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1 ‘QuEnHeSa’ Model – Draft 1 – September 2010 – Developed by Dr. Divya Singhal and Keshav

Ram Singhal

DRAFT – 1

FOR PRIVATE CIRCULATION AND PRIVATE REFERENCE PURPOSE

‘QuEnHeSa’ MODEL

FOR

INTEGRATED MANAGEMENT SYSTEMS

INTEGRATING QUALITY, ENVIRONMENTAL, OCCUPATIONAL HEALTH AND SAFETY

MANAGEMENT SYSTEMS

DEVELOPED BY

Dr. Divya Singhal

And

Keshav Ram Singhal

Please contact

Keshav Ram Singhal

117, Jeevan Vihar Colony, Anasagar Circular Road, Ajmer - 305004, India

Email – [email protected]




Ram Singhal

Draft 1 – ‘QuEnHeSa’ model for integrated management systems integrating quality, environmental, occupational

health and safety management systems

September 2010

Strictly prohibited to copy the material, without the permission from the developer.

FOR PRIVATE CIRCULATION AND REFERENCE

Being developed by

Dr. Divya Singhal

Keshav Ram Singhal

Suggestions and comments are invited.

Keshav Ram Singhal

117, Jeevan Vihar Colony,

Anasagar Circular Road,

Ajmer – 305004, India.

Email – [email protected]




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Foreword

‘QuEnHeSa’ Model is a model for integrating quality, env ironment, health and safety

management systems’ requirements into a single document, thus will benefit thousands of

organizations implementing ISO 9001:2008 QMS, ISO 14001:2004 EMS and OHSAS

18001:2007 Standards.

‘QuEnHeSa’ model is in development stage and this is the first draft of the ‘QuEnHeSa’ Model.

The developers of this model request management systems professionals and users and others

to assess the draft and communicate their comments and suggestions for improvement.

Suggestions for improvement will be acknowledged in the forthcoming issue of this model.

Dr. Divya Singhal

Keshav Ram Singhal




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CONTENTS

Forward

Introduction – General

‘QuEnHeSa’ model promotes process approach

Compatibility with other management systems

1 Scope

1.1 General

1.2 Application

2 Normative references

3 Terms and definitions

4 ‘QuEnHeSa’ – Integrated management systems

4.1 General requirements

4.2 Outsourced process

4.3 Documentation requoirements

4.4 ‘QuEnHeSa’ manual

4.5 Control of documents

4.6 Control of records

5 Management responsibility

5.1 Management commitment

5.2 Customer focus

5.3 ‘QuEnHeSa’ policy

5.4 ‘QuEnHeSa’ planning

5.5 Planning - ‘QuEnHeSa’ objectives and targets

5.6 Planning – Hazards identification and risks assessment procedure

5.7 Planning – Planning of product realization

5.8 Planning – Design and development planning

5.9 Planning – Environmental aspects5.10 Planning – Legal and other requirements

5.11 Planning – Programme for achieving ‘QuEnHeSa’ objectives and targets

5.12 Responsibility and authority

5.13 Management representative

5.14 Internal communication

5.15 Management review




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6 Resource management

6.1 Provision of resources

6.2 Human resources – Competence, training and awareness

6.3 Infrastructure6.4 Work environment

7 Design and development

7.1 Design and development inputs

7.2 Design and development outputs

7.3 Design and development review

7.4 Design and development verification

7.5 Design and development validation

7.6 Design and development changes

8 Purchasing

8.1 Purchasing process

8.2 Purchasing information

8.3 Verification of purchased product

9 Implementation, operation and product realization

9.1 Determination of requirements related to the product

9.2 Review of requirements related to the product9.3 Communication

9.4 Control of production and service arrangements including operational control

9.5 Validation of processes for production and service arrangements

9.6 Identification and traceability

9.7 Customer property

9.8 Preservation of product

9.9 Control of monitoring and measuring equipment

9.10 Participation and consultation with workers, contractors and interested parties

10 Emergency preparedness and response

10.1 Emergency preparedness

10.2 Emergency response

11 Monitoring, measurement, analysis and improvement




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11.1 General

11.2 Monitoring and measurement – Customer satisfaction

11.3 Monitoring and measurement – Internal audit

11.4 Monitoring and measurement of processes

11.5 Monitoring and measurement of product

11.6 Evaluation of compliance to legal and other requirements11.7 Control of nonconforming product, corrective action and preventive action

11.8 Analysis of data

11.9 Continual improvement

Notes

Bibliography




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‘QuEnHeSa’ MODEL

Introduction

General

‘QuEnHeSa’ Model is a model for integrating quality, environment, health and safety

management systems’ requirements into a single document, thus benefiting thousands of

organizations who are implementing ISO 9001:2008 QMS, ISO 14001:2004 Ems and OHSAS

18001:2007 Standards. The adoption of ‘QuEnHeSa’ Model should be a strategic decision of an

organization. The design and implementation of ‘QuEnHeSa’ model (implementation of

integrated QMS, EMS and OHSAS management systems) is influenced by:

organization’s environment (present and future) and the risks associated with the

organization’s environment,

varying needs of the organization,

particular objectives of the organization,products the organization provides,

processes the organization employs,

organization’s activities,

legal and other requirements,

size, type and structure of the organization

The purpose of ‘QuEnHeSa’ Model is to provide a model for integrating quality, environment,

health and safety management systems (an integrated management systems) and thus it not

the intention of this model to imply uniformity in the structure of the integrated management

systems as per this ‘QuEnHeSa’ model or uniformity of documentation.

