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You are an organization that does product certification and you want to be accredited. For accreditation approval, you must set up and manage your system according to the TS EN 45011 standard. You should also apply this guide, which contains general requirements for the product certification system, using Guide 65.
It is the standard that covers the principles and requirements for the adequacy, consistency and objectivity of the audit and certification of all types of management systems (such as quality management systems or environmental management systems) and for organizations performing these activities. In other words, an organization that will provide the certification service of management systems; accredited according to this standard.
If you are an experiment or calibration laboratory, if you want your measurement results to be accepted internationally; You must be accredited according to the TS EN ISO / IEC 17025 standard. This standard; It can be applied to any type of experiment and calibration laboratory. It is a standard that dominates the technical aspect and has overlapping points with 9001. Just because a laboratory has 9001 certification is not enough for its measurements to be considered reliable. However, it is similar to 9001; There are common aspects such as document control, records control, management review, objectives, laboratory policy, …. Unlike 9001; The laboratory must prove that it is competent in terms of infrastructure, personnel and equipment, and create and implement the relevant documentation. In addition, the best measurement uncertainty calculations should be made and a measurement uncertainty budget should be created. Placement and environmental conditions, test and calibration methods and validation of these methods, measurement traceability, sampling, transportation of test and calibration materials are also issues that need to be documented and managed.
It is the most widely documented quality management system. At the beginning of the studies, the operation in the company is analyzed. An accurate analysis; It ensures the establishment of a properly working and optimum system in the company. A management representative is appointed to accompany the work and be authorized in the execution of the system. Company employees are given training to raise awareness. After the company analysis, the system to be established is shaped, and appropriate forms are designed to ensure the flow between the units without clogging. Processes and interactions between them are determined. Priority is given to the procedures mandated by the standard, and if there are any other required procedures, they are created. The organizational structure of the firm is determined. All support documents needed for the functioning of the system and a quality manual as the constitution of the system are created. After all these preparations are completed, the certification process is completed by applying to any certification body desired by the company.
CE Mark is not a quality mark! The CE mark indicates the conformity of the product with the European Union product directives. Within the framework of harmonization, EU product directives have become mandatory in Turkey. In order to affix the CE mark to your product, you must first determine which directive(s) your product falls under. Your product may be covered by more than one directive, in which case you must meet the conditions of all directives your product enters. You should also determine whether your product requires Notified Body approval under that directive. If approval is required, you should be inspected by applying to a Notified Body after making the necessary preparations.
After that, you should determine the harmonized product standards under the relevant product directive. Adhering to harmonized standards is optional. However, it is a direct aid to you in affixing the CE mark to your product, it is recommended to comply. You should prepare your technical file together with fulfilling the technical requirements (testing, analysis, recordings,…) in the relevant standards. In your technical file; product description, life cycle declaration, usage instructions, list of applied standards, product trees, technical drawings, electrical circuit diagrams, material properties you use in production, quality control specifications, labeling and packaging, shipping conditions, test and inspection records, directive basic requirements checklist and a declaration of conformity. If your product requires a Notified Body, if the technical file you have prepared is checked and successful, there is a 4-digit Notified Body ID next to the CE mark you have attached to your product. In your declaration of conformity, you must also provide Notified Body information. If your product is a self-declaration product, you make your own declaration of conformity and affix the CE marking to your product. Even if it is a self-declaration, you must do all the technical work on your product in the same way as applying to the Notified Body in order to affix the CE mark. If the unfairly attached CE mark is detected as a result of market surveillance and inspection activities, it causes great sanctions.
TSE / TSEK Brand
An occupational health and safety policy in accordance with OHSAS18001, approved by the company's senior management, is created and documented, and announced to all employees. A procedure is established to identify ongoing hazards, assess risks, and take necessary control measures.
A procedure is established to define and reach the legal and other OHS conditions applicable to the company, and according to this procedure, the legal and other OHS conditions applicable to the company are determined. Legal and other conditions are communicated to the employees of the companies and other related parties. Occupational health and safety goals are established in a way that is consistent with the OHS policy for each relevant function and level in the company, and an OHS management program is created to achieve the determined goals.
Activities affecting OHS risks, responsibilities and authorities of personnel who manage, fulfill and verify processes, roles are defined and announced. A member of senior management is appointed with specific responsibility for the correct implementation of the OH&S management system, meeting the requirements in all areas of the organization and at each process step, and this assignment is documented. It is ensured that the competence of the personnel in the subjects that may affect OHS is defined in terms of appropriate education, training and/or experience, and the procedure for OHS training is established. Internal communication to ensure that OHS information is communicated to and received from employees and other relevant parties, the core elements of the ISG System and their interactions are identified and documented, the procedure for document control, control measures to control all documents and data in order to meet OHSAS18001 requirements. a procedure for identifying activities and operations related to identified risks where applicable, an inspection and test procedure for monitoring and measuring OHS performance on a regular basis, addressing and examining accidents, incidents, and nonconformities within the scope of OSH, taking action to mitigate the consequences thereof, corrective action /a procedure to identify responsibilities and authorities for initiating and completing preventive actions, confirming the effectiveness of corrective actions taken, for defining, maintaining and issuing OHS records The procedure is established, documented and implemented for the purpose of performing periodic OHS management audits to meet the requirements of the standards, an audit procedure for the company's top management to review the OHS management system at intervals determined by the firm to ensure its continuing suitability, adequacy and effectiveness.
TS EN ISO 13485 standard; It is an international standard that was created on the basis of TS EN ISO 9001 standard and contains special requirements for medical devices. This standard specifies the quality management system requirements for an organization that must demonstrate its ability to procure 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 regulatory requirements for quality management systems. Within the scope of this standard; A quality manual is created. Document control procedure, nonconforming product control procedure, corrective preventive actions, control of quality records, internal audits, technical file control, after-sales service procedure, risk management procedure according to EN 14971, design control procedure, product identification and traceability procedure, training procedure, monitoring and measuring devices control procedure, purchasing procedure, data analysis procedure and machinery equipment maintenance procedure are established. In addition, the manufacturer; An early warning system is created as a systematic approach that ensures that a device is on the alert with information from the market, in order to prevent a defect or medical performance deficiency from harming patients or third parties. If your products are sterile products, the procedure including the conditions to keep the situation under control is also documented.