HEAD OFFICE ADDRESS: SURAT OFFICE: F-7, SHUKUN Plaza, L. G. Corner, Maninagar, Ahmedabad - 380008. Gujarat, INDIA. 4, SULTAN Appt., Ranchod Nagar, Navsari-Surat Phone: (Telefax) +91 79 2546 3355; (M): +91 94267 56555 / 9601 601 345 / 94274 18288 Highway, Udhana, Surat - 394210. Gujarat, INDIA. Email: info@samratassociates.com; samrat.associates@gmail.com; mkt@samratassociates.com (M): +91 94267 56555 / 94282 43043 Website: www.samratassociates.com; www.indiamart.com/samratassociates

COMPANY PROFILE SAMRAT ASSOCIATES is promoted with an aim to provide Effective and Result oriented services in the avenues of various National & International Standards as following: System Certifications Quality Management System ISO 9001: 2008 | ISO/TS 16949: 2002 | ISO 13485: 2003 | AS 9100| ISO 10002: 2004 | BS 25999: 2004

Environment, Health and Safety Systems ISO 14001: 2004 | RC 14000 | REACH | OHSAS 18001: 2007 | ISO 30000: 2009

Food Safety Management System ISO 22000: 2005 |HACCP | BRC | KOSHER | HALAL | SQF | AIB | ORGANIC Certification | Fami-qs

IT Related Standards ISO 27001: 2005 | ISO 20000 | ISO 28000

Regulatory Standards Trade Mark | Copy Right | Bar-Coding | Environment Consultancy | Concern to Establish - NOC | CC&A | Central / State Pollution Control Board Regulations

Product Certifications International Product Certification

EUROPE | US | Canada | China

Medical Devices Certificat ion CE Marking (MDD, LVDD) | ISO 13485: 2003 | U.S. FDA [510(k)] Third Party Review

Restricted Substance Compliance & Hazardous Locations Certification RoHS | ATEX | HAZLOC. Corporate Trainings Awareness / Internal Auditors Training ISO 9001 | ISO 14001 | OHSAS | HACCP | BRC | ISO 22000 | ISO 27001

Business Excellence Training 5S | LEAN Manufacturing | Six Sigma | Kaizen | Effective Personal Productivity | JIT | TPM | APQP | PPAP | FMEA | HIZUNKA | KANBAN | KOBETSU

Soft Skill Training Behavioral Aspects (Group Decision Making, Team Work, Leadership, Communication) | Presentation Skills | Negotiation Skills

HOW WE ARE COMPETENT SAMRATs are having vast experience of successfully completed variousconsultancy projects with associated renowned International Certification Bodies like BUREAU VERITAS (BVQI), UL-DQS, LRQA, SAI GLOBAL, DNV, TUV - Nord / Austria / SUD / Rhineland, SGS, BSI, INTERTEK, URS, KBS, IQC, ICS, ABS QE, BM Trada, STQC, QA International, SCC, IQSR, IQCS, EQFS, MOODY, Benchmark, Equal Assurance, etc. Our organization is being managed by Professional Technocrat Management Consultants, who are Qualified & Experts in their related fields. Consequently the Principal Consultant is Registered Consultant in NABET (National Accreditation Board for Education and Training) in QCI (Quality Council of India) Government of INDIA Oriented Organization. We have built up a vast base of associates comprising an extraordinary powerful pool of intellectual resources that can be seamlessly harnessed in the execution of tasks of any degree of complexity.

Logos of Various Certification Bodies as Associated

OUR STRENGTH SAMRAT ASSOCIATES has also entered into a strategic alliance with some of the top professionals for sharing technical expertise in different areas. These Consultants have revolutionized the concept of providing Quality Consultancy Services by value added, cost effective & professional services which played a major role in their acceptance by several Large Organizations, now also focusing on SMEs (Small & Medium Enterprises). Our Greatest Assets – Our Team Mr. Abhimanyu Samrat (Principal Consultant) [ceo@samratassociates.com] Ø (Pursuing) Ph.D. (Quality Management – NIRMA University) Ø MBA (International Business – NIRMA University) Ø Lead Auditor (LA) - ISO 9001: 2008 (QMS) (BUREAU VERITAS - BVQI) Ø LA - ISO 14001: 2004 (EMS) (MOODY INTERNATIONAL) Ø LA - ISO 1345: 2003 (QMS-MD) (SGS-UK) Ø LA - CE MARKING (MDD) (SGS-UK) Ø LEAN FACTORY MANAGEMENT (Ahmedabad Management Association) Overall Industrial Experience of Total 8 Years which includes 5 Years in Management Consultancy & Trainings Ms. Payal Desai (Execution Manager) [exe@samratassociates.com] Ø B.Sc. Foods & Nutrition (M. S. University, Vadodara) Ø LA - ISO 9000 (QMS) Series of Standards (BSI) Ø LA - ISO 22000: 2005 (FSMS) (SAI GLOBAL) Overall Industrial Experience of Total 9 Years which includes 4 Years in Management Consultancy Mr. Nilesh Machwana (Execution Trainee) Ø M.Com. (Gujarat University, Ahmedabad) Overall Industrial Experience of Total 5 Years which includes 1 Year in Management Consultancy

