ISO 13485
Introduction
Due to the progress of the times, the human health need increases more and more, resulting in the popularity of the medical equipment manufacturing. Viewing of medical equipment in the play of the efficacy of medical care itself, there still exist risks, so the advanced countries have the requirements for the quality system along withthe rules and regulations of all medical equipment in order to ensure the effectiveness and safety of medical equipment.
However, if the medical equipment enterprises in the world shall follow all the different quality systems and regulatory requirements, then, the medical equipment industry in complying with these requirements must recurrent problems and lead to a big loss. Timely appear in ISO 13485 quality system for the medical equipment industry, creating to an everyone a mutually acceptable and comply with the broad road, as the ISO / TS 16949 covers the automotive industry to the requirements and special requirements of customers, the ISO 13485 also covers the common demands of the medical equipment industry and the special requirements of the Act, through the ISO 13485, you can open enterprises to enter the broad road of the medical equipment market.
The current version is ISO 13485:2016, which was released in March 2016. The main features of this revision are as follows:
- ISO 13485:2016 is applicable to organizations involved in the development, production, trade, installation and service of various medical devices; ISO 13485:2016 is applicable to those providing materials, accessories and components, in addition to the above types of organizations. Organizations for sterilization services, calibration services, distribution services, maintenance services, etc. It is conducive to the promotion and application of the new standard at more levels and in a wider scope, and better achieve the standard goal.
- The new version of the standard strengthens the risk management requirements, not only implements risk management for the entire life cycle of medical device products and services, but also clarifies the requirements for risk management of the process of quality control system, and proposes “applying risk-based methods to control quality control”. This version has significant changes compared to 2003 version.
- Others: increase requirements for procurement and supplier control; add complaint handling clauses; increase communication with regulatory agencies and report to regulatory agencies; strengthen post-marketing supervision requirements; Increased requirements for documented information; increased requirements for management systems related processes...etc.
Our advantages
- Issue quickly, you can obtain the certificates within 1.5 months.
- You can obtain the certificates within 3 weeks on urgent case.
- Qualified assessors can provide the enterprises with effective assessment service.
- We can issue multi-site ISO certificate for multi-national enterprises.
- While applying for ISO13485, If your enterprises would like to obtain the product CE certification simultaneously, the Alberglobal will give you a pleasant help.
Why should Certify the ISO 13485?
ISO 13485 is the required quality management system defined inthe EU technical directives 93/42/EEC while delivering your medical equipment to the EU industry,and
this quality management system standards of the medical equipment industry is widely accepted by other countries in the world. Therefore, the implementation of ISO 13485 is the best bridge for the medical equipment industry to build customer trust and conformity of the laws and regulations.
ISO 13485 standard emphasizes to maintain its effectiveness
The "continuous improvement" in the ISO 9001 standards are changed to "maintain its effectiveness," in the ISO 13485 standards .Because the effectiveness of the quality control system is the objective of the current regulations, This can lead to continuing to produce safe and effective products.
In accordance with ISO 13485 can be claimed in accordance with ISO 9001?
No,. ISO 9001 is a customer-oriented quality management system and ISO 13485 is a regulatory-oriented quality management system, They are different in meaning.
