SECTION - I

Q-EHS SYSTEM REQUIREMENTS

Q – EHS REQUIREMENTS
&
MR ROLE

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4: Q-EHS MANAGEMENT SYSTEM REQUIREMENTS
4.1 General Requirements
Preparation of process map based on organisation’s
business activities like COP,SOP,MOP and establish it’s
interaction through turtle diagrams
4.2.1 General documentation requirements
4.4.4 General documentation requirements (E/O)
Q-EHS policy & objectives (Targets – EMS)
Quality Manual
Documented procedures as required by standard
Records as required by standard

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4.2.1 General documentation requirements
4.4.4 General documentation requirements (E/O)
 Documents needed to ensure effective planning,
operation and control of processes / significant
environmental aspects / OH&S risks
 Internal Laboratory scope (Also see Clause 3.1.5 of
TS2)
 Description of scope of EHSMS
 Description of main elements of EHS and their
interrelation and reference to related documentation.

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4.2.3 Control Of Documents
4.4.5 Control of Documents ( E/O)
Periodic review of entire documentation wrt standard’s
requirements
4.2.3.1 Engineering Specifications
Review within 2 weeks
Effective date of implementation in production
Changes to affected documents of PPAP
4.2.4 Control of Records
4.5.4 Control of Records (E/O)
Customer specific requirements/legal requirements.
Proper disposal of records

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5. MANAGEMENT RESPONSIBILITY
5.3 Quality policy
4.2 EHS Policy (E/O)
 Is appropriate to the
- Purpose of organisation
- Nature, scale, environmental impacts/OH&S risks
 Include commitment to comply with requirements
(applicable legal & Other), Prevention of injury and ill health
& Continually improve
effectiveness of QMS
Prevention of pollution / OH&S management & OH&S
performance
 Shall provide frame work for establishing & reviewing
Q-EHS objectives
 Is communicated & understood internally (to all persons
working for or on behalf of organisation)
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5.3 Quality Policy
4.2 EHS Policy (E/O)
 Is reviewed for continuing suitability through MRM
5.4 Quality Planning
5.4.1 Quality Objectives
4.3.3 Objectives, Targets & Programme(s) (E/O)
Be established at relevant functions & levels and included
in Business Plan and to be utilised to deploy quality policy.
Shall be measurable and consistent with the Q-EHS policy
Process wise objectives identification, review & monitoring
during periodic MRM
Identification of objectives through risk analysis and
monitoring, review, updation, changes to documentation

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5.4.2 Quality Management System Planning
Planning to achieve Quality, Environmental and OHS
objectives
The integrity of QMS is maintained when changes to
QMS planned and implemented.

5.5 Responsibility Authority & Organization

5.5.1 Responsibility & Authority
4.4.1 Resources, roles, responsibility, accountability
and authority
Review of standards and identification of R&R for
respective level

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5.5.2 Management Representative
Shall be member of organisation’s own management
appointed by top management who has additional
responsibilities such as :
• Processes needed for QMS are established,
implemented and maintained.
• Reporting to top management the performance of
QMS and any need for improvement.
• Ensure the promotion of awareness of customer
requirements through out the organisation.
• Liaison with external parties on matters relating to
QMS.

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5.5.2 Management Representative
Other responsibilities includes:
• Plan and conduct internal audit.
• Ensure effective actions are planned and conducted.
• Plan and conduct periodic management reviews.
• Ensure decisions are followed up for implementation.
• Ensure ongoing review of auditor competency and
actions there off.

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4.4.1 Management Appointee

Shall be a member of Management, appointed by Top
Management, having defined Responsibility & Authorities.

