The Complete Guide to ISO 13485 Certification

1. Top Management Commitment & project plan

Top management must be engaged in the development and maintenance of the QMS, according to ISO 13485. Top management plays an important role, and as such, they must be engaged and qualified to lead.  The top management is responsible for holding regular meetings, communicating with the organization, constructing QMS policies, ensuring that the objectives are implemented, conducting reviews, and ensuring that the resources required to satisfy the QMS are accessible. Project planning is necessary to help organizations acquire ISO 13485 certification efficiently and ensure quality services and products. Therefore the basic strategy organizations should consider it is task breakdown, timeline, and skills and resources acquired through training.

2. Build competence and awareness

Most organizations undertake an annual performance review for their employees to evaluate their performance and effectiveness. Certification, education, skill development, and experience can all lead to competency. According to ISO 13485 strategy, it tends to result in personnel’s competency to perform the required work roles particular to their responsibilities. According to ISO 13485 certification, it tends to result in an individual’s competency to perform the required job functions particular to their responsibilities. Awareness fundamentally alters one’s mindset and strategy to Management System Standards. The advantages of awareness and competency help; Increase the organization’s profits.  Minimize rework, faults, customer dismissals, underutilization, and operational costs. Also, it enhances the customer’s delight and reduces employee and customer attrition. Thus, increase the trust of all stakeholders.

3. Develop process documentation

ISO 13485, as an international standard for Quality Management Systems in the medical industry, does necessitate specific documentations. The goal of QMS documentation is to: offer a good clear framework of the organization’s operations, to encourage process consistency and a better understanding of the QMS system, and finally, to demonstrate the organization’s success of its objectives and goals. A normal QMS documentation structure contains work Instructions and procedures, quality policy, manual, records, and quality control Plans. A normal QMS documentation structure contains work Instructions and procedures, quality policy, manual, records, and quality control Plans.

4. Implementation of the system to address gaps

Conducting a gap analysis is vital for implementing ISO 13485 certification. To perform a gap analysis or pre-audit ensures the assessment of the organization’s existing processes. They are compared with the standard requirements to which the organization needs to be certified. The pre-audit reveals the gaps between the organization’s existing system and the system required to achieve compliance. The information obtained from the gap analysis provides an implementation plan for ISO 13485 certification.

5. Internal audit

Internal auditing aims to look more closely at the organization’s processes and point out areas requiring improvement. The primary objective is not criticizing but rather finding methods to streamline operations to run more smoothly. ISO 13485 strongly emphasizes continuous improvement of the processes within the QMS, like increased cost and time efficiency. In general, internal audits are often used to maintain compliance and monitor and upgrade the organization’s objectives.

6. Third-party certification audit

Third-party auditing is effective when an organization implements its own QMS according to a standard set of ISO 13485 requirements. After the system has been developed and assessed, the organization should involve a third certification body to evaluate if the organization’s QMS complies with the certification audit. If that is so, the organization is certified. Regular audits are performed to ensure that the organization remains to comply with requirements for the duration of the certification until re-certification.