iso 13485 medical device quality management system-凯发k8国际首页登录

iso 13485 medical device quality management system

as medical devices are special products for saving lives and healing injuries, preventing and treating diseases, they are not only general listed products operating in the commercial environment in the world, but also subject to the supervision and management of national and regional laws and regulations, such as fda of the united states, mdd of the european union (european union medical device directive), and the regulation on the supervision and management of medical devices of china. therefore, it is not enough for medical devices to be standardized only according to the general requirements of iso 9000 standard. its applicable standards must be subject to legal constraints and operate in a regulatory environment. at the same time, the risks of medical devices must be fully considered, and risk management is required in the whole process of the realization of medical devices. for this reason, iso has issued iso 13485 standard (equivalent to yy/t0287 standard by the state food and drug administration), which puts forward special requirements for the quality management system of medical device manufacturers, and plays a good role in promoting the quality of medical devices to be safe and effective.

 

the full name of the iso 13485 standard is "medical device-quality management system-requirements for regulatory". developed by the sca/tc221 technical committee for standardization of quality management and general requirements for medical devices, this standard is an independent standard based on iso 9001 and is a management standard applicable in the regulatory environment, which clearly defines the quality management system requirements used for regulations. so in addition to the special requirements, it can be said that the iso 13485 standard is actually iso 9001 in the context of medical device regulations. the standard specifies the quality management system requirements for the relevant organizations, but is not a guide for the implementation of the iso 9001 standard in the medical device industry.

service content

iso 13485 standard is applicable to enterprises that fulfill the requirements of international, european and national laws and regulations for the development, manufacture and sale of medical products and medical equipment, enterprises that want to demonstrate their competitiveness and performance capabilities in the international, european and domestic markets, and enterprises that want to implement a documented management system according to this standard. suppliers and other service providers in the value-added chain must ensure that their products are consistent with customer requirements.

 

noa has a senior team of iso 13485 auditors and sufficient audit resources in china to provide you with localized and professional iso 13485 certification services in a timely manner, which can help customers improve the level of ensuring product quality, which is conducive to enhancing the competitiveness of enterprises and eliminating technical barriers in international trade.

related standards

  iso 13485:2017 "quality management system for medical devices - requirements for regulations"

 

  yy/t0287-2017 "medical device quality management system requirements for regulations"

value gain

  enhance and improve the management level of enterprises, avoid legal risks, and increase the visibility of enterprises;

 

  improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits;

 

  it is conducive to eliminating trade barriers and obtaining a pass to enter the international market;

 

  it is conducive to enhancing the competitiveness of products and improving the market share of products;

 

  effectively reduce the risk of product quality accidents or adverse events through effective risk management.

 

service process
q&a
 
how long does the system need to run before applying for certification?
before applying for certification, the system must have been running for at least 3 months.
after obtaining the certificate, how to query the authenticity and validity of the certificate?
the authenticity and validity of the certificate can be queried by logging into noa website (www.noagroup.com) and selecting "certificate / report query" in the "resource center", or by logging into the national certification and accreditation information public service platform( http://cx.cnca.cn )query.
after obtaining the certificate, how long is the certificate valid? is it necessary to review every year?
after obtaining the certificate, the validity period of the certificate is 3 years, and at least one on-site audit is required every year to keep the certificate valid.
what to do after the expiration of the certificate?
before the expiration of the certificate, we will arrange the customer service specialist to contact you actively to assist you in handling matters related to your re certification application.
our advantage
authoritative qualification
noa has been approved by certification and accreditation administration of the people’s republic of china(cnca)(cnca-r-2002-051), and has obtained qualification of china inspection body and laboratory mandatory approval (cma),and has passed the multiple approvals of china national accreditation service for conformity assessment (cnas), international accreditation service (ias), united kingdom accreditation service (ukas), joint accreditation system of australia and new zealand (jas-anz). noa has been approved by state administration for market regulation of china, and has been recognized as inspection and testing institution of china's special equipment, as well as the qualification of china's national equipment supervision and engineering supervision. noa-dci is the notified body of the ce directive of the european commission. noa has been recognized by the international electrotechnical commission (iecq) by obtaining electronic component quality assessment system. it is also a national inspection and assessment notified body of import and export commodity in china.noa is a high-tech enterprise in shanghai.
improve performance, realize asset value appreciation, and service throughout the entire value chain
from pre-design to post-operation, noa has the ability to guarantee the whole life cycle of the business. noa, as an independent third-party inspection company, has a large number of domestic and international standards and specifications proficient in design, welding, non-destructive testing, painting, packaging and other fields the experienced team of professional engineers and inspection experts, with more than ten years of experience in the domestic market, is familiar with all aspects of the domestic industrial equipment supply chain, and can provide you with technical support services for the full life cycle of technical services in a timely manner, combining various products. inspection, certification, testing, consulting, and auditing services can provide you with one-stop all-round comprehensive services.
quality, efficiency and service
noa has formed a mature and solid operation system in the development of more than 20 years. we let technical experts who are familiar with market regulations and testing standards and have professional industry experience to carry out inspection, evaluation and design review work. while meeting the requirements of domestic and international standards, we ensure that customers can obtain satisfactory service results in the first time with accurate time-sensitive management methods, and ensure that customers can seize the opportunity in the market competition.
service area
noa inspection services currently cover europe, australia, russia, some middle east regions and most regions in china. noa can ensure the consistency and continuity of customer service in different regions, and eliminate the impact of unfamiliar environments on customer quality. the guarantees and the impact of project implementation enable customers to participate in different markets across the country or around the world with flawless quality.
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