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Jul 01,2022
Wantaifu Biotechnology company has taken steps to further standardize its processes, control risks effectively, and gradually establish a standardized management model. Since mid-November, they have applied for quality management system certification using ISO9001 and ISO13485, and the review process was successfully completed by mid-December 2022.
On December 12th, a review team from Beijing Hua Guang Certification of Medical Devices Co., Ltd conducted a comprehensive review of our company's quality and safety management system. The review was conducted in accordance with the requirements of the ISO9001 and ISO13485 quality management system standards, and consisted of an on-site review and a comprehensive evaluation of Wantaifu's design and development, production, storage and circulation, and service. The purpose of the review was to assess the adequacy, suitability, and effectiveness of our quality and safety management system.
On-site review
Zhejiang Wantaifu Biotechnology Co., Ltd. actively participated in the first and second phases of the audit and certification work, in cooperation with the audit team from theology Co., Ltd.
The audit team conducted a comprehensive, strict, and detailed audit of various aspects of the company's operations, including R&D management, sales system, quality management, personnel management, environmental sanitation, employee training, safety management, and employee occupational health.
During the on-site assessment and acceptance process, the audit team provided suggestions and opinions on the company's quality management system and offered guidance to improve and develop the company's quality management work.
ISO9001
The company has received Quality Management System Certification.
According to Guan Hongyan, the chairman of Zhejiang Wantaifu Biotechnology Co., Ltd., the certification audit conducted was a comprehensive inspection of the company's management work. The audit team provided helpful suggestions and opinions that have guided the company's quality management work's improvement and development.
Zhejiang Wantaifu Biotechnology Co., Ltd. has successfully passed the quality management system certification for ISO13485 and ISO9001. These certification is an affirmation of the company's quality management.
ISO13485
Quality Management System Certification
Zhejiang Wantaifu Biotechnology Co., Ltd. was founded in May 2022, and has always emphasized the importance of maintaining high-quality products. The company has made the operation guarantee of the quality management system a fundamental aspect of its development. Moving forward, the company will continue to focus on enhancing employee training and quality management, and will strictly enforce the quality management system documents. Through the provision of superior products and services, Zhejiang Wantaifu Biotechnology Co., Ltd. aims to contribute to society.
What is the difference between ISO13485 and ISO9001?
ISO 13485 was first published as an industry-specific interpretation and was based on the quality requirements of ISO 9001, but has since evolved into a stand-alone standard whose text makes no references to ISO 9001 as a source material. Since its initial publication in 1996, and through editions in 2003 and 2016, ISO 13485 has become increasingly different from ISO 9001 and compliance with one standard does not necessarily imply compliance with the other.
What is the difference in the scope of application of the two?
The primary difference between ISO 13485 and ISO 9001 for medical devices is the scope of these quality standards.
ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size.
ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices. It places a more significant focus on regulatory compliance and offers less flexibility in the organizational process.
