CLEANIS is ISO 13485 certified

A quality guarantee in the production of Medical Devices, for 10 years

The CLEANIS Quality approach complies with legal and regulatory requirements in order to ensure the safety and performance conditions of medical devices.

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ISO 13485 is the internationally recognised standard for the implementation of quality management systems for medical device manufacturers. This system is based on 5 pillars:
  1. 1

    A commitment from Management

  2. The daily involvement of Management has allowed the processes/activities of the company to be implemented, developed and continuously improved. Management is involved in: the establishment of a quality policy and implementation of strategic quality objectives for each process,the establishment of environmental conditions,the establishment of a setting conducive for staff involvement. Conducting an annual review of all processes/activities of the company in order to identify areas of improvement in the efficiency of the company as well as the identification of improvement projects or the creation of new products.
  3. 2

    Staff involvement

  4. By raising awareness and training, CLEANIS greatly increases the motivation and involvement of the staff to achieve the company’s objectives.
  5. 3

    Process approach

  6. The CLEANIS quality management system is based on identifying and monitoring the processes/activities of the company. This approach significantly improves the effectiveness of the system by:

    • Shortening production cycles,
    • Optimising resources,
    • Allowing better communication (inter-process / activities),
    • Ensuring customer satisfaction.
  7. 4

    Controlled documentation

  8. This illustrates one of the founding quality principles within CLEANIS: “Write what must be done, do what is written and write what was done”. This principle allows for the sharing of practices and to effectively welcome new arrivals into the company.
  9. 5

    A mutually beneficial relationship with suppliers

  10. The company depends on its suppliers to produce goods and services. The spirit of partnership is evident by clear rules, open communication and collaborative approaches. By following this same quality approach, any adverse effects arising from the use of CLEANIS products must be reported:

    • By phone: 0 800 100 229
    • By email: information.vigilance@innothera.com