2. www.sqmcs.in01
Operational Risk Management Model

3. 02
About Us _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _03
Our Services _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _03 & 04
Our Team _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _04
Profile _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _05 & 06
ISO 9001_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 07 to 17
ISO 14001_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 18 to 29
OHSAS 18001 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _30 to 32
TS 16949 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _33 to 34
ISO 17025 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 35 to 38
Environmental Solutions _ _ _ _ _ _ _ _ _ _ _ _ _ _ 39
Training _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 40
www.sqmcs.in
INDEX

4. 03
SHUBHANGI QUALITY MANAGEMENT CONSULTANCY
SERVICES PVT LTD
Starting new journey with an objective of customer focus , to add more value to
Industries by implementing the system approach; across the organisation to
achieve the ultimate goal of continual improvement in Quality, Environment, Health
and Safety.
OUR MISSION
To provide effective, competitive and sustainable practical business solution to the
organisation to optimize operational efficiency in order to maximize the return on
investment & ultimately achieve the objectives.
www.sqmcs.in
OUR SERVICES
ISO systems implementation:
We assist clients in meeting the requirements of Consultancy, Certification, Training,
Implementation Documentation and Audit for following standards
ISO 9001-2008 and ISO-9001-2015-for Quality Management System .
ISO- 14001-2004 and ISO-14001-2015 for Environment Management System,
OHSAS 18001 for Safety and Health
TS-16949 for Quality Standard for automotive industries
ISO-17025 FOR Testing and Calibration NABL Accredation

5. 04
Our Senior Management Team
Other Team Members Of Our Company
Mrs. Snehal Sandeep Pujari Mrs. Aparna Anand Pade Mrs. Vidya Gunesh Dixit
Mrs. Priyanka Dinesh Joshi Mrs. Mamta B. Kewat Mrs. Reena Kamlesh Patel
Mr. Surendr Pillai
Mr. N M KULKARNI MR SANJEEV
MITAL
MRS SHUBHANGI
KULKARNI
www.sqmcs.in
Integrated management systems development
We integrate ISO management system for ISO-9001 ,ISO-14001 ,and
OHSAS-18001 and provide solutions into a single management system to comply
with various quality, Environment and safety standards
Training
Training to all employees (Shop Floor to Executive Management) in the fields of iso
system ,and Project Management to meet the job responsibilities of International
Standards
Audit and Gap analysis ISO SYSTEM
Which includes gap analysis audits, product, process, procedural, and systems auditing
Customized Solution
Supplier Audits, Check-list based audits, Internal audits, etc.
Environment solution
Support for obtaining the environment permissions like MoEF clearance NOC /CC&A
from State Pollution Control Board Environment Impact Assessment Studies Environment
Audit etc. Support to your Effluent treatment plant to obtain the desired results
Support for monitorining environment parameters
Mrs.Sujata Prasad
Ratnaparkhi

6. 05
Experience of 33 years in the Agrochemical Industries:
Sudarshan Chemical Industries,
Indag Product Ltd.,
Indofil Chemicals,
Sabero Organics Gujarat Ltd. &
Coromandel International Ltd.
Position held: Assistant Vice-President (Quality Assurance,
Quality Control, R&D and Technical Services).
Mr.Narayan.M.Kulkarni (Director)
M.Sc. (Organic Chemistry), Diploma in Business Management
(DBM), Masters Diploma in Business Administration,
Manufacturing and Marketing (MDBA).
Completed Training Program for lead Auditor for ISO-9001-2015
in the month of march 2016
During the 33 years of exposure, was looking after the statutory
requirements of the Factory by holding the position of Factory
Manager.
Have exposure of more than 10 years as a Management
Representative and involvement of creating the systems and its
implementation across the organization and monitoring the
effectiveness of internal audits and progress on continual
improvements through management review meetings
During my service also obtained the various permissions like
environmental clearance in environmental audits, CC&A, NOC
www.sqmcs.in

7. 06www.sqmcs.in
Mrs. SHUBHANGI KULKARNI (Director)
Shubhangi Kulkarni is B.Com. from SNDT University.
all the finance and commercial activities
Mr. SANJEEV MITAL
MBA (first class), Diploma-Computer and Graduation
in B.Sc.
Experdisation For Complience Of Iso,Nabh,nabl
Managing Supplier Performance
Years of experience as consultant in various international
standards series (NABH, NABL,ISO 9001,14000,18000,
17025, SA8000 ETC)
Excellent presentation and interpersonal skill
Implement, Audit and monitor various organization
Extensive knowledge of rapport building, and documentation
Possess good leadership skills
Strategy formulation
Mrs. Sujata Prasad Ratnaparkhi
Sujata Ratnaparkhi is B.Com. from Pune University.
Marketing, Training and Execution activities.

