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Certificate ISO 9001:2015. What is it needed for and how to get it

For most of our clients from the sphere of medical business, getting the ISO 9001:2015 certificate (also known as the QMS certificate) is not the ultimate goal. The point is that this document is an obligatory element of many legal procedures, without which it is impossible to run any type of activity.

Who needs it

The main categories of business entities in the sphere of medicine that need to get the QMS certificate (for a quality management or control system) are:

  • institutions that require the issuance of a certificate in accordance with the direct requirement of the law. For example, to issue medical certificates to seafarers;

  The  article on the topic: Issuance of  medical certificates to seafarers.

  • medical service providers, for whom certification is an intermediate step in getting another document. For example, to obtain the highest accreditation category, which, in turn, is required to engage in certain types of activities.

Our service: Accreditation of a medical institution (assistance in obtaining accreditation from the Ministry of Health)

The role of a lawyer

The ISO 9001: 2015 certificate for a medical institution is issued based on the results of an audit by a certification body that has undergone the necessary accreditation procedure. Since such bodies issue a QMS certificate completely independently, it is logical to ask, “Why is it worth turning to a qualified lawyer for help?

  • as noted above, getting an ISO certificate is usually not a goal in and of itself. This is only one of the steps towards getting another authorization document.

Practice shows that an assessment body can do the job flawlessly; however, due to inaccurate information transfer from the client, the QMS can be evaluated against the wrong classification of occupations. Important processes may not be taken into account, etc. The lawyer will see to it that the procedure is carried out flawlessly;

  • Lawyers' partnership with assessment bodies often allows for an audit without a visit to the location of the client, which is not always possible with the direct appeal;
  • the possibility of speeding up procedures due to the development of the necessary internal documentation, which should be in the medical institution.

Practical Case Study

One of the last projects in getting an ISO 9001: 2015 certificate which was successfully delivered by our company was support of the medical center that intended to issue medical certificates to seafarers.

By virtue of the provisions of the Manila Amendments to the International Convention for the STCW (on the training and certification of seafarers and keeping watch) in 1978, the issuance of medical certificates to the sea crew should be carried out under constant supervision, using a system of quality standards. 

This requirement is rather veiled in the current legislation, and, therefore, most medical institutions, planning this type of medical examinations, will learn about it only at the stage of inclusion in the appropriate register.

For QMS certification, our lawyers have helped to:
  • conclude an agreement between the client and the assessment body;
  • fill out an application for certification;
  • develop the necessary internal documents;
  • successfully pass the audit with the issuance of a certificate for a total of 1 month.
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