ISO 15189 accreditation: costs and timeline

According to the RvA , ISO 15189 accreditation takes six to twelve months. This applies to a new accreditation, to maintaining one and to an extension. The RvA does not say whether your own preparation is included in that, so add it yourself. The RvA fees are not the whole cost: internal hours, equipment, round-robin testing and quality monitoring count too. If you budget it this way, you can see in advance where the money and time go.

You will find the exact RvA fees and the time estimate per assessment in the current policy document BR001 . Those amounts are not repeated on this page, because they can change each year. For background, first read the transition to ISO 15189:2022.

Short answer: plan for six to twelve months for the RvA process. The biggest cost is usually your own staff, not the accreditation body. Ask the RvA for the current fees and time estimate before you set a budget.

What does ISO 15189 accreditation cost?

The costs fall into two types. The first you pay to the RvA. The second you invest in your laboratory yourself. That second group is often larger than the first, and it is regularly forgotten in a budget.

Cost item	What is included?	How to estimate it
RvA assessment	Application, document review, on-site assessment, any follow-up	Current RvA fees and the time estimate the RvA gives in advance
Recurring RvA costs	Costs after the award, such as monitoring assessments. Ask the RvA what applies to you	The current RvA fee
Round-robin testing	Participation in round-robin tests, mandatory for accredited labs	Quote or fee from the round-robin organiser
Internal effort	Process descriptions, risk register, internal audits, management review	Hours per employee multiplied by the internal hourly rate
Equipment and calibration	Calibrations, maintenance, reference materials	Supplier quotes
Support	Adviser for preparation, possibly a preparatory audit	Fixed assignment with a defined scope

On its page about the accreditation process , the RvA states that the full procedure is set out in RvA policy rule BR001 (beleidsregel BR001). You will find the phases and fees there. If you are unsure, ask the RvA for the current position.

The process in steps

The process follows fixed steps. The length of each step depends on how complete your preparation is and on the planning of the assessors.

Preparation (your own work, duration varies per laboratory)

Write procedures, the quality manual, the risk register and the list of tests. This is the biggest item in time, and the place where most laboratories fall behind.

Application and document review

You submit the application. The RvA reviews the documents before the on-site assessment takes place. An incomplete application costs time, because the assessment then starts later.

On-site assessment

A lead assessor and technical assessors visit. They follow samples through the whole process and ask staff questions. See the audit page for what happens on those days.

Resolving findings

You resolve non-conformities with a cause analysis and evidence that the measure works. Allow extra time and hours for this, especially if there are several findings.

Decision and after

After a positive decision, you receive the accreditation with a defined scope. According to the RvA accreditation specification for medical laboratories (ASR101) , a four-year accreditation cycle follows, with monitoring assessments and a reassessment. Include those later assessments in your budget.

Fictional calculation example for your internal budget

The following example is entirely made up. It shows how to add up the items. The amounts are assumptions for a fictional laboratory and are not RvA fees or market prices.

Item	Assumption	Amount
Internal project time	240 hours at an internal hourly rate of €65	€15,600
Calibration and additional equipment	Fictional allowance	€4,000
Round-robin testing over twelve months	Fictional allowance	€3,000
Support for preparation	Fictional allowance for an adviser	€5,000
Preparation subtotal	Excluding RvA fees and recurring RvA costs	€27,600

The subtotal is not the total budget. Add the current RvA costs, the recurring costs and any follow-up assessments. If the preparation runs two months longer, the internal project time increases too. Work this through before you present the timeline to the board.

A common mistake is underestimating the preparation. A laboratory that sets aside half a year for documentation can take a year, because the procedures only prove themselves in practice. Treat the preparation as its own project phase with its own owner.

Which time can you influence?

Not every month in the process is equally easy to shorten. Three factors make the difference.

The scope. The more tests you include in the accreditation scope, the more you have to justify. Start with the tests you already perform reliably. Also read the explanation of the difference from ISO 17025, because a similar scope choice applies there.

The evidence. An assessor wants to see that a measure works, not only that it exists on paper. Records covering a few months are often needed. There is no shortcut.

Internal willingness. If the laboratory management and the specialists see the process as their own project, the procedures move faster. If it is left with the quality officer, delays usually follow.

What the RvA does not do for you

The RvA gives you the process and the assessment. It does not write your procedures, and it does not decide how much you should invest in your own equipment. That makes budgeting your own job. Use the ISO 17025 page on costs and lead time as an example of a similar structure.

For the wider question of when accreditation pays off, see accreditation explained.

Checklist for your budget

Have you requested the current RvA fees and the time estimate per assessment?
Have you estimated the internal hours per employee and recorded the hourly rate?
Is round-robin testing for the next twelve months included in the budget?
Have you reserved funds for findings that lead to follow-up assessments?
Are the recurring RvA costs after the award included?
Have you planned preparation time as its own phase, with an owner?