Iso13485:2003 2003 standard is the full name of the medical equipment quality management system Used for regulatory requirements (Medical device - Quality management system - requirements for regulatory). The standard by the SCA/TC221 general requirements for medical devices quality management and standardization technology committee, is ISO9001:2000 on the basis of independent standards. Standard specifies the organization's quality management system requirements, but not the ISO9001 standard implementation guidelines in medical equipment industry. 

 

It gets all over the world since 1996, a wide range of implementation and application of the new hl-tech corporation standard released on July 3, 2003. With ISO9001:2000 standard is different, iso13485:2003 2003 is applicable Yu Fagui environment management standard: namely clear from the name is used in the regulations of the quality management system requirements. Medical apparatus and instruments in the world is not only just the general public goods in the business environment, it also affected by national and local laws, regulations, supervision, such as the United States FDA, the European Union, the MDD (eu medical equipment instructions), China's medical device regulatory ordinance. As a result, the standard must be bound by the law, in the regulatory environment, at the same time, must fully consider the risk of product of medical apparatus and instruments, in medical apparatus and instruments for risk management in the whole process of product realization. So in addition to the special requirements, can say hl-tech corporation is actually the medical devices regulations under the environment of ISO9001. 

 

Now the United States, Canada and Europe generally with ISO 9001, EN 46001 or ISO 13485 as a quality assurance system requirements, set up medical equipment quality guarantee system are based on these standards. Medical devices to enter the north American, European and Asian markets in different countries, shall comply with the relevant regulations. 

 

The characteristics of iso13485:2003 2003 standard 

 

1, the standard is only applicable to the medical equipment industry, has a strong professional standards independently 

 

The standard in the general said: "the main purpose of this standard is to facilitate the implementation of regulations for the coordination of the quality management system. As a result, the special requirements of this standard contains some medical apparatus and instruments, reducing the ISO9001 in not suitable for certain requirements as required by regulations. As a result of these cutbacks, quality management system in accordance with this standard organizations cannot claim that conform to the ISO9001 standard, unless it also accord with all requirements in the ISO9001 quality management system." 

 

2, will satisfy the medical device regulatory requirements in the prominent position 

 

Standard emphasizes the regulatory requirements, many places do not too much emphasis on customer requirement. This is because the customer satisfaction is not suitable for as a medical device regulatory goals, the coordinated with management system of laws and regulations of the world's goal is the same. 

3, standards continue to clear documented requirements 

 

According to the characteristics of the medical equipment industry, hl-tech corporation standards require documented procedures, work instructions, or requires more than 20. 

4, standards, special emphasis on medical equipment requirements 

 

Standard combining with the characteristics of medical equipment industry, increased a lot of professional rules. Such as the active implantable medical devices and implantable medical devices of special requirements. 

 

5, hl-tech corporation standard is a complement to the technical requirements for products 

In the introduction of the general standard explicitly pointed out that, "... is to emphasize the quality management system requirements specified in this standard is a complement to the technical requirements for products." 

 

6, to give special provisions to the cut 

 

All requirements of this standard is to provide medical apparatus and instruments for the organization, regardless of the type or size of the organization. If the regulations allow for design and development control, cut them in the quality management system can be considered to be reasonable. These rules can provide another kind of arrangement, these arrangements to note it in the quality management system. Organization has the responsibility to ensure that in the statement of compliance with this international standard reflects the control of design and development of cut. 

 

7, standard attaches great importance to the risk management requirements 

 

Standard 7.1 requirements "the organization shall in the whole process of product realization, establish documented requirements of risk management." 

8, the definition of the concept of "medical devices" further clear; 

9, this standard is not adopted by the FDA, but an accord with iso13485:2003 2003 requirements of the company is also easy to achieve the requirements of the FDA's QSR. 

 

10, the standard and other "quality management system, such as" ISO14001 and OHSAS18001 compatible. 

 

The standard applicable scope 

 

This standard is suitable for medical device design and development, production, installation and service or related services, such as design, development, and provide related industries. 

 

Defined in standard medical devices: manufacturer's intended use is for one or more of the following specific purpose for the benefit of mankind, whether used alone or in combination of instruments and equipment, instruments, machines, appliances, implant, in vitro reagent, or calibrator, software, material or other similar or related items. The aim is to: 

 

- disease diagnosis, prevention, care, treatment or ease; 

 

- damage diagnosis, monitoring, treatment, alleviate or compensate; 

 

-- anatomical or physiological process research, replace or adjust; 

 

Support or sustain life; 

 

Control of pregnancy; 

 

- medical instrument disinfection; 

 

- based on the samples taken from the body check in vitro to provide medical information. 

 

Its effects on the body surface or the body of the main design not by means of pharmacology, immunology or metabolism, but may have the means to participate in and play a supplementary role. 

 

The meaning of hl-tech corporation certification 

 

1, improve, and improve enterprise management level, avoid legal risk, increase of enterprise reputation; 

 

2, improve and guarantee the quality of products, make the enterprise to obtain greater economic benefits; 

 

3, is advantageous to the elimination of trade barriers, obtains the passport to enter the international market; 

 

4, to strengthen the competitiveness of the products, improve the product's market share. 

 

5, through effective risk management and reduce the product quality accidents or the risk of adverse events. 

 

6, improve the staff's sense of responsibility, enthusiasm and dedication.