ISO 13485 Certification In Malaysia
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.
IAS is one of the most prominent ISO Certification Bodies in Malaysia providing Certification of ISO 13485 in Malaysia. IAS has helped many businesses to get ISO 13485 Certification in Malaysia for their medical devices/equipment with international recognition.
ISO 13485 in Malaysia is applicable to any type of medical devices/equipment and certification is granted to an organization that can demonstrate that it has an effective quality management system for medical devices.
Certification of ISO 13485 in Malaysia is not limited to product manufacturers but also includes service providers, distributors, and laboratories that are involved in the life-cycle of a medical device/equipment.
IAS delivers ISO 13485 Certification services in Malaysia covering Wilayah Persekutuan Kuala Lumpur, Putrajaya, Labuan and covering all the major cities like Selangor, Terengganu, Johor, Kedah, Kelantan, Pahang, Negeri Sembilan, Perak, Melaka, Pulau Pinang, Perlis, Sabah and Sarawak.
The process to obtain an ISO 13485 Certification- Contact IAS by sending the Application Form and call us for a discussion and we are here to guide you in getting ISO 13485 certification.
- Make your Organization ready for certification by implementing and practicing the standard, monitored and continually improving.
- Majorly, the process of ISO certification includes 2 stages
Stage 1 Audit: Readiness Audit
Stage 2 Audit: Verifying the Effectiveness of the System
- The organization applying for ISO certification will be audited based on an extensive sample of its sites, services, process, products & functions.
- Any deviation is observed during the audit, deviation report will be submitted along with the detailed audit report. According to the grading of the deviations, IAS determines the time required for its closure including the correction and corrective actions which have to be approved by IAS. After the effective closure of Nonconformity, the Certificate is issued limiting to the scope that was audited.