On December 08, 2021, the Bureau of Indian Standards (BIS) has issued the Bureau of Indian Standards (Conformity Assessment) (Sixth Amendment) Regulations, 2021 further amending the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
A new Scheme-IX has been inserted in Schedule-II which deals with Conformity Assessment Scheme for Grant of licence to use or apply Standard Mark for goods and articles conforming to Indian Standard combined with conformity of management system to Indian Standard and conformity of process requirements. The Scope of the scheme is based on combination of product certification and management system along with process requirements, if applicable, the Bureau may grant licence to use or apply Standard Mark for goods or article manufactured in a manufacturing premises which conform to all requirements of Indian Standards for that product and demonstrates conformity of management system to the relevant Indian Standards and conformity to process requirements, as specified.
Key points discussed in the Scheme:
- Process of the scheme: The manufacturer shall identify:
- applicable Indian Standard for the product, and the applicable management system, as required, Indian Standard against which it intends to obtain a licence.
- machinery available in manufacturing premises and prepare a list and if any part of the manufacturing activity is outsourced, details of controls exercised shall be indicated.
- test equipment required to carry out testing in accordance with the relevant Indian Standard, relevant inspection and testing plan and prepare a list of the available equipment;
- for the tests which are permitted to be sub-contracted and not available with the manufacturer, he shall identify test facility outside the factory where such tests can be carried out and inform the same to the Bureau.
- Determination: The Bureau shall, on receipt of the application, examine if all required documents have been submitted in the application, and if the application is complete, it shall arrange audit for assessment of production process, conformity of product, management system and process requirements.
- Review: The Report of the evaluation visit shall be reviewed for its compliance with the requirements.
- Decision: The decision on the grant of the license shall be taken when the Bureau is satisfied that the manufacturer has necessary infrastructure for manufacturing quality product on a continuous basis, the test results indicate conformity of the product to the specified requirements is in conformity with the relevant Indian Standard.
- Labelling and Marking Requirements: Each product or the package or both under the license shall be marked with the licence.
- Validity of the Licence: The licence to use Standard Mark shall normally be granted for a period of 3 years. The licence to use Standard Mark is normally re-certified for a period of 3 years and shall be effective from the date specified in the order.
- Annexure-I deals with fee structure for application, audit, certification, re-certification.