ISO 15190 laboratory safety consulting for medical laboratories that protect their people.

What it is

What is ISO 15190 and what is it used for?

ISO 15190 is the International Standard titled "Medical laboratories — Requirements for safety". ISO describes its scope in one line: it specifies requirements for safe practices in the medical laboratory. It is developed by ISO/TC 212, the same technical committee responsible for ISO 15189, the standard for quality and competence in medical laboratories, and ISO itself describes ISO 15190 as providing guidance on medical laboratory safety.

The two standards answer different questions. ISO 15189 is about whether patient results can be trusted. ISO 15190 is about whether the laboratory is a safe place to produce them, for the people who work there and for anyone else who could be affected by what happens inside it.

Current edition. ISO 15190:2020, the second edition, was published in February 2020 and replaced the 2003 edition. ISO completed a systematic review and, in November 2025, marked the 2020 edition "to be revised"; a new project, ISO/AWI 15190, is registered in the committee's work programme and will replace it. No publication date for the revised edition has been announced, so ISO 15190:2020 remains the edition to work to. ISO 15189:2022 did not absorb it: ISO 15189:2022 replaced only ISO 15189:2012 and ISO 22870:2016.

Who it is for

Who needs ISO 15190?

Any medical laboratory that examines samples from patients has a safety obligation to its own people, whether it is a hospital department, an independent or reference laboratory or a public health service. Laboratories usually come to Sterling from one of four directions:

• Your laboratory is accredited, or seeking accreditation, to ISO 15189. You want safety handled with the same discipline as quality, and in the same management system, rather than as a separate binder kept by one person.
• A hospital group, client or tender asks how you manage safety. Referring hospitals, corporate clients and public tenders increasingly want to see a documented safety programme, and ISO 15190 gives your answer an international reference point.
• A regulator or health authority is looking at your laboratory. Where national rules apply, we map your programme to them and work alongside your legal and occupational health advisers; the standard does not replace the law.
• You run several laboratories or sites. Each site has grown its own way of working, incidents are handled differently, and management cannot see one picture. A single safety approach with local ownership fixes that.

What it covers

What are the ISO 15190 requirements?

ISO describes the standard as specifying requirements for safe practices in the medical laboratory. We do not summarise its individual clauses here: a programme is built from the standard itself, which you hold under licence, and every requirement is checked against it during the gap assessment. What we can describe is the work a Sterling ISO 15190 programme covers:

• Gap assessment: your current safety arrangements compared with ISO 15190:2020, area by area of the laboratory, with what already works kept.
• Risk assessment: the hazards in your laboratory's own activities identified, the risks evaluated and the controls agreed with the people who do the work.
• Procedures: safe working practices written for the way your laboratory operates, short enough to be used at the bench.
• Training and competence: staff, students and contractors trained on the practices that apply to them, with records to show it.
• Records: the incidents, inspections, checks and actions that show the programme operating, kept in one place.
• Internal audit and review: the programme audited against the standard, findings closed and results taken to management.
• Accreditation readiness: where your accreditation body looks at laboratory safety as part of your ISO 15189 assessment, the evidence it will ask for, ready before it arrives.

Putting it into practice

How do you implement ISO 15190?

There is no ISO 15190 certificate to obtain. You implement the standard, show that it operates and, if your laboratory is accredited to ISO 15189, fold the programme into the same management system your accreditation body already assesses. Sterling provides consulting and readiness support; any accreditation decision belongs to the accreditation body.

1. 01
   Agree the laboratories, disciplines and sites in scope.Confirm which areas, activities and people the programme covers, who will rely on it and any deadline set by a client, tender or assessment.
2. 02
   Gap assessment against ISO 15190:2020.Compare current arrangements with the standard, keep what works, and agree actions, owners, dates and the resources needed.
3. 03
   Assess the risks and put the controls in place.Complete the risk assessment with laboratory staff, write the procedures, train the people and start keeping the records.
4. 04
   Audit the programme and close the findings.An internal audit against the standard and a management review; we raise the findings first and see them closed with evidence.
5. 05
   Keep it working and ready for assessment.Inspections, incident follow-up, refresher training and audits continue; where the accreditation body reviews safety within ISO 15189, the evidence is current when it visits.

Check the route before you sign. If anyone offers an "ISO 15190 certificate", ask which scheme it belongs to, who accredits the issuer and whether your clients or your accreditation body will recognise it. For ISO 15189 itself, confirm that your accreditation body is a signatory to the Global ACI arrangement.

Cost

How much does ISO 15190 implementation cost?

The cost depends on the laboratory. A single-discipline laboratory with an established safety culture needs far less than a hospital service spread over several buildings with no common approach. Our commitment is a proposal that shows every part of the work, under one all-inclusive proposal.

Timeline

How long does ISO 15190 implementation take?

Timing depends on how many areas the risk assessment has to cover, how quickly staff can be released for training and how long the programme needs to run before an internal audit means something. We give you a planned timeline in the proposal once the scope is clear, with milestones your team can follow in Effivity.

If an ISO 15189 assessment or client deadline is coming, tell us at the start and we will plan backwards from it.

Your engagement

What your ISO 15190 engagement includes

Your agreed scope covers everything the laboratory needs for a working safety programme, from one team, under one all-inclusive proposal. Choose Design™, where we guide and your team does the work, or Drive™, where we manage the work with your people; either way Sustain™ keeps the programme current afterwards, and Automate™ runs it in Effivity.

• Scope, gap assessment and plan

  Areas, activities, owners and dates agreed before work starts.

• Risk assessment and procedures

  Built with your laboratory staff, on Sterling's template sets, for the way your laboratory actually works.

• Effivity ISO & GRC software

  Risks, incidents, inspections, training and audits in one workspace, included with the engagement at no additional cost.

• Training for everyone

  Internal auditor training for your audit team, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Internal audit and management review

  Conducted or facilitated as agreed, with findings closed with evidence.

• Accreditation readiness

  Where your ISO 15189 assessment reviews laboratory safety, the evidence prepared and support through the visit.

Sterling does not certify or accredit; where your laboratory is accredited, decisions remain with the accreditation body.

Often combined with

Standards organisations pair with ISO 15190

• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• ISO 10012ISO 10012 Measurement Management certification consulting: measurement processes and equipment controlled for valid results, ready for a certification audit.
• ISO 14065ISO 14065 accreditation and requirements for bodies verifying environmental information: GHG statements, footprints, the route, cost and timing factors.
• ISO 15189ISO 15189 accreditation consulting for medical laboratories: quality and competence for reliable, timely results, prepared for the accreditation assessment.
• ISO 17034ISO 17034 accreditation consulting for reference material producers: competence and consistent operation evidenced and prepared for accreditation assessment.
• ISO 20387ISO 20387 accreditation and requirements for biobanks: competence, impartiality and sample quality, with expert consultants, Effivity and an all-inclusive proposal.