Development of technical documentation, maintenance of implementation of the system at the enterprise
Technical Regulations of Ukraine prescribe the obligatory presence of the implemented quality management system at the enterprise.
ISO 13485 quality management systems – is the main standard for medical products. This international standard provides the one approach and mutual understanding between the manufacturers and the customers in the sphere of medical products all over the world.
Standard ISO 13485 is used by all participants in the chain of production and trade of medical products that includes designing, manufacture, assembly, sale, service, storage and transportation.
The advantages of certification by ISO 13485:
- possibility of free trade and acknowledgement by all organizations, that are members of the world chain of medical products delivery, in the countries of the world;
- increase of commercial value of the goods in terms of greater consumer confidence;
- improvement of the company’s image and brand, showing adherence to the requirements of international standards, the best practices and product quality and also adherence to applicable legislative and regulatory requirements;
- getting the opportunity to build the company’s business processes in compliance with high requirements of international and European standards;
- increase of sales volumes, improvement of the positions at existing markets and provision of access to new product markets;
- improvement of consumer’s confidence;
- getting competitive advantages in competition for profitable contracts and orders under other equal conditions;
- system and leading approach to the exposure of risks, development and implementation of control measures;
- EN ISO 13485 standard harmonizes with other international standards and certifications of management systems, such as ISO 9001, GMP and others, which gives the opportunity to construct effective management system.
ISO 9001 Quality management system
The group of standards ISO of 9000 series examines different aspects of quality management and contains some of the most famous ISO standards. The standards provide guidance and tools for companies and organizations, which prefer their products and services to qualify the clients’ requirements consequently and constantly improve the quality of products and rendered services.
ISO 9001 standard establishes the criteria for the quality management system and can be used by any organization regardless of its field.
More than one million companies and organizations are certified according to the standard ISO 9001 in more than 170 countries of the world.
ISO 9001 standard is based on the seven principles of quality management:
- customer focus;
- leadership;
- staff involvement;
- process approach; improvement;
- decision-making based on factual data;
- relationship improvement.
The advantages of ISO 9001 certification:
The presence of certified SMK according to ISO 9001 standard gives our companies the opportunity to be distinguished profitably at the market as effective quality management lets:
- satisfy the clients’ needs most effectively;
- use temporal and financial resources more effectively;
- eliminate the errors promptly;
- deduce motivation and staff involvement to a new level, contributing to the improvement of inner processes;
- get favorable terms of credit;
- improve company’s loyalty on the part of authoritative structures, partners and clients;
- provide services and goods of better quality.
As a result, the enterprise gets more clients and extends the possibilities of own business up to getting of state orders and work with foreign partners.
If the development of your company needs the implementation of quality management system and you need the development of the effective process organization, please, contact us.
Qualified specialists of 8L GROUP will provide qualitative and prompt maintenance of preparation of the correspondent technical documentation and the process of implementation of management system at your enterprise.