systems
 Planning requirements
 Operations requirements
 Performance Evaluation requirements
 Improvement requirements
 Comparison of requirements

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Introduction to Management Systems

 ISO (International Organization for Standardization) is the world’s largest developer


of voluntary International Standards.
 Founded in 1947, and since then published more than 21000 International
Standards
 Covering almost all aspects of technology and business.
 Members from 163 countries
 3368 Technical bodies taking care of standard development
 More than 135 people work full time in Central Secretariat in Geneva, Switzerland.

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Benefits of Management Systems

- Ensuring products and services are safe, reliable and of good quality.

- Strategic tools to reduce costs by minimizing waste and errors in increasing the
productivity of a business.

- Helping to access new markets, level the playing field for developing countries and
facilitate free and fair global trade.

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Structure of Management Systems

• All the management systems follow structure of PDCA

• Revised versions have the high level structure

• To describe the framework for a generic management standard

• To enhance the consistency and alignment of different management


system standards

QUALITY ASSURANCE
• Having QUALITYmore
similar core text of elements and emphasis CONTROL
on the specific
requirements of the standard

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High Level Structure of Revised Management Systems

QUALITY ASSURANCE QUALITY CONTROL

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Planning requirements

Context of the organization – Business environment

- Factors & Conditions effecting organizational approach


- Issues related to internal and external
- Related to QMS / EMS performance
- Risk & Opportunities

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Context of the
1 4.1 & 4.2 4.1 & 4.2 NIL
organization

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Planning requirements

Top Management committment

- Strategic Direction
- Accountability
- Integration to Business
- Promoting Improvement
- Promoting process approach & risk based thinking

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Top Management
1 5.1 5.1 4.1
Commitment

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Planning requirements

Policy

- Communicated, understood & implemented


- Available to interested parties
- Integration to Business
- Promoting Improvement
- Promoting process approach & risk based thinking

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Top Management
1 5.2 5.2 4.2
Commitment

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Planning requirements

Concept of Risk Based thinking

Risk

Effect of uncertainty on an expected result

Note 1: An effect is deviation from expected – positive or


negative

Note 2: Uncertainty is the state, even partial, of deficiency


QUALITY ASSURANCE QUALITY CONTROL
of information related to, understanding or knowledge of,
an event, its consequence, or likelihood

Note 3: Risk is often expressed in terms of a combination of


the consequences of an event and the associated likelihood
occurrence

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Planning requirements

Actions to address Risks & Opportunities

- Positive risk – Opportunity; Adverse Risk - Threat


- Process, products, services, activities
- Actions can also be for taking an opportunity
- Avoid risk, share risk, retain risk by informed decision
- Evaluate the effectiveness of actions taken

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Actions to Address
1 6.1.1 6.1.1 -
risk & Opportunities

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Planning requirements

Environmental Aspects & Hazard identification, Risk Assement &


determining controls

- Establih the criteria for identifying significant aspects / impacts


- Impact of Env aspects , considering life cycle perceptive
- Identification of hazards, risk assessment and determining control
- Document criteria, significant env aspects, hazards, risks and controls
-

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Env Aspects /
1 - 6.1.2 4.3.1 Hazard
Identification

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Planning requirements

Compliance Obligations

- Identifying & access related to env aspects / OH &S risks


- Maintaining the documented informaiton
- Resulting Risks & Opportunities
- Review & Update

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Compliance
Obligations / Legal
1 5.1.2 6.1.3 4.3.2
& Other
requirements

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Planning requirements

Objectives & Plan of aciton

- Communicated, understood & implemented


- updated as appropriate
- Plan of action What, Who, When, How

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Objectives &
planning to achieve
1 6.2 6.2 4.3.3
/ Objectives &
Programmes

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Planning requirements

Support – Resources
- Competency based on Education, Training OR Experience
- Actions can include mentoring, training, reassingment of currently employed
prersons, hiring or contracting a competent person
- Calibration / verificaiton of measuring equipments ( 9001)
Organizational Knowledge (9001)
- knowledge gained from experience, lessons learnet from past (both
failures & suceess), capturing & sharing undocumented knowledge and
experience, results of improvement in processes, products, services
- standards, academia, conferences, knowledge from customers / external
QUALITY ASSURANCE
providers QUALITY CONTROL

OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

1 7.1 to 7.3 7.1 to 7.3 4.4.2 Support

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Planning requirements

Communicatioin

- Internal & External

- Who, When, What, How, To whom

QUALITY ASSURANCE QUALITY CONTROL


OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

1 7.4 7.4 4.4.3 Communication

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Planning requirements

Docuemented information & Roles, responsibilities, authorities

- No mention of Manuals, documented procedures - Flexibility in


documentation

- No mention of Management representative – similar responsibilities and


authorities are assigned, but no requirements for a single MR

QUALITY ASSURANCE QUALITY CONTROL

OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Roles,
4.4.1, 4.4.4,
1 5.3 & 7.5 5.3 & 7.5 Responsibilities &
4.4.5, 4.5.4
Documentation

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Operations Requirements

8.5.5 – Post delivery activities (9001)

- Post-delivery activities can include actions under warranty provisions,


contractual obligations such as maintenance services, and supplementary
services such as recycling or final disposal

8.1 – Operational Planning & Control ( 14001 )

- Hierarchy of controls – Elimination, Substitution, Engineering &


Administrative
QUALITY ASSURANCE
- Consistent QUALITY CONTROL
of life cycle perspective – Design, procurement of materials,
delivery, transportation, use, end-of-life treatment or final disposal

OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

1 8.1 to 8.7 8.1 to 8.2 4.4.6 & 4.4.7 Operations

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Performance Evaluation

 The results of monitoring and measuring are reliable, reproducible and traceable
 Objectives
 Operational controls
 Compliance obligations
 Incident investigations
QUALITY ASSURANCE QUALITY CONTROL

OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

Performance
4.5.1, 4.5.2, Evaluation /
1 9.1 to 9.3 9.1 to 9.3
4.5.3.1, 4.5.5 Monitoring &
Measurement

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Improvement requirements

 Examples of Improvement
 Correction , Corrective Action , Continual Improvement
 Breakthrough change, Innovation, Re-organization

Evaluate need for action to eliminate the causes of non-conformity, in order it


does not reoccur or occur elsewhere

Update risks and opportunities determined during planning, if necessary


QUALITY CONTROL

OHSAS
No ISO 9001:2015 ISO 14001:2015 Element
18001:2007

1 10.1 to 10.3 10.1 to 10.3 4.5.3.2, 4.6 Operations

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Clause comparison

ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007

Context of the organization (title Context of the organization (title


4
only) only)

Understanding the organization Understanding the organization


4.1
and its context and its context

Understanding the needs Understanding the needs


and expectations of interested and expectations of interested 4.2
parties parties

Determining the scope of the


Determining the scope of the
QUALITY ASSURANCE
quality management system
environmental management 4.3 QUALITY
4.1 General CONTROL
requirements
system

Environmental management
Quality management system 4.4 4.1 General requirements
system

Leadership (title only) Leadership (title only) 5


Leadership and commitment Leadership and commitment 5.1
Policy Environmental policy 5.2 4.2 OH & S Policy

Organizational roles, Organizational roles, Resources, roles, responsibility,


5.3 4.4.1
responsibilities and authorities responsibilities and authorities authority and accountability

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Clause comparison

Planning (title only) Planning (title only) 6 4.3 Planning (title only)

Actions to address risk and Actions to address risk and


6.1
opportunities (title only) opportunities (title only)

General General 6.1.1

Environmental aspects 6.1.2 4.3.1 Environmental aspects

Compliance obligations 6.1.3 4.3.2 Legal and other requirements

Planning action 6.1.4

QUALITY ASSURANCE
Planning to take action 6.1.5 QUALITY CONTROL

Environmental objectives and


Quality objectives and planning to
planning to achieve them (title 6.2 Objectives, targets and programme(s)
achieve them (title only) 4.3.3
only)

