IndustriesTesting and calibration laboratories
ISO 17025 quality management software for testing labs
A testing lab needs every result defensible, every method current and every analyst's competence on record. QMSdesk™ is ISO 17025 quality management software that adds your lab's roles and minimum retention period to a platform that already runs your OOS investigations, CAPAs, documents and training.
Usual profiles for this work
Regulations they carry
ISO 9001; ISO 31000:2018; 21 CFR Part 11; ALCOA+ data-integrity principles; ISO/IEC 17025:2017; ICH Q10
- Retention floor
- 7 years
- Event workflows
- 9, including Quality-agreement deviation and Technology-transfer issue
A typical starting set. You choose your own profiles, and can add more at any time.
What ISO 17025 quality management software changes for your lab
01
Results you can stand behind
An out-of-specification result goes through a Phase 1 lab investigation and a signed review before anything else can happen. Nobody has to remember the order.
02
Competence you can show
Approve a method SOP and the training is assigned. Practical assessments are signed by a qualified assessor, and competency assessments sit on the same record.
03
Client audits you're ready for
Give a client's auditor a time-boxed, read-only account. They see and export what they need, and change nothing.
What the rules ask of you, and how QMSdesk supports it
ISO/IEC 17025 asks a lab to show it is competent and impartial: controlled methods, trained and assessed analysts, and every nonconforming result handled and corrected. If you test for regulated clients, their GMP or GLP rules apply to that work too. QMSdesk keeps the records for all of it in one place and applies the stricter rule when a client's regulation calls for it.
| Regulation | What it asks of you | How QMSdesk supports it |
|---|---|---|
| ISO/IEC 17025:2017 | Competence and impartiality for testing and calibration labs. | Laboratory Director, Technical Manager and Metrology Specialist roles, and 7-year minimum retention. Accreditation is yours to earn with your accreditation body. |
| Contract operations | Quality when you test under a client's quality system. | Quality-agreement deviations, technology-transfer issues, and the Sponsor Quality Manager and Quality Agreement Owner roles. |
| GMP, when you test GMP product | Your client's manufacturing rules, applied to your testing. | OOS Phase 1 within 1 business day, 10-year minimum retention, and EU GMP Annex 11. |
| GLP, when you run nonclinical studies | Study integrity for nonclinical safety studies. | Study Director sign-off and QAU findings. See GLP laboratories. |
| 21 CFR Part 11 | Electronic records and signatures you can trust as much as paper. | Electronic signatures and a hash-chained audit trail for every customer. |
Every customer also holds BASE, the quality baseline, which carries 21 CFR Part 11, ALCOA+, ISO 9001 and ISO 31000.
The profiles for your lab's regulations
Your lab's quality events already run on the platform. The ISO 17025 profile adds what's specific to a lab.
The ISO 17025 profile adds three laboratory roles: Laboratory Director, Technical Manager and Metrology Specialist. It sets a 7-year minimum retention period. It has no event types of its own, because your lab's quality events already have workflows. Laboratory Director and Technical Manager are set up as GxP-critical (critical to quality) roles, so overdue training for either one opens a risk.
BASE, held by every customer, carries the rest: incident, deviation, nonconformance, complaint, OOS/OOT and supplier-issue workflows, plus CAPA. Part 11 e-signatures sit at approval and closing steps, with every risk scored on a 5×5 matrix.
Contract operations, for testing you do under a client's quality system. A contract testing lab holds BASE, ISO 17025 and Contract operations together. That adds QA-agreement deviation and tech-transfer issue events, plus Sponsor Quality Manager and Quality Agreement Owner roles.
Adding GMP or GLP work? Add the profile, and the strictest rule applies. Under GMP, for example, the OOS Phase 1 deadline becomes one business day and the minimum retention period becomes 10 years.
Laboratory QMS software: the modules that matter most
OOS/OOT investigations
Two enforced phases, with no route around the signed Phase 1 review. Lab-error invalidations are trended by method, analyst and instrument, so a recurring cause shows up in your own records.
Deviations and nonconformances
Nonconforming work gets a signed disposition, and "use as is" needs a technical rationale. Client complaints are acknowledged against a 3-business-day deadline.
CAPA
Raise one from an event, a trend, an audit or a management review. After closure, an effectiveness check confirms the fix held. If it didn't, a new linked CAPA is raised.
Document control
Method SOPs are signed at authoring, review and approval by three different people. External standards are held as reference documents, with their issuing body, version and a "not internally approved" banner. License-restricted standards can be read in the app with download switched off.
Training and competency
Four ways to complete training: signed acknowledgment, a quiz, a practical assessment or an external certificate. Waivers are signed and time-limited.
Audit management
Internal audits with auditor independence built in, one register of every open finding, and read-only accounts for client auditors.
The providers you depend on are qualified by risk tier in supplier quality, with certificate alerts at 90, 60 and 30 days.
Every tier includes every module: document control, quality events, CAPA, change control, training, risk, audits, supplier quality, management review and reporting. See the whole platform
Questions buyers ask
Does the ISO 17025 profile add its own workflows?
No, and that's deliberate. Your lab's events already run on the platform's workflows for OOS/OOT, deviation, nonconformance, complaint and CAPA. The profile adds what's specific to a lab: three roles and a 7-year minimum retention period.
We test for pharmaceutical clients. What changes?
Add the Contract operations profile for QA-agreement deviations, tech-transfer issues and sponsor-facing roles. If you test GMP product, add the GMP profile too. The strictest deadline and the longest minimum retention period then apply.
Can we run GLP studies in the same system?
Yes. Add the GLP profile, and study deviations and QAU findings run alongside your lab's other quality events. See GLP laboratories.
Will QMSdesk get us accredited?
Accreditation comes from your accreditation body. QMSdesk gives you controlled documents, investigated results, corrective actions, audits and competence records, all on one hash-chained audit trail.
How long does setup take?
The target for a first working workflow is 8–12 weeks, depending on scope, data readiness and your team's availability. You configure and test in your own QMSdesk through the Configuration Runway.
How is QMSdesk priced?
By organization tier, never per seat, and every tier includes every module. See pricing.
Build your regulatory profile
Tell us what your lab does. We'll show you QMSdesk working under your regulations.
Early-stage and growth labs can apply for the 2026 Early Adopter Program.