8. 07 www.sqmcs.in
ISO 9001-2008 AND 2015/TS 16949-2009
Contents Of ISO 9001:2008 Quality
Management System
1 2 3Scope Normative Reference Terms and definitions
Quality Management System Management Responsibility4 5
Resource Management Product Realization6 7
Measurement, analysis and improvement8
DIRECT ADVANTAGES OF THE ORGANIZATION
Create a more efficient and effective business environment.
Increase customer satisfaction and retention.
Reduction in customer complaints by having Right – First Time.
Enhance marketing and branding of the organization.
Improve employee motivation, awareness, and morale.
Promote international trade.
Increases profit by having enhanced control over processes.
Reduce waste and increases productivity

9. 08www.sqmcs.in
Eight Fundamental Principle Of Quality
Quality
High Performance and Reliability
Cost
Outstanding Value at Every
Price Point
Delivery
Quick Response ( Development
/ Volume Production / Services )
Customer
Satisfaction
Q
CD
Customer Satisfaction

10. Customer
Requirement
Customer
Satisfaction
Resource
Management
Product
Realization
Measurement
Analysis &
Improvement
Management
Responsibility
Management Responsibility
Quality Police Quality
Business Planing
Management Review
QMS
Quality Planning Operation
Document Control
Record Retention
Resource Management
Education and Training Regulations
Personnel Workmanship Certification
Facility Equipment Management
Measurement , Analysis & Improvement
Customer Satisfaction Management
Internal Audit
Process / Product Monitor
Quality Improvement Team
Product Realization
Customer Requirement Management
Advanced Product Quality Planning
Validation of Process for production & service provision
Control Plan
Travel Card
Process Control
SPC / OCAP
Operation Procedure & Work Instruction
Engineering Change Notification
Identification & Traceability
QMS
09 www.sqmcs.in
OUR APPROACH
PDCA CYCLE
Plan Do
CheckAct
Increase in CS
(Customer Satisfaction)
Input
Identication of customer
needs and expectations
Output
Measurement and assessment
of customer satisfaction
Repeated review and improvement of work process to close the gap between customers and us

11. 10www.sqmcs.in
16 Steps for ISO 9001:2008 ISO 14001: 2004 AND
OHSAS 18001: 2007 Certification
1 Top Management must take a firm decision to implement Quality Management System
Top Management must allocate proper resources to implement the above decision.2
Human Resources (Management Representative {ISO coordinator} & Core Team toa
“prepare, implement, maintain & improve” the Quality System)
Time (minimum two to three hours per day (of core team) for initial three months tillb
achieving ISO Certification & afterwards at least one to two hours per week
(like every Saturday of core team).
Financial Resources. (Fees / charges for Trainings, documentation /consultancyc
(if outsourced) & ISO Certification / audit charges
3 Form a core team comprising minimum two employees (one senior & one junior) from
each department and appoint one member of core team as a Management
Representative (MR ISO coordinator) to co ordinate all ISO 9000 related activities.
(Which is mandatory as per ISO standard)
4. Establish a Training Plan
. Awareness Training for all employees (as it is a team work and all employees are parta
of Quality Management System).
. Documentation training for core teamb
. Internal Auditors training, to at least three to four members of core team. [For trainingc
Contact: “Quality Management Institute”

12. 11 www.sqmcs.in
5. Implement training plan / Conduct in house (within your company) training seminars
Or send your employees to attend open house training seminars (outside your
company which are open to all) for above mentioned training seminars.
.a Awareness Training for all employees
.b Documentation training for core team.
.6 Review the Existing Business Systems in your organisation in compar ISO with ISO
9001 ISO 14001 2006 OHSAS 18001 2007 requirements. (Gap analysis exercise)
.7 Formulate Quality Policy [Guiding document] and Quality Objectives [functional /
departmental targets / goals]
8 Formulate Six Mandatory Quality Procedures required by should cover for all three
standards
9 Formulate other Quality Procedures (QP), process flow charts (QFC), departmental
work instructions (WI) & other documents [i. e. forms / formats & etc. (QR, FM, FILE,
REG., etc.)] required to conduct the company operations and complete the
“Quality Manual”.
10 Implement the Newly established “Quality Management System” from a planned /
fixed date.
Arrange for “Internal Quality Auditors Training” to at least three to four members of11
Core Team. (Develop Self Assessment Capability)
12 Conduct first Internal Quality Audit. (After a gap of at least 30 days from the date of
implementation of system).
13 Make Application for certification to Certification Body (Submit Manuals for Approval
(Documentation review / audit. Pay Initial Certification charges to Certification Body
at least one month in advance.) [For certification contact : E mail: info@sqmcs.in ]
Conduct first Management Review Meeting and then call Certification Body for14.
conducting on site audit of your Quality System.
Initial Audit / Assessment by Certification Body and receiving “Recommendation15.
Letter”, (like a provisional certificate) at the time of closing meeting. (if CB feels that
your organizations QMS is conforming to ISO 9001 requirements)
Receive original Certificate from Certification Body. (normal time frame within 21 to16.
30 days from date of recommendation letter)
Note: After certification, Certification Body carries out surveillance audits after every
nine months. [0 9 18 27 36] and re certification audit (after three years).