This ‘QuEnHeSa’ model can be used by organizations, as a guide, to implement integrated

management systems and to assess the organization’s ability to meet customer, statutory and

regulatory requirements applicable to the product, and the organization’s own requirements and

also compliance to the requirements of this ‘QuEnHeSa’ model.

During the development of this ‘QuEnHeSa’ model, following principles are being considered:

customer focus,

leadership,

involvement of people,

process approach,system approach to management,

continual improvement,

factual approach to decision making,

mutually beneficial supplier relationships,

environmental performance,




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prevention of pollution,

health and safety performance,

prevention of accidents

‘QuEnHeSa’ model promotes process approach

This ‘QuEnHeSa’ model promotes the adoption of process approach while developing,

implementing and improving the effectiveness of the integrated management systems based on

this ‘QuEnHeSa’ model.

An organization has to determine and manage numerous linked activities. The process

approach of ‘QuEnHeSa’ model promotes the ‘Plan-Do-Check-Act’ methodology.

Sustainable performance in implementing ‘QuEnHeSa’ model is achieved through commitment,

planning, implementation, monitoring, measurement and continual improvement.

The ‘QuEnHeSa’ model requirements are organized into eight elements. Organizations

implementing ‘QuEnHeSa’ model must demonstrate their commitment for continualimprovement of the ‘QuEnHeSa’ management systems.

Compatibility with other management systems

The following standards have been taken into consideration during the development of this

‘QuEnHeSa’ model:

- ISO 14001- OHSAS 18001

- ISO 9001

This edition of ‘QuEnHeSa’ model is compatible with OHSAS 18001:2007, ISO 14001:2004

EMS, and ISO 9001:2008 QMS Standards.

Organizations wishing to implement integrated management systems will find this ‘QuEnHeSa’

model document as useful document.

1 Scope

1.1 General

This ‘QuEnHeSa’ model specifies requirements for integrated management systems (integrating

quality, environment, health and safety management systems) where an organization:

(a) needs to demonstrate its ability to consistently provide product that meets customer

requirements and applicable legal requirements,




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(b) aims to enhance customer satisfaction through the effective application of the model,

(c) wishes to establish, implement and maintain integrated management systems in

accordance with the requirements of this model,

(d) wishes to eliminate or minimize risk, including occupational health and safety risks,

(e) wishes to continually improve its performance,

(f) wishes itself of conformity with its ‘QuEnHeSa’ policy,(g) wishes to conduct self-assessment of their conformity with this ‘QuEnHeSa’ model

1.2 Application

Requirements mentioned in this ‘QuEnHeSa’ model are generic and are intended to be

applicable to all organizations, regardless of type, size and product they provide.

Where any requirement(s) of this ‘QuEnHeSa’ model are not applicable due to the nature of an

organization and its product, the same can be considered for exclusion, provided justification for

exclusion is clearly mentioned and such exclusions do not affect organization’s ability, or responsibility, to provide products that meet customer, applicable legal and other requirements.

2 Normative references

The following documents may be referred for the application of this ‘QuEnHeSa’ model:

- ISO 14001:2004, Environmental management systems – Requirements with guidancefor use,

- OHSAS 18001:2007, Occupational health and safety management systems – Requirements,

- ILO-OSH:2001, Guidelines on occupational safety and health management systems,- ISO 9000:2005, Quality management systems – Fundamentals and vocabulary,- ISO 9001:2008, Quality management systems – Requirements,- ISO 19011:2002, Guidelines for quality and/or environmental management systems

auditing

3 Terms and definitions

For the purpose of this ‘QuEnHeSa’ model document, the terms and definitions given in

normative reference documents shall apply.

‘QuEnHeSa’ means ‘Quality, Environmental, Occupational Health and Safety’.

4 ‘QuEnHeSa’ – Integrated management systems




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4.1 General requirements

The organization shall establish, document, implement and maintain an integrated quality,

environmental, health and safety management systems as per this ‘QuEnHeSa’ model and

continually improve its effectiveness in accordance with the requirements of this ‘QuEnHeSa’

model.

The organization shall

(a) determine the processes needed for the ‘QuEnHeSa’ management systems and their application throughout the organization,

(b) determine the sequence and interaction of these processes,(c) determine criteria and methods needed to ensure that operation and control of these

processes are effective,(d) ensure availability of resources and information necessary to support the operation and

monitoring of these processes,(e) establish policies and objectives in conformity with this ‘QuEnHeSa’ model, (f) promote awareness, motivation and involvement of people in the organization,(g) communicate the importance of meeting customer, applicable statutory and regulatory,

and organizational requirements,(h) participate in hazard identification, risk assessment and risk control activities and

studies,(i) continually improve processes and operational controls,(j) monitor, measure and analyze processes, and(k) implement actions necessary to achieve planned results

The organization shall manage processes in accordance with the requirements of this

‘QuEnHeSa’ model.

