ISO 13485:2016 is a certification standard for medical device industry. ISO 13485 certification fulfils your needs related to production control, pquality management, regulatory compliances & specific needs related to production of a particular medical device. ISO 13485 is basically a QMS for medical device industry that is why it is also known as MD QMS. ISO 13485 certificate satisfies potential customers & stakeholders with the fact that a device has been manufactured following internationally recognised ISO 13485 standard. Our ISO 13485 certification process is result oriented & customer focused. We are a pioneer ISO 13485 certification body of China. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization
ISO 13485 improves products & processes of a medical device company.
it guarantees the constancy of the manufacturing process, resulting in a stable and high quality of the services and products provided
it proves the effectiveness of the quality management systems by an independent third party
cost optimisation – lower operational costs, reduction of the costs of non-conforming products, savings in raw materials, energy and other resources
increased confidence of the public and state authorities for the manufacturers of medical devices
it simplifies the process to demonstrate conformity with the requirements of EU regulations and applicable government decrees
ISO 13485 certificate is universally recognized & it covers regulatory & statutory norms of most of countries, your product gets an expended market access.
ISO 13485 certification gives faith to your customers that device is safe for use & it meets requirements of most of recognized technical standards related to medical device.
Now ISO 13485:2016 certification standard has come with many changes.
Flexible . New standard ISO 13485:2016 is more flexible, because it allows you to make exclusions in section 6, 7 & 8 if it can be justified while in old standard ISO 13485:2013 exclusion was permissible only in section 7. In this way new standard ISO 13485:2016 is more flexible.
Regulations . In old standard ISO 13485:2013 a QMS had to established based on requirements of the standard & product, while in new version ISO 13485:2006 emphasis has been given on meeting regulatory requirements. Now QMS has to be established encompassing applicable regulatory requirements.
Risk Based Approach. In old version risk analysis approach was applicable to product realization only, while in new version ISO 13485:2016 risk based approach is applicable to all processes of QMS.
Enhanced Record Keeping. New standard ISO 13485:2016 expects you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has to be maintained in maintaining confidential health information.
Product Realization. New standard ISO 13485:2016 says to establish procedures for storage, handling of products, traceability, measurement & revalidation in addition to requirements of old standard ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing
Training of Users . The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.
The first reason for achieving ISO 13485:2016 compliance is patient safety, improved product compliance, and quality. After all, those are the drivers behind the standard. This in turn, means reduced product returns, reduced warranty costs, and increased customer satisfaction. These benefits then improve revenue and improve margins (profitability), and reduce the cost of quality, which reduces cost of goods sold. With these types of business benefits, one would think it would be easy to secure the funding needed to undergo ISO 13485:2016 certification.
Certification of quality systems for manufacturers of medical devices is based on EN ISO 13485:2016, which has been declared as a harmonized standard to the European Directives 93/42/ EEC, 90/385/EEC and 98/79/ EC in the Official Journal of European Union, which enables it to be used to demonstrate compliance with the requirements of these European directives.. This standard is applied in conformity assessment processes.
Medical device files requirements
Medical device files includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with regulatory bodies and quality standards, and, if required, servicing and installation records and their guidelines. Organizations should develop and maintain a medical device file for each product type or device family. Sub-clause 4.2.3 of ISO 13485:2016 sets requirements for various elements that should be incorporated in the medical device file. These elements include:
1) Establish and maintain a file for each device family – It is essential to understand a medical device family. For each group of devices that are considered to be a family, there must be a medical device file.
2) Keep reference documents showing conformity – For each medical device file, the organization should maintain references with their Certificate of Conformity to ISO 13485 and applicable regulatory requirements. This means that the medical device file should either contain the certificate of conformity, or it should refer to any document that proves that all processes in the development, manufacturing, packaging, storage, and handling conform to the requirements of ISO 13485 and applicable regulatory requirements. The reference can be a Quality Manual that is based on ISO 13485 and relevant regulatory requirements.
3) Incorporate a description of each family – The medical device file of each product family should incorporate a general description of the medical device, along with its intended use or purpose. It should also contain the master records for IFUs, i.e., instructions for use. The description should also include requirements for labeling, for example part code, device name, bar code, or CE requirement.
4) Develop and maintain procedures for each medical device family – Each medical device file must contain developed procedures, or specify procedures for production and all associated manufacturing processes, i.e., packing, inventory keeping, safe movement, and shipment of packed medical products. All manufacturing process flows, including the inspection points, for each medical device family need to be documented clearly.
5) Develop and maintain specifications and procedures for measurement of products – The medical device file should contain or refer to documentation of all specifications (e.g., device critical dimensions, material specifications, manufacturing specifications, and finishing specifications) for each stock keeping unit. It should also specify the procedure for inspection of devices in this family, the checkpoints in the processes, the critical parameters of the products, and which instruments will be used to inspect critical parameters.
6) Document procedures for servicing and installation – This requirement is exclusive to devices or services that require servicing or installation. The medical device file should maintain, where applicable, documented information for installation of a device and should specify the procedure for servicing. Documented information for installation of a device may contain steps for installation, or installation records. The procedure for servicing can include the frequency of routine maintenance, and the process flow for preventive maintenance and repairs.
A foundation for manufacturing, delivery, and use of medical devices. The concept and requirements of medical device files serve as the foundation for the manufacturing process, delivery, and use of medical devices, as they detail all manufacturing and functional aspects of the medical product lifecycle. Before the requirement of the medical device file, organizations had to comply with different sets of documentation for each aspect of the product lifecycle, or they had to organize something similar to the medical device file; otherwise, they would have faced serious gaps in manufacturing process flow. Organizations can effectively manage their manufacturing and shipment processes with the help of clear, documented procedures that are all centralized and controlled in a medical device file for each product device family.