Audits according to ISO 13485. Internal, precertification audits.
“Internal audits” firmly among the familiar concepts of progressive organizations, regardless of the profile of their activities. Currently, regular internal audits are not just an additional monitoring tool to identify potential for improvement and continuous perfection, but also in some cases it is the way to ensure conformity with the applicable regulations and legal provisions.
Internal audits could be carried out both with the involvement of external experts as outsourcers and directly with the involvement of employees of companies, provided that they have the relevant level of competence.
8L GROUP offers manufacturers of medical devices services of precertification or internal audit of the quality management system conformity with the requirements of the effective version of ISO 13485 standard.
We carry out audits both at the stage of establishment of the quality system, and in the course of its operation. At the stage of development and establishment of the system there is a need to verify its compliance with specified requirements. After the establishment – the audit will allow to evaluate the effectiveness and suitability of the system, take the necessary decisions. But even certified system is not always effective enough, in this case, you need an audit to identify the cause and to ensure that appropriate corrective actions are taken.
Audit is carried out in coordination with the client at any convenient time and in any period of operation of the company, but it is particularly appropriate at the stage of preparation of the company for certification by the Notified conformity assessment body. 8L GROUP auditors will carry out quick and high-quality audit that will give confidence in the results of the upcoming external audit.
Our auditors are leading industry experts, they have extensive experience in conducting audits according to ISO 13485 and other standards. They are progressive, professional and punctual.
During the audit, you will receive recommendations which allow to improve and optimize the quality management system in place, to bring it in conformity with the applicable legislation.
The main stages of the audit will be:
- preliminary examination of the set of documents, coordination of scope of work;
- coordination of timeline and format of the audit (audit could be carried out directly on site and remotely);
- development of audit plan and audit program, coordination of representatives of the parties;
- audit;
- preparing conclusions/audit report;
- development of recommendations for addressing the identified nonconformities.
Results of audit for the client could be described using the following key points:
- complete and objective view of conformity of the quality system with the established requirements;
- identification of weaknesses, receipt of recommendations on necessary changes and methods of their implementation;
- readiness for external audits, minimization of risk of identification of nonconformities by the Notified conformity assessment body in the course of certification procedure.
As a result of successful audit the parties are mutually satisfied with the fact that the causes for nonconformities are identified as well as methods and means to address them.
Entrust this process to professionals, save time and resources for new opportunities!