Chapter:1 Overview to ISO 9001:2015 QMS and ISO 14001:2015 EMS and

ISO 45001:2018

1.0 Background to the new standards

The rules of the International Organisation for Standardisation (ISO) require that all standards
are reviewed every five years to ensure that they reflect the best practice in the particular
subject and take into account any lessons that have been learnt during the application of the
standard. The outcome of these reviews is that standards are confirmed, revised or
withdrawn.

Every organization would like to improve the way it operates, whether that means increasing
market share, driving down costs, managing risk more effectively or improving customer
satisfaction. A Quality and Environment management system gives you the framework you
need to monitor and improve performance in any area you choose.
ISO 9001 and ISO 14001 is by far the world’s most established Quality and Environment
framework, currently being used by over ¾ million organizations in 161 countries, and sets the
standard not only for Quality and Environment management systems, but management
systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff
motivation and continual improvement.

ISO 9000 series of standards

ISO 9001 and ISO 14001 is one of a series of quality management system standards. It can
help bring out the best in your organization by enabling you to understand your processes for
delivering your products/services to your customers. The ISO 9001 AND ISO 14001 series of
standards consist of:

 ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind
the management systems and specifies the terminology used.
 ISO 9001 and ISO 14001 – Requirements: this sets out the criteria you will need to meet if
you wish to operate in accordance with the standard and gain certification.
 ISO 9004 – Guidelines for performance improvement: based upon the eight quality
management principles, these are designed to be used by senior management as a
framework to guide their organizations towards improved performance by considering the
needs of all interested parties, not just customers.
2.0 Why ISO 9001 AND ISO 14001 ? : -

1. Want to export.
2. Provide confidence to customers.
3. Reduce wasted efforts and resources.
4. Pathway to Total Quality Management.
5. Remove inter-departmental hassles.
6. Assure Top Management commitment and involvement.
7. Involves all functions, all departments at all levels.
8. Disciplined way of working.
9. Structure Quality and Environment Management to needs.
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10. Preventive, rather than curative.

11. Strategic business tool.
12. Enhances return on investment.

3.0 Benefit of ISO 9001 AND ISO 14001 revised 2015 standards : -

Benefits of ISO: 9001 and ISO 14001 is summarised below.

 Competitive advantage
ISO 9001 AND ISO 14001 should be top-management led, which ensures that senior
management take a strategic approach to their management systems. Our assessment
and certification process ensures that the business objectives constantly feed into your
processes and working practices to ensure you maximise your assets.
 Improves business performance and manages business risk
ISO 9001 AND ISO 14001 helps your managers to raise the organization’s
performance above and beyond competitors who aren’t using management systems.
Certification also makes it easier to measure performance and better manage business
risk.
 Attracts investment, enhances brand reputation and removes barriers to trade
Certification to ISO 9001 AND ISO 14001 will boost your organization’s brand
reputation and can be a useful promotional tool. It sends a clear message to all
interested parties that this is a company committed to high standards and continual
improvement.
 Saves you money
Evidence shows that the financial benefits for companies that have invested in and
certified their Quality and Environment management systems to ISO 9001 AND ISO
14001 include operational efficiencies, increased sales, higher return on assets and
greater profitability.
 Streamlines operations and reduces waste
The assessment of your Quality and Environment management system focuses on
operating processes. This encourages organizations to improve the Quality and
Environment of products and the service provided and helps to reduce waste and
customer complaints.
 Encourages internal communication and raises morale
ISO 9001 AND ISO 14001 ensures that employees feel more involved through
improved communication. Continued Assessment visits can highlight any skills
shortages sooner and uncover any teamwork issues.
 Increases customer satisfaction
The ‘Plan, Do, Check, Act’ structure of ISO 9001 AND ISO 14001 ensures that the
needs of the customer are being considered and met.

The above benefits can be summarised for internal benefits and external for ISO: 9001
certification as per details given below.

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3.1 INTRINSIC: -
* Competitiveness through cost reduction by eliminating waste, rework, and scrap
overtime.
* Improve efficiency, productivity and effectiveness.
* Increased customer confidence.
* Improve employee morale.
* Improve cycle time.
* Improve communication and quality of information.
3.2 EXTRINSIC: -

* Worldwide recognition and credibility.

