Certified Quality System Manager (CQSM)
The objective of the AAMI Credentials Institute is to be the trusted source for quality professional development and credentials for healthcare technology-oriented professionals and entities in higher education, industry, and healthcare delivery. To achieve this objective, the ACI offers a certification in quality systems management.
As healthcare becomes more complex, certification becomes an assurance of the competence of practitioners. Certification strengthens the public confidence in safer healthcare systems staffed by quality oriented providers. Quality system professionals seek this certification as a way of demonstrating their professional accomplishments, mastery of skills, and experience in core competencies.
The CQSM certification goes beyond assessing knowledge of standards and regulation. It is based on a holistic view of the roles and responsibilities of experienced quality system professionals and how they contribute to better, safer products.
Quality system managers oversee all aspects of quality assurance including establishing metrics, applying industry best practices, and developing new tools and processes to ensure that quality goals are met. They also manage the process and resources for identifying, correcting, and improving non-conformities in product specific policies, procedures, and protocols as well as product specifications. Additionally, all of this is accomplished in a manner that ensures compliance to all relevant regulatory requirements. Finally, quality system managers control, direct and/or lead the establishment and maintenance of an acceptable quality system and report on the performance of the quality system to executive management.
The CQSM certification program eligibility requirements reflect a relatively high level of education, years of medical device industry experience as well as years of quality system experience. The award of the certification is based on successfully passing an examination related to the knowledge and skills necessary to perform quality system functions.
Recertification requirements are a combination of work experience and continuing education to demonstrate sustained competency and knowledge in the quality system field.