The role of internal audits in MDSAP audits

As MDSAP deadlines draw near companies are asking how to prepare for the MDSAP audit. The most basic step for the success of any management system is to say what you do and do what you say. When the system as documented is captured to reflect the “As-Is” of how it is done then implanting the system leads to conformity at all levels.
Auditing Organizations (AOs) that will come to assess the conformity of the system will be using a process-based approach to the audit as also prescribed by ISO 13485 and ISO 19011. As such internal audit teams too should be trained to conduct process-based audits. This will ensure that the organization will be ready and familiar with the way the AO audit will be conducted. Process-based audits also allow a better look at how the system is working to meet objectives. In the aerospace industry PEAR diagrams are used to identify the inputs, resources and controls for each process to better understand the interrelation of them within the process, whether they are sufficient and how they interact with other processes.
In the process audits for MDSAP the AO will first start with an audit of the leadership (top management) to appreciate their commitment to the system as also their awareness of the risks impacting their system and the actions, they are taking to address them. At each level the auditors will be seeking evidence of competence, documentation and data control and monitoring and measurement being done.
Internal audit teams should use a grading system familiar to those used by MDSAP auditors and as prescribed by HTF/SG3/N19:2012. The grading system follows a scale of 1 to 5 with 5 being the most severe. This will enable a realistic look at the state of the system. Auditors will also focus on the design and development and production controls from a risk perspective. They will assess how well the outsourced providers are controlled and what risks were determined in assessing the type and extent of control to be applied.
As with all systems auditors will want to assess that a system exists to identify and deal with non-conformities including implementation of corrective action within the defined time frame. Internal audit personnel can gain a better understanding of MDSAP audits and how to prepare by enrolling in QMII’s suite of course offerings tailored to various levels of the organization. Keep in mind that MDSAP audits are longer in duration as the audit time is based on tasks and not the number of employees.