NABCB - bsc-icc.com
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April 20, 2021 (Rajesh Maheshwari) Issue Date Chief Executive Officer (Please refer http://nabcb.qci.org.in for validity of the certificate or contact NABCB for any related queries) Page 1 of 1 NABCB hereby confirms that BSCIC Certifications Pvt. Ltd. 1st Floor & work Offices, 5B/Sector 15A, Crown Plaza Mall, Faridabad – 121007 (Haryana), India complies with NABCB Accreditation Criteria for Certification Bodies (ISO/IEC 17021-1:2015 and ISO/IEC 17021-3:2017 for QMS and IAF MD 9:2017 for MDQMS) to carry out Quality Management Systems Certification in accordance with Standards detailed in accompanying Schedules The Scope of Accreditation is described in the accompanying Schedule(s) Accreditation Certificate No. : QM 030 Date of Initial Accreditation : March 15, 2007 Date of Last Renewal : July 15, 2018 Validity of Accreditation : July 14, 2022
Transcript of NABCB - bsc-icc.com
April 20, 2021 (Rajesh Maheshwari) Issue Date Chief Executive Officer (Please refer http://nabcb.qci.org.in for validity of the certificate or contact NABCB for any related queries)
Page 1 of 1
NABCB hereby confirms that
BSCIC Certifications Pvt. Ltd.
1st Floor & work Offices, 5B/Sector 15A, Crown Plaza Mall,
Faridabad – 121007 (Haryana), India
complies with
NABCB Accreditation Criteria for Certification Bodies (ISO/IEC 17021-1:2015 and ISO/IEC 17021-3:2017 for QMS and IAF MD 9:2017 for MDQMS)
to carry out
Quality Management Systems Certification in accordance with Standards detailed in accompanying Schedules
The Scope of Accreditation is described in the accompanying Schedule(s)
Accreditation Certificate No. : QM 030
Date of Initial Accreditation : March 15, 2007
Date of Last Renewal : July 15, 2018
Validity of Accreditation : July 14, 2022
April 20, 2021 (Rajesh Maheshwari) Issue Date Chief Executive Officer
(The schedule must be accompanied by the Accreditation Certificate No. QM 030 valid upto July 14, 2022)
Page 1 of 1
Schedule (Scope of Accreditation)
BSCIC Certifications Pvt. Ltd.
ISO 9001:2015 – Quality Management Systems
IAF Scope Description
01 Agriculture, fishing
02 Mining and quarrying
03 Food products, beverages and tobacco
04 Textiles and textile products
05 Leather and leather products
06 Wood and wood products
07 Pulp, paper and paper products
08 Publishing companies
09 Printing companies
10 Manufacture of coke and refined petroleum
products
12 Chemicals, Chemical products & fibres
13 Pharmaceuticals
14 Rubber and plastic products
15 Non-metallic mineral products
16 Concrete, cement, lime, plaster, etc.,
17 Basic metals and fabricated metal products
18 Machinery and equipment
19 Electrical equipment, optical and precision
equipments and medical and surgical
equipment
IAF Scope Description
22 Other transport equipment
23 Manufacturing not elsewhere classified
24 Recycling
25 Electricity Supply
26 Gas supply
27 Water supply
28 Construction
29 Wholesale and retail trade; Repair of
motor vehicles
30 Hotel and restaurants
31 Transport, storage and communication
32 Financial intermediation; real estate;
renting
33 Information technology
34 Engineering Services
35 Other services
36 Public administration
37 Education
38 Health and social work
39 Other social services
Schedule (Scope of Accreditation)
BSCIC Certifications Pvt. Ltd.
April 20, 2021 (Rajesh Maheshwari) Issue Date Chief Executive Officer
(The schedule must be accompanied by the Accreditation Certificate No. QM 030 valid upto July 14, 2022)
Page 1 of 1
ISO 13485:2016 – Medical Devices Quality Management Systems
Main Technical Areas (as per IAF MD 8:2017)
Description (Main Technical Areas)
Technical Areas
A1.1 Non-Active Medical Devices
General non-active, non-implantable medical devices
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.2 Active Medical Devices (Non-Implantable)
General active medical devices
Monitoring devices
Active (non-implantable) medical devices other than specified above
A1.4 In Vitro Diagnostic Medical Devices (IVD)
Reagents and reagent products, calibrators and control materials for:
• Clinical Chemistry
• Immunochemistry (Immunology)
• Haematology / Haemostasis / Immunohematology
• Microbiology
• Infectious Immunology
• Histology/Cytology
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A1.7 Parts or Services Distribution services (Distributors providing storage and delivery of Medical Devices, not acting as a ‘legal manufacturer’ for Medical Devices.)