Quality Objectives Environmental objectives 6.2.1 4.3.3 Objectives, targets and programme(s)

Planning actions to Planning actions to


6.2.2 4.3.3 Objectives, targets and programme(s)
achieve quality objectives achieve environmental objectives

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Clause comparison
Implementation and operation (title
Support (title only) Support (title only) 7 4.4
only)
Resources, roles, responsibility
Resources (tittle only) Resources 7.1 4.4.1
and authority
General 7.1.1
People 7.1.2
Infrastructure 7.1.3
Environment for the operation
7.1.4
of process
Monitoring & Measuring
7.1.5
Resources(tittle only)
General 7.1.5.1
Measurement traceability 7.1.5.2
Organization Knowledge 7.1.6
Competence, training and
Competence Competence 7.2 4.4.2
awareness
Awareness QUALITY ASSURANCE
Awareness 7.3 4.4.2 QUALITY CONTROL
Competence, training and
awareness
Communication Communication (title only) 7.4 4.4.3 Communication
General 7.4.1 4.4.3 Communication
Internal communication 7.4.2 4.4.3 Communication
External communication 7.4.3 4.4.3 Communication
Documented information (title Documented information (title
7.5 4.4.4 Documentation
only) only)
General General 7.5.1 4.4.4 Documentation
4.4.5 Control of documentation
Creating and updating Creating and updating 7.5.2
4.5.4 Control of records
Control of documented 4.4.5 Control of documentation
Control of documented information 7.5.3
information 4.5.4 Control of records

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Clause comparison
Operation (title only) Operation (title only) 8 4.4 Implementation and operation (title only)
Operational planning and control Operational planning and control 8.1 4.4.6 Operational control
Requirements for Products and Emergency preparedness and Emergency preparedness and
8.2 4.4.7
services (tille only) response response
customer communication 8.2.1
determining the requirements related to
8.2.2
products and services
review of requirements related to
8.2.3
products and services
Changes to requriements for products
8.2.4
and services
Design & Development of Products
8.3
and services(tittle only)
General 8.3.1
QUALITY
Design & Development ASSURANCE
of Planning 8.3.2 QUALITY CONTROL
Design & Development inputs 8.3.3
Design & Development controls 8.3.4
Design & Devleopment outputs 8.3.5
Design & Development changes 8.3.6
Control of externally provided
processes, products and services (tittle 8.4
only)
General 8.4.1
Type and extent of control 8.4.2
Information for external providers 8.4.3

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Clause comparison
production and service provision (tittle
8.5
only)

control of production and service


8.5.1
provision
identification and traceability 8.5.2
property belonging to customers and
8.5.3
external providers
preservation 8.5.4
post-delivery activities 8.5.5
control of changes 8.5.6
Release of products and services 8.6
control of non-conforming outputs 8.7
QUALITY
Performance evaluation ASSURANCE
(title only) Performance evaluation (title only) 9 QUALITY
4.5 CONTROL
Checking (title only)
Monitoring, measurement, analysis and Monitoring, measurement, analysis
9.1 4.5.1 Monitoring and measurement
evaluation (tittle Only) and evaluation (tittle Only)
General General 9.1.1 4.5.1 Monitoring and measurement
Customer satisfaction Evaluation of compliance 9.1.2 4.5.2 Evaluation of compliance
Analysis and evaluation
Internal audit Internal audit 9.2 4.5.5 Internal audit
General 9.2.1
Internal Audit programme 9.2.2

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Clause comparison

Management review Management review 9.3 4.6 Management review

General 9.3.1

Management review inputs 9.3.2

Management review outputs 9.3.3

Improvement (tittle only) Improvement (tittle only) 10

General General 10.1

Non-conformity and corrective Non-conformity and corrective


10.2 4.5.3.2
action action
QUALITY ASSURANCE QUALITY CONTROL
Continual Improvement Continual Improvement 10.3

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Thanks
www.tuvme.com
www.tuv-nord.com

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