Identity of MA to be made available to all persons working

under control of organisation.
Persons to take responsibility for aspects of OH&S over
which they have control

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5.5.2.1 Customer Representative

Designated by Top Management and having defined
Responsibilities & Authorities for Ensuring that
customer requirements are addressed internally
5.5.3 Internal Communication
Top Management shall ensure that appropriate
communication processes are established within
organisation and that the communication takes
place regarding effectiveness of the QMS

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4.4.3 Communication, participation & consultation
4.4.3.1 Communication
Establish, implement and maintain procedure(s) for
 Internal communication among various levels &
functions
 Communication with contractors and visitors to work
place
 Receiving, documenting and responding to
communication from external interested parties
4.4.3.2 Participation & Consultation
Safety committee composition, tenure, meetings,
actions

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5.6 Management Review
4.6 Management review – (E/O)
5.6.1 General
To be conducted by Top Management at planned intervals to
ensure continuing suitability, adequacy & effectiveness of
Q- EHSMS
Review shall include assessing OFI & the need to change to
Q-EHSMS including policy & objectives.
5.6.1.1 QMS Performance
All requirements of QMS and performance trends
Evaluation of Cost of Poor Quality (including regular reporting)
Results shall be recorded & shall provide evidence of
achievement of Quality Objectives specified in Business Plan
Customer satisfaction with product supplied

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5.6.2 Review input, 5.6.2.1 Review Input – Supplemental
4.6 Management Review input
Results of internal audits & evaluation of compliance with
applicable legal & other requirements.
 Results of participation & consultation
 Communication from external interested parties, including
complaints & customer feedback
 Process & EHS performance & Product conformity
 Extent to which objectives & targets have been met
Status of incident investigation, CAPA
 Follow up from previous Management reviews
 Changes / Changing circumstances including development in
legal & other requirements
 recommendation for improvement
Analysis of actual and potential field failures and their impact on
quality, safety & environment
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5.6.3 Review Output

Output from management review shall include decision and
actions related to
 Improvement of the effectiveness of QMS and its
processes
 Improvement of product related to customer
requirements
 Resources needs
 Possible changes to EHS performance, Policy, objectives
& targets & other elements of EHS
Records of Management review shall be maintained (4.2.4)

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6. RESOURCE MANAGEMENT
6.2 Human Resources
• Newly recruited employees, their roles &
responsibilities
• Updation to organisation charts whenever there are
changes
• In the event of major changes information to CB

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4.4.2 Competence, Training and Awareness – (E/O)
Make employees aware of
 Importance of conformity with EHS policy and
procedures including emergency prepardness
 OH&S consequences, actual or potential of their
activities, behaviour, EHS benefits of improved
performance, Environmental aspects & impacts
 Potential consequences of departure from specified
procedures
 Their roles & responsibility in achieving conformity with
EHS.

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6.2.2.3 Training on the job

New product, internal non conformities, customer
complaints, accidents, etc.
6.2.2.4 Employee Motivation and Empowerment
Suggestion schemes
Kaizen
Small group activities
6.3 Infrastructure
6.3.1 Plant, Facility & Equipment Planning
MDT approach for new product development
6.3.2 Contingency Plans

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6.4 Work Environment

Organisation shall determine and manage work environment
needed to achieve conformity to product requirements.

6.4.1 Personnel safety to achieve product quality

Product safety & Means to minimize potential risks to
employees shall be addressed especially in the design &
development process and manufacturing process activities.
6.4.2 Cleanliness of Premises
Organisation shall maintain premises in a state of order,
clean and repair consistent with the product and
manufacturing process needs

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7. PRODUCT REALIZATION
7.1 Planning of Product Realisation
4.4.6 Operation control – (E/O)
determine
 Quality objectives and requirements of the new product
 Operations that are associated with identified aspects
consistent with EHS policy / hazards where
implementation of controls is necessary to manage the risk
 Establish processes, documentation (procedures
& operating criteria to control situations where their
absence could lead to deviation from EHS policy &
objectives) consistent with EHS policy / hazards where
implementation of controls is necessary to manage the risk
Communicate applicable procedures to suppliers &
contractors
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7.1.2 Acceptance Criteria
7.1.3 Confidentiality
7.1.4 Change Control
7.2 Customer related Processes
7.2.1 Determination of requirements related to products
7.2.1.1 Customer designated special characteristics
Note 2: This requirement includes recycling,
environmental impact & characteristics identified as a
result of the organisation’s knowledge of product &
manufacturing processes (7.3.2.3)
Note 3: Compliance to item c) includes all applicable
government, safety & environmental regulations, applied
to acquisition, storage, handling, recycling, elimination or
disposal of materials.