4.2 Outsourced process

Where an organization chooses to outsource any process, the organization shall ensure control

over such process. The type and extent of control to be applied to such outsourced process

shall be defined and monitored.

4.3 Documentation requirements

The ‘QuEnHeSa’ management systems documentation shall include:

- documented statement of ‘QuEnHeSa’ policy mentioning organization’s policy for quality,environmental, occupational health and safety,

- documented statement of ‘QuEnHeSa’ objectives,- a ‘QuEnHeSa’ manual,- documented procedures and records required by this ‘QuEnHeSa’ model,




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- documents and records, determined by the organization to be necessary to ensureeffective planning, operation and control of its processes

4.4 ‘QuEnHeSa’ manual

The organization shall establish and maintain an ‘QuEnHeSa’ manual (in any form or medium)that includes:

- the scope of the ‘QuEnHeSa’ management systems, including details of and justificationfor any exclusions,

- the documented procedures established for the ‘QuEnHeSa’ management systems, orreference to them, and

- a description of the interaction between the processes of the ‘QuEnHeSa’ managementsystems

4.5 Control of documents

The organization shall control documents required by the ‘QuEnHeSa’ model. The organization

shall establish a documented procedure to define controls needed:

- to approve documents for adequacy prior to issue,- to review and update as necessary and re-approve documents,- to ensure that changes and current revision status of documents are identified,- to ensure that relevant versions of applicable and current documents are available at

points of use,- to ensure that documents remain legible and readily identifiable,- to ensure that documents of external origin are identified and their distribution controlled,- to prevent the unintended use of obsolete documents, and to apply suitable identification

to them if they are retained for any purpose

4.6 Control of records

Records provide evidence of conformity to requirements and of the effective operation of the

‘QuEnHeSa’ management systems. The organization shall control records established for the

‘QuEnHeSa’ management systems.

The organization shall establish a documented procedure to define controls needed for the

identification, storage, protection, retrieval, retention and disposition of records.

The organization shall ensure that records remain legible, readily identifiable and retrievable.The organization shall establish and document retention time of records.

5 Management responsibility




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5.1 Management commitment

Top management of the organization shall provide evidence of commitment to the development

and implementation of integrated management systems as per this ‘QuEnHeSa’ model and

continually improving its effectiveness by:

- communicating to the organization the importance of meeting customer, organizationalas well as statutory and regulatory requirements,

- establishing the ‘QuEnHeSa’ policy,- establishing the ‘QuEnHeSa’ objectives,- conducting management reviews, and- ensuring the availability of resources

5.2 Customer focus

Top management of the organization shall ensure that customer requirements are determined

and met with the aim of enhancing customer satisfaction.

5.3 ‘QuEnHeSa’ policy

‘QuEnHeSa’ policy shall cover the organization’s:

- quality policy- environmental policy, and- occupational health and safety policy,

Top management of the organization shall ensure that ‘QuEnHeSa’ policy:

- is appropriate to the purpose of the organization,- is appropriate to the nature, scale and environmental impacts of organization’s activities,

products and services,- is appropriate to the nature and scale of the organization’s occupational health and

safety risks,- includes a commitment to prevention of pollution,- includes a commitment to comply with requirements, including applicable legal

requirements and other requirements to which the organization subscribes which relateto the organization’s environmental aspects, and prevention of injury and ill health,

- includes a commitment to continually improve the effectiveness of the integratedmanagement systems as per this ‘QuEnHeSa’ model,

- provides a framework for establishing and reviewing ‘QuEnHeSa’ objectives,- is documented, implemented and maintained,- is communicated to all persons working for and on behalf of the organization with the

intent that they are made aware of their individual ‘QuEnHeSa’ obligations ,- is available to interested parties (including public), and- is reviewed periodically to ensure that it remains relevant and appropriate to the

organization




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5.4 ‘QuEnHeSa’ planning

Top management shall ensure that:(a) the planning of the ‘QuEnHeSa’ integrated management systems is carried out in order

to meet the requirements given in this ‘QuEnHeSa’ model, as well as the ‘QuEnHeSa’objectives,

(b) the integrity of the ‘QuEnHeSa’ integrated management systems is maintained whenchanges to the ‘QuEnHeSa’ integrated management systems are planned andimplemented.

5.5 Planning - ‘QuEnHeSa’ objectives and targets

Top management shall ensure that ‘QuEnHeSa’ objectives, including those needed to meetrequirements for product, are established at relevant functions and levels within theorganization. The ‘QuEnHeSa’ objectives and targets shall be measurable and consistent withthe ‘QuEnHeSa’ policy of the organization.

Accordingly, the organization shall establish, implement and maintain documented ‘QuEnHeSa’

objectives and targets, at relevant functions and levels within the organization.

The ‘QuEnHeSa’ objectives and targets shall include commitments:- to prevention of pollution,- to compliance with applicable legal requirements,- to compliance with other requirements to which organization subscribes, and- to continual improvement

When establishing and reviewing ‘QuEnHeSa’ objectives and targets, the organization shallconsider the significant environmental aspects, applicable legal requirements and otherrequirements, to which the organization subscribes. The organization shall also consider itstechnological options, its financial, operational and business requirements and interested

parties’ views.

