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Medical & Pharma

ISO 13485

ISO 13485: 2016 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. ISO 13485 international standard for medical devices quality management systems (QMS). Medical devices can be simple or complex, but all of these can benefit from being designed and manufactured under ISO 13485 which is the most widely used medical device QMS standard. It is required in Europe, Canada and many other countries for most devices. In the US the FDA Quality System Regulation (QS Reg.), also known as the cGMP, is required. Although the QS Reg. is structured very differently than ISO 13485, they have no conflicting requirements.ISO 13485 follows the process approach introduced in ISO 9001:2015. The process approach treats the QMS as a set of interrelated processes covering not only the manufacture of a product or provision of a service, but also management processes and support processes. A "process" is something that transforms a collection of inputs into outputs.

Integration with other standards:

ISO 13485 can be implemented as it has been based on ISO 9001. It is international recognition, and is an auditable standard which can be accredited by certification body. When a business already has ISO9001 in place, achieving ISO 13485 becomes much simpler. Quality Associates is an expert in system integration. We can embrace the ISO 13485 into other management systems such as ISO 14001, ISO 45001, ISO 9001 and others that related to your business as your needs. Please contact our customer service for inquiry. CONTACT US!

IH Training

ISO 13485: 2016

standard requirement training This course is designed to provide staff with the necessary knowledge to support their organization in achieving compliance to ISO 13485:2016 which specifies requirements for a quality management system where organisations needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The course includes;

Quality Management Principals

Process Approach and Risk-Based Thinking

ISO 9001:2015 and ISO 13485:2016 – Requirements

ISO 13485:2016 Implementation & tools

ISO 14971

ISO 14971 for medical device risk management-Your risk management system must function effectively to meet customer and regulatory requirements. However, this can be a daunting task as devices become more sophisticated and regulator expectations become more rigorous. We can support your team’s risk managements efforts for the entire product lifecycle - from initial product concept through end of life.

ISO 14971 helps your company establish, document, and maintain a systematic process to manage the risks associated with the use of a medical device.

Internal Audit

One of the key tools for ensuring the suitability and effectiveness of your aerospace Quality Management System (QMS) is the internal audit process. The internal audit process is a systematic way to compare what is actually happening in your processes to what the expected outputs of your processes are. By doing this you can ensure that your processes are happening as planned and therefore implemented correctly, and you can assess the effectiveness of the processes in place.

Learn the audit conventions for preparing, performing, reporting, and follow-up. You will learn what they need to know to conduct an audit using ISO 13485standard as required by customer.