Synergy Business Management Solutions

PROPOSAL
for

Integrated Management System

Implementation

as per

ISO 9001:2015 Standard

ISO 14001:2015 Standard
ISO 27001:2013 Standard

at

Glocare Labs Pvt. Ltd.

Kodambakkam, Chennai
.by

Synergy Business Management Solutions
admin@synergyworld.org
www.synergyworld.org


Proposal Ref : SBMS/GLPL/IMS/062017101 Rev.01
Date: JUNE 17th 2017

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Profile of Synergy

Synergy Business Management Solutions is an International Management Consulting firm,

handling operations in various countries e.g. Singapore, India, Nigeria, UAE, Myanmar, Nepal,
Bangladesh, Sri Lanka etc. For last 20 years Synergy has been contributing to transform business
processes in the domains of Health Care, Pharmaceuticals, Steel, Engineering, Automobile,
Banking & Finance, Aerospace, Food & Beverage, Information Technology (IT), Oil & Petroleum,
Chemical, Education etc. All the Consultants / Technical Experts of Synergy are highly competent
and experienced to add values in the areas of Quality, Risk Management, Environment, Energy,
Occupational Health & Safety, Food Safety, IT Security, Human Resource Management (HRM),
CMMi, Six Sigma and Total Quality Management (TQM) etc. Some of the clients of Synergy are –

International Institute of Bio Technology & Toxicology (IIBAT)

KCH Chemicals Pvt Ltd
CPR Chem Products
Morvel Pharmaceuticals
Rubamin Pharmaceuticals Pvt Ltd
Empee Group
Global Pharma HealthCare
Larsen & Toubro Limited
Hindustan Petroleum Corpn. Ltd.
Crompton Greaves Limited
Nesac (Ministry of Space Application Centre)
ISSA-DRDO (Ministry of Defence)
Chennai Port Trust
Airport Authority of India
Hewitt Associates, USA
AL Ghail Power LLC UAE
National Institute of Fashion Technology - NIFT
XLRI Jamshedpur
Konkan Railways
Kamraj Port Trust


Synergy Business Management Solutions has successfully implemented Quality Management
System as per ISO 9001:2008 Standard and got certified by Royal-Cert Germany (under Dakks
Germany accreditation).

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Objective of this Proposal

The objectives of this assignment are to assist Glocare Labs to

! Develop and implement the Integrated Management System (IMS) in accordance with

-ISO 9001:2015 Standard – Quality Management System
-ISO 14001:2015 Standard – Environment Management System
-ISO 27001:2013 Standard – Information Security Management System
-ISO 19011:2011 Guideline – Audit Management


! Adopt step by step approach towards Integrated Management System,
monitoring continual improvement on all fronts.

! Assist to add value in every facet of business activities and compliance of applicable
Statutory, Legal & Regulatory Requirements.


! Manage major changes required to achieve and sustain Total Quality Management.


! Understand and be able to explain the benefits of establishing the Integrated Management
System [IMS] which can enhance business performance.

! Guide to focus on preventive activities as per IMS requirements.

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What is Quality
Quality means fulfillment of ‘Customer’s Requirements’. Organisation implements Quality
Management System as per ISO 9001 international standard. The ISO 9000 family of
quality management systems standards is designed to help organizations ensure that they
meet the needs of customers and other stakeholders while meeting statutory and
regulatory requirements related to a product. ISO 9000 deals with the fundamentals of
quality management systems, including the eight management principles upon which the
family of standards is based on ISO 9001 deals with the requirements that organizations
wishing to meet the standard must fulfill. Third-party certification bodies provide
independent confirmation that organizations meet the requirements of ISO 9001. Over one
million organizations worldwide are independently certified, making ISO 9001 one of the
most widely used management tools in the world today. However, the ISO certification
process has been criticized as being wasteful and not being useful for all organizations.

In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of
implementing ISO 9001, and concluded that it is necessary to create a new IMS model for
the next 25 years. This is why commenced the official work on big revision of ISO 9001,
starting with the new QM principles. This moment was considered by important specialists
in the field as “beginning of a new era in the development of quality management
systems.” As a result of an intensive work of this technical committee, the revised standard
ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard
has not changed. However the structure and core terms were modified to allow the
standard to integrate more easily with other international management systems standards.
The 2015 version is also less prescriptive than its predecessors and focuses on
performance. This was achieved by combining the process approach with risk-based
thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.