5.6 Planning – Hazard identification and risk assessment procedure

The organization shall document procedure for ‘QuEnHeSa’ hazard identification, riskassessment and determination of necessary controls. The organization shall ensure that the‘QuEnHeSa’ risks and determined controls are taken into account when establishing,implementing and maintaining the integrated management systems as per this ‘QuEnHeSa’model.

The ‘QuEnHeSa’ hazard identification, risk assessment and control procedure shall beappropriate to the nature and extent of associated risks and take into account the following:

(a) routine and non-routine activities,(b) activities of all persons (including contractors and visitors) having access to the

workplace,(c) human behaviour, capabilities and other human factors,(d) identified hazards originating outside the workplace capable of adversely effecting the

health and safety of persons under organization’s control within the workplace(e) hazards created in the vicinity of the workplace by organization’s activities, (f) infrastructure, equipment and materials at the workplace,




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(g) changes and modifications (and proposed changes and modifications, if any) in theorganization, its activities or its product, and their impacts on operations, processes andactivities,

(h) applicable legal obligations relating to risk assessment and implementation of necessarycontrols,

(i) the design of work areas, organization’s processes, installation, machinery, equipment,

operating procedures and work organization, including their adaptation to humancapabilities

The organization’s methodology for ‘QuEnHeSa’ hazard identification and risk assessment (itsscope, nature and timing) shall be defined to ensure that the methodology is proactive ratherthan reactive. The methodology shall provide for the identification, prioritization anddocumentation of risks, and the application of controls, as appropriate.

When determining controls or changes to them to reduce the risks, the organization shallconsider according to the following hierarchy:

(a) elimination,(b) substitution,

(c) engineering controls,(d) signage / warnings and / or administrative controls,(e) personal proactive equipment

The organization shall keep up-to-date records of the results of identification of hazards, riskassessments and determined controls.

5.7 Planning – Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planningof product realization shall be consistent with the requirements of other processes as per this‘QuEnHeSa’ model.

In planning of product realization, the organization shall determine the following, as appropriate:(a) ‘QuEnHeSa’ objectives,(b) requirements of the product,(c) the need to establish processes,(d) the need to establish documents,(e) the need to provide resources,(f) required verification, validation, monitoring, measurement, inspection and test activities

specific to the product,(g) the criteria for product acceptance,(h) records needed to provide evidence that the realization processes and resulting product

meet requirements

A document specifying the processes of the integrated management system as per this‘QuEnHeSa’ model (including the product realization processes) and resources to be applied toa specific product, project or contract can be referred to as a ‘QuEnHeSa’ plan

5.8 Planning – Design and development planning




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The organization shall plan and control the design and development of product. During thedesign and development planning, the organization shall determine:

(a) the design and development stages,(b) the review, verification and validation that are appropriate to each design and

development stage, and(c) the responsibilities and authorities for design and development

Planning output shall be updated, as appropriate, as the design and development progresses.

5.9 Planning – Environmental aspects

The organization shall establish and implement a documented procedure:(a) to determine the environmental aspects of organization’s activities, products and

services within the defined scope of the integrated management systems as per this‘QuEnHeSa’ model that it can control and those that it can influence considering plannedand new developments, new and modified activities, products and services, and

(b) to determine those environmental aspects that have or can have significant impact(s) onthe environment

The organization shall document environmental aspects information.

The organization shall ensure that the significant environmental aspects are considered inestablishing, implementing and maintaining the integrated management systems as per this‘QuEnHeSa’ model.

5.10 Planning – Legal and other requirements

The organization shall establish and implement a documented procedure:(a) to determine and have access to the applicable legal requirements and other

requirements to which the organization subscribes related to its environmental aspects,

and(b) to determine how these requirements apply to its environmental aspects

The organization shall ensure that applicable legal and other requirements are considered inestablishing, implementing and maintaining the integrated management systems as per this‘QuEnHeSa’ model.

5.11 Planning – Programme for achieving ‘QuEnHeSa’ objectives and targets

The organization shall establish, implement and maintain programme(s) for achievingorganization’s ‘QuEnHeSa’ objectives and targets.

Programme shall include:(a) designation of responsibility for achieving ‘QuEnHeSa’ objectives and targets at relevant

functions and levels of the organization, and(b) the means and time-schedule by which they are to be achieved

5.12 Responsibility and authority




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Top management of the organization shall define responsibilities and authority andcommunicate the same within the organization.

5.13 Management representative

Top management of the organization shall appoint a member of the organization’s management

as ‘management representative’. The management representative, irrespective of other responsibilities, shall have responsibility and authority that includes:

(a) ensuring that processes needed for the integrated management systems as this‘QuEnHeSa’ model are established, implemented and maintained,

(b) reporting to top management of the organization on the performance of the integratedmanagement systems as per this ‘QuEnHeSa’ model and any need for improvement,

(c) ensuring the promotion of awareness of the ‘QuEnHeSa’ requirements (including customer requirements) and risk management proinciples throughout the organization,and

(d) liaise with external parties on matters relating to the integrated management systems asper this ‘QuEnHeSa’ model

5.14 Internal communication

Top management of the organization shall ensure establishing appropriate communicationprocesses within the organization and that communication takes place regarding theeffectiveness of the integrated management systems as per this ‘QuEnHeSa’ model.

