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‘QuEnHeSa’ MODEL
FOR
DEVELOPED BY
And
Please contact
117, Jeevan Vihar Colony, Anasagar Circular Road, Ajmer - 305004, India
Email – krsinghal@rediffmail.com
November 2010
Strictly prohibited to copy the material, without the permission from the developer.
Mobile – 91-9460900733
Email – krsinghal@rediffmail.com
We seek your active support for the development and release of „QuEnHeSa‟ model. Your support
contribution (such as US$ 25, 500 or more) will be acknowledged and you will be our partner in
disseminating the „QuEnHeSa‟ model to the international community and thus benefiting thousands of
organizations, who implement integrated management systems.
Support contribution may be sent to KESHAV RAM SINGHAL at above address by cheque.
Please mention your email id along with your name, address and occupation, while sending the support
contribution.
Please note that this is an informative version of the model – draft 2 with limited
information.
„QuEnHeSa‟ Model is a model guide for integrating quality, environment, health and safety
management systems‟ requirements into a single document, thus will benefit thousands of
organizations implementing quality management system, environmental management system,
and occupational health and safety management systems Standards.
We started our efforts to develop an integrated management systems‟ model in June 2010 and
issued the first draft of „QuEnHeSa‟ model in September 2010. „QuEnHeSa‟ model is in
development stage and this is the second draft of the „QuEnHeSa‟ Model. „QuEnHeSa‟ model
has been developed to be compatible with ISO 9001:2008 (Quality), ISO 14001:2004
(Environmental) and BS OHSAS 18001:2007 (Occupational Health and Safety) management
systems.
Suggestions for improvement are invited. We would be glad to know your specific opinion
whether this model will be helpful to organizations implementing integrated management
systems.
We received a number of requests to send the draft of the model from various corners of the
world including Albania, Australia, Brazil, Canada, Denmark, Finland, Ireland, Italy, Netherlands,
Portugal, UAE, UK, USA etc. The copy of the first draft of the model was sent to hundreds of
professionals free of charge. We expected their comments and suggestions for improvement.
Many of the professionals have appreciated our efforts through their email and many forwarded
their suggestions. We are happy to mention a few of them as under:
Robert Wimmers (Netherlands) stated – “The ISO 9001 governs the relationship between
producer and client. The ISO 14001 governs the relationship between producer and its
environment (be it local or global). The OHSAS 18001 governs the relationship between the
producer and its internal employees and visitors. The main challenge facing anyone integrating
these systems is to make certain any and all relationships are fully covered by the integrated
system.”
Helmut Jilling (Cleveland, Ohio) stated – “I liked it, and fully support the idea of integrating the
systems. I have audited many companies who use a fully integrated approach. However,
wouldn‟t it be simpler to call it Q+EHS instead of QuEnHeSa.” He also stated – “The integration
sounds like a good approach.”
We appreciate Alice Correa (Brazil), who specifically sent us her specific comments on the
contents of the model. Alice also stated – “First, I must say I have a particular view of integration
of quality, environmental and health and safety issues. I see integration as not only integrating
what the system have in common but also integrating issues that are just present in one of the
systems and can add values to the QuEnHeSa performance as a whole. In this way these three
aspects of business can be integrated in practice and not only on paper. The guide you have
provided is a good reference but I believe much focused in the common issues among
standards. It is helpful once it puts all the requirements in one single document. It could also, in
my opinion, be a great contribution if it highlighted the possibility of integration of „what is not
common‟ in that case it would be more of implementation guidance.”
Martin Anderson (UK) has been very kind, who provided us his specific comments. Martin also
stated – “You could add an appendix showing the mapping between the QuEnHeSa and
standards (just to verify completeness). Outsourced process, I think this needs more thought
and guidance. 9.10 – Participation can also include consultation on Operational, Quality and
Environmental issues. 10 – Emergency preparation should also require tests of contingency
plans, and the analysis of the results.”
Andrew Cutz (Canada) stated about the QuEnHeSa model – “An interesting idea …”
4 ‘QuEnHeSa’ Model – Draft 2 – Informative Version – November 2010 – Developed by Dr.
Divya Singhal and Keshav Ram Singhal
Priyavrat Thareja (India) stated – “QuEnHeSa model essentially carries the same format as
QMS, thus simple to understand and integrate.”
We are thankful to Sally Goodman (UK), who reviewed our model draft 1 and suggested a few
points related to policy, planning, human resources, addressing competence of auditors etc. A
few suggestions are under consideration, which he suggested for movement and integration of
sections, such as, section 5.6 (Planning – Hazard identification and risk assessment procedure)
before section 5.5 (Planning – „QuEnHeSa‟ objectives and targets), section 5.5 (Planning –
„QuEnHeSa‟ objectives and targets) after section 10 (Planning – Legal and other requirements),
section 5.15 (Management review) at the end, section 9.9 (control of monitoring and measuring
equipment) be part of section 11 (Monitoring, measurement, analysis and improvement).
