Course · 5 hours of CPD
Build a POCT quality management system that runs itself
Turn scattered procedures and good intentions into one quality management system: a quality manual, document control, risk and CAPA, internal audit and management review, built for a point of care service and sized to your risk.
Free to complete, with a certificate for your CPD portfolio. If it helps you, an optional donation at the end keeps it free for the next team.
Who this is for
- POCT coordinators building or tightening a quality system
- Quality managers folding POCT into an existing quality management system
- Private clinic and pharmacy leads who need a defensible system
- Anyone told to sort out the paperwork and unsure where to start
What you will leave able to do
- Explain what a POCT quality management system must contain and why
- Build a document-control system that staff actually use
- Size quality control, competency and documentation to real clinical risk
- Run a nonconformity and CAPA process that closes the loop with evidence
- Plan and run internal audits and a management review
- Assemble a minimum viable quality management system for your own service
Syllabus
Module by module
01 What a quality management system really is
- System thinking versus doing isolated tasks
- The quality policy and the quality manual
- Scope, objectives and the process approach for POCT
02 Document control people actually use
- The document hierarchy: policy, procedure, work instruction, form, record
- Version control, review cycles and controlled copies
- Writing procedures that work at the bench
03 Risk management and the risk-based approach
- Risk-based thinking, proportionate to device and clinical risk
- Identifying and rating hazards in a POCT service
- Using risk to size QC, competency and documentation
04 Nonconformity, CAPA and incidents
- Recognising and recording a nonconformity
- Correction, corrective action and preventive action
- Root cause without blame, and closing the loop with evidence
05 Internal audit and management review
- Planning an audit schedule you can keep
- Auditing on objective evidence, not personalities
- Management review inputs, outputs and continual improvement
06 Assemble your quality management system
- The minimum viable document set
- Roles, responsibilities and embedding it so it survives churn
- Your 90-day quality management system build plan
Led by a specialist who has worked every side of POCT
Your course lead has spent a career in point of care testing: implementing, validating and supporting services day to day inside hospitals, consulting to device manufacturers and distributors on POCT and market access, and leading product management for POCT IT solutions. Every module draws on that mix of bench, business and digital, done for real.
Pricing
Free for everyone
Online course
Free
- Full course access
- 5 hours of CPD, certificate included
- Document-control and QMS templates
- A QMS-on-a-page you build as you go
Whole service
From £750
- In house, up to 12 staff
- Your own document set reviewed live
The online course is free for individuals and teams. If the standards change, your materials are updated free.
Questions, answered
Is this the same as the ISO 15189 course?
No. The ISO 15189 course maps the standard. This course teaches you to build and operate the quality management system that sits underneath it, whether or not you are pursuing accreditation.
We are a small clinic. Is a full quality management system overkill?
The system scales down. A two person clinic needs the same defensible spine, just lighter. The course builds a minimum viable version around your own service.
Does this count as CPD?
The course represents 5 hours of CPD with a certificate for your portfolio, designed to support HCPC and professional CPD schemes.
What will I have at the end?
A worked document set, a risk and CAPA process, an audit schedule and a QMS-on-a-page for your service, plus the templates to keep them running.