Please also see 9.3.

5.15 Management review

Top management of the organization shall review organization’s integrated managementsystems as per this ‘QuEnHeSa’ model, at planned intervals, to ensure its continuing suitability,

adequacy and effectiveness. Management review shall include assessing opportunities forimprovement and the need for changes to the integrated management systems, including the‘QuEnHeSa’ policy and ‘QuEnHeSa’ objectives.

The organization shall maintain management review records.

The input to the management review shall include information on:(a) results of audits,(b) feedback from customers and interested parties,(c) process performance,(d) product conformity,(e) status of corrective action,

(f) status of preventive action,(g) follow-up actions from previous management reviews,(h) changes that could affect the integrated management systems, and(i) recommendations for improvement

The output from the management review shall include any decisions and actions related to:(a) improvement of the effectiveness of the integrated management systems and its

processes,




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(b) improvement of product related to customer requirements, and(c) resource needs

6 Resource management

6.1 Provision of resources

The organization shall determine and provide resources needed (a) to implement and maintain

the integrated management systems as per this ‘QuEnHeSa’ model and continually improve its

effectiveness, and (b) to enhance satisfaction of the customers and interested parties by

meeting requirements, including customer requirements.

Resources include human resources and specialized skills, organizational infrastructure,

technology and financial resources.

6.2 Human resources – Competence, training and awareness

Personnel, performing task for the organization or on its behalf affecting conformity to productrequirements or may have an impact on health, safety and environment shall be competent on

the basis of appropriate education, training, skills and experience.

The organization shall:

(a) determine and define the necessary competence for personnel performing work for the

organization or on its behalf,

(b) identify training needs,

(c) provide training or take other actions to achieve the necessary competence,

(d) evaluate the effectiveness of the training or actions taken,

(e) ensure that its personnel are aware of the relevance and importance of their activities

and how they contribute to the achievement of the ‘QuEnHeSa’ objectives and targets,

and

(f) maintain appropriate records of education, training, skills and experience

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure to achieve conformity

to requirements of the integrated management systems as per this ‘QuEnHeSa’ model.

Infrastructure includes, as appropriate:

(a) building, workspace, facilities and associated utilities,

(b) process equipment (hardware and software),(c) plant, tools and equipment, and

(d) support services, such as transport, communication, information system

6.4 Work environment




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The organization shall determine and manage work environment needed to achieve conformity

to requirements of the integrated management systems as per this ‘QuEnHeSa’ model.

7 Design and development

7.1 Design and development inputs

The organization shall determine inputs relating to product requirements and maintain records.

Design and development inputs shall include:

(a) functional and performance requirements,

(b) applicable legal requirements,

(c) where applicable, information derived from previous similar designs, and

(d) other requirements essential for design and development

The organization shall review design and development inputs for adequacy. Input requirementsshall be complete, unambiguous and not in conflict with each other.

7.2 Design and development outputs

The organization shall approve outputs of design and development prior to release, which shall

be in a form suitable for verification against the design and development inputs.

Design and development outputs shall:

(a) meet the input requirements for design and development,

(b) provide appropriate information for purchasing, production and service provision,

(c) contain or reference product acceptance criteria, and(d) specify the characteristics of the product that are essential for its safe and proper use

7.3 Design and development review

At suitable stages, the organization shall perform systematic reviews of design and

development in accordance with planned arrangements in order to (a) evaluate the ability of the

results of design and development to meet requirements, and (b) identify any problems and

propose necessary actions.

Representatives of functions concerned with design and development stage(s) being reviewed

shall be included as participants in such reviews.

The organization shall maintain records of the results of the reviews and any necessary actions.

7.4 Design and development verification




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The organization shall perform design and development verification in accordance with planned

arrangements to ensure that the design and development outputs have met the design and

development input requirements.

The organization shall maintain records of the results of the verification and any necessary

actions.

7.5 Design and development validation

The organization shall perform design and development validation in accordance with planned

arrangements to ensure that the resulting product is capable of meeting the requirements for the

specified application or intended use, where known. Wherever practicable, the organization

shall complete the validation prior to the delivery or implementation of the product.

The organization shall maintain records of the results of validation and any necessary actions.

7.6 Design and development changes

The organization shall identify design and development changes and maintain records. The

organization shall review, verify and validate design and development changes, as appropriate,

and approve before implementation.

The review of design and development changes shall include evaluation of the effect of the

changes on the constituent parts and product already delivered.

The organization shall maintain records of the results of the review of changes and any

necessary actions.

8 Purchasing

8.1 Purchasing process

The organization shall establish, implement and maintain procedure related to purchasing. The

organization shall determine the ‘QuEnHeSa’ risks associated with the product to be purchased.

The organization shall apply the type and extent of control applied to the supplier and the

purchased product, which shall be dependent upon the effect of the purchased product on

subsequent product realization or the final product. The organization shall ensure that

purchased product conforms to specified purchase requirements.

