Documents your team will actually use
Assessors judge a laboratory first by its documents: the quality manual, the procedures behind every test, and the records that show those procedures are followed. Generic templates rarely survive that scrutiny, because they describe a laboratory that is not yours.
We write and revise your documentation against ISO 15189:2022, ISO 9001 and ISO 22735, and align it with CAP checklists or Joint Commission standards where those apply. Each document is built around your own tests, equipment, staffing and structure.
Every engagement leaves your laboratory with a complete, audit-ready document set, issued under document control and written to be used by your team rather than filed away for the assessor.
How it works
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Document gap review
We compare your existing documents with the standard and your accreditation body's requirements, and list what is missing, outdated or uncontrolled.
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Drafting for your laboratory
Documents are written around your tests, equipment, staffing and structure, keeping whatever already works.
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Review with your team
Drafts go through your section leads and quality manager, so each procedure matches how the work is really done.
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Approval and document control
Final documents are numbered, approved and issued through a controlled system with version history.
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Handover
We walk your quality team through the new document set so they can maintain and revise it themselves.
What you receive
Quality manuals
ISO 15189, ISO 9001 and ISO 22735 quality manuals, structured around the clauses of the standard.
Procedure manuals and SOPs
Management and technical procedures for each section, written to your tests and equipment.
Safety manuals and IQCPs
Laboratory safety manuals, and individualized quality control plans for the tests that need them.
Staffing, training and delegation
Staffing plans, training plans and a delegation matrix showing who is authorised to do what.
POCT programme policy
Governance for point-of-care testing carried out outside the main laboratory.
Quality improvement plans
Documented quality objectives and the actions and indicators used to track them.
Common questions
We already have documents. Do we start again?
No. We start from what you have, keep what works, and revise or add only what the standard and your accreditation body require.
Can you write a single document, such as a quality manual?
Yes. You can commission a full, audit-ready document set, or individual documents to close specific gaps found at an internal audit or assessment.
Will the documents be specific to our laboratory?
Yes. They are written around your tests, equipment, staffing and structure, and reviewed with your team before release, so they describe how work is actually done.
Do you set up document control as well?
Yes. Documents are numbered, approved and issued through a controlled system. Document control and records management is also covered in our QMS training if your team needs it.