ISO 13485

 

GENERAL INFORMATION

ISO 13485: 2003 / GOST R ISO 13485-2004 is an international industry standard developed by the International Organization for Standardization ISO. The current version of the standard was released in 2003. There is also an updated version of 2016, which will become mandatory in 2019 (three years after its publication). The standard contains requirements for a quality management system for medical device manufacturers and was published by the International Organization for Standardization ISO on July 15, 2003, abolishing the old standards ISO 13485: 1996 and ISO 13488: 1996. The requirements for the quality management system established in this standard are additional to the technical requirements for the product.

The purpose of this standard is to promote the introduction of harmonized established requirements for medical devices into quality management systems. ISO 13485 includes some specific requirements for medical devices and also excludes certain requirements that are not established, and therefore organizations whose quality management systems meet the requirements of this standard can not claim compliance until their quality management systems are will satisfy all requirements without exception. And also ensuring the full openness and accessibility of the processes for regulating the circulation of medical devices for subjects of medical devices.

The standard defines the requirements for the quality management system that can be used by the company in the design, development, manufacture, installation and maintenance of medical devices, as well as in the design, development and provision of related services. ISO 13485 can also be applied by internal and external (in relation to the company) stakeholders, including certification bodies, to assess the company's ability to meet customer requirements and requirements established in accordance with regulatory documents.

ISO 13485 defines the requirements for a quality management system in cases where a company needs to demonstrate the ability to supply medical products and provide related services that meet the requirements of the consumer and the established requirements applicable to these medical products and related services. The requirements of the standard apply to companies offering medical products to the market, regardless of the type or number of these companies.

 

IMPLEMENTATION (CERTIFICATION) BENEFITS 

• many medical products export possibility to the countries of the Customs Union and the EU;
• ensuring the economic stability of the company in the existing medical device manufacturers market and the ability to enter new markets;
• high degree harmonization of the standard with other international standards, including ISO 9001 and GMP, which simplifies the creation of integrated management systems;
• clear alignment of the company's business processes, effective internal resources allocation, personnel responsibility and authority within the existing management system;
• improving the products quality, as well as its commercial value in terms of greater consumer confidence, and as a result, increased sales;
• enhancing the image of an company demonstrating adherence to the international standards requirements , best practices and product quality, and compliance with applicable legislative and regulatory requirements;
• an additional advantage when participating in tenders.

 

WHY BELPROJECTCONSULTING?

We have a competent and qualified staff of expert consultants with experience in the management systems development, implementation and certification in accordance with ISO 13485 in both the European and the EEA certification systems. Before we start preparing the company for certification for medical products CE marking and/or development of QMS in accordance with ISO 13485, we collect data necessary for the formation of a financially optimal scheme for the Customer, which, through existing partnerships between our company and Certification can achieve double saving money in comparison with similar offers of our competitors!!!

As part of the training, we assist in finding a notified attorney (in accordance with the requirements of MDD 93/42) in the territory of the European Economic Union. We provide all the necessary regulatory documentation. Including in Russian.

The cost of services of international (European and Eurasian) certification bodies is indicated in US dollars and euros at the rate of the National Bank of Belarus on the day of payment.
 
The top management of the company should clearly present plans for its near future: if the prospective market for medical products is the countries of the Eurasian Economic Union, then for effective competitive advantage and implementation of a number of legislative requirements, it is sufficient to develop, implement and certify QMS in accordance with ISO 13485 any local authorized body on certification.

If you decide to promote your medical products outside the EEA, then customers will require a CE certificate in accordance with European Directive 93/42 on Medical Devices Directive first, the abbreviated common abbreviation is "MDD". The directive, depending on the complexity class of the medical device, requires either the ISO 13485: 2003 (EN ISO 13485: 2012) sections implementation without certification, or, together with the CE certification procedure, additionally certify the quality management system.

