Quality Management System – Medical Devices

As part of our commitment to impartiality with our applicant and certified organization relationships, InterGlobal Certification manages neutrality on an individual staff auditor level and on an account level to ensure objectivity across all assessment activities. InterGlobal Certification has also established an independent external committee to review the effectiveness of these controls. The committee has the authority to make decisions affecting the business to safeguard against the compromise of impartiality, such as by actions of self-interest, self-review, familiarity, or intimidation.

InterGlobal Certification applies the procedures detailed within ISO/IEC 17021-1, as well as other normative references governing the audit activities within the scope of certification. An organization’s obligations at the time of application are communicated in the form of a certificate agreement and vendor terms within our master services agreement. Supplemental details that support certificate decisions concerning granting, refusing, maintaining, renewing, suspending, restoring, or withdrawing certification, in addition to the expansion or reduction of certificate scopes, are also described within this agreement.

Certificate decisions are facilitated by a centralized team of subject matter experts who review each audit file for conformity to the internal quality system maintained by the certification body and normative references made applicable via the management system’s certification body accreditation. A summary of the procedures performed and the objective evidence inspected as part of our examination is communicated in an audit report at each assessment’s conclusion. The report is accompanied by a recommendation from the appointed lead auditor who performed certification activities under the oversight of the accredited certification body.

End users or readers who are in receipt of certificate awards issued by Coalfire Certification can determine the validity and status of certification by accessing the public certificate directory.

InterGlobal Certification reserves the right to suspend certificates of its clients at any time due to situations involving, but not limited to, violations to the certificate agreement, negligence, concealment of material facts, non-conformance to the underlying audit criteria, investigations, complaints, and unpaid invoices for services rendered. Certification is invalidated at any point within a suspension period. All suspensions are clearly labeled within the affected certificate entry available in the public certificate directory.

The use of the certification body’s seal and accreditation marks are strictly controlled, and permissions governing their use may be limited or withdrawn at any time without notice. The certification body’s seal is not to be used in individual email signatures, business cards, or any print or digital forms that may allude to a misrepresentation of the certified scope. Logos and marks may only be applied while the certificate is in good standing per the public certificate directory. For any suspended or revoked certificates, the associated seal or marks are not permitted for use in advertisement or digital media. If the agreement between the certification body and the certified organization is terminated, all permissions relating to the use of the certification body’s seal and accreditation marks are withdrawn and the use of these identifiers is required to be amended at the earliest reasonable opportunity.