Mask Production and ISO13485

ISO 13485

Recently, We ave received many enquired about ISO 14644 and ISO 13485 certification for the production of masks.

What is ISO

The full name is an international standardization organization. ISO has formulated more than 10,000 international standards including technical guidances testing standards and management system standards. Around 20 management system standards can be used for certification. Not all international standards can be used for certification.

ISO Management System Certification

Since most of the ISO management system standards can be applied to various industries but not for a specified industry, the standards are generic. ISO management system standard is a management method or management approach. Each ISO management system standard has different management principles. Because it is a management principle, the ISO management system standard does not directly teach your company how to comply with ISO. Most people may not grasp easily. The theme of ISO 9001 is quality, which is a way to manage quality. The theme of ISO 13485 is the quality of medical device, which is a way to manage the quality of medical devices.

For example: When a mask manufacturer passed an ISO13485 certification audit  by UK accredited certification body (such as SGS, BV, Lloyd’s, BSI ..) covering operation and management of a company. The mask manufacturer received a UK Accredited ISO13485 certificate. The ISO13485 certificate states that the operation and management of masks manufacturers meet ISO13485 requirements. However, it cannot be claimed that the mask conforms to ISO13485, because ISO13485 is a certification of the company’s management practices, not a certification of the mask itself.

ISO 14644

ISO 14644-1:2015 defines the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones.ISO Class number means the rating how much particulate of specific sizes exist per cubic meter. The “cleanest” cleanroom is a class 1 and the “dirtiest” a class 9

ISO 13485

ISO 13485 is a quality management system standard for medical devices, which comes from the ISO 9001 quality management system standard. ISO 13485 ensures that manufacturers continue to design, develop, produce, install and deliver safely and in compliance with relevant regulatory requirements and the intended purpose of medical devices. Different countries  have different applicable regulatory requirements. Manufacturers shall review relevant regulatory requirements where medical devices are for sales.

To put it simply, ISO 13485 addresses the manpower, machines, materials, method, production environment, and the product safety.

  • Personnel need to be competent, have received relevant training and have knowledge of their job
  • Production machinery needs regular maintenance and meets production requirements
  • Material storage and handling should be based on material characteristics and supplier guidelines
  • The production method is relatively simple because most of the automated production
  • Environmental control cleanliness, temperature and humidity (clean room is of course ideal environmental control)
  • Conducting Risk management of the safety of the product itself (ISO 14791)
  • And comply with legal requirements (if the product is exported, the product needs to meet local legal requirements)
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