Iso 13485:2016 medical devices — quality management systems — requirements for regulatory purposes (mdqms) published by international organization for standardization (iso) for the first time in 1996, iso 13485 contains a comprehensive quality management system for the design and manufacture of medi
Iso 13485:2016 medical devices — quality management systems — requirements for regulatory purposes (mdqms) published by international organization for standardization (iso) for the first time in 1996, iso 13485 contains a comprehensive quality management system for the design and manufacture of medical devices.
ISO 13485 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.
Who Should Use ISO 13485?
Any organization involved in one or more stages of the life cycle of medical devices and related services, including:
Any organization that wants to establish, implement, operate, and maintain an MDQMS.
You may face the risks and lost opportunities involved with not having an ISO 13485:
Requirements of ISO 13485:2016
Clause 4 Quality Management System
Clause 5 Management Responsibility
Clause 6 Resource Management
Clause 7 Product Realization
Clause 8 Measurement, Analysis And Improvement
MLOK’s methodology and approach to making your company ISO 13485 complied for certification
We use the four stages of the most practical and methodological process to help you achieve ISO 13485 certification.
Stage 1: Planning
Conduct Kick-Off Meeting to:
Stage 2: Documentation
Drafting and writing of ISO 13485 compliant documents:
Stage 3: Implementation
Stage 4: External Audit
Mlok holdings sdn bhd stands as a premier provider of iso management system standards consulting and training services, renowned for its unparalleled expertise and commitment to excellence.
At mlok holdings sdn bhd, we adhere to a meticulously crafted business model, leveraging our wealth of experience and industry expertise to guide organizations through the intricacies of iso-related management systems standards consulting and training services, ensuring seamless compliance with industry regulations and optimization of operational efficiency.
Our clientele encompasses a diverse spectrum of industries and sectors, reflecting our commitment to serving a wide array of organizational needs. With over 3000 successful clients, our tailored solutions cater to:
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