Consultancy for Quality Management - Isabell Decker

About me

"Who ceases to improve has ceased to be good“
Richard Schmitz (*1937), Manager „Brenner’s Park-Hotel“, Baden-Baden

 Qualification

  • Certified Lead Auditor ISO 9001
  • Certified Internal Auditor ISO 13485
  • Certified Quality Management Officer ISO 13485
  • Quality Management Officer ISO 9001
  • External Quality Management Consultant ISO 9001 and ISO 13485
  • Pharmaceutical Technician

 Professional Experience

  • More than 10 years as Quality Management Officer DIN EN ISO 9001 in the pharmacy sector
  • Since 2018 Lead Auditor for certification bodies with numerous certification audits performed
  • Internal Auditor DIN EN ISO 13485 in the sector of medical technology
  • Performance of internal audits according to standards ISO 9001 and DIN EN ISO 13485
  • Performance of supplier audits in medical technology according to DIN EN ISO 13485
  • Some time as assistant for quality management in medical technology according to DIN EN ISO 13485 (performance of internal audits and supplier audits, complaint management, inspection equipment monitoring, change management, documentation and creation of controlled documents)
  • QMS created for the following among others: Medical practices, pharmacies, specialist service for inclusion...
  • Expertise in these sectors: pharmacies, medical practices, rescue services, medical technology, label printing, tube production, pharmaceutical imports/exports...
  • Coaching in Quality Management

Focal points of expertise
  • Implementation and maintenance of quality management systems according to standards ISO 9001 and ISO 13485
  • Performance of internal audits according to standards ISO 9001 and ISO 13485
  • Performance of supplier audits according to standards ISO 9001 and ISO 13485
  • Adoption, Governance and Updating of your QM-System according to standards ISO 9001 and ISO 13485

Your Benefits
  • Quality Management in close proximity - Pforzheim, Enzkreis District as well as in the state of Baden-Württemberg and nationwide within Germany
  • Expertise in the sectors of healthcare and medical technology as well as the associated quality management systems
  • Expert consultancy in quality management and uncomplicated performance and processing of orders
 
 
 
 
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