* Access to European and world markets.
* Qualification to bid on new contracts.
* Improved corporate Quality and Environment image.
* Tool for motivating suppliers to conform.
* Reduction in customer audit.

4.0 ISO 9001 AND ISO 14001 Documented Information: -

The total documentation for a comprehensive Quality and Environment system under ISO:
9001:2015 is reduced drastically compared to ISO 9001 and ISO 14001 old standard. This
Documented information can be any form like Quality and Environment manual, procedures,
records etc and standard is now not asking for Quality and Environment Manual any more. As
per list given below at few places now documented information is required.

List of Documented information required under ISO 9001 AND ISO 14001:2015

1. Scope of the Quality and Environment management system(4.3 )

2. Information to support operation of the processes (4.4.2a)
3. Information to to have confidence that the processes are being carried out as
planned(4.4.2b)
4. Quality and Environment policy (5.2.2)
5. Quality and Environment Objectives (6.2.1)
6. Evidence of fitness for purpose of the monitoring and measuring resources (process
monitoring and maintenance records ) (7.1.5.1)
7. Calibration or verification records ( 7.1.5.2)
8. Competence records for employee experience, qualification, skill or certification etc
(7.2d)
9. Necessary information for effectiveness of QMS AND EMS (7.5.1b)
10. Change control and version control- change control sheet (7.5.3.2)
11. Master list and distribution list of documented information ( 7.5.3.2)
12. External origin documents necessary for planning and execution of QMS AND EMS
(7.5.3)
13. Establish confidence on processes - Process monitoring sheet and monitoring records
(Process execution ,monitoring against planning) (8.1c)

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14. Confirmation of customer’s requirement in cases of verbal orders or no written statement

provided by customer(8.2.3.1)
15. Contract review results and information on customer requirements (8.2.3.2a)
16. Information for any new requirements for the products and services( 8.2.3.2b)
17. Changes to the customer requirement in cases of amendment ( 8.2.3)
18. Information needed to demonstrate Design and development requirements have been
met ( 8.3.2j)
19. Information on design and development inputs ( 8.3.3)
20. Information for design and development controls( 8.3.4)
21. Information on design and development outputs output and suitability- development
verification sheet ( 8.3.5)
22. Information on design and development changes, result of reviews, authorization of the
changes, action taken to prevent adverse impacts ( 8.3.6)
23. Information for evaluation, selection, monitoring of performance and re evaluation and
actions arising from evaluation on external providers(8.4.1)
24. 25.Results of evaluation of external providers - External providers selection and
evaluation records (8.4.2)
25. Characteristics of the goods and services as inspection test plan or specification
sheet(8.5.1a)
26. Traceability related records( Where necessary) to maintain unique identification (where
necessary)8.5.2
27. Records for property of the customer or external provider is lost, damaged or otherwise
found to be unsuitable for use(8.5.3)
28. 29.Results of the review of changes for production and service provision, person
authorizing and action arising from review and action taken- change management (8.5.6
)
29. .Release of goods and services for delivery to the customer.; final inspection report or
release note; Evidence of the conformity with acceptance criteria (8.6)31.
30. .Information for non conformity ( 8.7.2)
31. Results for measurement, analysis and evaluation for effectiveness of QMS AND EMS(
Objective monitoring records(9.1)
32. Audit programme and the audit results-audit records.(9.2.2f)
33. Results of management reviews including actions taken- minutes of management
review.(9.3.3)35.Nature of the nonconformities and any subsequent actions taken- non
conformity and authorization records(10.2.2)
34. Results of corrective action(10.2.2b)

5.0 Introduction to ISO 45001:2018 systems

5.1 Introduction
The industries are required to grow to satisfy the need of the society but at the same
time they need to do all this in an occupation, Health and safety acceptable manner.
Of late, industries have been reactive towards OH&S management and follow up of
safe production practices. In this scenario, the concept of OHSMS through plan
approach of system implementation for occupational, health and safety issues are
taking shape.

