ISO 13485 CERTIFICATION
Quality Management System (QMS)
ISO 13485 SPECIFICS
ISO 13485:2003 respectively. EN ISO 13485:2012 (EN ISO 13485:2012) is a standard specifically designed for the needs of developers, manufacturers, service companies, installation and implementation of other activities and services related to medical devices. The above mentioned European Standard (EN) is also harmonized to the directives 93/42/EEC, 90/385/EEC and 98/97EC and can be use in demonstrating conformity with some quality system requirements for the EC declaration of conformity. Standard focuses on process approach and facilitate the harmonized medical devices requirements.
Experience and our improvement
Difference between ISO 13485 and ISO 9001
Although this standard is built on the basis of ISO 9001 there are some different requirements, especially the difference in maintaining the continuity of quality and efficiency than in the general permanent continual improvement (ISO 9001), there is a difference in the requirement to meet customer requirements and needs unlike general customer satisfaction. It is a very big emphasis on traceability in production and post-production phase (development-supplier-manufacturer-dealer-client-patient-authority)
Documents and records
Given that the scope of required records and documents is also affected by the national - european and international MEDDEV regulatory requirements and a greater emphasis on traceability of all procedural steps The range of documents and records compared to ISO 9001 is at least twice.
The basic philosophy of LL-C is using experienced auditors in the field of medical devices. To find critical points of your quality management system and to show the compliance as well as risk arising from their inadequate performance. Next, we consider the system settings of feedback mechanisms and parameters for evaluation of processes as KPI outputs for the management.
Our approach to the selected elements of the standard
5.3. Quality policy.
This is a part of the firmís strategic vision. Leading the defined policies of quality declares its future trend and view on the needs of clients and their solutions. During the audit we evaluate the policy of quality on the one hand of whether it is consistent to the general strategy of the firm, and whether it isnít formed perfunctorily or incomprehensibly. On the other hand we judge its objectivity for the firmís possibilities
7.2.2 Review of requirements related to the product.
From experience we know that the clientís most frequent complaint, misunderstanding or disappointment arises from an insufficient ascertainment of his requirements. The solution is a clear and understandable declaration of the parameters of your products, the conditions of their use or existence in the offer (catalogue, internet, package). The solution is a detailed assessment of the clientís needs and his purpose for needing your product or service. During the audit we concentrate on progress and also the experience of the employees for the review of the requirements.
7.5.3 Identification and traceability.
It isnít necessary to identify individual parts or products if it is proved that the method of their technological cultivation guarantees their irreplacability. Despite this we require the introduction of a certain method of identification or record-keeping because during a dispute, claim or simple analysis we need to know which particular product we are talking about.
8.2.3 Measurement and monitoring of processes.
Possibly this is the least popular element. Bear in mind, however, that with its good and informal application we can achieve savings when you will not have to perform several individual measurements.
Will the quality management system help marketing?
On the contrary, he marketing must create the requirements for quality management system. It is important how the quality is feeling by the customer. There are many fields where the supplier is sufficient compliance with product standards, but it is necessary to bear in mind that the customer perceives the quality not only as useful characteristics of the product, but also assesses the quality of related services and communication. In many fields of standardized requirements for quality standards do not exist or is insufficient to respond to modern trends.
What you will get passing the certification?
What you will get passing the certification? If Leaving aside the primary objective of the customer to obtain the certificate, and our obligation to assess compliance with standard. We realize that the audit takes a considerable amount of time of large number of busy workers and executives. Therefore, we try to client to compensate the time loss during the audit by added value. Our auditors focus on the essential things and finding opportunities for improvements. From this point of view, we nominate our auditors regard to their skills, communication skills and analytical thinking in particular.
Content of other rules.
Content of other rules. We respect the established practice in the firm; the scope of management documentation must respect the internal needs. Nevertheless, based on experience, that too detailed a wide range of documentation leads to the fact that not enough staff to get familiarized with the whole range. In present flexible market requirements the company management will not be able to carry out continuous changes in the documentation. If you have qualified and experienced staff, you do not to create extensive descriptions of their activities. Effective way is the practical training, software and automated solutions.