13. 12www.sqmcs.in
ISO-9001-2015 key changes way forward for
certification process
PROCESS
July 2015 - Final Draft
International
Standard
September
2015 - Publication
of International
Standard - ISO 9001:2015
September
2018 - All ISO 9001:2008
clients should have
successfully transitioned
to the new standard
Transition Timeline (Planned Dates )
KEY CHANGES - ISO-2015
New Structure ISO-90012008 There are Eight clauses Where as iso-9001-2015 there
are Ten clause s
Process Approach ISO 9001:2015 promotes the process approach beyond the existing
requirements of ISO 9001:2008 Risk management becomes a foundation of the standard
Preventive action is no more existing in the revised standard. This is being replaced with
risk based thinking. 2015 will take a risk-based approach to determine the type and extent
of controls appropriate to each external provide and all external provision of goods and
services. The proposed standard addresses risks which can affect conformity of goods
and services as well as customer satisfaction.
Context of the Organization two new clauses have been added to the standard.
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties.
Quality Management Principles
So far the standard was based on eight quality management principles. In this standard the
earlier existing eight principles have been reduced to seven quality management principles
Products and Services:
In 2008 version of the standard the term "product" was used. This term also included
services. changed to "Goods and Services“ Products and Services".
Documented procedures in ISO 9001:2008 = Maintain documented information in
ISO :2015
1
2
3
4
5
6
7

14. No Exclusions:I SO :2008 version allows organizations to exclude the standard requirements
under the following conditions:
Exclusions are allowed for the requirements which can not be applied due to the nature of the
business.Exclusions are limited to clause 7 (Product Realization)of the standard.
Such exclusions do not affect the organization's ability to provide products which meet the
customer requirements and also the applicable legal requirements.
The new standard does not make any reference to exclusions. However in Annex A, the•
standard clarifies that the organization can not decide a requirement to be not applicable if it
falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure
to achieve the conformity or to enhance customer satisfaction.
Work Environment:
The term "work environment" used in ISO 9001:2008 has been replaced with "Environment
for the operation of processes
8
9
Purchased Product:
The term "purchased product" has been replaced with "externally provided products and
services
Supplier
The term "supplier" has been replaced with "External provider".
This does not meet that organizations would need to change this term in their QMS as well.
Organizations can still maintain the term "supplier", "vendor", "contractor", "consultant" etc.
as per their own need.
10
11
Quality Management Principles
So far the standard was based on eight quality management principles. In this standard
the earlier existing eight principles have been reduced to seven quality management principles
ISO-9001-2008
• QUALITY MANAGEMENT PRINCIPLE
1) Customer Focus
2) Leadership
3) Involvement of people
4) Process Approach
5) System approach to
Management
6) Continual Improvement
7) Factual approach to decision
making
8) Mutually beneficial supplier relation ship
ISO-9001-2015
• Quality Management Principle
1) Customer Focus
2) Leadership
3) Engagement Of People
4) Process Approach
5) Improvement
6) Evidence-based Decision Making
7) Relationship Management
13 www.sqmcs.in

15. 14www.sqmcs.in
Structure
ISO-9001-2008
1) Scope
2) Nominative reference
3) Terms and definition
4) Quality Management System
5) Management Responsibility
6) Resource management
7) Product realization
8) Measurement ,analysis, improvement
ISO-9001-2015
1) Scope
2) Nominative reference
3) Terms and definition
4) The Organization and its context
5) Leadership
6) Planning
7) Support
8) Operation
9) Performance evaluation
10) Improvement
2 - Risk management becomes a foundation of the standard Each
major revision of the standard introduces a concept that allows
certified companies to reach a new level of maturity
ISO 9001:2015 promotes the process approach beyond the existing requirements of
ISO 9001:2008.Clause 4.4 (Quality management system and its processes provides
specific requirements for adopting a process approach
ISO-9001-1987 iSO-90011994 ISO-9001-2000 ISO-9001-2008 ISO-9001-2015
Procedure Preventive Action Process approach
and PDCA
Process approach
and PDCA
Risk and
opportunities

