
Practical quality systems that strengthen laboratory performance—not simply prepare you for the next assessment.
Platinum Quill helps testing laboratories build sustainable quality systems, improve operational performance, prepare for accreditation, and maintain long-term compliance with confidence.
ISO/IEC 17025 | ISO 15189 | ISO 9001 | GLP | GMP
Platinum Quill was founded on a clear principle: Quality systems should strengthen laboratory operations—not burden them.
With more than 20 years of experience in laboratory operations, quality management systems, accreditation readiness, auditing, technical competency, and process improvement, Angela helps laboratories translate complex requirements into practical systems that work.
Her experience includes supporting accredited laboratories, multisite organizations, international laboratory environments, initial accreditation, and the resolution of significant nonconformances.
Angela also performs laboratory assessment activities under contract with accreditation bodies, bringing practical insight into how quality systems are evaluated in real accreditation environments.
Assessment activities performed under contract with accreditation bodies are conducted independently and separately from Platinum Quill consulting engagements. Platinum Quill does not represent or speak on behalf of any accreditation body.
Identify weaknesses before they become assessment findings and establish systems that withstand external scrutiny.
Build quality processes that remain effective after the consulting engagement concludes.
Develop defensible qualification, training, authorization, and competency systems.
Remove unnecessary complexity, clarify responsibilities, and improve laboratory workflows.
Resolve root causes and systemic weaknesses rather than repeatedly treating symptoms
Access senior-level quality expertise without immediately adding a full-time quality executive..
Build the Foundation
Establish the policies, processes, responsibilities, documentation, and controls required for an effective laboratory quality system.
Relevant services: Quality management system development; quality manuals; policies and procedures; SOPs and work instructions; document and record control; quality objectives; risk-based planning.
Prepare for Accreditation
Evaluate readiness, identify gaps, organize evidence, and prepare personnel for external assessment.
Relevant services: ISO/IEC 17025 readiness; ISO 15189 readiness; ISO 9001 support; gap assessments; mock assessments; scope expansion preparation; accreditation action plans.
Demonstrate Competence
Establish evidence that personnel, methods, equipment, and technical processes are capable and controlled.
Relevant services: Technical competency programs; training-needs assessments; qualification and authorization; method verification and validation support; measurement traceability; technical record review.
Strengthen Operations
Improve processes so the quality system supports efficient and consistent laboratory performance.
Relevant services: Process mapping; workflow analysis; responsibility clarification; document standardization; management review; quality indicators; operational optimization.
Resolve and Recover
Respond effectively to findings, recurring nonconformances, or quality system breakdowns.
Relevant services: Root cause analysis; corrective action planning; remediation management; audit-response preparation; effectiveness verification; accreditation recovery support.
Sustain Excellence
Maintain a healthy quality system through independent review, leadership oversight, and continual improvement.
Relevant services: Internal audits; follow-up audits; ongoing advisory support; fractional quality leadership; quality system monitoring; continual improvement planning.
Priority client groups: Small independent laboratories; small-to-midsize pharmaceutical organizations; small-to-midsize medical device organizations; multisite laboratory networks; and laboratories facing accreditation or quality-system challenges.
Best for audits, assessments, documentation projects, training, and targeted improvements.
Best for initial accreditation, reassessment, surveillance, or scope expansion.
Best for significant findings, recurring nonconformances, ineffective corrective actions, or accreditation concerns.
Best for organizations needing experienced quality leadership without immediately creating a full-time role.
Best for laboratories seeking continued access to senior quality expertise.
Tell us where your laboratory is today, where it needs to be, and what stands in the way.
Platinum Quill will help you identify the most effective path forward.
Platinum Quill, LLC
Laboratory Quality Systems | Accreditation Readiness | Auditing | Training | Executive Advisory
Email: info@platinum-quill.com
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