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Operational Risk Management Model

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

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INDEX

03

SHUBHANGI QUALITY MANAGEMENT CONSULTANCY SERVICES PVT LTDStarting 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 MISSIONTo 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.

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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

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

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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 solutionSupport 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

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

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Mrs. SHUBHANGI KULKARNI (Director)Shubhangi Kulkarni is B.Com. from SNDT University.

all the finance and commercial activities

Mr. SANJEEV MITALMBA (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 RatnaparkhiSujata Ratnaparkhi is B.Com. from Pune University.

Marketing, Training and Execution activities.

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ISO 9001-2008 AND 2015/TS 16949-2009

Contents Of ISO 9001:2008 Quality Management System

1 2 3 Scope 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

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Eight Fundamental Principle Of Quality

QualityHigh Performance and Reliability

CostOutstanding Value at Every

Price Point

DeliveryQuick Response ( Development / Volume Production / Services )

CustomerSatisfaction

Q

CD

Customer Satisfaction

CustomerRequirement

CustomerSatisfaction

ResourceManagement

ProductRealization

MeasurementAnalysis &

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

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OUR APPROACH

PDCA CYCLE

Plan Do

CheckAct

Increase in CS (Customer Satisfaction)

InputIdentication of customerneeds and expectations

OutputMeasurement and assessment of customer satisfaction

Repeated review and improvement of work process to close the gap between customers and us

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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 to a “prepare, implement, maintain & improve” the Quality System)

Time (minimum two to three hours per day (of core team) for initial three months till b 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 /consultancy c (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 part a of Quality Management System).

. Documentation training for core team b

. Internal Auditors training, to at least three to four members of core team. [For training c Contact: “Quality Management Institute”

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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 of 11 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 for 14. conducting on site audit of your Quality System.

Initial Audit / Assessment by Certification Body and receiving “Recommendation 15. 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 to 16. 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).

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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 context4.2 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

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

SupplierThe 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) Leadership3) Involvement of people 4) Process Approach 5) System approach to Management 6) Continual Improvement7) 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

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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

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

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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•

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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

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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-AContinual

Improvement

4.6 Management

Review

4.1 General

4.2Environmental

Policy

4.3.1 Environmental Aspects4.3.2 Legal / Other Requirements4.3.3 Objectives ,Targets & Programs

404.1 Resource Roles Responsibility an Authority4.4.2 Competence, Training Awareness 4.4.3 Communication 4.4.4 Documentation4.4.5 Control of Documents 4.4.6 Operational Control 4.4.7 Emergency preparedness/Response

ISO 14001 Process

010 C4 y1 cO leSI

startEnvironmental

Policy

Plans for Continuous

Improvement

Planing

Objectives &Targets

Resumes

Awareness

Communication

Documentation & Control

OperationalControl

EmergencyPlanning

Monitoring Measurement

Non.Conformance

Records

Auditing &Management

Review

Nature & environmental impactsCommitment to improveLegal aspects

identify environmental aspectCompanies activities Product and services Procedures control

Set measurement targetsEstablish a time frame anti pollution measureslegislation compliance

Defined responsibilitylocation Transportation Human Sources

Competence Training Commination

internal External bodiesMedia

policy & procedures Records statusPreservation

Audits recordsAssess compliance

Reports to management Opportunities for improvement

Storage preservation

Disposaldata protection

Records Conative actions

Preventive actionsAction reviews

objectivesKPI’s

CalibrationVerification Cycle

System Compliance

Assessmentsplans

Prevention Testing

identify aspects & impactsAbsence planning

operating Criteria Companies environmental impacts

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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

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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

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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

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Structure of ISO 14001:2015

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Clause structure (4-6)

4. Context of the organizationUnderstanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the XXX management system XXX management system5. LeadershipLeadership and commitment Policy Organizational roles, responsibilities and authorities 6. PlanningActions to address risks and opportunities Objectives and plans to achieve them.

Clause structure (7-10)

7. SupportResourcesCompetenceAwarenessCommunicationDocumented information8. OperationOperational planning and control9. Performance evaluationMonitoring, measurement, analysis and evaluationInternal auditManagement review10. ImprovementNonconformity and corrective actionContinual 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

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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 andExpectations 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.

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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 is planning of the overall business strategydocumented 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

CommunicationDocumented information

ResourcesCompetenceAwareness

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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 asManagement 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.

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• 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

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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•

ContinualImprovement

OHSASPolicy

ManagementReview

Checking andCorrective Action

Implementationand Operation

Planing

InitialReview

Risk Management ProcessOHSAS 18001:2007 Safety and Healh

Communicate

&

consult

Identify Risks

Analyse the Risks

Evaluate the Risks

Treat the Risks

Establish the Context

Co

mm

un

ica

te &

co

ns

ult

As

se

ss

Ris

k

Mo

nit

or

& r

ev

iew

NO ACCIDENT INDUSTRIES/ROAD /

ISO 18001:2007 MODEL

Risk Analysis

OH &SPolicy

Objectives &Activities

OH & SConcept

Control measures and activity program

Implementationin organisations

Continual improvement of the integrated OH & S management system

EX

TE

RN

AL

RE

QU

IRE

ME

NT

S

IN

TE

RN

AL

R

EQ

UIR

EM

EN

TS

Laws &Regulations

Processes &Working Plan Results

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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•

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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•

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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

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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 AND 4.5

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 QUALITY 4.12

RECORDS INTERNAL AUDITS4.13

TECHNICAL REQUIREMENTS

5.1 GENERAL

PERSONNEL5.2

ACCOMMODATION5.3

TEST METHODS AND 5.4

VALIDATION

EQUIPMENT5.5

5.6 MEASUREMENT TRACEABILITY

SAMPLING5.7

HANDLING OF TEST AND CALIBRATION ITEMS5.8

ASSURING THE QUALITY OF TEST AND 5.9

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

ExamplesQuality ManualQuality Policy Statement

Processes, e.g.,to train Personnel

Sample Testing &Equipment Calibration Step-by-Step

MaintenanceTest & Training Records

Policies& Objectives

Processes&

Standard Procedures

Step-by-Step OperatingProcedures &

Work Instructions

Checklists, Forms, Records

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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.

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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

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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

B-13 Chintamani Residency, Bibwewadi, Pune, 411037 kulkarnin@sqmcs.in info@sqmcs.in |

www.sqmcs.in 91 9824751402 |