Quality Management System in the Medical Sector ISO 13485: 2003 Standard
It determines the special requirements required by the quality system for those working on medical devices.
EN 46000 Standards (EN 46001 and EN 46002), published in 1993 and covering the sterilization process for medical device manufacturers, transferred to the EN 550 series, explains the quality system requirements for all medical devices. In order to implement EN 46000 Standards together with ISO 9001: 2008 Quality Management System, ISO 13485 Medical Sector Quality Management System has been established.
ISO 13485 Medical Sector Quality Management System Standard; It was created to configure manufacturers, distributors, importers and exporters and the organizations that provide these services. This system complies with the EU Medical Devices Directive and is implemented with the CE brand.
TS-EN-ISO 13485: 2003 standard It is an international standard that is created on the basis of the TS-EN-ISO 9001: 2008 standard and contains special conditions for medical devices.
This standard covers quality management system requirements for an organization that must demonstrate its ability to provide medical devices and consistently meet customer needs and regulatory requirements applicable to medical device related services. The main purpose of this standard is to facilitate harmonized medical device legislation requirements for quality management systems.
TS-EN-ISO 13485: 2003 standard is the latest version of 13485 and is based on the 9001: 2008 process approach model. ISO 13485: 1996 and 13488: 1996 are older models of this standard that are not based on the process approach.
ISO 13485: 1996: ISO 9001: 1994
ISO 13488: 1996: ISO 9002: 1994
is based on.
Basic contents and additional demands against ISO 9001
* Concepts and definitions
* Product master files
* Storage times
* Maintenance and working environment
* Risk management
* Clinical evaluation
* Diagnostics and traceability
* Production (Cleaning and contamination control, installation, protection, validity, sterile products, software, storage)
* Feedback system
* Faulty products
Note: Certification according to ISO 9001: 2008 is not the primary target! Companies that fulfill ISO 9001: 2008 do not automatically fulfill ISO 13485: 2003!
1- Historical Development of ISO 13485 Medical Quality Management System
* ISO 13485: 2003, published on 15.07.2003
* EN ISO 13485: 2003, published on 24.07.2003
* EN ISO 13485: 2003 was harmonized on 02.04.2004. However, the new EN ISO 13485: 2003 replaces only EN ISO 13485: 2008 and ISO 13488: 2008, and the transition period is three years.
* EN 46003 will remain in effect in conjunction with EN ISO 9003.
* The European foreword of EN ISO 13485: 2003 says that EN 46003 should be configured to add to process orientation immediately.
2-ISO 13485 Medical Quality Management System Standard Items
0.2 Process approach
0.3 Relations with other standards
0.4 Compatibility with other management systems
2 Cited standards and / or documents
3 Terms and definitions
4 Quality management system
4.1 General terms
4.2 Documentation requirements
5 Management responsibility
5.1 Management´s commitment
5.2 Customer orientation
5.3 Quality policy
5.5 Responsibility, authority and communication
5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.4 Working environment
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.5 Provision and provision of production and service
7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8.2 Monitoring and measurement
8.3 Checking the inappropriate product
8.4 Data analysis
Annex A (informative) Mapping between ISO 13485: 2003 and ISO 13485: 1996 Annex B
3- ISO 13485 Medical Quality Management System Terms
For the purposes of this standard, the terms and definitions given in ISO 9000 apply, along with those listed below.
Supplier ————-> Organization ———-> Customer
The term "establishment" replaces the term "supplier" in the ISO 13485: 1996 edition and indicates the unit to which this standard is applied. Likewise, the term "supplier" replaces the term "subcontractor".
Wherever the term "product" is included in the entire text of this standard, this term "product" can also mean "service".
When the conditions for applying to "medical devices" are determined, these conditions apply equally to the related services provided by the organization.
The recipes given below should be considered as general recipes, the recipes provided by national legislation may differ slightly from them, but they come first.
Active medical device that can be placed in the body: Active medical device intended to be placed in the human body, either partially or completely, by surgical or medical means, or for medical intervention in the natural ways of the human body or to be left in the human body after the procedure.
Active medical device: