ISO 13485 outlines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. When the standard was revised in 2016, greater emphasis was placed on training. While training is an important part of all ISO medical device standards, ISO 13485 training requirements now specify that "the organization shall determine any user training needed to ensure specified performance and safe use of the medical device." This is similar to the European Union's Qualified Person (QP) role.
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The ISO 13485 training requirements outlined in the latest version of the standard, ISO 13485:2016, emphasize training to quality processes, establishing competence, and awareness of personnel duties. In a nutshell, a medical device manufacturer is required to evaluate the efficacy of its ISO 13485 training commensurate with risk, i.e., the risk associated with the work employees perform. This closely resembles the requirement for a Qualified Person (QP) contained in the EU Commission Proposal for a new regulation to cover medical devices. A QP is defined as the manufacturer's authorized representation who is responsible for regulatory compliance. This person should work within the organization.
Broadly, QP training covers the regulatory compliance requirements associated with the design, manufacture, release and post-market surveillance activities of medical devices in Europe. Expertise can be demonstrated with a diploma or formal qualification in natural sciences, medicine, engineering or another relevant field of study, plus a minimum of two years of professional experience in regulatory affairs or quality management systems specific to medical devices. In some cases, additional work experience (five years or more, can satisfy the academic requirements. Because ISO 13485 certification is often the first step toward compliance with European regulatory requirements, ISO 13485 training is highly recommended.
ISO 13485 conformance is proven through a rigorous internal and external auditing and certification process. ISO, i.e., the International Organization for Standardization, itself does not provide certification. Conformity assessments (external audits) and certificates are provided by independent third-party certification bodies, known as registrars. Internal audits are conducted by employees of the medical device company, or consultants hired by the company for the purpose of conducting an ISO 13485 audit. Many times these consultants also provide ISO 13485 training so that internal auditors learn how to lead their own audits efficiently and effectively. When hiring a certification/accreditation expert to provide ISO 13485 training, it is important to find a trainer who can provide:
Once auditors receive ISO 13485 training, they will be ready to create an ISO 13485 audit checklist to perform internal audits. Remember, an internal audit can be conducted on a product or service, particular quality process or an entire quality management system. An audit checklist, a list of tasks that must be executed during an ISO audit, helps ensure that nothing fails between the cracks.
ISO 13485 training is available to teach auditors how to create a simple audit checklist, but here are some questions that must addressed:
1) What is the auditor planning on inspecting?
2) Was the inspection provoked or is it a routine procedure?
3) Will the auditor need access to specific documentation during the audit?
4) Is there a planned methodology for the quick retrieval of documentation and proof of all essential audit trails
5) Will the auditor need access to specific personnel members during the audit?
ISO 13485 training that a checklist that meets your company's needs will help ensure an effective quality audit.
MasterControl is a global provider of quality management software solutions for regulated companies. In addition to software, the consulting arm of MasterControl, MasterControl QCC (Quality and Compliance Consulting) offers guidance and training in seven core regulatory, compliance and quality disciplines: regulatory acceptance, supply chain management, validation/qualification, certification/accreditation services, QMS, new product acceptance and quality process training, including ISO 13485 training.
QCC ISO 13485 training is led by QMS experts and lead auditors who are recognized as top leaders in their field. Each consultant/trainer brings a minimum of 20 years of real-world GxP experience to your project. Aside from providing auditor and lead auditor ISO 13485 training, QCC can also help you obtain ISO 13485 certification, which can add tremendous value to your brand.
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