16. ISO - 9001 - 2015
The new ISO 9001:2015
The emphasis on leadership
Organizational Context responsiveness to business environment
The focus on risk based management preventive action
Emphasis on objectives,measurement and change
Increase emphasis on achieving value for organization and its customers
Communication and awareness
Others:
Fewer prescriptive requirements.
Documented Information Decreased emphasis on documentation
Outsourcing is now External Provision
No requirement for Management Representative
No requirement for Quality Manual
1
2
3
4
5
6
What are the significant proposed changes?
7
8
9
10
11
15 www.sqmcs.in

17. 16www.sqmcs.in

18. The first three clauses in ISO 9001:2015 are largely the same as those in
ISO 9001:2008, but three are considerable difference between ISO 9001:2008 and
ISO 9001:2015 from the fourth clause onwards. The last seven Clauses are now
arranged according to the PDCA cycle (Plan, Do, Check, Act). The following figure
shows this.
How To Go About Implimentation ISO-9001-2015
FOR ISO-9001-2008 ALREADY CERTIFIED COMPANIES
Get consultant to assist your organizational the transition•
Carry out Gap analysis on your iSO-90012008 QMS based ISO-9001-2015 criteria and•
then plan how you are going to fill these gap
Review your Policy Manual and SOP,S to ensure they meet relevant ISO-9001-2015•
requirement
Induct every one in to new QMS•
Train your Internal auditors on ISO-9001-2015 requirement•
Carry out your internal audit based on the your ISO-9001-2015 criteria•
Carry out your management review of the QMS performance and effectiveness ,including•
internal audit results
Schedule the recertification audit with your Certification Body or Registar For•
ISO-9001-2008 Already Certified Companies
Get a consultant to lead the QMS development project•
17 www.sqmcs.in

19. 18www.sqmcs.in
ISO 14001-2004 & ISO 14001- 2015 Environment - EMS
INPUTS PROCESS OUTPUTS
An ISO 14001 EMS addresses the impact of a company's activities, products and
services on the environment. The EMS provides a formalized structure for ensuring that
environmental concerns are addressed, and works to both control a company's
significant environmental impacts and achieve regulatory compliance.
To stay compe ve, organiza ons
need a sound environmental
management system (EMS)
ISO 14001 is a globally
recognized management system
standard

20. 19 www.sqmcs.in
18 Elements of ISO 14001 - 2004
4.5.1 Monitoring and Measurement
4.5.2 Evaluation of Compliance
4.5.3 Non+Canfarmity, Corrective
Action & Preventive Action
4.5.3 Control of Records
4.5.4 EMS Audits
4.5 Checking / Corrective
Action
4.4 Implementation
4.3 Planning
P-D-C-A
Continual
Improvement
4.6
Management
Review
4.1 General
4.2
Environmental
Policy
4.3.1 Environmental Aspects
4.3.2 Legal / Other Requirements
4.3.3 Objectives ,Targets &
Programs
404.1 Resource Roles Responsibility an Authority
4.4.2 Competence, Training Awareness
4.4.3 Communication
4.4.4 Documentation
4.4.5 Control of Documents
4.4.6 Operational Control
4.4.7 Emergency preparedness/Response
ISO 14001 Process
010 C4 y1 cO leSI
start
Environmental
Policy
Plans for
Continuous
Improvement
Planing
Objectives &
Targets
Resumes
Awareness
Communication
Documentation
& Control
Operational
Control
Emergency
Planning
Monitoring
Measurement
Non.
Conformance
Records
Auditing &
Management
Review
Nature & environmental impacts
Commitment to improve
Legal aspects
identify environmental aspect
Companies activities
Product and services
Procedures control
Set measurement targets
Establish a time frame
anti pollution measures
legislation compliance
Defined responsibility
location
Transportation
Human Sources
Competence
Training
Commination
internal
External bodies
Media
policy & procedures
Records status
Preservation
Audits records
Assess compliance
Reports to management
Opportunities for improvement
Storage
preservation
Disposal
data protection
Records
Conative actions
Preventive actions
Action reviews
objectives
KPI’s
Calibration
Verification Cycle
System Compliance
Assessments
plans
Prevention
Testing
identify aspects & impacts
Absence planning
operating Criteria Companies
environmental impacts

