Violation of international standards and legislation of Ukraine during calculation of standard time for the conformity assessment of medical devices with the Technical Regulations may result in termination of the certificate of conformity. Why is this and how to avoid it Tatyana Pazerskaya, Director, Chief Auditor with 20 years of experience of the conformity assessment body Improve Medical, tells:
– How does determination of the cost of conformity assessment of medical devices with the Technical Regulations begin?
– The conformity assessment of medical devices with the Technical Regulations begins with calculation of time necessary to verify the organization depending on the company size and the conformity assessment procedure selected.
It is the amount of time per one auditor of the conformity assessment body that forms the basis of the pricing formula according to Resolution of the Cabinet of Ministers of Ukraine of July 12, 2017, No. 514. It stipulates the procedure for determining the cost of works that the conformity assessment bodies should follow: the standard time for performance of works (days of audit) and the estimated cost per unit of time in relation to the manpower engaged, the cost of works, including administrative and other indirect production costs are taken into account.
However, the essential determination of the amount of time necessary for audit is based on the common international standards ISO/IEC 17021, ISO/IEC 17065, and the standards itemizing such requirements – guidelines IAF MD 5, IAF MD 9. The above documents are mandatory for implementation by all accredited conformity assessment bodies in Ukraine. Otherwise the designated bodies may be deprived of accreditation.
– What parameters is the conformity assessment body guided by during determination of the audit time?
– The starting point for determining the time is the number of personnel, availability of separate production sites, and number of shifts in a particular enterprise. Further, the base time is adjusted for factors that can reduce or increase the audit time.
The conformity assessment body Improve Medical uses a special dependency table of enterprise data for calculating audit days. In Europe, market surveillance institutions may test implementation of quality management system for manufacturers of medical devices. During such control, the manufacturer has the right to request the documents of the conformity assessment body to verify whether the audit time was calculated correctly.
For the conformity assessment body to calculate audit days, the application for audit must have the following sections:
– number of employees of the enterprise;
– number of production sites that belong to the manufacturer;
– subcontractors/suppliers of the manufacturer
– number of shifts.
For example, in the production with 100 employees in accordance with the table, the total audit time of the quality management system will be 10 days at the first and second stages. The first stage is evaluation of documents, which should end with site visit. The second stage is direct verification of the quality assessment system and technical documents.
In this case, the maximum possible reduction of this period is 20%, i.e. we can reduce the time only up to 8 days, of which the share of the second stage is 80%, or 6.4 days.
If the commission of the conformity assessment body consists of 2 auditors, we can divide the time into two, thus, it will turn out to be a little more than 3 days of stay of the auditors at the enterprise.
I would pay attention that the price of the total number of audit days is calculated. The increase in the number of auditors, as shown above, reduces the total amount of time spent, brings less inconvenience, reduces the time and, accordingly, the payment of the engaged employees of the inspected enterprise. There may be cases when the manufacturer will issue an invoice to the authorized representative in Ukraine for the fact that its employees were cut off from the production process during the audit.
– Is the accuracy of pricing estimate of the conformity assessment body verified in Ukraine?
– The National Accreditation Agency annually inspects the conformity assessment bodies during confirmation of accreditation. If the results are unsatisfactory, the National Agency may apply to the Ministry of Economic Development and the Ministry of Health, which regulate designation of the conformity assessment body. The conformity assessment body will be obliged to perform the necessary corrective actions or may cancel the designation.
Thus, it is very important for the top management of manufacturers to understand that their employee when fulfilling the task: “to find a cheaper option and assess conformity of medical devices quicker” may do more harm than good. The companies often do so, they are satisfied with the service of obtaining a certificate, when 1 auditor arrives for 1-2 days without taking into account of and reference to the actual number of employees at the place of production. However, it will work smoothly until a precedent happens. It means until the regulatory authorities verify the conformity assessment body and terminate validity of the certificate of conformity.
Therefore, I urge manufacturers and their authorized representatives to be careful and adhere to the above standards in their work during conformity assessment.
– How can the audit time be reduced?
– The audit time can be reduced by 30% through a remote audit, e.g. holding a Skype conference.
It should also be taken into account what units or production sites should be verified during the audit. Sometimes, the conformity assessment body meeting the needs of the clients is ready to visit only one of the sites. This is a serious violation if medical devices supplied to Ukraine are designed and produced at such sites. The certificate of conformity specifies the sites that experts of the conformity assessment body visited and assessed.
– What other points are taken into account during calculation of conformity assessment?
– According to the Technical Regulations for high-risk medical devices (e.g. class three), the first stage audit (assessment of documents) should be carried out on-site. Thus, the problem of ensuring confidentiality of information about developments, which manufacturers often do not want to transfer to the conformity assessment body remotely, is resolved.