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4.3.1 Environmental aspects
4.3.1 Hazard identification, risk assessment &
determining controls
 When determining controls, or considering changes to
existing controls consideration shall be given to reducing the
risks according to following hierarchy:
 Elimination
 Substitution
 Engineering controls
 Signage/warnings and/or administration controls
 PPEs
 Organisation shall document & keep the results of
identification of hazards, risk assessments, aspects that can
have significant impacts and determined controls up-to-date
 Organisation shall use this in establishing, implementing and
maintaining EHSMS
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4.3.2 Legal & Other requirements
Establish, implement and maintain procedure for
 Identifying and accessing to applicable Legal & Other
requirements that are applicable to it
 Consider in establishing, implementing and maintaining
the EHSMS
 Keep this information up to date
 Communicate relevant information on legal & other
requirements to persons working under control of the
organization and other relevant interested parties.

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7.3 Design and Development
7.3.1 Design & Development Planning
Use of APQP approach

7.3.4.1 Monitoring
Measurements at specified stages of D&D shall be
defined, analysed and reported with summary results as
input Management Review

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7.3.5 Design & Development Verification
 Shall be performed in accordance with plan(7.3.1)
-to ensure that D&D outputs have met D&D input requirements
 Records of results and necessary actions shall be maintained(4.2.4)

7.3.6 Design & Development validation

 Shall be performed in accordance with plan(7.3.1)
- to ensure that resulting product is capable of meeting specified
application or intended use, where known
 Where practical validation shall be completed prior to delivery or
implementation of product
 Records of results and & necessary actions shall be
maintained(4.2.4)

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7.3.6.2 Prototype Programme
Implemented when required by customer & where
possible same suppliers, tooling and manufacturing
process be used
7.3.6.3 Product Approval Process
Organisation shall conform to a product and
manufacturing process approval procedure recognized
by customer
This product and manufacturing process approval
procedure shall also be applied to suppliers.

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7.4 Purchasing
7.4.1.1 Regulatory Conformity
Ensure all purchased products or materials used in product
comply with applicable regulatory requirements
7.4.1.2 Supplier QMS Development
 Develop supplier QMS with goal of conformity to the
requirements of ISO / TS 16949:2002
 As a first step supplier shall be ISO 9001:2000 certified by
a third party certification body unless otherwise specified
by customers

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7.4.3.2 Supplier Monitoring

Supplier performance would be monitored through:
 Delivered part quality
 Customer disruptions including field returns
 Delivery schedule performance ( Including premium
freight)
 Special status customer notifications related to quality or
delivery

Organisation shall promote supplier monitoring of performance

of their manufacturing processes

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7.5.2 & 7.5.2.1 Validation Of Processes For

Production & Service Provision
Organisation shall validate all processes for Product &
Service provision. Establish arrangements including:
 Defined criteria for review and approval of the process
 Approval of equipment and qualification of personnel
 Use of specific methods and procedures
 Requirements for records(4.2.4)
 Revaluation

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7.6.3 Laboratory Requirements

7.6.3.1 Internal Laboratory

Shall have defined scope including capability to perform
required inspection, test or calibration services. Scope
shall be included in QMS documentation.

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8. MEASUREMENT, ANALYSIS &

IMPROVEMENT
8.1 General
8.1.1 Identification of Statistical Tools
Appropriate statistical tools for each process shall be
determined during APQP and included in control plan

8.1.2 Knowledge of statistical concepts

Basic statistical concepts, such as variation, control
(Stability), process capability and over adjustment shall be
understood & utilised through out the organisation.

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8.2 Monitoring And Measurement
8.2.1 Customer Satisfaction
Organisation shall monitor information related to customer
perception as to whether the organisation has met customer
requirements. The methods shall be determined.
8.2.1.1 Customer Satisfaction – Supplemental
Shall include:
 Delivered part quality
 Customer disruptions including field returns
 Delivery schedule performance
(Including incidences of premium freight)
 Customer notification related to quality & delivery issues
The organisation shall monitor performance of manufacturing
processes to demonstrate compliance with customer
requirements for product quality and efficiency of the
process.

