An audit of the valid quality management system (QMS) at an enterprise is the first and, perhaps, the most important stage of preparation for the inspection control by Roszdravnadzor, as well as for production certification with a view to obtain an ISO 13485 certificate of compliance.
Types of Audit
Audit can be conducted either in-house (first party audit) or by outsourced experts (external audit). External audit is also divided into second and third party audits.
Second party audit is conducted by specialists of a partner company (interested party). Its result will help a partner (or potential partner) assess the possible risks of cooperation.
Third party audit is conducted by an entity not interested in audit results, e.g., a consulting company.
The external audit aims to determine, if an enterprise meets the requirements of ISO 13485 and if a company is ready for the inspection control by Roszdravnadzor or for certification audit.
Advantages of external audit:
- Objectivity. Outsourced specialists are less likely to overlook any faults than company employees.
- Efficiency. Consulting company experts are deeply experienced and qualified, as well as know any specifics the Roszdravnadzor inspectors or auditors of a certification body may attend to.
- Greater significance of audit results for company management. Confidence in the inspection results by third-party specialists is higher than the results of an internal audit.
External Audit Procedure
The audit includes two stages:
- Adequacy check. It is performed to determine how well the quality management system documents comply with the requirements of ISO 13485. It may be performed either by comparing the requirements of ISO 13485 with the relevant QMS documents or in the opposite way — through the step-by-step verification of the QMS documents and determination of their compliance with the requirements of the standard.
- Compliance check. At this stage, it is determined how well the documentary QMS is implemented in production and maintained at various stages. The focus is on comparing the actual implementation of documented procedures and the ISO 13485 requirements.
Main Stages of Audit.
- Determination of the goals, timing and criteria of the audit, formation of a group of expert auditors, work plan preparation
- Check of the compliance of documentation with the requirements of ISO 13485 (adequacy check)
- Compliance audit (check of the actual use of QMS documents at an enterprise)
- Report preparation and presentation to interested parties, final meeting with the organization’s management based on the audit results
- Development of recommendations for the enterprise’s QMS adjustment, their approval and implementation
- Verification of implementation of recommendations and evaluation of effectiveness.
The duration and content of the audit depends on many factors. They are influenced by the size and type of entity, type of activity, availability of subcontractors, etc.
Operating Principles of Our Auditors
When contacting First Complex Registration Company, you can be sure that our specialists will conduct a high-quality audit that will help you properly prepare for the inspection control by Roszdravnadzor or for a certification audit.
Our basic operating principles:
- Full confidentiality. Information about your company will remain with the audit experts.
- Independence, impartiality and objectivity. Our auditors are unbiased and rely only on verified information.
- Uniformity. The audit is always conducted in accordance with a formally established procedure, which allows for objective comparison and tracking of changes.
- Consistency. Each QMS process is assessed from the perspective of its relationship with other processes and functioning within the entire quality management system.
- Documentation. All results and procedures will be documented for further analysis and preservation of information about the actual state of the management system.
After the audit by our experts, you will receive specific recommendations on what needs to be adjusted in the QMS to pass inspection control or certification audit. This will allow you to save time and money considerably.