The organization shall evaluate and select suppliers based on their ability to supply product in

accordance with the organization’s requirements. The organization shall establish the criteria for

selection, evaluation and re-evaluation of suppliers.

The organization shall maintain records of the results of evaluations and any necessary actions

arising from the evaluation.




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8.2 Purchasing information

The organization shall ensure that purchasing information clearly describes the product to be

purchased, including, where appropriate,

(a) requirements for approval of product, procedures, processes and equipment,

(b) requirements for qualification of personnel,(c) ‘QuEnHeSa’ requirements, and

(d) verification arrangements, if any

The organization shall ensure the adequacy of specified purchase requirements prior to their

communication to the supplier.

8.3 Verification of purchased product

The organization shall determine, establish and implement the inspection or other activities

necessary for ensuring that purchased product meets specified purchase requirements.

The organization shall state the intended verification arrangements and method of product

release in the purchasing information, where the organization intends to perform verification at

the supplier’s premises.

9 Implementation, operation and product realization

9.1 Determination of requirements related to the product

The organization shall determine:

(a) requirements specified by the customer,

(b) requirements for delivery and post delivery activities,

(c) requirements not stated by the customer but necessary for specified or intended use,

where known,

(d) legal requirements applicable to the product,

(e) any additional requirements considered necessary

9.2 Review of requirements related to the product

The organization shall review the requirements related to the product. This review shall be

conducted prior to the organization’s commitment to supply a product to the customer (e.g.submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts

or orders) and shall ensure that:

(a) product requirements are defined,

(b) contract or order requirements differing from those previously expressed are resolved,

and




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(c) the organization has the ability to meet the defined requirements

The organization shall maintain records of the results of the review and actions arising from the

review.

Where the customer provides no documented statement of requirements, the customer

requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant

documents are amended and that relevant personnel are made aware of the changed

requirements.

9.3 Communication

The organization shall determine and implement effective arrangements for communicating with

customers in relation to:

(a) product information,

(b) enquiries, contracts or order handling, including amendments, and

(c) customer feedback, including customer complaints

With regard to occupational health and safety hazards and integrated management systems as

per this ‘QuEnHeSa’ model, the organization shall establish, implement and maintain procedure

for:

(a) internal communication within the organization,

(b) external communication with contractors and visitors,

(c) receiving, documenting and responding to communication with external interestedparties

9.4 Control of production and service arrangements including operational control

The organization shall ensure planning and carrying out production and service arrangements

under controlled conditions that include, as applicable:

(a) availability of product characteristics description,

(b) availability of work instructions, as necessary,

(c) the use of suitable equipment, the availability and use of monitoring and measuring

equipment,

(d) the implementation of monitoring and measurement, and

(e) the implementation activities for product release, delivery and post delivery activities

The organization shall establish, implement and maintain documented procedure to control

situations to avoid deviation from the ‘QuEnHeSa’ policy, objectives and targets. The procedure




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shall stipulate the operating criteria. The organization shall communicate applicable procedures

and requirements to suppliers, including contractors.

The organization shall determine and control those operations and activities that are associated

with the identified hazards to manage environmental impact, and health and safety risks

including management of change.

The organization shall implement and maintain:

(a) operational controls, as applicable to the organization and its activities, and integrate

such controls into the overall integrated management systems as per this ‘QuEnHeSa’

model,

(b) controls on purchased goods, equipment and service,

(c) controls on contractors and other visitors to the workplace,

(d) documented procedure and stipulated operating criteria to handle situations where

absence of the documented procedure or stipulated operating criteria could lead to

deviation from the ‘QuEnHeSa’ policy and objectives

9.5 Validation of processes for production and service arrangements

The organization shall ensure validation of any processes for production and service

arrangements, where the resulting output cannot be verified by subsequent monitoring and

measurement, so as to demonstrate the ability of the processes to achieve planned results.

The organization shall establish arrangements for validation of processes including defined

criteria for review, criteria for approval of processes, approval of qualification of personnel,

approval of equipment, use of specific methods and procedures, and revalidation.

The organization shall arrangements for maintaining records of validation and re-validation.

9.6 Identification and traceability

Where appropriate, the organization shall identify the product by suitable means throughout

product realization.

The organization shall identify the product status with respect to monitoring and measurement

requirements throughout product realization.

Where traceability is a requirement, the organization shall control the unique identification of theproduct and maintain records.

9.7 Customer property

The organization shall exercise care with customer property, while it is under organization’s

control or being used by the organization. The organization shall identify, verify, protect and

safeguard customer property provided for use or incorporation into the product. If any customer




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property is lost, damaged or otherwise found to be unsuitable for use, the organization shall

report this to the customer and maintain records.

9.8 Preservation of product

The organization shall preserve the product during internal processing and delivery to the

intended destination in order to maintain conformity to requirements. As applicable, preservationshall include identification, handling, packaging, storage and protection. Preservation shall also

apply to the constituent parts of a product.

9.9 Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurement to be undertaken and

monitoring and measuring equipment needed to provide evidence of product conformity to

determined requirements and operational performance.

