The value of quality system certification in medical equipment bidding

Release date: 2009-11-02

Excerpt from China Medical News
Moderator: Reporter Ma Yanhong
Guest expert: Deputy Secretary-General of Shaanxi Medical Device Association, Medical Device Evaluation Expert of State Food and Drug Administration, Consultant and Evaluation Expert of Shaanxi Provincial Government Procurement Center Senior Engineer Ouyang Keyong
Editor's note:

At present, in the medical device bidding activities, the requirements for “Quality Management System Certification” (referred to as quality system certification) are getting more and more attention, which is a significant improvement compared with a few years ago. However, the industry still has some ambiguous understanding of the quality system certification, resulting in many problems in the relevant provisions of the medical equipment bidding documents, such as contradictions, some illogical and legal, some have not paid attention to this emphasis, the results As a result, the bidders were misled and the bid evaluation experts were inaccurate, and the fair competition in the medical device market and the quality of the bidding were affected. In this issue, we invite industry experts to exchange some of the problems they have encountered in the practice of medical device bidding for many years, hoping to cause discussion with a view to reaching a consensus.

Q: Is quality system certification a necessary qualification for companies in medical device bidding?

Ouyang Keyong: In the medical device industry, the quality system certification usually refers to the certification of ISO9001:2000 (hereinafter referred to as ISO9001) and ISO13485:2003 (hereinafter referred to as ISO13485). These two standards are “equivalently adopted” as the national and industry standards of China and are numbered GB/T 19001-2000 and YY/T 0287-2003, respectively. The “T” in the two numbers is “recommended”, indicating that these two are recommended standards and are neither mandatory nor mandatory. The necessary qualifications should be limited to the mandatory requirements specified by national laws and regulations and national standards. For example, the medical device registration certificate is necessary, and the quality system certification is voluntarily chosen by the enterprise. It is a third party conducted by a nationally recognized certification body. behavior.
At present, there are only seven kinds of medical devices that are mandatory for CCC certification in the country. Of course, CCC certification should be listed as an essential qualification for these seven medical devices. It should be noted that some medical equipment bidding documents include CCC certification and ISO9001 and ISO13485 certification as necessary qualifications, which is obviously unreasonable and incorrect.

Q: In the bidding, bidders are often required to provide ISO9001 and ISO13485 certifications. Is this requirement correct and reasonable?

Ouyang Keyong: To answer this question, let me first talk about the relationship and difference between ISO9001 and ISO13485. The two standards of the old version, ISO 9001:1994 and ISO 13485:1996, are closely related. The latter is a supplement and stipulation of the former general requirements, the latter is not an independent standard. For the medical device industry, before 2003, both standards were required at the same time. However, in 2003, the new version of ISO13485 came out, and the old version was invalidated. The new version of ISO13485 is based on the new version of ISO 9001 in 2000, which was formed by a limited number of additions, deletions, changes and interpretations. It is an "independent" standard for the medical device industry. Obviously, the medical device industry should be organized and implemented in the new ISO13485 in certification and work practices.

So, why do many medical device companies have both ISO9001 and ISO13485 certifications? There are many reasons. For example, these companies also produce and operate other non-medical device products; or the company has followed the old two standards of "bundling" and did not correct it in time; or corporate decision makers do not understand the difference between the two new standards. And the possible contradiction; or the historical reasons such as ISO13485 certification after ISO9001 certification.

For medical device bidding, it should be clear that if the "quality system certification" is required, the ISO13485 certificate is required instead of ISO9001. Based on this understanding, it is more accurate to directly replace the “quality system certification” with the “required YY/T 0287-2003/ISO13485:2003 certification certificate” in the bidding documents.

Q: As mentioned above, ISO13485 certification should not be included in the necessary qualifications for bidding. That is to say, if there is no ISO13485 certification, it should not be disqualified. Then, what is the significance of the bidder's request for ISO13485 certification?