21. 20www.sqmcs.in
BENEFITS OF ISO 14001:2004
• Reduce liability and risk
• Facilitate better business processes
Minimize waste and energy bills•
• Lower distribution costs
Improved corporate image•
• Improve compliance
Meet concerns of interested parties•
Gain international recognition•
• Improve marketing potential
WE offers comprehensive services that will help
you achieve your ISO 14001:2004 EMS goals
We can
Conduct an initial gap analysis and aspect impact analysis.•
Help you establish policies and objectives•
Identify documentation requirements andassistancein achieving required level of•
documentation.
Manage implementation schedules, training, follow-up actions•
WAY FORWARD FOR CERTIFICATION TO
YOUR ORGANISATION
By setting an environmental policy, then making the environmental concerns of the
organization clear (Aspects) and defining what will be done to control them
(Objectives and Targets), planning is accomplished.
Then, by establishing organizational structure, personnel responsibilities, competency•
and training, implementation begins.
Communication practices, documentation control & procedural documents,•
operational control and emergency preparedness define the operation portion of the
program. These items are usually included in an EMS Manual, which documents a
program to accomplish the Objectives and Targets set above.
The organization's methods for measuring and monitoring its environmental impacts•
is also included along with practices for identifying non-conformance and for
implementing corrective and preventive actions.
These, along with routine systems audits and record keeping constitute the EMS•
checking and corrective

22. 21 www.sqmcs.in
ISO-14001-2O15 KEY CHANGES WITH RESPECTIVE
TO ISO-14001-2004 AND WAY FORWARD FOR
CERTIFICATION PROCESS
ISO 14001:2015 Timeline
ISO 14001:2015 Certification Transition Timeline
Transition Timeline
September start of 3 years transi on period
to September 2018
•Cer fica ons to ISO 14001:2004 will no longer
bevalida er September 2018
September
Published
Interna onal

23. 22www.sqmcs.in
Process approach / PDCA cycle
Context of the Organization (4)
Risk-based
thinking
What are the changes?
Structure of ISO 14001:2015
SCOPE
NORMATIVE REFERENCES
TERMS AND DEFINITIONS
CONTEXT OF THE ORGANIZATION
LEADERSHIP
PLANNING
SUPPORT
OPERATION
PERFORMANCE EVALUATION
IMPROVEMENT
1
2
3
4
5
6
7
8
9
10

24. 23 www.sqmcs.in
Structure of ISO 14001:2015

25. 24www.sqmcs.in

26. 25 www.sqmcs.in
Clause structure (4-6)
4. Context of the organization
Understanding the organization and its context Understanding the needs and expectations
of interested parties Determining the scope of the XXX management system XXX
management system
5. Leadership
Leadership and commitment Policy Organizational roles, responsibilities and authorities
6. Planning
Actions to address risks and opportunities Objectives and plans to achieve them.
Clause structure (7-10)
7. Support
Resources
Competence
Awareness
Communication
Documented information
8. Operation
Operational planning and control
9. Performance evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
10. Improvement
Nonconformity and corrective action
Continual improvement.
Define the context of the organization Clause 4 of the 2015 standard is a new
requirement and deals directly with defining the “context of the organization.”
Organizations are now expected to consider all external and internal issues that
may affect the outcomes of the EMS, including any environmental conditions that
may affect the organization.
4.1 Understanding the organization and its context the organization must determine external
and internal issues relevant to its purpose and that affect its ability to achieve the
intended outcome(s) of its EMS
Environmental Conditions: climate, air quality, land use, existing contamination, natural
resource availability, biodiversity, etc
Context of the Organization

27. 26www.sqmcs.in
Context of the Organization
.1 Understanding the organization and
its context
External issues
• Culture
• Social
• Political
• Legal
• Regulatory
• Financial
• Technological
• Economic
• Natural
• Competitive context
(International, national,
regional or local)
Internal Issues
• Activities
• Products and Services
• Strategic direction
• Culture
• People
• Knowledge
• Processes
• System
Clause 4.1 - Needs and
Expectations of Interested Parties
5) Leadership & review of the Environmental Policy The requirements of the 2015
standard are similar to the 2004 revision, but with one fundamental difference.
There is now a greater emphasis on the incorporation of the EMS into the strategic
planning and direction of the organization as a whole
PLANING
Assess risks and opportunities Section 6.1 addresses risks and opportunities, and is
completely new in the 2015 standard.
The standard states that all environmental aspects should be considered, but also other
influencing factors such as compliance obligations and organizational context. On the
basis of this, plans should be formulated for tackling these risks and opportunities, with
the desired outcome being that the EMS can meet its planned outcomes and display
continual improvement.
This represents a key change in the 2015 revision, and ensuring this is addressed in your
EMS effectively will not only ensure compliance, but improved performance and the
gateway to continual improvement. standard.

