IQA & MRM
Internal Quality Audit (IQA)
Internal Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO 13485 standards from the 2003 to 2016, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
Quality audits can be an integral part of compliance or regulatory requirements. One example is the US Food and Drug Administration, which requires quality auditing to be performed as part of its Quality System Regulation (QSR) for medical devices (Title 21 of the US Code of Federal Regulations part 820).
Maven Auditors can conduct Quality Internal Audits to ensure required compliances as per applicable standards are in place, most important objectives of an internal quality audit is measuring the effectiveness of an organization's quality management system, for this to happen, our auditors first meets their overriding responsibility of establishing and maintaining a system regarding quality policy, goals, resources, processes and effective performance including monitoring and measuring the system's effectiveness and efficiency, generate an exhaustive audit report to find out all possible non-compliances during External audits.
Management Review Meetings (MRM)
A Management Review is a formal, structured meeting which involves top management and takes place at regular intervals throughout the year. They are a critical and required part of running an Quality Management System.
The purpose of a Management Review meeting is to review and evaluate the effectiveness of your Management System, helping you to determine its continued suitability and adequacy. The Management Review does this by encouraging top management to consider the degree by which the Management System:
- Achieves the expected results
- Meets the organisation’s requirements
- Functions in accordance with the established operating procedures and processes
- Is capable of identifying non-conformities and monitoring subsequent corrective and preventive actions.
A Management Review also ensures that all levels of management are made aware of any changes, updates, revisions, etc. to the day-to-day workings of the Management System itself.
As Management Reviews are so important to getting the most out of a Management System, the member of senior management that has overall responsibility for the Management System is also accountable for convening, attending and reporting on Management Reviews.
And as most of the Senior Management are not having sufficient time for conducting above activities we Maven can help you conduct these meetings as per ISO requirements & make the most of it.