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TNV encourage to adopt and implement latest available standards ISO 9001:2015 & ISO 14001:2015, hence no application shall be accepted after 01st Jan. 2017 for ISO 9001:2008 & ISO 14001-2004 standard, earlier this date was 01st Sept. 2017. Existing client may continue using their certification status till the validity of the standards i.e. 15th Sept. 2018

TNV's is not anymore Accredited by JAS-ANZ (Joint Accreditation System of Australia & New Zeland) for QMS, EMS, OHSAS and FSMS with effect from 30th January 2017. Accordingly all Accredited certificate issued by TNV for QMS, EMS, OHSAS and FSMS with JAS-ANZ logo is recalled as use of logo of JAS-ANZ with the name of TNV is unauthorised and not fair and all such certificate have been removed from JAS-ANZ portal by 30th April 2017. TNV advise our client to contact us for surrender of certificate. if clietn dont want to continue with TNV, they may choose any Certifictaion body of its choice.

TNV is certified by Exemplar Global for Lead Auditor Course of ISO 9001

TNV Have aproval for location Nepal, Kuwait, Bangladesh and United State of America as a additional location in Financial year 2013-14, Further TNV have started in Taiwan, Qatar, Maldives, Egypt, Vietnam, South Africa and Brazil.. Board of the Director have considered aspects for the overseas operation and expanding to many countires; we invite inquiries for Business Association or franchises for ISO Certification Services. 

TNV's Accreditation of JAS-ANZ (Joint Accreditation System of Australia & New Zeland) for QMS, EMS, OHSAS and FSMS is revked by 30th January 2017. Accordingly all Accredited certificate issued by TNV for QMS, EMS, OHSAS and FSMS shall stand cancelled and all the certificate shall be removed from JAS-ANZ portal by 30th April 2017. If client is looking from JAS-ANZ accredited certificate, client may please take transfer of the certificate on time to any JAS-ANZ accredited CAB or any other Certification body of thier choice.

Managing Director, TNV Mr. Pragyesh Singh Visited South Africa our Marketing office at Cape Town

Managing Director, TNV Mr. Pragyesh Singh is visiting Indonesia for signing contract for starting operation there.

Payment Notice for India: Please be informed that TNV Certification Pvt. Ltd. does not accept any payment in cash or in any other company name, Clients are advised to please make sure that they make all payment to TNV Certification Pvt. Ltd. with Service tax at the prevailing rate of the Government of India.  In India; staff or business associates of the TNV are authorized to carry out marketing and to Collect Client Application form, quotation, assessment and Payment from clients in the name of "TNV Certification Private Limited" only. We accept cheques, Demand Draft, Pay Order, NEFT or RTGS only, the payments which are made in any other name than "TNV Certification Private Limited" shall not held us responsible in any manner. If someone claim for the guaranteed Certification from TNV, Please don’t rely on such false commitment, Certification is result of Assessment. All the operational and technical activities such as review of Applications, Audit Planning, Certification Decisions, and Issuance of Certificates are carried at head office of TNV Certification Private Limited at Lucknow, UP India only. Outside India, payment can be made in the name of Local Partner, but you are advised to please verify the name of the business associates on the website of the company in Global Menu.

TNV's Lead Auditor Training Program for ISO 14001, OHSAS 18001, ISO 22000, ISO 27001, ISO 13485, ISO 28000, ISO/TS 16949 planned in August 2015, September 2015, October 2015, November 2015, and December 2015. Exemplar Global certified Course

Managing Director, TNV Mr. Pragyesh Singh Visiting Egypt, UAE and Taiwan for Annual Review of Overseas office in June.

TNV’s Logo is the Registered Trademark of the TNV vide Trade Mark Number 2420078 Dated 31st October 2012 J. No. 1620 at Sl. No. 1183020 in Class 35 for Business and Risk Management, Administration and Auditing, Management System Certification Services, Product Certification Services, Compliance & Other Certification Services, Any misuse of the logo shall be governed as per provisions of Trade Marks Act 1999.

The impetus for the development of ISO 45001 came from the British Standards Institute (BSI), which proposed to ISO in 2013 that OHSAS 18001 be considered as the basis for an international standard. ISO agreed and established a committee to oversee its development. As the proposers, BSI took on the role of Secretariat to the new committee (ISO PC 283). The first meeting of ISO PC 283 took place in London in October 2013, where key decisions were made, for example, that the standard would contain the requirements and include interpretative guidance as an annex. The WG was established and further divided into Task Groups (TGs) to separate the workload into manageable sections, so that each TG could focus on one or more clauses of the draft standard

Public Notice: 

With effect from 30th Jan 2017, JAS-ANZ Accreditation have been revoked as TNV could not inform JAS-ANZ withdral informaiton of the DAC. an  appleal in this respect is pending with JAS-ANZ, TNV have not recieved any communication in respect of appeal submitted against cancellation  of the accreditaiton of the TNV. Informaiton of the same have been filed to IAF in this reference to ensure execution of the appeal submitted.

