Technology, Software, Products

What is ISO 13485?   ISO 13485 is an international standard published by the International Organisation of Standardisation (ISO) that shares the requirements for a comprehensive Quality Management System (QMS) for the design and manufacture of medical devices. The products include medical devices in the categories of medical equipment, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products. The latest version of the standard is ISO 13485: 2016 and meets the requirements of IEC 60601-2-25: 1993 + A1: 1999 safety of Electrocardiograms. It is has kept up with the changes in technology and regulatory requirements in the supply chain for medical devices and related services. ISO 13485: 2016 has replaced ISO 13488: 1996, ISO 13845: 2003, EN 46001: 1997 and EN 46002: 1997. ISO 13485 : 2016 Certification Benefits Accredited ISO 13485 : 2016 certification has various advantages including: •  Improved Credibility in t...

What is ISO 22000? ISO 22000 is a family of standards for Food Safety Management System (FSMS) to help organisations in the food chain prepare, pack, distribute and sell food that is safe for consumption. ISO 22000: 2005is a Food Safety Management System helps minimise food-borne hazards so that safe food products are delivered to the final consumer. ISO 22000 is compatible with the ISO 9001 standard. It can be implemented alone or with other ISO standards.Contact an ISO certification company in India if you want to get ISO 22000 certified. Benefits of ISO 22000 Certification to the Food Industry Here are a few reasons why you should consider getting an ISO 22000: 2005 certification for your organisation: •  High-quality Products: A robustFood Safety Management System (FSMS) helps maintain the quality of food products at all stages of the food chain since the organisations at all stages of the food chain can follow the ISO 22000 standard. • Reduction in the Rate of Food-bo...

ISO 9001 is a widely-recognised quality management system standard that belongs to the ISO 9000 family of standards.International Organisation for Standardisation (ISO) first published the ISO 9000 family of standardsin 1987 based on BS 5750 series of standards from BSI proposed to ISO in 1979. Since then ISO 9000 standards have been adopted across the globe in different industries and revised numerous times to stay relevant with the changing times.ISO 9001:2015 is the latest version of the said standard. ISO Certification Services If an organisation wants to get ISO certification services , it must first contact an ISO certification company. Based on where the organisation is on its ISO 9000 certification journey, the certification company carries out an independent assessment and suggestsa plan of action to help it comply with the ISO standard.  There are two types of audits required for an organisation to become registered to the standard, internal and external. ...