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In highly regulated industries like life sciences, robust auditing processes are essential to maintaining quality, safety, and compliance. At Regulatus we provide comprehensive first-party and second-party auditing services to help businesses meet regulatory standards, optimize operations, and strengthen their supply chains. We offer quality management system auditing in accordance with the principles of, and (if needed) the requirements of ISO 19011 and to a variety of standards including, but not limited to ISO 13485 and ISO 9001. The following audit services are provided directly by us:
We can also support the sourcing and engagement of third party certification bodies and attend or host these audits.
Furthermore, we can also provide support to third party certification bodies in terms of internal audits to ISO 17021-1 or contracted third party audits (contracted to a specific auditor/reviewer).
Many of our consultants are IRCA registered, and all are appropriately trained, with evidence of competence provided as standard.
