Robert-Walser-Platz 7
CH-2503 Biel
Tel. +41 32 513 67 67
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When we create a Quality Management System (QMS) for our customer, our goals are 1) to generate full acceptance for quality management at the customer, 2) provide the benefits this provides for the business  and 3) emphasize the importance and value add to the concerning employees.

The QMS is tailored to meet the company specific demands of our customers. The general practise is as follows:

Determination of the frame

  • Clarification of the field of application
  • Clarification of the product risk classes
  • Proper norms and guidelines for such related product
  • Development of essential requirements according to the applicable directives (is required later for the certification too)
  • Definition of a useful profile of the ISO certification for the company (What should be included and could be excluded? Determining which annex the conformity assessment should be made?)

Definition process map and development process

The basics for the subsequent work are prepared together. The goal is to customize a process map and development process for your Company’s product. This includes

  • Implementation by the involved employees and management: Communicate why it needs an ISO certification?
  • Definition of the process map
  • Definition of the development process

Development and implementation of processes inclusive templates etc

In this phase the processes and SOP’s are developed and critically reviewed. ISS offers the following services:

  • Cooperation for the defined documentation structure, process profiles, processes, SOPs, checklists, etc.
  • Construction and implementation of special processes for medical devices (risk classes 2 and 3)
  • Construction and implementation of special processes for medical software development after ISO 62304 inclusive software validation process
  • Training of the affected employees and partners
  • Additional support in accordance with other requirements related to Company specific  needs

ISO 13485 Certification of the company

ISS will accompany your business for the certification through a Notified Body (NB). To receive certification, ISS provides the following services:

  • Support with internal trainigs (documents, structure, implementation, certificates etc.)
  • Preparation and implementation internal audit inclusive report
  • Preparation of the pre-audit through the NB
  • Postprocessing of the pre-audit, support at the processing of deviations

ISS is able to support the certification of a company according to ISO 13485 in the following ways:

  • Preparation of the audit, discussion of the application of personnel
  • Accompaniment of the audit and any subsequent evaluation
  • Cooperation at the reconditioning of the deviations from the audit