Principal Auditor (RABQSA): ISO 13485:2016

In 2014, Lori obtained the Principal Auditor (RABQSA) certification from Exemplar Global.

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The Qualification Based Quality Management System (QMS) program has been accredited under ISO17024:2003. To ensure continued maximum effectiveness, a quality management system requires regular performance assessment. This is best achieved by using competent auditors. The benefits being:

  • Provides international recognition for professionals managing quality management systems in accordance with ISO9001:2008 & ISO19011:2011. This also includes ISO13485:2003; with an update to ISO13485:2016.
  • Provides proof of competence to effectively manage quality issues via extensive examination of knowledge, work experience and competence to audit.

Built in liaison with industry representatives in accordance with ISO 19011:2018, Exemplar Global’s Medical Device Management Systems Certification Program provides Lori with proof of her competence to effectively manage medical device issues.

Medical Device Single Audit Program (MDSAP) Internal Auditor

In 2019 and 2020, Lori obtained the Medical Device Single Audit Program (MDSAP) Internal Auditor certification from Exemplar Global and European Union Medical Device Regulation (EU MDR) certification from Oriel STAT A MATRIX.

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The program provides international recognition for auditors who conduct Medical Devices audits using national or international management system standards (eg. ISO 13485:2016), or other management system standards, normative and industry references that are recognized by Exemplar Global.

Lori conduct internal audits in a medical device organization that has MDSAP quality management system certification. Through this certification she has demonstrated that she has competency in the medical device QMS requirements for the MDSAP participating countries. Exemplar Global’s MDSAP Internal Auditor Certification gave Lori recognition to stand out from the crowd.

Through extensive examination of Lori’s knowledge and personal attributes, Exemplar Global’s MDSAP Internal Auditor Certification can give you proof of Lori’s competency to effectively audit following the MDSAP Audit Model.

Built in liaison with industry representatives, Exemplar Global’s MDSAP Internal Auditor Certification provides Lori with proof of her competency to effectively audit the quality management systems of MDSAP certified organizations.

EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)

Lori participated in the interactive, case study-based training that prepared her to audit to EU Medical Device Regulation requirements using real-life scenarios and examples.

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This class was designed for experienced Auditors who are already familiar with ISO 13485 and ISO 14971, Lori gained the knowledge and experience needed to perform internal and supplier audits to the EU MDR requirements.

This class was offered through Oriel STAT A MATRIX, which is a registered training provider for Exemplar Global. Lori achieved a passing grade on the course’s final exam and earned both a certificate recognized by Exemplar Global as evidence of her competency as well as an Oriel STAT A MATRIX credential in assessing proficiency.

U.S. Regulatory Affairs Certification (RAC)

In 2010, Lori obtained the U.S. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).

Regulatory Affairs Certification, known as the RAC, is the only certification specifically for regulatory professionals in the healthcare product sector. The RAC credential is a professional distinction that denotes commitment to excellence, pursuit of knowledge and career advancement. RAC-credentialed professionals are among the current and rising leaders in the regulatory profession. They work in all parts of the world and in many settings, including industry, government and academic organizations.

Link to Regulatory Affairs Professionals Society

Certified Quality Auditor (CQA)

In 2010, Lori obtained the Certified Quality Auditor (CQA) certification from the American Society for Quality (ASQ).

The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system’s adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.

Link to the American Society for Quality