TNV is a largest ISO Certification Body in india |  TNV provides ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, ISO 27001, ISO 13485, TS 16949, ISO 28000 Lead Auditor Training Course |  TNV provides Certification Servcies for QMS, EMS, OHSAS, FSMS, ISMS, EnMS, ITSMS, BCMS, CE and Star Rating.. |  TNV is an International Certification Body based in India |  ISO Certification Services in Lucknow, Kanpur, Varanasi, Allahabad, Delhi, Mumbai, Kolkata, Bangalore, Chennai, Goa, UP, Bihar, Patna, Jharkhand, Punjab, Himanchal Pradesh, Madhya Pradesh, West Bengal, Assam, Maharashtra, Jammu & Kashmir. |  Fresh accreditation application to DAC have beed submitted for ISO 9001, ISO 14001, OHSAS 18001, ISO 22000 and HACCP |  TNV Provides IAS Accredited Certificate in association with a Korea based Accreidted Certification body and we offers QMS, EMS, OHSAS, FSMS, ISMS, EnMS, BCMS, ISO 1002, ISO 10004 and ISO 13485 |  For any inquiry related to application or Certified Clients, please write to info@isoindia.org |  TNV is an International Certification Body based in India |  TNV have no relationship with JAS-ANZ with effect from 30th Jan 2017. |  TNV have applied to DAC for accreditation of QMS, EMS and OHSAS |  TNV Can issue ISO certificate in Bangladesh, Bahrain, Bulgaria, Egypt, France, Gabon, Germany, India, Indonesia, Iran, Kuwait, Italy, Malaysia, Maldives, Nepal, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Sri Lanka, Taiwan, Turkey, United Arab Emirates, United Kingdom and United States of America |  OHSAS 18001 changing to ISO 45001 download guidance document for transition |  #ISO-9001-2015Certification #ISO-14001-2015Certification #OHSAS-18001-2007Certification #ISO45001Certification #ISO-22000Certification ISO-27001Certification #ISO-22301Certification ISO-50001Certification #ISO-20000-1Certification | 
ISO 13485:2016

Structure of ISO 13485:

ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector. ISO 13485 Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001. The ISO 13485 standard is for medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory.  ISO 13485 Certification is an objective evidence of compliance of the requirements

Validating Your Quality Management System

Certifications build trust – a crucial factor when it comes to medical devices. EN ISO 13485 is the international standard for quality management systems for medical devices. We examine your quality management practices for medical devices, focusing on design and development, production, customer service, and assembly. Benefit from the positive effects of a quality management system: lean processes, efficient work flows, and international recognition.

Mandatory procedure in ISO 13485:

Please refer the newsletter of the TNV

In addition, the following standard sections of ISO 13485:2016 require ‘the establishment of 10 mandatory documented procedures in addition to ISO 9001:2008’ to define and control the requirements and practices of these operational areas:

7.      Design & Development – to ensure a controlled, consistent design and development process (Clause 7.3.1)

8.      Purchasing Process –to ensure the purchased product conforms to specified purchase requirements (Clause 7.4.1)

9.      Particular Requirements for Sterile Medical Devices – to ensure validation of sterilization processes. (Clause 7.5.2.2)

10.  Identification –to ensure that devices returned are identified and distinguished from conforming product (Clause 7.5.3.1)

11.  Traceability –to define the extent of product traceability and the records that must be kept (Clause 7.5.3.2.1).

12.  Preservation of Product – to ensure the conformity of product during internal processing and delivery to the intended destination (Clause 7.5.5).

13.  Control of Monitoring and Measuring Devices – to ensure that monitoring and measurement can be and is carried out consistently with the monitoring and measurement requirements (Clause 7.6)

14.  Feedback – to ensure an adequate system to provide early warning of quality problems and for input into the CAR/PAR processes (Clause 8.2.1).

15.  Analysis of Data – to ensure that data demonstrating the suitability and effectiveness of the quality management system is determined, collected and analyzed and to evaluate any improvements to QMS effectiveness (Clause 8.4).

16.  Advisory Notices: Improvement, General – to address the issuance and implementation of advisory notices and notification to regulatory authorities, as required. Such procedures must be capable of implementation at any time. (Clause 8.5.1).

In addition, there are certain clauses that require documented procedures only under specific conditions as well as requirements that require documentation, but not necessarily a 'documented procedure'. These are:

17.  Infrastructure – When maintenance activities, or their lack, may affect product quality, documented requirement for such activities will be defined (Clause 6.3).

