-ISO Certification-
QUALIT
CERT
ISO 13485 Certification & Consulting Service in Malaysia
Qualitcert stands out as the premier provider of ISO 13485 certification and consulting services in Malaysia, renowned for its expertise in quality management systems for medical devices and its commitment to ensuring compliance with regulatory standards. With a deep understanding of ISO 13485 requirements and their significance in ensuring the safety and effectiveness of medical devices, Qualitcert offers tailored consulting services to guide organizations seamlessly through the certification process. Their approach includes comprehensive assessments, gap analysis, development of quality management frameworks, documentation support, and strategic guidance to ensure alignment with ISO 13485 standards. From implementing quality control measures to conducting audits and providing staff training on quality management principles, Qualitcert empowers organizations to achieve ISO 13485 certification effortlessly. Recognized for its reliability, expertise, and dedication to quality in the medical device industry, Qualitcert serves as the trusted partner for businesses in Malaysia seeking ISO 13485 certification and demonstrating their commitment to producing safe and effective medical devices.
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Approach and Methodology used to implement Management System Standard
Implementing an ISOΒ standards involves a structured methodology to ensure that the organization effectively meets the requirements of the chosen standard and achieves certification. Sometimes defined methodology may vary depending on factors such as the size of the organization, its industry, and the complexity of the ISO standard being implemented, the following steps provide a basic framework
OUR
Process
1, Determine the ISO Standard
2. Understand the Requirements
3. Training and Awareness
4. Implement the System
5. Internal Audit
6. Certification
Benefits of having ISO Certification
Enhanced Credibility and Reputation
Legal and Regulatory Compliance
Enhanced Customer Satisfaction
Access to Global Markets
Environmental Sustainability
Information Security
Our Achievements and Success
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ISO 13485:2016
ISO 27001:2022
ISO 20000-1:2018
ISO 29001
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