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What is Environment

Environment is the sum total of all surroundings of a living organism, including natural forces and
other living things, which provide conditions for development and growth as well as
of danger and damage. Living things do not simply exist in their environment. They constantly
interact with it. Organisms change in response to conditions in their environment. The environment
consists of the interactions among plants, animals, soil, water, temperature, light, and other living
and non-living things.

The environment is something you are very familiar with. It's everything that makes up our
surroundings and affects our ability to live on the earth—the air we breathe, the water that covers
most of the earth's surface, the plants and animals around us, and much more.

The word environment is used to talk about many things. People in different fields of knowledge
(like history, geography or biology) use the word differently. An electromagnetic environment is
the various radio waves that equipment such as radio and radar can meet.

In recent years, scientists have been carefully examining the ways that people affect the
environment. They have found that we are causing air pollution, deforestation, acid rain, and other
problems that are dangerous both to the earth and to ourselves. These days, when you hear people
talk about “the environment”, they are often referring to the overall condition of our planet, or how
healthy it is. In psychology and medicine a person's environment is the people, physical things,
places, and events that the person lives with. The environment affects the growth and development
of the person. It affects the person's behavior. It affects the person's body and mind.

Environmental management system (EMS) refers to the management of an organization's

environmental programs in a comprehensive, systematic, planned and documented manner. It
includes the organizational structure, planning and resources for developing, implementing and
maintaining policy for environmental protection.

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Brief details of Information security management system – ISO 27001

Information is a valuable asset that can make or break your business. When properly managed it
allows you to operate with confidence. Information security management gives you the freedom to
grow, innovate and broaden your customer-base in the knowledge that all your confidential
information will remain that way. ISO 27001 is a specification for an information security
management system (ISMS). An ISMS is a framework of policies and procedures that includes all
legal, physical and technical controls involved in an organization's information risk management
processes. According to its documentation, ISO 27001 was developed to "provide a model for
establishing, implementing, operating, monitoring, reviewing, maintaining and improving an
information security management system." ISO 27001 uses a risk-based approach and is
technology-neutral. The specification defines a six-part planning process:

• Define a security policy.

• Define the scope of the ISMS.
• Conduct a risk assessment.
• Manage identified risks.
• Select control objectives and controls to be implemented.
• Prepare a statement of applicability.

The specification includes details for documentation, management responsibility, internal audits,
continual improvement, and corrective and preventive action. The standard requires cooperation
among all sections of an organisation.

BENEFITS OF ISO 27001:2013

• Identify risks and put controls in place to manage or eliminate them

• Flexibility to adapt controls to all or selected areas of your business
• Gain stakeholder and customer trust that their data is protected
• Demonstrate compliance and gain status as preferred supplier
Meet more tender expectations by demonstrating compliance

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Stages for Implementation

! CORE TEAM FORMATION

! GAP ASSESSMENT

! PROCESS MAPPING

! GUIDANCE FOR DOCUMENTATION

! TRAINING

! GUIDANCE FOR IMPLEMENTATION

! INTERNAL AUDIT

! DATA ANALYSIS & MANAGEMENT REVIEW

Implementation Approach

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Scope of our Works

Gap Assessment

During this phase, we shall conduct a thorough assessment to understand the existing level of
compliance and performance against the requirements of the International Standards (ISO 9001,
ISO 14001 and ISO 27001). Post Gap Assessment, we shall submit a ‘GAP Assessment Report’ for
Top Management’s Review.

Process Mapping

During this phase we shall identify the various types of Processes and Sub-Processes being
explored to handled various activities. A comprehensive Process Mapping shall be done to identify
Core Processes, Management Processes and Support Processes.

Training
a) Awareness Training (to be imparted to the Core Group Members)

b) Implementation Training (to be imparted to the Core Group Members with an

objective to prepare a Team of Trainers who will impart Training to their Team
Members/Employees across the Organization. The selected Trainer’s efforts shall
be monitored and validated by Synergy).

Guidance for Documentation

During this phase, we shall guide the Team members how to prepare various Documents (e.g.
Apex Manual, Quality Plan, Risk Assessment Report, Emergency Plan, Process Flow Chart,
Integrated Management Policy and Objectives, Standard Operating Procedures, Reference
Documents, Templates etc.) as per the requirements of the international Standards.

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DOCUMENTATION LEVELS

•  IMS POLICY & OBJECTIVES

LEVEL 1

•  IMS APEX MANUAL

LEVEL 2

•  PROCEDURES
LEVEL 3

•  WORK INSTRUCTIONS

LEVEL 4
•  FORMATS /CHECKLISTS

Guidance for Implementation

During this phase, we shall guide the Team members how to get the Integrated Management
System implemented based on the Gap Assessment Report, Requirements of the international
Standards, Statutory & Regulatory requirements and Customer’s Needs.

