N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

Letter No.:-NQSC/GEN/2011-12/500 Dated 09.07.11

Subject: - An introductory letter, regarding CONSULTANCY and

TRAINING for global system, management and product certifications such as ISO 9001:2008, ISO 14001:2004, HACCP(Food Safety), CE MARKING,SA 8000,TS 16949 ,WHO-GMP, Drug License , ISO 13485-2003 ,OHSAS 18000 and other certifications as per customer requirement.
Dear Madam/Sir,

This is an introductory letter, for global system, product and management system certifications. In this regard, please find herewith brief details of our organization, work carried out by us, and other detailsABOUT OUR ORGANIZATION:We are in the field of certifications activity since last 12 years. We have provided consultancy to more than 350 companies and at present more than 20 companies are in pipeline for ISO 9001:2008, ISO 14001:2004, ISO 13485:2003,CE Marking, OHSAS-ISO 18001, TS 16949, SA 8000, WHO-GMP, Drug License and HACCP certifications in different sector and different location in India and Overseas eg Indian Oil (IOCL)Indian Railways for manufacturer of PSC sleepers, Indian Railways work shop & organization, Institutions ( Haryana Engineering college, Tecnia Institute, Krishna Engineering- Kurukshetra), IOCL ,Pharmaceuticals, Medical Devices, Surgical Devices, Ophthalmic devices, Heavy M/C Manufacturing, Electrical & Electronic

Page 1 of 9

Device ( Su-Kam Power System Ltd-Gurgaon & Baddi) , Software Developments, Banking, Service Industries.. etc .

N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

FEW MAJOR CLIENTS CE /ISO 13485/WHO- GMP CERTIFIED UNDER OUR CONSULTANCY:

M/s Denex International Bhiwadi (CP :-Mr Puneet Dhawan,09810048912) M/s Hitech Medicare Devices Pvt. Ltd-Allahabad (CP:- Mr Alok Srivastav 09889034850) M/s Tarun Enterprises Allahabad (CP:-Mr Tarun Jaggi, 09335154556) M/s Dispokit Surgical Pvt. Ltd- Bhiwadi (CP:-Mr Vinod Kr 01120057864 M/s Madhu Instrument Delhi (CP:-Mr Amit Gupta 9810333853) M/s Atlas Surgical Co. Ltd- Delhi (CP:- MR Puneet Narula 09810013329) M/s Jindal Medical & Scientific Pvt. Ltd-Delhi (CP:-Mr P.K. Aggarwal 09312431090) M/s Quality Needle P. Ltd-Noida (CP:-Mr RC Pandey 09818100019) M/s Auxin Life Science Pvt. Ltd-Surat (U/P)

Page 2 of 9

(Mr Bhavesh Khatiwala 09327632093) M/s Medicare Products Inc. Delhi (CP:-Mr Pradeep Aggarwal09312431090) M/s Bio-Med Healthech Ltd-Mumbai (Dr Mukesh Daftery 09820072942) M/s Su-Kam Power System Ltd- Gurgaon & Baddi (Mr. Rakesh Singh Chauhan 09971991891)

N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

M/s Medical Products Services-Delhi (CP:- Mr Praddep Saini 011-25925960/61) M/s Revital Healthcare (EPZ) Ltd-Mombasa, Kenya (CP:-Mr. Goswami-+254737979011) M/s Action Construction Ltd (ACE Crane)-Faridabad ( CP:-Mr A. Guglani 09899005380) M/s United Ukrane technology Pvt. Ltd.- Faridabad ( CP :-Mr Paramvir Singh 09818310888) M/s Stic Pen Limited Delhi (CP : Mr Bhatacharya-011-28115162)
M/s Dominant Offset Limited-Gurgaon (CP:-Mr Y.R.Saini-0124-4682000)

M/s S.S. Technomed Pvt. Ltd-Tronica City , Gaziabad (UP) (CP: Mr Naveen Sharma-9811098577) M/s Surgi- Aid Medical Equipments -Surat (CP:Dr Rahul P.Vyas-9925199910) M/s Endo-Med Pvt Ltd-Delhi

Page 3 of 9

 (CP:Mr Kanwar Sehgal-9810070477

N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

M/s Hema Engineering Industries Ltd-Gurgaon (CP:Mr Rakesh Singh-9810786962) M/s Confident Dental Equipment Limited-Banglore (CP:Mr Kartik MV-080-23280801 M/s META MEDICARE -Delhi (CP:Mr Kuldeep Singh -09899936364) M/s MEDITECH (INDIA)-BHIWANI (CP:Mr S Bansal -09812266676) M/s Life Line Medical Devices- Gurgaon U/P (CP:Mr Akash Batra - 9811629907) M/s Care Medical Pvt . Ltd. Gorakhpur (UP) (CP: Mr Badre Alam - 09389430157) M/s Esteem Industries Inc. Baddi (HP) (CP: Mr Mhendre Tondan - 09805339999) M/s Narang Scientific Works Pvt Ltd-Delhi (CP: Mr NC Srivastava - 09810253727) M/s Premier Medical Systems & Devices Pvt . Ltd. -Noida (CP: Mr K.K. Ghos-9811551145) M/s Advance Life care Pvt Ltd-Delhi (CP: Mr Kamal Aggarwal -9810014050) M/s Amar Instruments Ahmedabad, Gujrat U/P (CP: Mr Bharat Rathod -09426039135)