Our Team of Associate Technocrats Dr. Vijay Prajapati (Associate Consultant) Ø MD Pathology Ø PG Diploma In Hospital & Healthcare Management Ø LA - ISO 9000 (QMS) (BVQI) Ø LA - ISO 14001: 2004 (EMS) from (BVQI) Overall Experience of Total 7 Years as an MD Pathologist which includes 3 Years in Certifications Auditing Mr. S. K. Garud (Associate Consultant) Ø B.Sc. Chemistry Ø Diploma In Industrial Safety Ø LA - ISO 9000 (QMS) Series of Standards (MIS) Ø LA - ISO 14001: 2004 (EMS) (SAI GLOBAL) Overall Experience of Total 36 Years in Dyestuffs Industries which includes 2 Years in Certifications Auditing Mr. Kaushik Dave (Associate Consultant) Ø B. Tech. (Dairy) Ø Diploma (Marketing Management) Ø LA - ISO 22000: 2005 (FSMS) (SAI GLOBAL) Overall Experience of Total 16 Years in Dairy Industries which includes 2 Years in Certifications Auditing Ms. Jigisha Dave (Associate Consultant) Ø B. Sc. (Microbiology) Ø Expert in WHO, GMP (FOOD & DRUGS) & CE Marking for Medical Devices Overall Experience of Total 19 Years in Pharmaceuticals & Medical Surgical Industries which includes 2 Years in Certifications Auditing Mr. Ramesh Sharma (Marketing Executive) Ø B. Com. (Gujarat University, Ahmedabad) Overall Industrial Experience of Total 35 Years which includes 3 Year in Marketing

ISO 9001: 2008 (QMS) Introduction Newly established version ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM (QMS) has been developed and recommended by the ISO (International Organization for Standardization) headquartered in Geneva, Switzerland. The ISO 9000 series of standards are applicable to all organizations that want to ensure a consistent ability to satisfy customer requirements. Certification to ISO 9001: 2008 is accepted world wide as an assurance to customers, sub contractors and prospective partners that the company is reliable and able to consistently meet its contractual obligations. It is more process based, the execution will be more compatible with how our clients do business, and will break down the artificial barriers between the elements of the standard that have existed, by focusing more on process flows, customer satisfaction and continual improvement of the QMS, as it is believed that these changes will allow us to provide more added value for the clients. ISO 9001: 2008 is based on eight quality management principles providing a framework to guide organizations towards continual improvement. Benefits of ISO 9001: 2008

• Provides Crown for the Organization as an ISO 9001: 2008 Certified Company.

• Increases the effectiveness and efficiency of the organizations. • factual decision-making. • Provides controlled methods for measurement and monitoring of process and

products. • Ensures sustained customer satisfaction by producing, delivering services and

providing support functions that meet customer needs and expectations. • Structures the operations of the organization to achieve a desire result. • Provides better understanding of the relationship between cost and benefits. • Involves top management in the improvement of QMS. • Provide and organization wide, consistent and comprehensive approach and

clarifies roles and responsibilities and linkages to all interested parties. • Provide a systematic, visible way to lead and operate an organization that

continually improves performance.

INTERNATIONAL REVIEW Some benefits found by Over 3,50,000 Companies worldwide, registered with ISO 9001

• Improved consistency of service and product performance • Higher customer satisfaction levels. • Improved customer perception • Improved productivity and efficiency • Cost reductions • Improved communications, morale and job satisfaction • Competitive advantage and increased marketing and sales opportunities.

85% of registered firms report external benefits (Dun and Bradstreet findings)

1. Higher perceived quality 2. Greater customer demand

95% report internal benefits 1. Greater employee awareness 2. Increased operational efficiency 3. Reduced scrap expense

Registered companies site the benefits of ISO 9000 Registration as: a. Improved management ó 86% of respondents b. Better customer service ó 73% of respondents c. Improved efficiency ó 69% of respondents

30% of registered companies experience increased customer demand. (Irwin Professional publishing survey results show)

• 50% of registered companies have decreased number of customer audits. • 69% of registered companies have a competitive advantage in their market. • 83% of registered companies’ products have higher perceived quality in the

marketplace. Start seeing these benefits in your organization

• Benefits start with your implementation project; you do not need to wait until registration is achieved to start seeing the improvements.