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8.2.2 Internal Audit / 4.5.5 Internal Audit
Conduct internal audits at planned intervals to determine whether
QMS :
 Conforms to planned arrangements
 Conforms to requirements of Q-EHS Standards
 Conforms to QEHSMS established by the organisation
 Is effectively (Properly) implemented and maintained
 Is effective in meeting organisation’s Policy & Objectives(O)
Audit programme shall be planned & based on (Environmental)
importance of area (Operations)/results of risk assessment to
be audited, as well as results of previous audits
The organisation shall define :
1) Audit criteria, 2) Scope, 3) Frequency, 4) Methods

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8.2.2 Internal Audit (Contd.)
 Selection of auditors & conduct of audit shall ensure
objectivity and impartiality
 Documented procedure(TS2) shall be established for:
 Responsibilities
 Requirements for planning
 conducting audits
 Reporting results
 Maintaining records
 Audittee shall ensure that actions are taken without undue
delay to eliminate detected non conformities and their
causes.
 Follow up activities shall include verification of the actions
taken and reporting verification results
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8.2.2.1 Quality Management System Audit

The organisation shall audit its QMS to verify compliance
with ISO/TS 16949:2002 requirements
8.2.2.2 Manufacturing Process Audit
The organisation shall audit each manufacturing process to
determine its effectiveness
8.2.2.3 Product Audit
Organisation shall audit products at appropriate stages of
production and delivery to verify conformity to all specified
requirements such as:
 Product dimensions
 Functionality
 Packaging and labeling at defined frequency

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8.2.2.4 Internal Audit Plans

Internal audits shall cover all quality management related
processes, activities and shifts, and shall be scheduled
according to an annual plan.
When internal /external non conformities or customer
complaints occur the audit frequency shall be appropriately
increased.
Note: Specific checklist should be used for each audit

8.2.2.5 Internal Auditor Qualification

The organisation shall have internal auditors who are
qualified to audit the requirements of ISO/TS 16949:2002

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8.2.3 Monitoring And Measuring Of Processes
4.5.1 Monitoring & measurement
Monitoring of company level data, EHS objectives
8.2.3.1 Monitoring & Measurement of Manufacturing
Processes
 Process studies shall be conducted for all new
manufacturing processes to verify process capability
(e.g. ppk Study)
 Results of process studies shall be documented

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8.2.4.2 Appearance Items
4.5.2 Evaluation of compliance
Establish, implement and maintain procedures for
4.5.2.1 Periodical evaluation of compliance with applicable
legal requirements
4.5.2.2 Periodical evaluation of compliance with applicable
other requirements

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8.3.3 Customer Information

Customer shall be promptly informed in the event that NC
product has been shipped
8.3.4 Customer Waiver
 Customer concession or deviation permit shall be obtained
prior to further processing whenever product or
manufacturing process in different from that of
currently approved.
 Records of expiration date or quantity authorised shall be
maintained
 Compliance to original specification and requirements shall
be ensured after expiration of authorisation
 Material shipped on an authorisation shall be properly
identified on each shipping container
 This applies equally to suppliers. Requests from supplier
shall be agreed before submission to customer

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4.4.7 Emergency Prepardness & response
 Onsite emergency plans
 The organization shall respond to actual emergency
situations and prevent or mitigate the adverse
environmental impacts/OH&S consequences.
 Periodically review and if necessary, revise its emergency
preparedness and response procedures, especially,
following an accident or emergency situation (EMS)
 Periodically test its procedures to respond the emergency
situations, where practicable involving relevant interested
parties (OHSMS)
 Emergency response plans to include need of interested
parties e.g. Emergency services and neighbours (OHSMS)

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8.4 Analysis Of Data

 Appropriate data resulting from monitoring and
measurement shall be determined, collected and analysed
to demonstrate suitability & effectiveness of QMS and to
evaluate where continual improvement can be made
 Analysis of data shall provide information relating to:
 Customer Satisfaction(8.2.1)
 Conformity to product requirement(7.2.1)
 Characteristics and trends of processes and products
including opportunities for preventive action
 Suppliers