As far as the documentation for the CE marking of medical products is 70-80% identical with the QMS documents for ISO 13485, and the conformity assessment does not duplicate the verification of the same documents, then, in the absence of the Directive requirement to receive a QMS certificate, the company saves labor and financial resources on the management system certification procedure.

Additional Information:
CE-certification of a single product or group combined into one Technical File (TCF) will cost:
- for class I - 1900-2200 euros,
- for class IIa - 2200-3000 euros,
- for class IIb - 2700-3400 euros.
- for class III - 4200-5000 euros,

CE-certification of an In-Vitro product or a group of one in one Technical File (TCF) will cost:

- for self-diagnosis - 800-1000 euros,
- for products from sheet B - 1500-1800 euros,
- for products from sheet A - 2500-2800 euros,

MD with the use of products of animal origin - in addition to the price of 700-950 euros.

MD with the use of pharmaceuticals - in addition to the price of 1700-2000 euros.

Annual inspections:

- for class I - 700-1000 euros,
- for class IIa - 1100-1500 euros,
- for class IIb - 1600-1800 euros.
- for class III - 2000-3000 euros,

If several TCFs are claimed (you will receive as many certificates as you claim TCF files), the amount is multiplied. But if the products are similar in terms of functionality/manufacture, then a discount of up to 10% will be given for the total amount.

 

THE COMPANY GENERAL ACTIONS SCHEME THE BEFORE CONCLUSION OF THE AGREEMENT:

  • Appeal to LLC "BelProjectConsulting";
  • Familiarization of the customer representatives with the certification general scheme  (consultation is free with departure and/or by phone);
  • Collecting of initial information on products and prospective markets for medical products;
  • The certification body definition (the certification bodies of the EAEC countries are unacceptable to receive CE marking according to MDD 93/42.  All information on European bodies is contained in a single European database NANDO, which can be found on the EU website at: http://ec.europa.eu/enterprise/newapproach/nando/);
  • Contract conclusion for consulting services for preparation for certification in accordance with MDD 93/42 for obtaining CE-marking and / or QMS in accordance with ISO 13485 (EN ISO 13485).

 

APPROXIMATE PLAN FOR MEDICAL PRODUCT SAFETY MANAGEMENT SYSTEM DEVELOPMENT AND IMPLEMENTATION IN CONFORMITY WITH ISO 13485:

  • Definition of the certification body and the need for CE marking for manufactured medical products;
  • Familiarization with the documents on the main activities of the CUSTOMER, including the management structure, the charter, the staffing table, licenses, types of work;
  • Definition of the list of documentation required for the management system in accordance with the ISO 13485 requirements;
  • The development program preparation, implementation and certification of QMS;
  • Methodological assistance in the organizational and administrative documentation development for the management system implementation and maintenance:

Development of management system documentation (the list can be changed):

1. OS Human Resources
2. OS Infrastructure
3. OS Processes related to the consumer
4. Methodological assistance in organizational and administrative documentation drafting for the management system documents implementation :
5. Orders for the Organization standards implementation
6. Providing methodological assistance in the development of the Organization's Policy and Objectives in the MS field
7. Providing methodological assistance in organizing training planning for MS requirements (training plan)
8. OS Design and development
9. OS Purchases
10. OS  Production and service management
11. OS Products preservation
12. OS "Identification and traceability."
13. OS "Data analysis."
14. OS "Procedure for Hazard Identification, Risk Assessment and Risk Management"
15. Quality manual

 

  • Methodological assistance for the Organization internal auditors group establishment 
  • Methodological assistance in organizing internal audits
  • Organization's QMS joint internal audit for compliance with the ISO 13485: 2003, MS ISO 19011: 2011 requirements 
  • Methodological assistance in documenting the internal audit results.
  • Methodological assistance in compiling reports
  • Methodological assistance for the documents submission for certification
  • Methodological assistance in the certification audit passing

 

Задать свой вопрос