28. 27 www.sqmcs.in
Objective
Align EMS objectives with the company’s strategy
standard specifically prescribes that environmental management should now be
incorporated into the organization’s business processes and strategic direction-making
processes. For instance, your top team will now need to demonstrate that this is part of
the strategic , so you must ensure that this isplanning of the overall business strategy
documented within the business plan or equivalent document
Identify and evaluate environmental aspects
There are some key changes between the 2004 and 2015 revisions in how you are
expected to evaluate your environmental aspects.
A “lifecycle perspective” of your products and services now needs to be considered, and
potential abnormal and emergency situations need to be taken into account when planning.
Again, consideration and plans to demonstrate these considerations must now be built into
your EMS documentation.
For example, if your product or service range has recently been extended, can you prove
that the environmental aspects of these new services have been fully considered and
documented, and actions decided upon to mitigate and remove them?
Determine the compliance obligations
In the 2004 revision, there was a requirement for complying with statutory and regulatory
requirements, but in the 2015 revision “interested parties”and their “needs and expectations”
must also be considered.
Both of these combined now become “compliance obligations.” Again, the organization
must document and demonstrate that this has been understood and considered, and the
selection process defined.
For example, considering legal requirements is no longer enough; you now must also
consider the needs of all external and internal stakeholders
Support
Communication
Documented information
Resources
Competence
Awareness

29. 28www.sqmcs.in
Operational control
In the 2015 version, “operational control” becomes “operational planning and control,” and
the scope of this clause is expanded. The context of the organization,
risks and opportunities, environmental aspects, and compliance obligations all must now
be considered when specifying methods of operational control.
This should lead to defined methods of operational control, performed by specified and
competent individuals, with the goal being that the EMS performs within the predicted
parameters.
Again, these changes must be planned and documented within the appropriate places in
your EMS. For instance, can you show evidence that your responsible person is trained
and “competent
Environmental performance
The revision also makes a point of the importance of measuring and monitoring to
environmental performance.
There is also specific mention of the measurement of external, procurement, and
outsourced services, so the message is clear: the organization remains responsible for
outsourced and external processes and the subsequent conformance or nonconformance
to objectives and targets.
Again, this process will need to be defined, documented, and followed through in order for
your EMS to conform to the 2015 revision.
Improvement
Measuring and reporting There is a general improvement of reporting requirements in the
2015 standard.
We have mentioned environmental performance above, but other functions such as
Management Review
and internal audit are also mentioned,
specifically in terms of being reported “to top management.” This change makes it clear
that top management, who are directly responsible for strategic planning and the
integration of the EMS into the organization’s strategic direction, must be made aware of
and make decisions on the basis of these results. Again, it is advised that the importance
and process steps of this are documented as well as implemented in your EMS.

30. 29 www.sqmcs.in
• WAY FORWARD FOR CERTIFICATION OF ISO-14001-2015
• Transition period: Sept 2015 -> Sept 2018
• ISO 14001-2004 :certifications will expire after transition period
• Recommended actions:
• Identify gaps
• Implementation plan
• Training and awareness
• Update the existing EMS and verify
• Liaise with your Certification Body for transition

31. 30www.sqmcs.in
OHSAS 18001:2007
BY implementing and certifying an Occupational Health and Safety Management
System (OHSMS) demonstrates a clear commitment to worker safety.
OHSAS 18001 is an international standard, applicable to any industry.•
It helps organizations to define occupational health and safety policies and•
objectives.
It enables better control of hazards from normal operations and unusual situations•
Its framework is based on two main concepts of continual improvement and•
regulatory compliance
KEY ELEMENTS OF FOR OHSAS 18001:2007
• Health Safety Policy
Hazard identification, risk assessment and determining controls•
Legal and other requirements•
Objectives and OHS program(s)•
Resources, roles, responsibility, accountability and authority•
Competence, training and awareness•
Communication, participation and consultation•
Operational control•
Emergency preparedness and response•
Performance measuring, monitoring and improvement•
Continual
Improvement
OHSAS
Policy
Management
Review
Checking and
Corrective Action
Implementation
and Operation
Planing
Initial
Review

32. Risk Management Process
OHSAS 18001:2007 Safety and Healh
C
o
m
m
u
n
icate
&
co
n
su
lt
Identify Risks
Analyse the Risks
Evaluate the Risks
Treat the Risks
Establish the Context
Communicate&consult
AssessRisk
Monitor&review
NO ACCIDENT INDUSTRIES/ROAD /
ISO 18001:2007 MODEL
Risk Analysis
OH &S
Policy
Objectives &
Activities
OH & S
Concept
Control measures and
activity program
Implementation
in organisations
Continual improvement of the
integrated OH & S management system
EXTERNAL
REQUIREMENTS
INTERNAL
REQUIREMENTS
Laws &
Regulations
Processes &
Working Plan Results
31 www.sqmcs.in

