IMS Medical & Clinical Diagnostic Laboratories (GLP, ISO/IEC 17025, ISO 15189, ISO 9001)
IMS Medical & Clinical Diagnostic Laboratories (GLP, ISO/IEC 17025, ISO 15189, ISO 9001)
GLP, ISO/IEC 17025, ISO 15189 and ISO 9001 met once, in one system, across the whole diagnostic pathway.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Policies | 5 |
| Procedures & SOPs | 14 |
| Forms & Records | 15 |
| Checklists & Audit Tools | 6 |
| Registers, Logs & Matrices | 1 |
| Training & Awareness | 2 |
| Guides & Work Instructions | 4 |
Key documents
| Reference | Document | Format |
|---|---|---|
| QM-01 | Integrated Management System Manual | Word |
| SOP-14 | GLP Study Management OECD 21 CFR 58 | Word |
| SOP-08 | Ensuring the Validity of Results IQC EQA PT | Word |
| SOP-06 | Examination Process Method Selection Verification Validation | Word |
| CHK-01 | Internal Audit Checklist Clause wise Integrated | Word |
| CHK-06 | GLP Study Facility Inspection Checklist | Word |
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Overview
Medical and clinical diagnostic laboratories are judged twice over: by accreditation bodies on technical competence, and by clinicians on whether a result can safely be acted upon. This integrated management system harmonises Good Laboratory Practice, ISO/IEC 17025 testing competence, ISO 15189 medical laboratory quality and ISO 9001 into a single framework across the pre-analytical, analytical and post-analytical pathway, so overlapping requirements are satisfied once rather than in parallel document sets that drift apart.
An integrated manual carries laboratory policy and impartiality safeguards, with policies on quality and biosafety, patient data protection, ethics and patient rights, and GLP study integrity, alongside a stated scope of accreditation and examination menu. Procedures operationalise sample collection, handling and transport; method selection, verification and validation; reporting and release of results; internal quality control, external quality assessment and proficiency testing; equipment calibration and metrological traceability; nonconforming work and corrective action; risk, internal audit and management review; and GLP study management under the OECD principles and 21 CFR Part 58. Guidance addresses measurement uncertainty, metrological traceability and reference intervals with decision rules, while clause-wise checklists convert accreditation criteria into daily bench practice.
What this system covers
- Pre-analytical control — requisition, chain of custody, sample acceptance and recorded rejection
- Analytical control — method selection, verification and validation, measurement uncertainty and metrological traceability
- Validity of results — internal quality control charting, external quality assessment and proficiency testing
- Post-analytical release — report review and verification against reference intervals and decision rules
- GLP study management — study plans and protocols under the OECD principles and 21 CFR Part 58, with facility inspection
- Equipment — acceptance of new instruments, history cards, calibration and maintenance scheduling
- Competence — training, assessment and authorisation of analysts across the integrated standards
- Improvement — corrective action, risk assessment, complaints, internal audit and management review
Who it's for
Laboratory directors and quality managers in diagnostic laboratories pursuing ISO 15189 or ISO/IEC 17025 accreditation, consolidating systems that grew up separately, or answering findings from a recent assessment. Every document is editable to your test menu, analysers and structure. You end with one coherent suite instead of competing manuals: technical and quality requirements aligned, analyst competence evidenced, and each released result traceable through the controls that produced it.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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