Services

From creating QM manuals to introducing and maintaining QM system standards to audits, qualifications, validations and process management, you can count on me.

My portfolio includes not only medical technology standard ISO 13485 with its diversity, but also IATF 16949:2016 or DIN 9001:2015. Through my partner network I can offer you access to experienced IATF 16949:2016 or DIN 9001:2015 auditors. Strategic realignment or restructuring in these standards is also implemented by me and my partners.

You tell us your requirements from controlling parts to developing suppliers and in-house control or as interim manager and much more.

We respond to your needs with...
...an immediate operational solution?
...preparations to meet the standards for large and small businesses?
...the fulfillment of customer quality requirements?
...the identification of internal and external corporate risks?
...adequate training regarding 9001, 13485 and IATF?
We will realize it for you...

Our portfolio

  • Creation of QM manuals with work and procedure instructions
  • Introduction and maintenance of QM system DIN EN ISO 13485:2016
  • Introduction and maintenance of QM system 9001:2015
  • Technical files
  • FMEA
  • Product Risk Management (ISO 14971)
  • Auditor in ISO 13485, ISO 19011 and ISO 9001
  • Internal audits
  • External supplier audits
  • Accompaniment and support during official inspections
  • Implementation of qualifications, validations, problem-solving
  • Capa management systemic deviation reporting
  • Personnel certification
  • Support of development projects and documentation
  • GAP analysis
  • Regulatory support (from the idea to the development to approved medical devices and placing on the market)
  • GMP-compliant documentation in hard copy
  • I offer a very broad network with specialists who also have longstanding experience in IATF and 9001:2015 as well as VDA 6.3 auditing (1st & 2nd party audits IATF, 1st & 2nd party audits ISO 9001:2015, potential analysis VDA 6.3, process audit VDA 6.3, troubleshooting)

Have I roused your interest?

Then contact me!

  • Obere Klingen 5 . 72406 Bisingen
  • 0173 2888 095
  • info@mole-consulting.de
Der Mittelstand