Ouyang Keyong: It should be said that the bidding party requires the enterprise to provide the ISO13485 certification, and it is reasonable to give the bidders with the certification appropriate points according to the evaluation method, which reflects the maturity of the user's quality consciousness.
At present, the industry has such an understanding: "Quality system certification is just to edit more documents, complete a process, and spend money to buy a 'diploma'." Is this the reality? It cannot be said that this kind of bad phenomenon does not exist. However, the value of quality system certification must not be denied.
If you compare a certificate to a “diploma,” this is a more rigorous and more realistic “diploma” than a college degree. Because the whole process of certification is dynamic and time-sensitive. During the period of validity, supervision and audit shall be conducted. If the validity period expires, a review and review shall be conducted. If the requirements are not met, the certificate will be suspended, cancelled or cancelled. In this sense, this is stricter, more realistic, and more reliable than a static, life-long diploma. In view of this, the ISO13485 quality system certification should be given an “appropriate weight” in medical device bidding.
ISO13485 certification is a conformity assessment of the quality management of medical device companies. It is the confirmation of the quality management system to meet the basic requirements (the pass line). Its maturity, effectiveness, improvement and speed of improvement are very different among different enterprises. Great difference. For example, both companies have passed the ISO13485 certification, but the gap between the two may be 60 points and 99 points. This is in line with the original foundation of the company, the quality system certification, the continuity of the process, and the occupation of the certification body. Both ethics and professionalism are relevant. In the bid evaluation, you should pay attention to the start time, history, and product coverage of the certification. You can also ask the third-party certification body to provide the dynamic information of the recent supervisory review or review review.
In recent years, some medical device companies and products that have passed third-party certification have been ordered by the state regulatory authorities to suspend production for rectification or rectification within a time limit. This reminds enterprises to choose carefully for certification bodies.
In the bid evaluation, the judges should also pay attention to the examination of the qualifications of the certification body, check whether it has the “Approval of Certification Body” of the Certification and Accreditation Administration (CNCA), whether it meets the “approval scope of business”, and the brand of the certification body, Do some market research with professional ethics and professional standards.

Q: In the bidding, the “after-sales service” item is listed in the sub-item of the evaluation of the comprehensive scoring method. The judges usually grasp the proportion based on their own impressions of the brand and the reputation of the company. So, how to make the impression in the bid evaluation based on it?

Ouyang Keyong: The judgment of these impression points is inevitably inaccurate because of the difference in information and the scale of the ruling. If ISO13485 certification can be provided, the evaluation and recognition of its after-sales service will add a relatively objective material from a third party. Because the concept of "product" in the ISO13485 standard has been extended to "related services", it can be understood that ISO13485 certification not only covers after-sales service in the usual sense, but also includes certification of a wider range of related services such as installation and training.
In the bid evaluation, the inspection report of the product registration is one of the basis for reviewing whether the technical indicators are true. However, there is a conspicuous warning in the inspection report: this report is only responsible for the samples submitted for inspection. This has led to a series of problems, such as the technical indicators that are only reflected in the inspection report for inspection samples? Can the performance and technical specifications of mass-produced products be basically consistent with the registration standards and samples for inspection? What is the stability of product quality? Obviously, the advantage of technical indicators does not mean that the stability of quality is high. It should be said that product performance evaluation by the market and users for a long time is a reliable evaluation of its quality stability. However, before the perfect institutional market evaluation system was established, its operation was difficult. Secondly, ISO13485 certification should be a realistic choice for evaluating product quality stability.
When the judges understand more about the scientific management connotation of the ISO13485 standard, they will agree that the ISO13485 quality system certification should at least be one of the objective basis for quality stability evaluation. In addition, the "product certification" of medical devices should also be one of the objective basis. It can be said that the quality of its products and related services is difficult to ensure continuous stability without the ISO13485 strict certification. Recognizing this point, it is of great practical significance for the government to purchase medical equipment in large quantities in a centralized bidding process.
Shanghai Medical Device Industry Association

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