IMS Non-Clinical R&D Laboratories (GLP, ISO/IEC 17025, ISO 15189, ISO 9001)
IMS Non-Clinical R&D Laboratories (GLP, ISO/IEC 17025, ISO 15189, ISO 9001)
Written for laboratories whose studies must remain reconstructable years after the final report has been signed.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 4 |
| Policies | 3 |
| Procedures & SOPs | 25 |
| Forms & Records | 34 |
| Checklists & Audit Tools | 8 |
| Registers, Logs & Matrices | 3 |
| Job Descriptions & Organisation | 2 |
| Training & Awareness | 2 |
| Guides & Work Instructions | 6 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-QM-01 | Integrated Quality Manual | Word |
| AGS-QP-12 | Study Plans, GLP Study Conduct and Study Director Responsibilities | Word |
| AGS-QP-22 | Quality Assurance Programme (GLP QAU) | Word |
| AGS-QP-10 | Method Selection, Verification and Validation | Word |
| AGS-F-19 | GLP Study Plan | Word |
| Certificate of Analysis | Word |
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Overview
Non-clinical research and development laboratories running safety and regulatory studies answer to monitoring authorities and study sponsors, not only to accreditation bodies. This integrated system brings the OECD Principles of Good Laboratory Practice, FDA 21 CFR Part 58, ISO/IEC 17025, ISO 15189 and ISO 9001 into one controlled framework built around study integrity: study plans and protocols, Study Director and personnel responsibilities, test-item characterisation and handling, standard operating procedures, raw-data capture, archiving and final report certification. A quality assurance programme independent of study conduct supplies the inspections and audits that GLP requires.
An integrated quality manual and a compliance scheme map each principle to a control. Procedures run across organisation and impartiality, facilities and environmental conditions, equipment calibration and metrological traceability, handling and storage of test and reference items, method selection, verification and validation, sampling, evaluation of measurement uncertainty, and ensuring the validity of results. Guidance addresses data integrity and the ALCOA+ principles, decision rules and statements of conformity, and GLP principles for non-clinical studies, while chain-of-custody records, study plans and certificates of analysis carry the day-to-day evidence. The ISO/IEC 17025 and ISO 15189 layers add technical-competence rigour for analytical and bioanalytical work.
What this system covers
- GLP study lifecycle — study plans and protocols, Study Director responsibilities and final report certification
- Independent quality assurance — a GLP quality assurance unit programme kept separate from study conduct
- Test and reference items — receipt, chain of custody, characterisation, storage and retention
- Data integrity — raw-data capture, ALCOA+ principles, data change control and archiving
- Analytical competence — method verification and validation, measurement uncertainty, sampling and decision rules
- Facilities and equipment — calibration periodicity, performance verification, environmental monitoring and biosafety inspection
- People — competence and authorisation matrices, deputising arrangements and training effectiveness
- Reporting and release — certificates of analysis, report review, and acceptance criteria for internal quality checks
Who it's for
Contract research organisations, toxicology and bioanalytical laboratories, and research facilities preparing for inspection by a GLP monitoring authority or for a sponsor's audit. Study directors, quality assurance staff and quality managers adapt the documents to their study types, test systems and facilities. The outcome is a laboratory in which study conduct, raw data and independent quality assurance are systematised, and a completed study can be reconstructed from its records on request.
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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