• One of the fastest and most effective ways to implement ISO 9000 is to use The Documentation and Training Package from SAMRAT ASSOCIATES.

• By using this package you will implement a professionally designed Quality Management System in the most cost effective manner available.

HOW TO START We are available with years of expertise at your site

• Use our professionally designed Quality Manual, Procedures and Forms.

– Save countless hours of your time by editing these proven procedures instead

of starting from scratch. – These procedures document processes to meet the requirements of the

standard, and are ready for you to tailor for your organization. Quality Manual, Procedures and Forms

• All documented in Microsoft Word and Excel, they are easy to edit and use. • These documents have been used by many different types of industries for

successful registration to newly published ISO 9001: 2008 standard. Physical Requirements

• We suggests our best knowledge on the construction of the plant • We offer the better layout of plant

Train your employees

• We offer the most convenient and cost effective training available. • Computer based training provides each employee with an introduction to the

standard and what it means to them Computer Based Training

• Employees can take the training at any convenient time • Appealing visual and audio content keep the employees attention

ACTION PLAN PHASE-I [TIME SPAN - 10 DAYS]

[Brief Introduction to ISO 9000 Series and Quality Management System, Exchange of Information On Company’s existing Quality System and Organization Structure, Appointment of M.R.]

q Brief Introduction to ISO 9000 Series of Standards. q Detailed know how on different clauses of ISO 9001 and their importance in

successfully managing an organization. q Information on Documentation required in ISO 9001 i.e. Quality Manual, Procedure

Manual, formats, Work Instructions, etc. q Brief discussion on benefits of implementing and maintaining ISO 9001 QMS. q Collection of information regarding company’s existing Quality Management System

and Finalizing Organization Structure. q Defining Functional Responsibilities and Authorities of various personnel. q Collection of Information related to company’s products and processes. q To appoint one employee as a Management Representative (M.R.) who will look after

all the documents related to ISO Quality Management System. PHASE-II [TIME SPAN - 15 DAYS] [Finalization of Quality Policy and Objectives, Formats for all Departments Quality Plans, Work Instructions, etc.] q Detailed discussion with each department managers / heads on their existing records

in accordance with ISO Requirements. q Defining Company’s Quality Policy and Objectives. q Finalization of Quality Plans, Work Instructions, etc. q Detailed individual explanation to each staff member contributing to company’s

Quality Management System about importance of recording data and maintaining the same.

PHASE-III [TIME SPAN - 15 DAYS] [Review and Finalization of Quality Manual, Procedure Manual, etc. and Implementation of Quality Records / Formats] q Implementation and filling up of formats and recording data as per ISO requirements. q Preparation of Quality Manual with MR. q Preparation of Department wise Procedures with each department’s manager / head.

q Review and finalization of Complete Quality and Procedure Manuals and getting it approved from company’s top management.

q Detailed information on company’s total documentation staff members.

q Brief session on ISO Awareness to shop floor employees to ensure one understands the importance of adhering to company’s Quality Management System.

PHASE-IV [TIME SPAN - 10 DAYS] [Review of Records, Training for Internal Audit and Management Review Meetings, Measurement and Monitoring Of Processes] q To train few employees in conducting Internal Audit of ISO Quality Management

System. q Plan for Internal Audits. q Brief Introduction of activities related to Management review Meetings. q To explain in detail Measurements and Monitoring of Processes. PHASE-V [TIME SPAN - 10 DAYS] [Conducting Internal Audits, Management review Meetings, Corrective and Preventive Actions, Monitoring and Measurement of Processes] q Conduct Internal Audit by Independent and Trained Personnel in a Documented

Manner. q To record the findings of Internal Audit and bring them to the attention of respective

personnel. q Submission of various quality records in MRC Meetings. q Desired Modifications to quality system in association with documented procedures

and ISO 9000 Quality Management System. q Determine corrective and preventive actions required to be initiated in the organization. PHASE-VI [TIME SPAN - 10 DAYS] [Pre assessment and Final Certification] q Assisting in liaison with Certifying Bodies. q Fine tuning of documents for Pre assessment Audit. q Implementation based on procedure and Quality Manual. q Certification Audit by Certifying Body.

ISO 14001: 2004 (EMS) Introduction

In response to international concern for deterioration in the Environment, the ISO 14000 standard was formulated to allow companies to make environmental issues an intrinsic component of business policy and practice. Compliance to the ISO 14000 standard is a sign that management of a company is prepared for the legal requirements of tomorrow and signals to the marketplace the fact that the company follows environmentally sound practices.

The standard contains the core element for management of companies’ activities and processes. It is applicable for both manufacturing and service sectors. The ISO 14001 is focused in terms of requirements for a specific policy for environmental issues, aspects identification for setting objectives and target besides compliance with applicable legislative and other regulatory requirements.

