ISO13485 is called "the requirements of medical device quality management system for laws and regulations" in Chinese. Because medical devices are special products for saving lives, helping the wounded, preventing diseases and treating diseases, it is not enough to regulate only according to the general requirements of ISO9000 standard. Therefore, ISO organization has issued iso13485:1996 standard (YY / T0287 and YY / t0288), which puts forward special requirements for the quality management system of medical device manufacturers The quality of medical devices to achieve safe and effective play a good role in promoting. [1]

The implementation version up to November 2017 is iso13485:2016 medical device quality management system for regulatory requirements. The name and content have changed from previous versions.

Chinese name

Requirements of medical device quality management system for laws and regulations

Foreign name

Medical devices——Quality management systems——Requirements for regulatory purposes

Release time

1996

Nature

Medical device quality management system

Applicable object

Medical product manufacturer service provider, enterprise

Scope of application

International application

Recent updates

2016

Catalog

00001.1 introduction to medical devices

00002.2 introduction to development

00003.3 new features

00004.4 applicable objects

00001.5 differences

00002.6 standard change

00003.7 certification conditions

00004.8 certification process

00001.9 certification materials

00002.10 certification significance

Introduction to medical devices

ISO 13485：2016 Medical devices——Quality management systems——Requirements for regulatory

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Objectives (requirements of medical device quality management system for regulations) is the current version as of November 2017.

----The following is the introduction of the old version, which has been voided. Some of the content can still be referred to. -

The full name of ISO13485:2003 standard is medical device quality management system requirements for regulation. This standard was established by SCA / tc221 Technical Committee for quality management and general requirements standardization of medical devices. It is an independent standard based on ISO9001:2000. The standard specifies the quality management system requirements for relevant organizations, but it is not the implementation guide of ISO9001 standard in the medical device industry.

Since the standard was issued in 1996, it has been widely implemented and applied all over the world. The new edition of ISO13485 standard was officially issued on July 3, 2003. Different from the ISO9001:2000 standard, ISO13485:2003 is a management standard applicable to the regulatory environment: it is clear from the name that it is the quality management system requirements for the regulatory environment. In the world, medical devices are not only general listed commodities running in the commercial environment, but also subject to the supervision and management of national and regional laws and regulations, such as the FDA of the United States, the MDD of the European Union (EU medical device directive), and the regulations on the supervision and management of medical devices of China. Therefore, the standard must be subject to legal constraints, operate in a regulatory environment, and fully consider the risk of medical device products, requiring risk management in the whole process of medical device product realization. So in addition to the special requirements, it can be said that ISO13485 is actually ISO9001 under the environment of medical device regulations.

ISO 9001, en 46001 or ISO 13485 are generally used as the quality assurance system requirements in the United States, Canada and Europe. The establishment of medical device quality assurance system is based on these standards. For medical devices to enter the markets of different countries in North America, Europe or Asia, the corresponding regulatory requirements shall be followed.

Development Brief

With the development of history, ISO organization revised this standard and upgraded it to ISO13485:2003. Most medical equipment manufacturers began to consider ISO9001:2000 + ISO13485:2003 + CE certification as a package solution when establishing quality management system. ISO 13485 standard (Chinese equivalent conversion Standard No. YY / T0287) has been regarded as the basis of quality management system certification in medical device industry. This standard is based on the ISO 9001:1994 standard, adding the special requirements of the medical device industry, that is, the so-called 1 + 1 standard. Therefore, to meet the requirements of ISO 13485 standard is to meet the requirements of ISO 9001:1994 standard. After the promulgation of ISO 9001:2000 standard, ISO / TC 210 has issued a new ISO 13485:2003 standard (the Chinese equivalent conversion of YY / T 0287-200x standard is being submitted for approval). Recently, BS EN ISO 13485:2012 (medical device quality management system for regulatory requirements) has been updated, but this update does not change the main content of the standard (only the preface and annex parts are modified) and only the European scope (EN standard). Please also note the British Standards Institute (BSI) for the subsequent update process.

New characteristics

Standard name ISO 13485:2003

The new standard is independent

The name of the new standard is "medical device quality management system for regulatory requirements". New standard 1.1 general "points out:" the main purpose of this standard is to facilitate the implementation of the regulatory requirements of the coordinated quality management system. Some requirements in ISO 9001 that are not suitable as regulatory requirements have been deleted. As a result of these deletions, organizations whose quality management systems comply with this standard cannot claim to comply with ISO 9001 unless their quality management systems also comply with all the requirements of ISO 9001. "

The role of new standards

The new standard 0.1 "general rules" points out: "this standard specifies the requirements of quality management system, according to which the organization can carry out the design and development, production, installation and service of medical devices, as well as the design, development and provision of relevant services. This standard can also be used internally and externally (including certification bodies) to assess the organization's ability to meet customer and regulatory requirements. It is worth emphasizing. "

In 0.2 "process method"

The new standard only