Page 4 of 9

N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

Page 5 of 9

CERTIFICATION DETAILS:Standards ISO 9001:2008 ISO 14001:2004 CE Marking ISO 22000:2005 / (HACCP) SA 8000:2001 TS 16949:2009 WHO-GMP ISO 13485:2003 OHSAS 18001:2007 NABH NABL BRC Applicable for Quality Management System certification for all type of Organizations/institutions/service sector Environmental Management System Conformity to European norms [Medical devices, Toys, IVD, LVD ,RoH & Heavy machinery] Food safety certification of food items & supplements Social Accountability certification eg health, safety & Labour welfare For automotive products/components certification World Health Organization & Good Manufacturing Practice certification Regulatory requirements of medical devices/product Occupational Health Safety & Management System Certification (OHSAS) National Accreditation Board of Hospital National Accreditation Board of Laboratory British Retails Consortium for Global Standards for Food Safety

N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA

Page 6 of 9

M) 9810236683,9818731372, 0124 4271683

Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

OUR RESPONSIBILITIES & SERVICES FOR CERTIFICATION ACTIVITY TO YOUR ORGANIZATION:Preparation & updation of TCF(Technical Construction File ) Preparation for Site Master File as per Drug & Cosmetic Act-1940 Risk Analysis of your products/devices as EN-ISO 14971:2009. Essential Safety Requirements of your products/devices as per MDD: 93/42/EEC as amended Directive 2007/47/EC. e) Quality Plan for Incoming Materials & Final Inspection Plan to Meeting the Quality Standards/relevant standards f) Sampling plan for inspection & testing for raw material, packaging material & finish foods g) Preparation of Check List that shall contain the total check points /inspection criteria at different stage of process. h) Determination of Applicable/harmonized standards i) Preparation of warning & instruction for use j) Control of drawing k) System for pre & post marketing vigilance mechanism l) System for clinical evaluation & trial for new developed products or design changed products. m) Handling system for customer complaints n) Product RE-CALL system o) Product stability studies plan & system. p) Validation system for special process & packaging process q) Products identification & traceability system r) Control of documents & records s) Requirement of Clean Room & sterilization validation t) Application of safety symbols on labels EN 980:2008. u) Help for Clean Room requirements as per ISO 14644 1 & 2 (ISO Clause-7& 8) v) Other entire works required for certification a) b) c) d)

N Q S C

Page 7 of 9

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

BENEFITS AFTER GETTING CERTIFICATION:Your Organization will see the following benefits gradually after getting Certification:a. A defined system for working & monitoring of work for different stage of Process. b. Responsibility, Authority & Accountability shall be cleared after implementation of system. c. Effective control on customer Drawing, Sample, different applicable specification and standards, regarding their modification status d. Help to your office for proper house keeping, record updating and retention of records & documents. e. The records & fillings shall be improved gradually & traceability of the filling system shall also be improved gradually. f. Effective control on purchasing of RM suppliers /Sub contractors. g. Inspection criteria in defined manner for each stage and treacebility of work done at different stage shall be effective. h. Reporting of day-to-day activity at site shall be improved. i. Effective control on wastage & rejection shall be improved and data of rejection shall be easily available. j. The control on client & their satisfaction shall be increased effectively to fulfill their stated requirement. k. The action on customer complaints & their corrective/ preventive action shall be defined & documented, which shall help to your Organization for reoccurrence of such type of problem in future. l. Control on re-work shall be improved.

Page 8 of 9

N Q S C

NUTAN QUALITY SYSTEM CONSULTANT

OFFICE: - H.No.-177, Sector-30, Gurgaon (HRY.)-122001, INDIA M) 9810236683,9818731372, 0124 4271683
Services for Quality System Consultancy: ISO 9000, ISO 14000. TS 16949, HACCP, SA, WHO-GMP,ISO 13485:2003,OHSAS & CE Certification (LVD, MDD , & Machinery Directive), NABH, NABL, Drug License , System Maintenance and Training

m. After getting this certification, your Organization can participate & compete in National & International tenders. n. Your working system shall be compliance with International QMS & shall be checked & approved by third party .So this certification will help you tell about your Organization of your working system.
We are available round the clock as per your need at Mobile No.09810236683, 09818731372 0124 -4271683.

I would like to assure you, provide best services at all times. Looking for ward to your quick response & maintaining long-term business relationship.

FOR NUTAN QUALITY SYSTEM CONSULTANT

R.S.MISHRA

CEO
[QLA for QMS, EMS & HACCP IRCA-UK] Income Tax PAN No.:- AHCPM0976C, Service Tax Code (Registration No.): -AHCPM0976CCST001 & Premise Code SE0302/1MGC/443/07 TAN No . RTKR06151F

Page 9 of 9