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OHSMS

OH&S Management System (OHSMS) refers to a system used by an Organisation to

manage its activities, product or services in such a way to minimize or eliminate the
adverse impacts on Occupation, Health and safety of workers. More explicitly, the
OHSMS is that part of the overall management system viz. organizational structure,
planning activities, responsibilities, practices, procedures, processes and resources
which are necessary for developing, implementing, reviewing and maintaining the
organisation’s OH&S policy.

Evidently, OH&S Management System is not a Hi- Tech mechanism to address

Occupation, health and Safety issues of an organisation. Basically OHSMS is a manual
system consisting of three components namely:
I. Design or development of elements of OHSMS
II. Documentation and
III. Implementation

Of course, the documentation can be supported by software.

Unlike the Quality Management System which concentrate only on customers

satisfaction, the OHSMS is required to satisfy different stakeholder e.g. employees,
shareholders, regulatory authorities, customers and general public as well. Also, quality
can be defined by technical specification and so satisfying the customers is relatively
easier. Whereas in case of OHSMS it is dependent on diverse interest of the
Stakeholders In addition, the OHSMS is required to ensure compliance with relevant
legislation and regulations. Thus the scope of application and operation of OHSMS is
wider than that of QMS.

5.2 The need of OHSMS

With the growing Health and safety awareness, compulsions and competition, it is
becoming imperative to not only manufacture but source raw materials and sell
products in manner that is taking care of OH&S issues.

Global trade henceforth would reinforce flow of safer goods and services, in which only
OH&S complying companies shall be able to retain and enhance their share of growing
international market.

While all industrial enterprises are required to comply with growing number of OH&S
regulation, it is only those, who proactively seek to demonstrate OHSMS performance
far beyond compliance, would be the market leaders.

Credibility comes in only when an independent, well respected, internationally

recognized third party speaks of these OH&S achievements. Then it not only carries
conviction but also impacts the consumer mind favourably.

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Occupation, Health and Safety Management System (OHSMS) certification is one such
opportunity that can enable the companies acquires the label of sound enterprises and
improves their economic performance at the same time.

5.3 Why implement OHSMS?

 Systematic approach
 Improved communication
 Improved compliance
 Improved profitability
 Reduction in liability and risk
 Improved internal management
 Confidence with stakeholders
 Improved employee confidence / faith
 Market credibility / image
 Improved emergency preparedness

5.4 Developing an OHSMS: -

Any organisation may develop its own OHSMS Management System to address
OHSMS issues arising out of its activities, product or services. The elements of such a
system may be decided by the organisation itself depending upon the need.

Such a system may be functioning well to enhance the OHSMS performance; still it will
lack credibility and conviction. In these circumstances third party certification of
OHSMS is required. For this purpose the organisation’s OHSMS has to be designed,
developed and implemented as per specification of recognised standards.

Thus OHSMS scope is as below.

 Must be based on control of causes, not hazards and risks reactive

 Must address all management elements of control
 Must address Normal / Abnormal / Emergency conditions
 Must have measurable parameters
 Must be goal driven
 Must be relevant to risks
 Must involve all
 Must promote continual improvement
 Management and not control / eradication
 OHSMS is managing risks and hazards
 The essence of hazard management is to avoid high risks, manage medium
risks and live with low risks

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6.0 ISO 45001 Standards: -

The standards are generic, i.e. applicable to both manufacturing and service
organisation, in public and private sectors. They say what should be done by an
organisation to manage the impact on the OH&S of its activities, but do not dictate how
to do it. Thus ISO 45001:2018 have impact on the issues listed below.
6.1 Following issues for Industry are considered
 Occupational concern for the organisation
 Health issues
 Safety of workers
 Water use
 Other Resource Use
 Hazardous Substances
 Biological Hazards
 Radiation
 Waste
 Noise
 Community Concerns
 Wildlife & Habitats
 Accidents & emergencies
 Planning Issues
 Interface with other Health & Safety Issues

ISO 45000 series of standards can be classified as the specification standard and
guidance standard. ISO 45001:2018 are the only specification standard to which
companies would be registered.

The overall aim of this international standard is to support OHSMS system. However, it
is not intended to be used to create non-tariff trade barriers or to increase or change an
organisation’s legal obligations.