18.  Work Environment – When contact between personnel and the product or work environment may adversely affect product quality (Clause 6.4):

18.1 documented requirements for health, cleanliness and clothing of personnel will be defined

18.2  If work environment conditions may adversely affect product quality:

18.2.1    documented requirements for work environment conditions and

18.2.2    documented procedures/work instructions to monitor and control work environment conditions

18.2.3    Document any special arrangements to control contaminated or potentially contaminated product so that other product, personnel or the work environment are not contaminated.

19      Planning of Product Realization – Requirements for risk management throughout product realization will be documented. (Clause 7.1)

20      Review of Requirements Related to the Product – Customer product requirements are defined and documented (Clause 7.2.2)

21      Control of Production & Service Provision – The documented procedures, requirements, work instructions and reference materials required to complete production and service activities in a controlled manner must be identified. (Clause 7.5.1.1)

22      Cleanliness of Product and Contamination Control – Documented requirements for cleanliness of product, under the conditions defined in the standard. Please review for applicability. (Clause 7.5.1.2.1).

23      Installation Activities – Compare your product requirements to standard for applicability. For example, the application of a bandage would not be considered installation; however, if its application must be effected in a particular fashion in order to work properly, documented requirements may be needed. (Clause 7.5.1.2.2).

24      Validation of processes for Production and Service Provision – Is computer software used that might affect product conformance to specified requirements? If so, documented procedures for software validation are required. (Clause 7.5.2.1)

Benefits at a Glance

EN ISO 13485 certification by the TNV Certification Pvt. Ltd. allows you to:

·         Expand market Access (Increase device sales by accessing more markets.)

·         Meet Regulatory Requirements         

·         Brand Equity: Demonstrate that medical devices are produced safely & Communicate your high standards of quality

·         Gain a competitive edge

ISO 13485 certification also help organization in :

·         Reducing operating costs

·         Establishing business credentials

·         Improved stakeholder relationships

·         Entering in global markets

·         Ensuring Legal compliance

·         Ensuring Customer satisfaction

·         Improving risk management

Integrated Services:

·         EN ISO 13485 certification with ISO 9001.

·         EN ISO 13485 certification with ISO 14001.

·         EN ISO 13485 certification with OHSAS 18001.

·         EN ISO 13485 certification with CE Compliance.

·         EN ISO 13485 certification for processing of medical devices

Four Steps to Your Certificate

1.      Application and decide financial terms by signing Contractual Agreement: Consultation and preliminary assessment during which we inspect your site and review your quality management documentation.

2.      Stage-1 Audit: We audit your site to determine whether you are eligible for certification or analyze all the required information on your company. We review your quality management documentation for compliance with EN ISO 13485.

3.      Stage- 2 Audit: On-site, we examine how your quality management system is applied in practice and evaluate how effective it is.

4.      Certificate: If you meet all the criteria, we issue a certificate confirming compliance with standards and the integrity of your quality management system.

Risk Management according to EN ISO 14971

ISO 14971 for the application of risk management specifies a process for a manufacturer to identify the hazards associated with medical device, including in vitro diagnostic (IVD) medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The risk management file must have that particular defined and documented Risk management process that addresses risk analysis, evaluation and control, collection of production and post-production data to validate or change previous risk determinations.

Quality Management System according to EN ISO 13485

Introduction to ISO 13485

·         To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.

·         ISO 13485 is not a product standard. It’s a process standard.

·         Therefore, it’s not enough to establish a quality management system that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations

ISO 13485:2016 is based on the ISO 9001:2015 process model and based on Annexure SL.

ISO 13485:2016 was written as a model to meet the quality system requirements of various global regulations.

With the shift in emphasis to be model for regulatory requirements, the writers of ISO 13485:2016 removed the emphasis on customer satisfaction from ISO 9001:2015.

ISO 13485 has not been adopted by the FDA, who will continue to have separate Quality System Regulation (QSR) requirements, however, the FDA participated in writing ISO 13485:2003 to make sure their requirements and ISO 13485:2016 are aligned.

ISO 13485:2016 was not written to be a business improvement model—it was written as a tool for maintaining the effectiveness of processes.

Unlike ISO 9001:2015, ISO 13485:2016 will not allow manufacturers to rationalize documentation. In order to ensure companies meet regulatory requirements, ISO 13485:2016 is more prescriptive, and requires that certain procedures still need to be documented.

Risk management is also a very key element of ISO 13485:2016.

There is no significant relationship between ISO 13485:2016 and ISO 9001:2015—the Quality Management System fundamentals standard.

ISO 13485:2016 is compatible with other “non-quality” management systems such as ISO 14001, or OHSAS 18001