With its service ISS is always very close to the operating policies.
ISS understands the daily challenges to connect with quality management systems and regulatory requirements and therefore can support you actively and towards product entry and implication.
Our quality management services are oriented in accordance to regulatory guidelines (e.g. 93/42/EWG, 98/79/EG, 21CFR820).
Implementation of Quality Management Systems
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
The technical documentation (TD) is an essential part of a medical device and a core element of the submission dossier. The TD is based on the regulatory strategy of our customer and in cooperation with the Regulatory Affairs department (according to NB-MED/2.5.1/Rec5 and/or 21CFR820 DHF/DMR/DHR).
Accompaniment product CE marking
The Notified Bodies (NB) usually examines the required technical documentation for CE marking a product. ISS provides the following services to receive the CE marking for a product:
- Determination of the TD structure
- Analysis of the existing TD, and documentation of existing gaps in the information (Gap analysis)
- Definition of concrete proposals for compiling the TD and the path to successful CE marking
- Preparation and accompaniment of the audit through the NB
- Processing of uncertainties and deviations needed to be addressed by the NB
Interim Quality Manager Services
A change of personnel within the Quality Management may significantly impact a company’s success. Finding a replacement can take too long and put additional stress on the company. To bridge such a situation ISS offers the following support:
- Temporarily drive the daily defined responsibilities of the on-site quality manager until a replacement can be hired
- Trainig (on the job) of employees with specialists in the quality field
- Implementation of process trainigs with employees
- Implementation of internal audits
- Supplier assessments with audits on-site
Regulatory and process audits can constitute major challenges for customers, whether the assessment is through a Notified Body (NB), an internal audit or a supplier audit.
ISS offers the following support with respect to audits:
- Preparation and implementation of internal audits by trained auditors
- Preparation and implementation of on-site supplier audits by trained auditors
- Preparation and accompaniment of audits of the NB, briefing employees
- Planning and implementation of “friendly audits” or “mock audits” as preparation for an audit by the NB
- Support for the reconditioning of deviations and improvements suggested by the NB
Examples of services:
Management of projects or sub-projects primarily in the fields of medical technology, injection molding, biocompatibility.
Building of a compliant technical documentation (eg. STED-Format, etc.)
Requirements engineering, specifications, development of design verification and validation plans, accomplishment of design verifications and validations.
Support and guidance in the development, documentation and validation of processes.
Support and guidance in construction of microbiology concepts for clean room production.
Value Engineering: Increase productivity of manufacturing processes while taking into account the product compliance and without reducing the product quality.
Transfer of production or IP technology into Switzerland or from Switzerland to other countries. The services of ISS AG hereby extend from project management to procurement of production equipment, process validation, regulatories and quality management throughout every stage of process audits by the certification body.
Anne-Catherine Morancy Meister
Team Leader Q & Engineering Support