Our services are conducted using the four-eyes principle, which mandates the evaluations by the audit team and product experts be followed by an independent review for final decision.

Transfer of Certification applications are also being accepted, in addition to applications for Certification Renewal. You are provided documented results that can be immediately applied for making adjustments in your processes prior to commencing with the mandatory audits. guide understanding of ISO 13485 and its application is given by first listing the full text of ISO 13485, followed by the intent of that section and relevant guidance. The process facilitates timely and effective preparation for the official EN ISO 13485 audit process. Official confirmation certifying the integrity of your quality management system and complete compliance to the standards.įirst-time applicants benefit greatly from opting to undergo the preliminary audit. On-site evaluation of quality management system for excellence in areas of applied practice and efficiency. The only difference is the addition of the Z annexes. Voluntary site inspection and quality management documentation review assessing your readiness for full-scale Phase I & II auditing.Īssessment of certification eligibility determined by results of on-site audit, quality management documentation analysis and business assessment. With respect to ISO 13485:2016, there is no difference in the main text between EN ISO 13485 and ISO 13485.