33. 32www.sqmcs.in
Services We Offer - Achieve OHSAS 18001:
2007 Certification.
WE offers comprehensive services that will help you to achieve OHSAS 18001:2007
certification. We provide assistance
Thoroughly review organization's existing programs and systems (gap analysis)•
Identify risks / hazards and applicable laws and regulations•
Establish OSH policy and objectives•
Identify documentation requirements•
Train personnel•
Implement new programs such as internal audit and management review•
Help you seek certification of the OHS program In addition to consulting (online & onsite),•
we provide following training
BENEFITS OF OHSAS 18001:2007
•production time loss
Potential cost savings- workers compensation, manufacturing disruptions•
Demonstrate commitment to the protection of staff, property and plant•
Demonstrate legal compliance•
Allows standardization within companies with multiple operation sites•
Systematically plan, control, and monitor operations through operational controls•
Enhance reputation for safety and occupational health•
Reduce insurance premiums•
Becomes integral part of a sustainable strategy•
Encourage more effective internal and external communication•
Increased employee awareness and involvement•
Improve safety culture•

34. 33 www.sqmcs.in
AUTOMOTIVE-QUALITY-TS 16949:2009
TS 16949 applies to the design/ development, productionand, when relevant,
installation and servicing of automotive - related products. It is based on ISO 9001
The ISO/TS 16949 is an ISO technical specification aiming to the development of a
quality management system in Automobile Companies that provides for continual
improvement, emphasizing defect prevention and the reduction of variation and
waste in the supply chain. It is based on the ISO 9001 and the first edition was
published in March 2002 as ISO/TS 16949:2002. TS
ADVANTAGES OF TS 16949 CERTIFICATION
•Provide & enhanced customer confidence and
satisfaction, which in turn can lead to increased
business opportunities.
Commercial advantage confirming your efficiency•
and guaranteeing the quality of your processes and
their development.
Common language to improve understanding of•
quality requirements hence reducing confusion.
Ensures your products and services effectively meet•
customer specific requirements.
Ensuring mistake proffering mechanism for•
prevention of defects in earlier stage.
Reduction in variation of quality &Increased•
efficiency of production.
Provide frame work to measure your progress•
towards continual improvement of business
performance creating a benchmark.
Helps improve your organizational performance.•

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ISO / TS 16949 IMPLEMENTATION RESULTS IN THE
FOLLOWING DIRECT ADVANTAGES OF THE
ORGANIZATION
• Create a more efficient and effective business environment.
Increase customer satisfaction and retention.•
Reduction in customer complaints by having Right – First Time.•
Enhance marketing and branding of the organization.•
Improve employee motivation, awareness, and morale.•
Promote international trade.•
Increases profit by having enhanced control over processes.•
Reduce waste and increases productivity.•
WE offers comprehensive services that will help you
to achieve ISO / TS 16949:2009 QMS certification.
• Systematically examine organization's operations and processes.
Review existing information and systems (gap analysis).•
Process effectiveness and measurement parameters.•
Establish quality policy and objectives.•
• Design and develop operation procedures.
Assistance in design verification / process validation / process control documents•
including drawings, FMEAs,APQP, control plans, and operator instructions etc.
Identify documentation requirements & develop effective documentation system•
including quality manual,SOPs, flow charts, templates, formats, check lists etc.
Train employees at all the levels on TS 16949.•
Implement ISO / TS 16949 quality management system in the organization effectively.•
Help you seek certification for ISO / TS 16940 QMS and successfully get certified•

36. 35 www.sqmcs.in
ISO:17025 NABL ACCREDITATION FOR
TESTINGAND CALIBRATION LABORATORIES
WHAT IS ISO:17025 NABL?
ISO:17025 is the main standard used by testing & calibration laboratories.
Originally known as ISO guide, ISO:17025 was initially issued by the
international organization for the standardization in 1999. It was first published in
2001 & on 2005.
ISO17025 NABL ACCREDITATION FOR
TESTING AND CALIBRATION LABORATORIES