Any accomplishment requires the effort of many people and this work of developing
„QuEnHeSa‟ model is no different. This model is the result of a collection from various sources,
such as magazines, periodicals, speakers, writers, participants, emails, discussion notes at
various internet sites and groups, over the last many years. Unfortunately, sources were not
always noted or available, hence it is difficult for us to provide an accurate acknowledgement.
Regardless of the source, we wish to express our gratitude to all those who may have
contributed to this work, even though anonymously.
Acknowledgement
Introduction – General
1 Scope
1.1 General
1.2 Application
2 Normative references
5 Management responsibility
6 Resource management
8 Purchasing
Notes
APPENDIX – 1
APPENDIX – 2
APPENDIX – 3
APPENDIX – 4
Bibliography
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 to follow in setting up and operating
integrated management systems (integrating quality, environment, occupational health and
safety management systems). This model incorporates the features on which developers of
„QuEnHeSa‟ model have reached a consensus. It is 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.
During the development of this „QuEnHeSa‟ model, following twelve principles have been
considered:
customer focus,
leadership,
involvement of people,
process approach,
system approach to management,
continual improvement,
factual approach to decision making,
mutually beneficial supplier relationship,
environmental performance,
prevention of pollution,
health and safety performance,
prevention of accidents
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.
The „QuEnHeSa‟ model requirements are organized into eight elements (see clauses 4 to 11).
Organizations implementing „QuEnHeSa‟ model must demonstrate their commitment for
continual improvement of the performance and effectiveness of the integrated management
systems.
Resource
Provision of resources
management Human resource - competence, training and awareness
Infrastructure
Work environment
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,
(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.
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.
(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,
13 ‘QuEnHeSa’ Model – Draft 2 – Informative Version – November 2010 – Developed by Dr.
Divya Singhal and Keshav Ram Singhal
(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.
Where an organization chooses to outsource any process, the organization shall ensure control
over such process. The organization shall define and monitor the type and extent of control on
the outsourced process so as to ensure conformity of all customer and legal requirements.
While determining the control over the outsourced process, the organization shall consider
following factors:
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 justification
for any exclusions,
- the documented procedures established for the „QuEnHeSa‟ management systems, or
reference to them, and
The organization shall control documents required by the „QuEnHeSa‟ model. The organization
shall establish a documented procedure to define controls needed:
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
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 performance and effectiveness by:
Top management of the organization shall ensure that customer requirements are determined
and met with the aim of enhancing customer satisfaction.
- quality policy
- environmental policy, and
- occupational health and safety policy,
Top management shall ensure that „QuEnHeSa‟ objectives, including those needed to meet
requirements for product, are established at relevant functions and levels within the
organization. The „QuEnHeSa‟ objectives and targets shall be measurable and consistent with
the „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.
When establishing and reviewing „QuEnHeSa‟ objectives and targets, the organization shall
consider the significant environmental aspects, occupational health and safety risks, applicable
legal requirements and other requirements, to which the organization subscribes. The
organization shall also consider its technological options, its financial, operational and business
requirements and interested parties‟ views.
The organization shall establish a documented procedure for „QuEnHeSa‟ hazard identification,
risk assessment 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 be
appropriate 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,
(g) changes and modifications (and proposed changes and modifications, if any) in the
organization, its activities or its product, and their impacts on operations, processes and
activities,
(h) applicable legal obligations relating to risk assessment and implementation of necessary
controls,
(i) the design of work areas, organization‟s processes, installation, machinery, equipment,
operating procedures and work organization, including their adaptation to human
capabilities
17 ‘QuEnHeSa’ Model – Draft 2 – Informative Version – November 2010 – Developed by Dr.
Divya Singhal and Keshav Ram Singhal
The organization‟s methodology for „QuEnHeSa‟ hazard identification and risk assessment (its
scope, nature and timing) shall be defined to ensure that the methodology is proactive rather
than reactive. The methodology shall provide for the identification, prioritization and
documentation of risks, and the application of controls, as appropriate.
When determining controls or changes to them to reduce the risks, the organization shall
consider according to the following hierarchy:
(a) elimination,
(b) substitution,
(c) engineering controls,
(d) signage / warnings and / or administrative controls,
(e) personal protective equipment
The organization shall keep up-to-date records of the results of identification of hazards, risk
assessments and determined controls.
The organization shall plan and develop the processes needed for product realization. Planning
of 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 (including environmental, occupational health and safety
product requirements),
(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 to
a specific product, project or contract can be referred to as a „QuEnHeSa‟ plan
The organization may apply requirements mentioned in 5.8 and 7 to the development of product
realization processes.
