DNV MEDCERT Quality Policy

The neutrality and competence of our service is the basis for the trust placed in us by health professionals, patients, authorities, and the medical device industry.

• We are an integral part of the implementation of European Directives focusing on the safety of patients, users, and third parties, and we are fully aware of our role.
• The reliable provision of a continuous and high-quality service is the responsibility of our staff. Top Management undertakes all steps needed and provides the necessary means to achieve these goals. This includes, for example, the employment of a sufficient number of qualified staff members to be able to perform the certification procedures we are commissioned to perform in compliance with the requirements.
• All documents, information, product samples, and any other objects submitted to us by our customers shall be treated as “strictly confidential” in all cases and by all staff members of our company. This also extends to the members of the Scientific Advisory Board and our contractors. All individuals, groups, and companies involved in this process are contractually obliged to maintain strict confidentiality.
• We receive the requirements of our customers, review them, and meet them within the scope of the regulations and requirements.
• Our service is available to all interested parties anywhere in the world. All customers are treated equally regardless of nationality, organization, company or individual.
• We ensure that our activities are offered without any commercial or financial pressure and exclude any bias in the certification activities.
• We ensure impartiality, independent decisions and a fair and correct relationship to every customer. This implies the prevention of intimidation and self-interested threats, the keeping of a strict separation between assessment and certification on one hand and independence of personnel from external influence on the other, the maintenance of our neutrality and the exclusion of any consulting or similar activity.
• We have installed a Committee for Safeguarding Impartiality which consists of representatives of parties affected by our activities.
• We fully understand the importance of impartiality and ensure the objectivity in all our certification activities. We will not provide any certification in cases when a relationship poses an unacceptable threat to our impartiality.
• We manage any foreseeable conflict of interest.
• We will never certify the management system of another certification body, offer or provide any consultancy or internal audits to our certified customers.
• We will never outsource audits to any other organization.
• Consultant companies are not permitted to market or link their activities to our certification activities. We will take action if we see inappropriate claims from consulting companies stating or implying that certification would be simpler, easier, faster or less expensive if customers are using our services. In addition, we will not state or imply that certification would be simpler, easier, faster or less expensive if a specific consultancy organization were used.
• To avoid any conflict of interest, we ensure that personnel, employed in the past by a customer, will be used in the corresponding areas not before the end of a fixed time of competitive restriction.
• We will take action and respond to any threats to our impartiality arising from actions of other persons, bodies or organizations.
• All our personnel, either internal or external, or committees, who could influence our certification activities, will act impartially and will not be put under commercial, financial or any other pressure which could compromise their impartiality.
• We require all our internal and external personnel to reveal any circumstances known to them that may present them or us with a conflict of interest. In such cases we will not use any internal or external personnel unless they can demonstrate that there is no conflict of interest.
• We use the accreditation mark only for premises that are included in our scope of accreditation.
• We make claims of our accreditation only in respect of activities which has been grated accreditation.
• We will never use our accreditation in a manner that brings the accreditation body into disrepute.
• We will never make a statement regarding accreditation that may be considered misleading or unauthorized.
• We will never allow the fact that our accreditation is used in a manner that anybody may imply that a product, process or person is approved by the accreditation body.
• Complaints and appeals are handled by MEDCERT according to a defined procedure. For the procedure please go here: Verification of Complaints.

Declaration of interests with regard to impartiality

We, members of the Certification Body management, hereby declare, that we are not designer, manufacturer, supplier, installer, owner or maintainer of devices which we assess, nor the authorized representative of any of those parties.  We do not engage in any activity referred to in Annex VII section 1.2.3 points (b) to (d) of Regulation (EU) 2017/745.  This does not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes.  Further to this, we are not linked to any organisation which itself provides consultancy services as referred to in Annex VII section 1.2.3 point (d) of Regulation (EU) 2017/745.  With our procedures, we assure that our assessment personnel and subcontractors involved in the assessment activities meet these requirements with regard to quality management systems and devices which they assess.  The level of our remuneration, as well as the level of remuneration of the assessment personnel and subcontractors involved in the assessment activities, does not depend on the results of the assessments.

(The individual signatures are kept on file).