Medical device ISO134852016Quality management system certification

About ISO9001 I believe that everyone is already very familiar with, then ISO13485 is what, here first with you popular science.

ISO13485 standard is applicable to the medical device regulatory environment under the quality management system standard, its full name is "medical device quality management system for regulatory requirements" it uses the relevant concept of PDCA based on the ISO9001 standard, compared with ISO9001 standard for all types of organizations ISO13485 is more targeted and focused For organizations related to the design and development, production, storage and distribution, installation, service and disposal of medical devices.

In order to enhance the image and competitiveness of the company's medical wheel, the company decided to apply for medical device quality management system certification, to customers, partners and regulatory authorities to show the enterprise's professionalism and responsibility, in the market competition, certification can be used as an important advantage of the company to help the medical division win more business opportunities. Our company conducted a certification audit for two and a half days from October 14 to October 16. In order to meet the smooth progress of the audit, we have paid a lot of time and energy to prepare for the work. And I also learned a lot of things in it, accumulated a lot of work experience.

The audit is divided into two phases

The first stage:

First understand the basic situation of the establishment and operation of the medical device quality management system, and determine whether the conditions for the second stage of audit are met.

The second stage:

Evaluate the conformity and effectiveness of the establishment and operation of the company's medical device quality management system to determine whether certification registration can be recommended.

his time, Guangdong Enterprise Certification Service Co., Ltd. appointed  Mr. Wang and Mr. Zeng to be the auditor, the key audit projects mainly include the following aspects:

1. Quality manual: Review whether the quality manual fully states the enterprise's quality policy, objectives, organizational structure, responsibilities and authority, as well as the scope and process of the quality management system, and conforms to the requirements of the IS013485 standard.

2. Procedure documents: Check whether the procedure documents cover all aspects of the standard requirements, such as document control, record control, internal audit, management review of nonconforming product control, corrective measures and preventive measures, and are operable.

3. Operation instructions: Review whether the operation instructions are detailed and accurate to guide the specific operations of each key production or service link.

The main process of the audit is a sampling inspection process, according to the prepared documents to implement the audit. On-site audit is to spot check multiple equipment, observe multiple production processes, etc., to find whether it meets the evidence provided.

In the audit process, the audit teacher upheld a rigorous attitude, strictly followed the relevant standards and requirements, and conducted a comprehensive and in-depth review and inspection of the company's management system through various ways such as consulting documents, on-site inspection, communication and communication.

At the same time, once a problem is found in the audit process, it will be feedback on the spot to ensure that the problem can get timely attention. With the continuous in-depth development of audit activities, the company not only dug out some potential problems and risk points, but also put forward a series of practical improvement measures and suggestions. We have also successfully passed an external audit, proving that our quality management system meets the requirements of the 13485 standard and has obtained certification.