The organization shall plan and control the design and development of product. During the
design and development planning, the organization shall determine:
(a) the design and development stages,
(b) environmental, occupational health and safety design and development requirements,
Planning output shall be updated, as appropriate, as the design and development progresses.
The organization shall ensure that the significant environmental aspects are considered in
establishing, implementing and maintaining the integrated management systems as per this
„QuEnHeSa‟ model.
The organization shall ensure that applicable legal and other requirements are considered in
establishing, implementing and maintaining the integrated management systems as per this
„QuEnHeSa‟ model.
The organization shall establish, implement and maintain programme(s) for achieving
organization‟s „QuEnHeSa‟ objectives and targets.
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 per this
„QuEnHeSa‟ model are established, implemented and maintained,
(b) reporting to top management of the organization on the performance of the integrated
management 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 as
per this „QuEnHeSa‟ model
The output from the management review shall include any decisions and actions related to:
20 ‘QuEnHeSa’ Model – Draft 2 – Informative Version – November 2010 – Developed by Dr.
Divya Singhal and Keshav Ram Singhal
(a) improvement of the effectiveness of the integrated management systems and its
processes,
(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.
Personnel, performing task(s) for the organization or on its behalf affecting conformity to product
requirements or may have an impact on health, safety and environment shall be competent on
the basis of appropriate education, training, skills and experience.
(a) determine and define the necessary competence for personnel performing work for the
organization or on its behalf,
(b) identify and plan 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:
The organization shall determine inputs relating to product requirements and maintain records.
Design and development inputs shall include:
The organization shall review design and development inputs for adequacy. Input requirements
shall be complete, unambiguous and not in conflict with each other.
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.
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.
The organization shall maintain records of the results of the verification and any necessary
actions.
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.
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 a documented procedure related to purchasing process. 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.
The organization shall ensure that purchasing information clearly describes the product to be
purchased, including, where appropriate,
The organization shall ensure the adequacy of specified purchase requirements prior to their
communication to the supplier.
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.
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:
The organization shall maintain records of the results of the review and actions arising from the
review.
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:
With regard to occupational health and safety hazards and integrated management systems as
per this „QuEnHeSa‟ model, the organization shall establish a documented procedure for:
The organization shall ensure planning and carrying out production and service arrangements
under controlled conditions that include, as applicable:
The organization shall establish a documented procedure to control situations to avoid deviation
from the „QuEnHeSa‟ policy, objectives and targets. The procedure shall stipulate the operating
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.
(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
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.
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 the
product and maintain records.
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
26 ‘QuEnHeSa’ Model – Draft 2 – Informative Version – November 2010 – Developed by Dr.
Divya Singhal and Keshav Ram Singhal
property is lost, damaged or otherwise found to be unsuitable for use, the organization shall
report this to the customer and maintain records.
The organization shall preserve the product during internal processing and delivery to the
intended destination in order to maintain conformity to requirements. As applicable, preservation
shall include identification, handling, packaging, storage and protection. Preservation shall also
apply to the constituent parts of a product.
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.
(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 a documented procedure for the participation, consultation and
appropriate involvement of workers in hazard identification, risk assessments, incident
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 with
contractors where there are changes that affect their health and safety.
In planning the organization‟s emergency response, the organization shall consider the needs of
relevant interested parties (such as emergency services and neighbours).
The organization shall periodically review and, where necessary, revise its emergency
preparedness and response procedure.
The organization shall respond to actual emergency situations and accidents and prevent or
mitigate associated adverse environmental impacts, health and safety risks.
The organization shall periodically test its emergency preparedness (including test of
contingency plan) and response procedure, where practicable, and carry out analysis of results.
The organization shall establish a documented 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 of their 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.
The organization shall establish a documented procedure to determine methods for obtaining
and using, and monitor information relating to customer perception regarding meeting customer
requirements.
The organization shall maintain records relating to monitoring and measurement of customer
satisfaction.
The organization shall ensure that internal audits of the integrated management systems as per
this „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 define the competence of the internal auditor on the basis of education, training and
experience to ensure competent auditor conducts internal audit.
The organization shall establish a 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 conduct follow-up activities to verify the actions taken and reporting of
verification results.
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 corrective
actions shall be taken as appropriate.
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 arrangements have been satisfactorily completed, unless
otherwise approved by relevant authority and where applicable by the customer.
The organization shall establish a documented 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.
The organization shall establish a documented procedure to record, investigate and analyze
incidents so as to:
(a) determine underlying health and safety deficiencies and other factors that may cause or
contribute to the occurrence of incidents,
The organization shall perform investigation in a timely manner. The organization shall take
appropriate action with regard to the identified need for corrective action and opportunities for
preventive action. (Please see 11.8 also)
The organization shall establish a documented procedure for dealing with actual and potential
incidence/nonconformities and for taking corrective action and preventive 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.