The company has to make targets related to OH&S issues for long run and
achievement for the same. Also provisions for emergency so that OH&S is no where
affected by the company. The elements of ISO 45001:2018 are listed below.

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I. OH&S Policy
II. Planning
1. Planning for hazard identification, risk 3. Objectives and targets.
assessment and risk control 4. OHSMS Management Program.
2. Legal and other requirements.
III. Implementation and Operation
1. Structure and responsibility. 5. Document control.
2. Training, awareness and competence. 6. Operational control.
3. Consultation and Communication. 7. Emergency preparedness and
4. OHSMS documentation. response.
VI. Checking and Corrective Action
1. Performance measurement and 3. Records.
monitoring. 4. OHSMS Management System audit
2. Accidents, incidents, non-conformance
and corrective and preventive action
V. Management Review

The ISO 45001:2018 Specification envisages 5 Core Elements for OHSMS, for the
purpose of certification by third parties. These are:

1. Commitments and Policy

An organization should define its OH&S policy and focus on what needs to be done
for ensuring continual OHSMS performance. It should also ensure commitment to
the policy.

2. Planning
An Organization should formulate a plan to fulfil its OH&S policy.

3. Implementation
For effective implementation an Organisation should develop the capabilities and
support mechanisms necessary to achieve its OH&S policy, objectives and targets.

4. Measurements and Evaluation

An organization should measure, monitor and evaluate its OHSMS performance.

5. Reviews and Improvement

An organization should review and continually improve its OH&S management
system, with the objective of improving its overall OHSMS performance.

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6.2 Purpose and benefits of OH&S (ISO 45001): -

Organizations certified to ISO 45001:2018 would achieve significant competitive edge

over Organizations engaged in similar operations (activities, products and services), as
it reflects the proactiveness of organization to protect the OH&S through preventive
mechanisms rather than corrective one.
A well functioning OHSMS provides confidence to the organization and the various
stakeholders as well that and give the benefits as listed below:
1. Increase the Acceptance from financial institutions, Bank, Public, Insurance etc.
2. Improve Industry - Government Relations.
3. Improve OH&S Performance, which in turn increase productivity of man and
machines.
4. Meet customer’s OH&S expectations and maintain good public relations.
5. Govt. benefits.
6. Ability to Meet;
a. National/ International Legislation
b. Regional Variation in Legislation
7. Health and Safety of Workers
8. Public Image.
9. Consumer Opinion
10. Inter-company/ international Trade.
11. Increase Employee Confidence.

7.0 Steps for installation of ISO 9001 and ISO 14001:2015 Quality and
Environment Management System and ISO 45001:2018:
All the progressive units in India, which are in the export market today, have adopted
some system of obtaining the final product quality. However, in this system there are
generally a lot of rework and wastage’s. Experience of other industries in India and
outside India shows that extensive efforts on the part of each and every person in the
organisation are needed for upgrading the existing system to meet the requirements of
ISO: 9001 quality system. In revised ISO 9001 and ISO 14001:2015 standard
approach of risk identification and taking necessary actions are required.

The time required for installation of this system in any company may vary depending
upon their present status and work culture. The total cost involved consultancy body,
fees of certifying body, resource requirement etc. depending on infrastructure available
with the company establish system and complexity of work involved.

1. Conduct awareness programmes (Top + Middle + Bottom Level).

2. Form a task force for documentation.
3. Prepare documents of Quality and Environment system.
4. Implementation and train all personnel in the use of procedures and formats.
5. Train internal auditors.

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6. Carry out aspects and impacts and risk assessment. Conduct hazard-risk
assessment
7. Assess the system through an internal audit.
8. Take corrective actions for non-compliances.
9. Apply for certification.
10. Assess the system through second round of internal audit.
11. Avail pre-certification audit of certifying body.
12. Take actions on suggestions given by them.
13. Maintain and improve the system by third round of internal audit.
14. Final audit by certifying body.

Conclusion: -
Quality and Environment under ISO 9001, ISO 14001 and ISO 45001:2018 will not give
company the more of the best product producer. But what it will give to the company is a
more consistent product and a system of operation that is totally oriented to the customer's
needs. It will require a lot of hard work and a lot of headaches, but it will be paying in terms
of Quality Assured product.

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