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Expertise

With over twelve years' experience in setting up, implementing and maintaining ISO 9001, Good Clinical Laboratory Practice, ISO 17025 and ISO 15189 Quality Management Systems James QA can cover all aspects of Laboratory Quality Management. Extensive experience from start-up implementation through to refinement of established procedures. 
Quality Management System Development
Auditing
Documentation Development / Review

  • ISO 9001:2015

  • ISO 17025:2017

  • ISO 15189:2022

  • GCLP

  • GCP

  • ISO 13485:2016

  • IVDR and MDR

  • Laboratories

  • IVD manufacturing

  • Gap analysis

  • Assessment Preparation

  • ​Data Integrity mapping

  • Creation of audit calendars

  • Audit checklists and documentation 

  • Risk assessments and Risk Management Systems

  • Conducting audits of facilities, processes, studies, SOPs, protocols 

  • Onsite and remotely

  • Quality Manuals

  • Processes

  • SOPs

  • Risk Management Systems / Risk Assessments / Logs

  • Forms

  • Checklists

  • Audit calendars

  • Post Market Surveillance

Vendor Assessments

  • Supplier risk analysis

  • Vendor audits/quality assessments

  • Supplier verifications / assessments

  • Remote assessments

  • Supplier questionnaires

​

 

Assessment Preparation

  • Preparation for certification and accreditation assessments.

  • BSI certification

  • UKAS accreditation

Ideagen Quality

  • Q-Pulse configuration and implementation

  • Managed lists

  • Security groups and settings

  • CAPA wizards and templates

  • Asset Management

  • Audit calendar creation

 

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