quality

QUALITY

Biolife

Biolife Medical Pvt. Ltd. has established comprehensive Quality Management Systems that integrate compliance with the Indian FDA and applicable international standards (ISO 13485, Medical Device Directive) & follow below quality features.

  • Fully automated German Blood Bag RF welding machine
  • Automated Sterilization, Dryer & Solution filling process.
  • ISO certification( EN ISO 13485:2012/ISO 13485:2003/ISO 9001:2008 )
  • In house fully equipped classified Microbiology lab, Physical & Chemical lab.
  • Highly classified clean room manufacturing facility.
  • CE certification

 

BLM ’s Quality Systems are specifically intended for the design and development, manufacture, and supply of Blood Bags.

Copies of these certificates can be obtained on request once samples are requested.

ISO 13485 is a recognized standard prescribing quality assurance management for the manufacture of medical devices. ISO 13485 presents a basic model for quality assurance covering design and development controls, manufacturing, installation, and servicing. Certification of compliance to the Medical Device Directive is required to allow the manufacturer to create the Declaration of Conformity and to affix the CE mark with the notified body number to their product labeling.

BLM has established Quality Systems that incorporate the elements of these standards. Some fundamental principles of the BLM Quality Systems include the following:

  • Top Management actively supports the achievement of product and service quality by creating and deploying a written Quality Policy;
  • The BLM Quality Systems have been created and maintained by keeping a comprehensive set of controlled procedures/documents and having the resources needed to achieve quality.
  • Work that affects product and service quality is carried out as controlled processes. This requires that the processes are effectively managed by establishing defined procedures, controlling documentation, maintaining records of authorizations, auditing the quality system to keep it current, taking corrective action, calibrating measuring and test equipment.

 

Certificates