The main elements of the ISO 14001: 2004 standard

• Environmental policy – planning • Implementation and operation • Monitoring and corrective action • Management review

Benefits of ISO 14001: 2004

• Minimizes organization impact on environment • Improves operational efficiency for cost saving • Identifies opportunities for cost saving. • Energy conservation • Reduce environmental liability. • Improves societal image.

OHSAS 18000: 2007 (OH&S) Introduction The Active Quality System provides a common toolset of features based on the proven Deming Cycle of “Plan – Do – Check – Act” for continuous improvement, to manage, maintain and utilize organization data effectively and efficiently. Planning ACTING § Defining OH&S Policy. § Identifying OH&S Hazards and Risks. § Identifying Legal and other OH&S

Requirements. § Defining Objectives and Targets. § Defining Management Programs and

Plans. § Defining Indicators, Processes and

Management Responsibility.

§ Manage Data Analysis. § Manage Continual Improvement. § Manage corrective and preventive

actions (CAPA). § Management Review.

DOING CHECKING § Defining structure and responsibility. § Manage Competence, Awareness and

Training. § Manage Internal and external

Communication. § Information & Document

Management. § Manage Records and Operation

Control. § Manage Emergency preparedness and

response. § Manage Scheduling. § Manage Nonconformance - accidents

and incidents investigations.

§ Monitoring and Measurement of Processes.

§ Manage handling and investigating Nonconformance.

§ Manage Internal and external OH&S Audits and Manage Records.

§ Internal and external assessments.

§ Control of Monitoring and Measuring Devices and Performance Management.

§ Performance indicators Management.

Benefits § Improve Health and Safety Management performance § Reduce Health & Safety Incident with the management System § Reduce Health & Safety Incident Costs with the management System § Reduce OH&S Hazards and Risks with the management System § Comply with the requirements of Risk Management System as per OHSAS 18001

with the management System

ISO 22000: 2005 (FSMS) Introduction

• ISO 22000: 2005 – Food Safety Management Systems (FSMS) Requirements for any organization in the food chain and needed to develop a food safety management system.

• The ISO 22000: 2005 family is a series of standards for organizations in the food chain.

The difference between ISO 22000: 2005 and the HACCP

• Codex HACCP is an excellent guidance document, provides information about the principles of HACCP

• ISO 22000: 2005 is an auditable standard. • Having general requirements for a food safety management system. • Validation, verification and improvement of the food safety management system. • Management responsibility. • Resource management. • Planning and realization of safe products.

It’s not only for food processors

• Food safety is as strong as the weakest link in the food chain. • Therefore, ISO 22000: 2005 is written to be used by all organizations that are in the

food chain, regardless of size or position in the food chain. • It also provides a common description for a food safety management system

regardless of whether or not an organization must also comply with national regulatory HACCP requirements.

The benefits after implementing ISO 22000: 2005

• A clear, auditable and global standard, which provides a state of the art definition of a food safety management system.

• Incorporating the five preliminary steps and seven principles of Codex HACCP. • A direct link between pre-requisite programs and the HACCP plan designed to

increase the effectiveness of the food safety management system. • Providing an approach and structure in alignment with both QMS & EMS. • Improving internal communications on food safety issues with staff & Enhancing

customer satisfaction and improving your image with customers.

CE MARKING Introduction

One of the most critical elements of marketing products in Europe is proper use of “CE MARKING”. This has become so crucial in some cases now, that it has become synonymous for “Passport to Europe” for your product. However, since policy makers of European Union and its subsequent applicability to products originating from other countries other than originally conceived CE marking European Union has led to confusion among manufacturers from Asia. Which products can become “CE MARK” Not all products can be marked with CE. For most products, a single set of harmonized regulations, known as Directives, has replaced individual national rules, thus making life easy for the manufacturers. CE marking is required for “New Approach” Directives (those that have been published since 1987) and now there are about 20 directives approximately. Technical File This documentation supports your declaration of conformity. Supporting documentation in your technical file can help limit liability when prepared by an independent, third party certification body. Directives 89/106/EEC Construction Products 89/336/EEC Electromagnetic compatibility 94/9/EC Equipment & Protective Systems in Potentially explosive atmospheres. 93/15/EEC Explosive for civil uses 98/37/EEC Low voltage equipment 98/37/EEC Machinery safety 90/385/EEC Medical devices: Active Implant able 93/42/EEC Medical devices: General 93/79/EC Medical devices: In Vitro diagnostic 89/686/EEC Personal protective equipment 99/5/EC Radio and telecommunication terminal equipment 96/98/EC Marine Equipment 97/23/EC Pressure Equipment Directive