Where the corrective / preventive action identifies any hazards (new or changed) or the need for
any controls (new or changed), the procedure shall define requirements for the proposed action
to be taken through a risk assessment prior to implementation.
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:
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.
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 performance and 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 organization shall continually improve the performance and 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.
1.1 General (QuEnHeSa) – Clause 1.1 (ISO 9001:2008) – Clause 1 (ISO 14001:2004)
1.2 Application (QuEnHeSa) – Clause 1.2 (ISO 9001:2008) – Clause 1 (ISO 14001:2004)
4.1 General requirements (QuEnHeSa) – Clause 4.1 (ISO 9001:2008) General requirements
– Clause 4.1 (ISO 14001:2004) – Clause 4.1 (OHSAS 18001:2007)
4.2 Outsourced process (QuEnHeSa) – Clause 4.1 (ISO 9001:2008) General requirements
4.3 Documentation requirements (QuEnHeSa) – Clause 4.2.1 (ISO 9001:2008) – Clause
4.4.4 (ISO 14001:2004) – Clause 4.4.4 (OHSAS 18001:2007)
4.4 „QuEnHeSa‟ manual (QuEnHeSa) – Clause 4.2.2 (ISO 9001:2008)
4.5 Control of documents (QuEnHeSa) – Clause 4.2.3 (ISO 9001:2008) – Clause 4.4.5 (ISO
14001:2004) – Clause 4.4.5 (OHSAS 18001:2007)
4.6 Control of records (QuEnHeSa) – Clause 4.2.4 (ISO 9001:2008) – Clause 4.5.4 (ISO
14001:2004) – Clause 4.5.4 (OHSAS 18001:2007)
6.1 Provision of resources (QuEnHeSa) – Clause 6.1 (ISO 9001:2008) – Clause 4.4.1 (ISO
14001:2004) – Clause 4.4.1 (OHSAS 18001:2007)
6.2 Human resources – Competence, training and awareness (QuEnHeSa) – Clause 6.2
(ISO 9001:2008) – Clause 4.4.2 (ISO 14001:2004) – Clause 4.4.2 (OHSAS 18001:2007)
6.3 Infrastructure (QuEnHeSa) – Clause 6.3 (ISO 9001:2008)
6.4 Work environment (QuEnHeSa) – Clause 6.4 (ISO 9001:2008)
7.1 Design and development inputs (QuEnHeSa) – Clause 7.3.2 (ISO 9001:2008)
7.2 Design and development outputs (QuEnHeSa) – Clause 7.3.3 (ISO 9001:2008)
7.3 Design and development review (QuEnHeSa) – Clause 7.3.4 (ISO 9001:2008)
7.4 Design and development verification (QuEnHeSa) – Clause 7.3.5 (ISO 9001:2008)
7.5 Design and development validation (QuEnHeSa) – Clause 7.3.6 (ISO 9001:2008)
7.6 Design and development changes (QuEnHeSa) – Clause 7.3.7 (ISO 9001:2008)
9.1 Determination of requirements related to the product (QuEnHeSa) – Clause 7.2.1 (ISO
9001:2008)
9.2 Review of requirements related to the product (QuEnHeSa) – Clause 7.2.2 (ISO
9001:2008)
9.3 Communication (QuEnHeSa) – Clause 7.2.3 (ISO 9001:2008) – Clause 4.4.3 (ISO
14001:2004) – Clause 4.4.3 (OHSAS 18001:2007)
9.4 Control of production and service arrangements including operational control
(QuEnHeSa) – Clause 7.5.1 (ISO 9001:2008) – Clause 4.4.6 (ISO 14001:2004) –
Clause 4.4.6 (OHSAS 18001:2007)
9.5 Validation of processes for production and service arrangements (QuEnHeSa) – Clause
7.5.2 (ISO 9001:2008)
9.6 Identification and traceability (QuEnHeSa) – Clause 7.5.3 (ISO 9001:2008)
9.7 Customer property (QuEnHeSa) – Clause 7.5.4 (ISO 9001:2008)
9.8 Preservation of product (QuEnHeSa) – Clause 7.5.5 (ISO 9001:2008)
9.9 Control of monitoring and measuring equipment (QuEnHeSa) – Clause 7.6 (ISO
9001:2008)
9.10 Participation and consultation with workers, contractors and interested parties –
Clause 4.4.3 (OHSAS 18001:2007)
Email:
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
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 and you will be our
partner in disseminating the „QuEnHeSa‟ model to the international community and thus benefiting
thousands of organizations, who implement integrated management systems.
Support contribution may be sent to KESHAV RAM SINGHAL at above address by cheque.
Persons / organizations providing support contribution will be sent draft 2, final draft and issue – 1 of the
„QuEnHeSa‟ model.
Please mention your email id along with your name, address and occupation, while sending the support
contribution.