Typically, we recommend implementing a new ISO 13485 quality system plan over a period of 6 months. The reason for this is that people can only read procedures and complete training at a certain pace. Since there are approximately 30 procedures required for a full quality management system, an implementation pace of one procedure per week allows a company to complete 90% of the reading and training in six months.
| Month | Implementation& Training |
|---|---|
| 1 Month | Quality Management System Management Responsibility |
| 2 Month | Resource Management Planning of product realization |
| 3 Month | Customer Related Processes Design & Development |
| 4 Month | Production & Service Provision Control of Monitoring & Measurement |
| 5 Month | Monitoring & Measurement Control of non-conforming product Analysis of Data |
| 6 Month | CAPA Regulatory Requirements |
By performing this we will help you to progress successfully towards the requirements of QMS certification.
Meditix will perform independent standalone pre-audits or a gap analysis audit against your objective standards.
A Gap Analysis is mainly a determination of the degree of conformance of your organization to the requirements of a specification or standard (ISO, API, OHSAS, etc.). A Gap Analysis is mainly a document review or a “show me the evidence” type activity, evidence which usually will come in the form of a record or document. During a Gap Analysis there is very minor auditing being done, rather key process owner or project stakeholders will provide the evidence they may have –or not- for each of the requirements set forth in the specification or standard chosen.
Audit support services allows us to negotiate on behalf of our clients. It is a chance to explain our strategy and rationale to the decision makers
We have high demand by clients to assist them to prepare for audits they need to complete on their suppliers/sub-contractors/outsourcing suppliers or support them during audits from their clients or external bodies.
Our Auditing and Audit Support services include:
Internal audit services outsourcing
An Internal Audit is an activity that also seeks to determine the degree of conformance of your organization to the requirements of a specification or standards (ISO, API, OHSAS, etc.) or to your own organizational requirements. This audit is performed in more than one dimension, through review of documentation evidence and also through actual questioning of employees.
Effective internal audit functions require a diversity of skills that many companies find difficult to source and retain. Maintaining world class internal audit resources requires significant investment in recruiting, training and professionally developing internal audit personnel. Add to that the cost of the latest methodology, technology and management’s time and resources.
To help companies meet the demands of maintaining an effective internal audit function, Meditix has developed its Internal Audit Services (IAS) Outsourcing department. Meditix is a private sector internal audit organization. With our people, methodologies and technology we are able to solve all the internal audit needs of any organization.