International Organization for Standardization has been working to publish standard for specific industry. Let us today highlight the standard for medical devices. ISO 13485 Certification- Quality Management System for Medical Devices accommodate norms for safe manufacturing to distribution of medical devices. The primary objective of the standard is to maintain harmony between the legal requirements and the management system. It is obligatory to accomplish ISO 13485 Standard for companies exporting medical devices to other countries. If you wish to get certified with ISO 13485 Standard here are 6 steps that you need to follow:
Step 1: Planning for the implementation of a quality system: if you fail to plan, you plan to fail. Everything, before you implement it, needs a plan. The plan will help to know how, when and why we are doing something. Companies must first plan by consulting a certifying body for example SIS Certifications (one of the leading bodies in the world).
Step 2: Follow the regulatory norms: Organizations must comply with the procedures and statutory norms of ISO 13485 Standards.
Step 3: Implementation of the Standard: Formulation or following the measures won’t work if you don’t execute and implement them in your procedures. So companies need to heed up on infringing them in their functioning system
Step 4: Documentation: One of the important steps is documentation. Organizations must complete their documentation as per the requirement of ISO 13485 Standard. If you wish to know the required documentation, get in touch with the SIS Certifications team.
Step 5: Management Process: Key management processes are corrective and preventive measures, internal audit, and management reviews. It is a very important element of ISO 13485 Certification to integrate the risk assessment and business processes.
Step 6: Certification Audit: Certifying body conducts the audit at two stages, stage 1 and stage 2. If the procedures are properly followed in the operational system, you are ready to get the certification.
ISO 13485 Certification for medical devices incorporates an efficiently effective management system. it helps to reinforce commitment to provide safe and quality products. If you belong to the industry of medical devices, get certified with ISO 13485 Standard today.