ISO 13485


International standard ISO 13485 was developed in 1996 based on ISO 9001. It establishes quality requirements for manufacturers of medical devices and their control systems. ISO 13485 covers, registers and controls the entire journey of a product – from the procurement of raw materials to delivery to the consumer.

Unlike ISO 9001, the standard requires continuous improvement and quality improvement. The emphasis is on customer requirements, risk management and maintaining a safe design of medical devices. The second distinctive features of the ISO 13485 can be noted that, under the instructions of the management company should always develop a risk management plan step-by-step description of actions in situations of increased risk.

Also in ISO 13485 contains requirements to:

  • hygiene of the entire production (from personnel to equipment);
  • sterility of the product;
  • environmentally friendly production and products;
  • documenting all phases of product development;
  • more scrutiny of the products;
  • qualitative feedback of the client and the company.

The benefits of the apply of the ISO 13485
ISO 13485 is important for companies developing and producing medical products. Standard ISO 13485 allows the:

  • properly distribute rights and responsibilities between employees;optimally manage its resources;
  • become more prestigious in the eyes of customers;
  • to enter international markets.

USA, Canada, Japan, Taiwan and European Union countries do not allow the export of medical products not certified according to ISO 13485.

Why should you choose certified services in our company?

Our MNC Group is the leader on the Ukrainian market, certification of quality management systems in the medical industry. All staff are leading international specialists who have certificates confirming their qualifications, and extensive experience. Call us, and we will offer you the best certification service on the most advantageous terms in Ukraine.

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