The expanding of the competence of the inspection body that is CERTINSPECT accredited for the standardized domain
As part of the project, the documentation of the quality management system was compiled according to the SR EN ISO 17020 : 2005 requirements.
There were revised the specific inspecting procedures for textile fabrics and yarns.
Also, new specific procedures were conceived for:
- the inspecting of dressings and bandages;
- the inspecting of sutures ;
- the inspecting of the absorbent cotton wool.
The functioning of the quality management system was verified by effecting 2 practical inspections (for dressings and for bandages) at two economic agents, producers of medical devices accomplished form textile materials.
I. The establishing of the manners of evaluating the requirements imposed by the harmonized standards, the medical devices that are the project objective;
II. the revising of the documentation of the quality management system and the drawing up of the specific procedures needed for accrediting the new inspections;
III. the verifying of the quality management system functioning by effecting practical inspections;
IV. the evaluating, by RENAR, of the quality management system for the purpose of accreditation obtaining, according to the SR EN SIO 17025 requirements (for the inspection of three types of textile products: woven fabrics, yarns, dressings, bandages, cotton wool).
- the legislation in the field of evaluating the textile product conformity;
- the European standards that are harmonized and adopted as Romanian standards, applicable to the medical devices that are the project objective;
- requirements for introducing the medical devices that are the project objective on the market;
- methods (method standards) of evaluating the identified requirements.
- the documentation of the quality management system revised according to the SR EN ISO CEI 17020 : 2005 requirements;
- a specific procedure for the dressing and bandage inspection;
- a specific procedure for the suture inspection;
- a specific procedure for the cotton wool inspection.
- an inspection file for the inspected suture lot;
- an inspection file for the inspected dressing lot;
- and internal audit account;
- the minutes of the analysis of the quality management system.
- The accreditation in accordance with the RENAR requirements (the quality handbook, general and specific procedures, confidentiality commitment, evidence concerning the staff competence, assurance of juridical liability, balance sheet, property documents, the INCDTP founding decision and statute, etc).
Paper – symposium TEX TEH 2008