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1-History of IS0 13485: 2003 Medical Devices Quality Management Systems
2- IS0 13485: 2003 Online Application Form
This Standard is aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
The newly published EN IS013485: 2003 Medical Devices Quality Management Systems. Requirements for Regulatory Purposes now includes a requirement for senior management "buy-in" as specified in ISO 9001:2000. However the primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of BS EN ISO 9001 that are not appropriate as regulatory requirements. Therefore, while BS EN ISO 13485:2003 has the same format as BS EN ISO 9001:2000 and most of the same requirements, compliance with BS EN ISO 13485:2003 does not provide conformity with EN ISO 9001:2000.
BS EN ISO 13485:2003 supersedes EN ISO 13485:2001 and EN 1S0 13488:2001 which will be withdrawn in July 2006. To maintain their certified status all organizations within the medical devices industry must adopt EN 13485:2003
Major differences between EN IS013485: 2003 and ISO 9001:2000 are the requirement to maintain the effectiveness of the system rather than improve it; emphasis on meeting customer and regulatory requirements as against increasing customer satisfaction and a greater requirement for documented procedures which include:
§ Those documents required by regulation
§ Responsibility and authority
§ Training procedure, if required
§ Maintenance requirements
§ Health, cleanliness, clothing
§ Environmental conditions
§ Control of contaminated product
§ Risk management
§ Customer requirements
§ Design and development
§ Purchasing process including traceability records and records of verification
§ Reference materials and reference measurement procedures
§ Labeling and packaging
§ Installation and verification
§ Sterilization process validation
§ Identification and validation
§ Preserving product including shelf life
§ Monitoring, measurement and measuring devices
§ Sterilization records, servicing records, batch records, validation
Differences in research and development activities:
§ Determine design transfer activities
§ Document design planning outputs
§ Include risk management in input
§ Approve inputs
§ Document design outputs
§ Include specialist as needed in design review
§ Complete validation before delivery
§ Include clinical trial as required
Added programs to consider:
§ Clinical evaluation
§ Risk management
§ Clinical trials
§ Cleanliness of product and contamination control
§ Requirements for implantable devices
§ Communication of advisory notices
ACAR Consultancy Services specialize in putting in simple uncomplicated quality management systems, that meet the requirements of the EN ISO 13485 medical devices standard, without unnecessary administration
ISO 14971:2007 Risk Management Certification Program
Overview
ISO 14971:2007 is a state-of-the-art, international standard that is quickly being recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices.
The ISO 14971:2007 for the application of risk management is designed to help manufacturers introduce safe medical devices into the market place. The manufacturer is responsible for identifying and controlling not only the risks associated with their medical device, but evaluating interactions with other devices. The standard also allows for other healthcare manufacturing organizations to use the process [and obtain certification]. This might include human tissue, animal care products, pharmaceutical manufacturers, etc. who may choose to use this standard.
The standard requires that Top Management demonstrate its commitment to risk management by;
a) establishing the process,
b) setting the policy for acceptable risk, and
c) reviewing the effectiveness of the process at determined intervals.
The risk management certification program by ACAR will bring focus to this aspect of the process, and ensure that the manufacturer understands any significant gaps in the organization’s process.
1-History of IS0 13485:2003 Medical Devices Quality Management Systems
In November 2000 the Standards EN ISO 13485:1996 and EN ISO 13488:1996 have been accepted as European Standards for replacing the EN 46001 and the EN 46002. (The Standards EN 46001 and EN 46002 were only valid until: 28.2.2004) These Standards are published as EN ISO 13485:2000 and EN ISO 13488:2000 and effective. These Standards are very similar to the EN 46001 and EN 46002 and they are based on the EN ISO 9001(1994) and the EN ISO 9002 (1994), which were valid until 15.12.2003.
In November 2003 the Standard EN ISO 13485 "Medizinprodukte Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke" has been publicated. The assembling and the structure are based on the EN ISO 9001:2000. The Standard EN ISO 13485:2003 has been harmonized by mid of 2004. The Standards EN ISO 13485:2000 and EN ISO 13488:2000 have been withdrawn and replaced by the Standard EN ISO 13485:2003 on July, 31 2006.
The Standard EN ISO 13485:2003 is an independent Standard, but it refers to EN ISO 9001:2000. The terms of content are mainly taken over from the EN ISO 9001:2000 and they are completed with the specified requirements to medical devices. Therefore the EN ISO 13485:2003 is clearly more extensive than the EN ISO 9001:2000. The intention of the EN ISO 13485:2003 is the fulfillment of the legal requirements. The intention of the EN ISO 9001:2000 is the improvement of the competitiveness.
The requirements of the new EN ISO 13485:2003 are mainly identical to the EN ISO 13485:2000 or rather EN ISO 13488:2000. The law "Medizinprodukte-Gesetz" and the MDD 93/42/ECC are remaining the basis.
EN 46003
This European Standard specifies the quality system requirements for the final inspection and test of medical devices, which are more specific than the general requirements specified in EN ISO 9003:1994. The Standard EN 46003 is not a „stand alone" standard and it can only be used in combination with EN ISO 9003:1994. The specific requirements of the EN 46003 only apply to named groups of medical devices; in-vitro diagnostics and active implantable medical devices are excluded. For sterile medical devices this Standard is not sufficient.
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