ISO 13485 Standards and its Certification
IAS is providing the service of ISO Certification audits for various international standards. Out of these Standards, ISO 13485:2016 certification specifies the requirement of Quality Management System of Medical devices/equipments that consistently meet the Customer and applicable regulatory requirement. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device/equipment.
ISO 13485 is generally harmonized with ISO 9001 and the basic difference is that ISO 9001 requires Organization to demonstrate continual improvement whereas ISO 13485 requires an Organization to demonstrate the quality management system for medical devices is effectively implemented & maintained.
Adapting to the certification of ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as exhibiting the commitment to the safety & quality of medical devices.ISO 13485 is beneficial for many organizations and can be used by suppliers and external parties that are involved with providing medical device products.
This ISO 13485:2016 certification helps to expand your business locally and in global market and also definitely help to impress your clients with the quality of the business and its products.
IAS is one of the most prominent ISO Certification Bodies in Malaysia. IAS conducts auditing and providing ISO certification in Malaysia for various standards in Malaysia. It also delivers ISO 13485 Lead Auditor Training , ISO 13485 Internal Auditor Training, and ISO 13485 Awareness/Foundation Training in Malaysia. All these certification and Training services by IAS for the country is managed from its office in Malaysia and provides services including the local cities of Malaysia like Kualalumpur, Selangor, Penang, johor Bahru, Melaka & Ipoh.
Stage 1Audit : Readiness Audit
Stage 2 Audit : Verifying the effectiveness of the System