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8.4.1 Analysis & Use Of Data

Trends in quality and operational performance shall be
compared with progress toward objectives and lead to action
supporting:
 Development of priorities for prompt solutions to
customer related problems
 Determination of key customer related trends and
correlation for status review, decision making and long
term planning
 An information system for the timely reporting of product
information arising from usage
Note: Data should be compared with those of competitors
and/or appropriate benchmarks

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8.5 Improvement
8.5.1 Continual Improvement
Continually improve the effectiveness of the QMS through
use of:
 Quality Policy
 Quality Objectives
 Audit Results
 Analysis of data
 Corrective & Preventive Actions
 Management Review

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8.5.1.1 Continual Improvement Of The Organisation

Organisation shall define a process for continual
improvement (see annex B of ISO 9004:2000)
8.5.1.2 Manufacturing Process Improvement
Continually focus upon control and reduction of variation in
product characteristics and manufacturing process
parameters.
Note1 : Controlled characteristics are documented in the
control plan
Note2: Continual improvement is implemented once
manufacturing processes are capable and stable, or product
characteristics are predictable and meet customer
requirements

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8.5.2 Corrective Action
4.5.3(E), 4.5.3.2(O) Non conformity, CA & PA
 Organisation shall take action to eliminate the cause of
nonconformities in order to prevent recurrence and shall be
appropriate to the effects of the nonconformities encountered
 Documented (TS2) procedure shall be established for:
 Reviewing non conformities (including customer
complaints), Identifying and correcting NCs & taking actions
to mitigate their impacts/OH&S consequences
 Determining the cause of nonconformities

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8.5.2 Corrective Action
4.5.3(E), 4.5.3.2(O) Non conformity, CA & PA
 Evaluating the need for action to ensure that non
conformities do not reoccur
 Determining and implementing actions needed
 Records of the results of action (4.2.4)
 Reviewing corrective actions
 Necessary changes to made to EHSMS documentation
 Where CA/PA identifies new or changed hazards or need for
new or changed controls, the proposed action to be taken
through risk assessment process before implementation.
 Any CA or PA taken to eliminate causes of NCs shall be
appropriate to magnitude of the problems and
commensurate with the risks encountered

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4.5.3.1 Incident investigation

Establish, implement and maintain procedures to record,
investigate and analyse incidents in order to:
Determine OH&S deficiencies and other factors causing or
contributing to occurrence of incidents
Identify the need for corrective actions
Identify opportunities for preventive actions
Identify opportunities for continual improvements
Communicate results of such investigations
Perform investigations in timely manner
Document and maintain results of incident investigations

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8.5.2.1 Problem Solving

 Shall have a defined process for problem solving
leading to root cause identification and elimination
 If customer prescribed problem solving format exists,
the same shall be used
8.5.2.2 Error Proofing
Shall use error proofing methods in their corrective action
process
8.5.2.3 Corrective Action Impact
The corrective actions shall be applied to other similar
processes and products and controls implemented, to
eliminate the cause of a non-conformity.

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8.5.2.4 Rejected product test/analysis

 Analyse parts rejected by customer’s manufacturing plants,
engineering facilities and dealership
 Cycle time for this process shall be minimised
 Records of analysis shall be kept and made available upon
request.
 Corrective actions to prevent recurrence shall be
initiated
Note: Cycle time should be consistent with the determination of
root cause, corrective action and monitoring the effectiveness of
implementation

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8.5.3 Preventive Action
4.5.3 Incident investigation, Non conformity, CA & PA
 Organisation shall determine action to eliminate the cause of
potential nonconformities in order to prevent occurrence and
shall be appropriate to the effects of the potential problems
 Documented procedure shall be established for:
 Determining potential non conformities & their causes
 Evaluating the need for action to prevent occurrence
of non-conformities
 Determining and implementing actions needed
 Records of the results of action (4.2.4)
 Reviewing preventive actions

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