The organization shall establish its processes to ensure that monitoring and measurement can

be carried in a manner consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, the organization shall:

(a) calibrate or verify, or both the measuring equipment, at specified intervals or prior to use,

against measurement standards traceable to measurement standards or record the

basis of calibration or verification (where no measurement standards exist),

(b) adjust or re-adjust the measuring equipment as necessary,

(c) mark identification on the measuring equipment in order to determine its calibration

status,

(d) safeguard the measuring equipment from adjustments to prevent invalidating the

measurement result,(e) protect from damage and deterioration of the measuring equipment during handling,

maintenance and storage

When the measuring equipment is found not to conform to requirements, the organization shall

assess and record the validity of the previous measuring results, and also take appropriate

action on the equipment and product affected.

The organization shall maintain records of the results of calibration and verification.

When computer software is used in the monitoring and measurement of specified requirements,the organization shall confirm its ability to satisfy the intended application, prior to initial use and

reconfirm as necessary.

9.10 Participation and consultation with workers, contractors and interested parties

The organization shall establish, implement and maintain procedure for the participation,

consultation and appropriate involvement of workers in hazard identification, risk assessments,




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incident investigation and determination of controls, in the development and review of policies

and objectives related to occupational health and safety and their representation.

The organization shall inform participation arrangements and who is their representatives on

occupational health and safety matters to workers.

The organization shall establish, implement and maintain procedure for consultation withcontractors where there are changes that affect their health and safety.

10 Emergency preparedness and response

10.1 Emergency preparedness

The organization shall establish, implement and maintain procedure to identify potentialemergency situations and potential accidents that can have impact on the environment, healthand safety risks and how the organization will respond to such situations and accidents.

In planning the organization’s emergency response, the organization shall consider the needs ofrelevant interested parties (such as emergency services and neighbours).

The organization shall periodically review and, where necessary, revise its emergencypreparedness and response procedure.

10.2 Emergency response

The organization shall respond to actual emergency situations and accidents and prevent ormitigate associated adverse environmental impacts, health and safety risks.

The organization shall periodically test its emergency preparedness and response procedure.,where practicable.

11 Monitoring, measurement, analysis and improvement

11.1 Performance measurement and monitoring

The organization shall establish, implement and maintain procedure to monitor, measure,

analyze and improve, on a regular basis, the key characteristics of organization’s operations

including environmental, health and safety performance that can have a significant ‘QuEnHeSa’

impact, including determination of applicable methods and statistical techniques and extent oftheir use, (a) to demonstrate conformity to product requirements and requirements of the

integrated management systems as per this ‘QuEnHeSa’ model, (b) to ensure conformity of the

integrated management systems, and (c) to continually improve the effectiveness of the

integrated management systems.




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The procedure shall provide qualitative and quantitative measures appropriate to the needs of

the organization. The procedure shall include recording of information to monitor performance,

effectiveness of controls, applicable operational controls and conformity with the organization’s

‘QuEnHeSa’ objectives and targets.

The organization shall maintain records relating to monitoring and measurement.

11.2 Monitoring and measurement – Customer satisfaction

The organization shall determine methods for obtaining and using, and monitor information

relating to customer perception regarding meeting customer requirements.

11.3 Monitoring and measurement – Internal audit

The organization shall ensure that internal audits of the integrated management systems as perthis ‘QuEnHeSa’ model are conducted at planned intervals to:

(a) determine whether the integrated management systems conforms to the planned

arrangements, to the requirements of this ‘QuEnHeSa’ model and to the integrated

management systems requirements estabnlished by the organization,

(b) determine whether the integrated management systems have been properly

implemented and maintained,

(c) determine whether the integrated management systems of the organization is effective

in meeting the organization’s ‘QuEnHeSa’ policy and objectives.

(d) provide information on the results of audits to the management

The organization shall plan audit programme considering the status and importance of the

processes, operations and areas to be audited, as well as the results of previous audits. The

organization shall define audit criteria, scope, frequency and methods. The organization shall

ensure objectivity and impartiality of the audit process through selection of auditors and conduct

of audits. The organization shall not allow auditors to audit their own work.

The organization shall establish documented procedure defining the responsibility and

requirements for planning and conducting audits, establishing records and reporting results.

The organization shall maintain records of the audits and their results.

The organization shall ensure to take any necessary corrections and corrective actions without

undue delay to eliminate detected nonconformities and their causes.

The organization shall conduct fol low-up activities to verify the actions taken and reporting of

verification results.




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11.4 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and their applicable measurement

of the organization’s processes. These methods shall demonstrate the ability of the processes

to achieve planned results. When planned results are not achieved, correction and correctiveactions shall be taken as appropriate.

11.5 Monitoring and measurement of product

The organization shall monitor and measure the characteristics of the product to verify that

product requirements have been met. The monitoring and measurement shall be carried out at

appropriate stages of the product realization process in accordance with the planned

arrangements. The organization shall maintain evidence of conformity with the acceptance

criteria.

The organization shall maintain records indicating the persons authorizing release of product for

delivery to the customer.

The organization shall ensure that the release of product and delivery of service to the customer

shall not proceed until the planned arrangement have been satisfactorily completed, unless

otherwise approved by relevant authority and where applicable by the customer.

11.6 Evaluation of compliance to legal and other requirements

The organization shall establish, implement and maintain procedure for periodically evaluating

compliance with legal requirements and other requirements to which the organization

subscribes.