37. 36www.sqmcs.in
Quality system requires implementation of two sets of
requirements/standards and activities. The essential
components are :
Management requirements [ Clause 4] | Technical requirements [Clause 5 ]
MANAGEMENT REQUIREMENTS
4.1 ORGANIZATION
QUALITY MANAGEMENT SYSTEM4.2
DOCUMENT CONTROL4.3
REVIEW OF CONTRACTS4.4
SUBCONTRACTING OF TESTS AND4.5
CALIBRATION
PURCHASING SERVICES AND SUPPLIES4.6
SERVICE TO THE CLIENT4.7
4.8 COMPLAINTS
CONTROL OF NON-4.9
CONFORMING WORK
CORRECTIVE ACTION4.10
PREVENTIVE ACTION4.11
CONTROL OF QUALITY4.12
RECORDS
INTERNAL AUDITS4.13
TECHNICAL REQUIREMENTS
5.1 GENERAL
PERSONNEL5.2
ACCOMMODATION5.3
TEST METHODS AND5.4
VALIDATION
EQUIPMENT5.5
5.6 MEASUREMENT TRACEABILITY
SAMPLING5.7
HANDLING OF TEST AND CALIBRATION ITEMS5.8
ASSURING THE QUALITY OF TEST AND5.9
CALIBRATION RESULTS
REPORTING THE RESULTS.5.10
KEY STEPS TOWARDS ACCREDITATION ARE
ISO17025 accreditation should be well thought out and well prepared. It can be quite
expensive but can also have big benefits.
The balance between costs and benefits should be worked out and documented.
Going for ISO17025 will impact the entire laboratory and supporting services such as
human resources, documentation and finance departments. Therefore, while the decision
to initiate and fund the project will be made by management, all affected departments
should be involved in the process.
The entire process is divided into two phases: Investigation phase and implementation
phase. In the investigation phase information is collected to decide if going for accreditation
makes business sense.
Once the decision is made the laboratory develops and implements documentation
in preparation for the Accreditation assessment.

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DOCUMENTATION
Examples
Quality Manual
Quality Policy Statement
Processes, e.g.,
to train Personnel
Sample Testing &
Equipment Calibration
Step-by-Step
Maintenance
Test & Training Records
Policies
& Objectives
Processes
&
Standard Procedures
Step-by-Step Operating
Procedures &
Work Instructions
Checklists, Forms, Records

39. 38www.sqmcs.in
policy documents the laboratory intent and goal of the laboratory to conform with
ISO requirements.
Quality manual describes the approaches to achieve quality data. It includes quality
policy.
A process describes how various quality requirements can be achieved.
Standard operating procedures or working procedures are step by step instructions
on how to exactly perform a specific task .
Records are generated on day by day basis.
All records should be well controlled.
BENEFITS OF ISO 17025:2005
National & international recognition
Recognizes the technical competence Of laboratory staff.
Assures the client that results are Technically valid.
Provides comparability in Measurements
Decision makers can rely on test Result
Improves staff motivation
Ensures better support in the event of Legal challenges.
To assist in the development of t new Programmes.
To reduce technical barriers in trade.
Saves money by getting it right first Time.

40. 39 www.sqmcs.in
ENVIORNMENT SUPORT TO INDUSTRIES
Continuous Support
WE OFFER SERVICES FOR OBTAINING ENVIRONMENTAL PERMISSIONS FROM
VARIOUS GOVERNMENT AGENCIES AND OTHER REQUIREMENTS.
Environmental Clearances – MoEF.
NOC from State Pollution Control Board.
Consolidated Consent and Authorisation from Pollution Control Board of respective
states.
Environmental Impact Assessment studies.
Environmental audit.
Hazardous Waste Returns.
Water Cess Returns.
We Offer Services On Waste-water Treatment
Projects
Turnkey Projects of Effluent Treatment Plant (ETP).
Supply of equipment’s & Consumables
We Offer Services On Environmental Monitoring
Services
Water & Waste water Analysis
Ambient Air Monitoring
Stack Monitoring
Work Place Monitoring
Noise Monitoring
MSW/Hazardous waste Analysis
Soil/Sludge Analysis

41. 40www.sqmcs.in
Training solutions from Shubhangi Quality
Management Consultancy Services Pvt. Ltd. is
considered to be the best in terms of course
delivery, content and effectiveness.
ISO Awareness Training
ISO implementation training
ISO documentation training
ISO executive overview training
ISO Internal Auditor Training
ISO Aspect impact Identification
Training
ISO Hazards Identification Risk
Assessment Training
7QC tools
5S
Designing Customer Feedback /
complaint handling system
Range of ISO Managements System Related Training

42. B-13 Chintamani Residency, Bibwewadi, Pune, 411037
kulkarnin@sqmcs.ininfo@sqmcs.in |
www.sqmcs.in91 9824751402 |