1. What is ISO 13485?

ISO 13485 specifies the requirements of a Quality Management Systems for medical devices industry.

The QMS requirements are focusing on the ability of the organization to provide/produce the medical devices and/or related services that consistently meeting the customer and applicable regulatory requirements.

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2. Which organization can certify to ISO 13485?

Organizations which involved in one or more stages of the medical device life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support).

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3. How long it took to certify to ISO 13485?

It is very depending on the organization’s urgency to certify to ISO 13485.

Basic rule of thumb, organization need to have 3 months performance data before can proceed to Certification Audit.
Different Certification Body might have different requirements on this, please contact your Certification Body on this. 

Commonly, from project start until achieved certification, it is around 6 months to 1 year.

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4. Is it all my product and/or services required to be included in the ISO 13485 scope?

Only product that would be used in medical devices manufacturing and/or services provided on the medical devices would be included.

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5. Benefit of obtain ISO 13485?

• Compliance to the Medical Device Regulation 2012 (For Medical Device Manufacturer in Malaysia)
• Medical device manufacturer preferred to have supplier whom certify with ISO 13485, which increase their confidence towards product quality.
• Better understanding towards the manufacturing process and the relevant control
• Product being manufactured to a high degree of assurance

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6. What is the main difference between ISO 9001 and ISO 13485?

ISO 9001 focus on continual improvement for the effectiveness of QMS, however, ISO 13485 focus on maintain the effectiveness of the QMS.

ISO 13485 advocates the idea which do the things right the first time and maintain it along the way, to achieve and maintain the consistency in the product quality.

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7. Who need to be involved in the ISO 13485 certification?

All the employee whom involved in the medical device life-cycle within the organization required to be involved, such as, design & development, acquisition of raw material until product shipment and customer feedback.

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8. Does the effort to obtain ISO 13485, similar with ISO 9001?

To obtain ISO 13485 certification, the effort is significant difference with ISO 9001.

In the ISO 13485, a lot of requirements are related to the manufacturing activities to assure that organization able to produce the product with consistent quality.

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