The organization shall maintain records of the results of the periodic evaluation.

11.7 Control of nonconforming product, corrective action and preventive action

The organization shall establish, implement and maintain documented procedure for dealing

with actual and potential incidence/nonconformities and for taking corrective action andpreventive action.

The organization shall ensure that product which does not conform to product requirements is

identified and controlled to prevent its unintended use or delivery.

The procedure shall define requirements for:




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(a) reviewing incidents, nonconformities and customer complaints,

(b) determining potential incidents and nonconformities,

(c) determining the causes of incidents and nonconformities,

(d) identifying and correcting nonconformities and taking actions to eliminate the causes of

incidents and nonconformities and to mitigate their health and safety consequences,

(e) investigating incidence and nonconformities by competent personnel, determining theircauses and taking actions in order to avoid their recurrence,

(f) evaluating the need for action to prevent nonconformity and implementing appropriate

actions designed to avoid their occurrence,

(g) recording results of corrective action and preventive action taken, and

(h) reviewing the effectiveness of corrective action and preventive action taken

The procedure shall define the controls and related responsibilities and authorities for dealing

with incidents and nonconformities.

Where applicable, the organization shall deal with nonconforming product by one or more of the

following ways:

(a) by taking action to eliminate the detected nonconformity,

(b) by authorizing its use, release or acceptance under concession by relevant authority and

where applicable by the customer,

(c) by taking action to preclude its original intended use or application,

(d) by taking action appropriate to the effects, or potential effects of the nonconformity when

nonconforming product is detected after delivery or use has started

When nonconforming product is corrected it shall be subject to re-verification to demonstrate

conformity to the requirements.

The organization shall ensure that any corrective action or preventive action taken to eliminate

the causes of actual and potential nonconformities shall be appropriate to the magnitude of

problems and commensurate with health and safety risks encountered.

Records of the nature of the nonconformity and any subsequent actions taken, including

concessions obtained, shall be maintained.

11.8 Analysis of data

The organization shall determine, collect and analyze appropriate data to demonstrate the

suitability and effectiveness of the integrated management systems as per this ‘QuEnHeSa’

model and to evaluate where continual improvement of the effectiveness of the integrated

management systems can be made. This shall include data generated as a result of monitoring

and measurement and from other relevant sources.

The analysis of data shall provide information relating to:




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(a) customer satisfaction,

(b) conformity to product requirements,

(c) characteristics and trends of processes and products including opportunities for

preventive actions, and

(d) suppliers

11.9 Continual improvement

The organization shall continually improve the effectiveness of the integrated management

systems as per this ‘QuEnHeSa’ model through the use of ‘QuEnHeSa’ policy, ‘QuEnHeSa’

objectives and targets, audit results, analysis of data, corrective and preventive actions and

management review.

NOTES

1. The term ‘legal requirements mean statutory and regulatory requirements.

2. The term ‘product’ applies to (i) product intended for a customer or required by a

customer, (ii) any intended output resulting from the product realization processes.

3. A single document may address the requirements for one or more procedures.

4. A requirement for a documented procedure may be covered by more than onedocument.

5. Post delivery activities include (i) actions under warranty provisions, (ii) contractual

obligations (such as, maintenance services), and (iii) supplementary services (such as

recycling, final disposal).

6. Customer property also includes intellectual property and personal data.




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BIBLIOGRAPHY

1. ISO 9000:2005, Quality management systems – Fundamental and vocabulary

2. ISO 9001:2008, Quality management systems – Requirements

3. ISO 14001:2004, Environmental management systems – Requirements with guidance

for use

4. OHSAS 18001:2007, Occupational health and safety management systems –

Requirements

5. ILO-OSH:2001, Guidelines on occupational safety and health management systems,

6. ISO 19011:2002, Guidelines for quality and/or environmental management systems



30 ‘QuEnHeSa’ Model – Draft 1 – September 2010 – Developed by Dr Divya Singhal and Keshav

‘QuEnHeSa’ model development plan

Issue of ‘QuEnHeSa’ model draft 1 – September 2010Issue of ‘QuEnHeSa’ model draft 2 – November 2010

Issue of ‘QuEnHeSa’ model final draft – January 2011Publication of ‘QuEnHeSa’ model (Issue no. 1) – March/April 2011

Please send your comments to

Keshav Ram Singhal117, Jeevan Vihar Colony, Anasagar Circular Road, Ajmer – 305004, India.

Email:[email protected]

Your Active Support NeededFor

‘QuEnHeSa’ model

We seek your active support for the development and publication of ‘QuEnHeSa’ model. Your support contribution (such as US$ 25, 500 or more) will be acknowledged in the forthcoming issueof the ‘QuEnHeSa’ model and thus you will be our partner in disseminating the ‘QuEnHeSa’ model to the

international community and thus benefiting thousands of organizations, who implement integratedmanagement systems.

Support contribution may be sent to keshav Ram Singhal at above address by cheque.Persons / organizations providing support contribution will be sent all drafts and issue – 1 of the

‘QuEnHeSa’ model.

Please mention your email id along with your name, address and occupation, while sending the supportcontribution.

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