Certificate iso 9001, iso 13485

ISO 9001 Certificate, Quality Certificate, etc.) – a document issued according to the rules of the certification system in order to confirm the conformity of the quality of work and services in an organization with the requirements of current ISO 9000 standards.

Send us the following information to the post office: the name of the standard for compliance with which certification will be carried out, area of ​​activity, number of employees, location of the company, presence of branches and their remoteness.

The set of documents that you receive when certifying the QMS from us:

– certificate on SMK;
– certificates of 2-3 experts on the appointment of internal auditors;
– audit plan;
– audit report;
– act of non-compliance with the QMS during certification (minor non-compliance);
– the right to use the system mark.

ISO 13485

ISO 13485 or the quality management system for manufacturers of medical devices is a standard developed based on ISO 9001, but with fundamental differences with it. If ISO 9001 is constantly being modified, then ISO 13485 only requires implementation and support. ISO 13485 imposes more stringent requirements on the quality management system and is used for companies involved in the design, development, manufacturing, installation of medical equipment and customer service.

ISO 13485 has a number of requirements for companies producing medical products:

documentation of the design and development of medical devices
requirements for product cleanliness and pollution control
requirements for sterile medical devices
hygiene requirements for equipment, personnel and premises
feedback requirements for timely warning of quality problems