Guidance for Business Plan Preparation

We shall guide how to develop the Business Plan to ensure ‘Continual Improvement’ of your all
processes ensuring ‘effective Integrated Management System’.

Guidance for formulating Integrated Policy, Objectives with Goals

During this phase, we shall guide the Top Management and Team Members how to formulate
Integrated Policy and Objectives to ensure ‘Continual Improvements’ in every facet of the business
processes and effectiveness of Risk Management.

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Coordinating Internal Audit & Management Review process

We shall coordinate with the Management Representative and Team members to conduct the
Internal Audit and Management Review Meeting.

Guidance for closure of Non-Conformances

We shall guide the Auditees and team Members to understand the intrinsic merits of each Non-
Conformance and how to initiate (a) Correction (b) Root Cause Analysis (c) Corrective Action and
(d) Preventive Actions ensuring ‘Continual Improvement’.

Coordination with the Certification Body during Stage I and Stage II Audit

During these phases, we shall coordinate with the Certification Body to get the Stage I and Stage II
Audits conducted comfortably. It is relevant to mention that all of our Consultants are Lead
Auditors having average 250 mandays of Audit Experience (including in the Health Care and
Pharmaceutical, Laboratory sectors). This expertise will assist to ensure effective Audit
Management resulting Certification.

Guidance for ‘Continual Improvements’

On all fronts, while handling this assignment, we shall ensure effective implementation of
INTEGRATED Management System ensuring ‘Continual Improvement’ and

‘Business Transformation”.

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Commercial Details

Proposal Ref : SBMS/GLPL/IMS/062017101 Rev.01 Date: JUNE 17th 2017
Assignment INTEGRATED Management System Implementation and Certification
as per ISO 9001:2015, ISO 14001:2015 and ISO 27001:2013 Standards
Organisation’s Name
Glocare LABS Pvt Ltd.
Frontier Mediville Bio-tech SEZ, Edur Village,Gummidipoondi Taluk,
SITE 1
Thiruvallur District, Tamilnadu 601201.
Scope of Activity : Clinical
SITE 1 2A, 3rd Floor,Ganga Nagar 4th street, Kodambakkam, Chennai-600024.
Scope of Activity : Bio Analytical, Pk and Statistics and Report Preparation
" GAP Assessment
" Process Mapping
" Document Review
" Training
" Risk Assessment for ISO 9001, ISO 14001 & ISO 27001
Scope of Work
" Guidance for Documentation
" Guidance for Implementation
" Guidance for Internal Audit + MRM
" Guidance during Stage 1 Audit
" Guidance during Stage 2 Audit
" Certification
DETAILS OF PROFESSIONAL FEES, CERTIFICATION AND ACCREDITATION BODIES :

OPTION 1 OPTION 2 OPTION 3

SUSTAINABLE
CERTIFICAITON BODY RIR CERTIFICATION CERTIFICATION
===> DAS CERTIFICATION UK INDIA AUSTRALIA
ACCREDITATION BODY UKAS - UNITED
==> KINGDOM IAS-USA JAS-ANZ AUSTRALIA
ISO 9001:2015 85000 75000 80000
ISO 14001:2015 95000 75000 85000
ISO 27001:2013 95000 75000 85000
TOTAL 275000 225000 250000
Note : (a) Service Tax / GST will be extra at actual (b) Annual Surveillance Audit Fees would be Rs.20000
per certificate per year (c) Payment Terms (i) 30% advance along with the PO (ii) 40% after completion of
the Documentation (iii) 30% after completion of Internal Audit (d) Travel, Boarding and Lodging Expenses
of the Auditor of Certification Body shall be extra at actual (e) Professional Fee includes guidance for
compliance and certification fees (f) Validity of this Offer - till June 30th 2017.

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TENTATIVE PROJECT SCHEDULE FOR IMPLEMENTATION OF INTEGRATED MANAGEMENT SYSTEM

J U L Y A U G U S T S E P T E M B E R
Week Week Week Week Week Week Week Week Week Week Week Week
S# Activity
1 2 3 4 1 2 3 4 1 2 3 4
1 GAP Assessment
2 Process Mapping
Awareness
3
Training
4 Risk Assessment
Document
5
Preparation
Draft Document
6 Issue
Document
7 Finalisation
Internal Audit &
8 MRM
9 Closure of NC
10 Stage 1 Audit
11 Closure of NC
12 Stage 2 Audit

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