ISO 15189:2022 Accreditation Kit

ACCREDITATION OF YOUR LABORATORY IN RECORD TIME

Achieve ISO 15189 accreditation quickly, efficiently and hassle-free. Click this button to download several examples of the procedures and registration forms:

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All ISO 15189:2022 documentation in a matter of minutes

Can you imagine being able to produce all the documents required by ISO 15189 in just a few minutes? What if we told you that this dream could now become a reality?
Introducing our ISO 15189 Accreditation Kit, designed to simplify your life and maximize your time. These templates will allow you to fulfill all your ISO 15189:2022 documentation needs quickly, easily and stress-free.
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187 ISO 15189 editable templates

Documents in Word and Excel so that you can adapt them to your laboratory without any problem.

1 Risk Matrix

This tool contains 32 examples of risks with the entire management process done.

Free specialized support

An expert will accompany you in the implementation of ISO 15189 in your clinical laboratory via email.

8 Implementation Guides

These guides will help you implement ISO 15189:2022 without hiring a consultant.

497 usd

U.S. Dollars

Don’t have time to build ISO 15189:2022 documents?

Building all the ISO 15189:2022 documentation takes months or even years if you don’t have the necessary knowledge and experience.

Now imagine what you could do in the lab if you no longer had to worry about all the Management System documents. The Accreditation Kit makes it possible.

When you download it you will have in your hands all the mandatory documents plus others commonly used in a clinical laboratory. All you have to do is change a couple of things and the document is ready in minutes.

Is the ISO 15189:2022 Accreditation Kit suitable for my laboratory?

The answer is a resounding YES. This Kit is designed to save you a lot of money and free you from hundreds of hours of work that in the end only cause you stress. The Accreditation Kit contains:

1 Quality Manual

This manual also contains the quality objectives and policy.

36 Procedures

Uncertainty, method validation, risk management, non-conforming work, and many more.

90 Formats

It contains all the formats to capture the technical information of the clinical laboratory.

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7 Instructions

These documents contain more detailed instructions for performing certain specialized laboratory activities.

1 Risk Matrix

This tool contains 32 examples of risks with all the steps done!

5 Method Validation Templates

These templates designed in Excel will save you a lot of time and effort in validating your methods.

Gap Analysis

With this tool you will be able to perform the Gap Analysis of all the requirements of the ISO/IEC 17025 standard.

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Document Master List

With this Excel tool you have organized all the SG documentation.

FREE Support

An expert will answer any questions you may have regarding the editing of the documents via email. You are entitled to a maximum of 10 queries.

8 Implementation Guides

These guides are designed to successfully implement the most important aspects of ISO 15189.

1 Uncertainty Calculator

This tool allows you to perform all measurement uncertainty calculations in compliance with ISO 15189.

FREE download the complete list of ISO 15189:2022 documents

Click the button to download the complete list of procedures and registration forms contained in the ISO 15189:2022 Accreditation Kit.

All documents comply with the requirements of ISO 15189:2022

Advantages of acquiring the Kit:

  • You save a lot of hours of work.
  • You build the documentation in record time.
  • You save on hiring an external consultant.
  • You are on target, because the documents comply with ISO 15189:2022.
  • You no longer have to attend those long and boring meetings to build documents.

This ISO 15189:2022 Accreditation Kit is for you if:

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You don't have time

If what you need is time, then don’t waste it building documents, because these are already done!

You want to save money

With the Accreditation Kit you can SAVE up to 90% compared to an external consultant.

You want to meet the target

All KIT documentation complies with the requirements of ISO 15189:2022.

You want to do it yourself

There is nothing more rewarding than achieving victory through your own efforts.

These are the most frequently asked questions before buying the kit:

How can documents be edited?

All documents are in Microsoft Word and Excel so you can edit the documents without any problem.

 

What are Implementation Guides?

Implementation Guides are PDF documents that contain very detailed steps to comply with certain requirements demanded by the standard, some of which are:

– The guide for risk management.
– The guide for method validation.
– The guide for uncertainty estimation.

 

What should I do with the documents?

Very easy. You just need to take each template and start entering some data from your own laboratory, don’t be scared, these data can be the name of the laboratory, or changing the name of the quality leader to quality manager; things of that nature, nothing complicated.

 

How long does it take to have the laboratory documentation ready?

Look, in the time we have been advising laboratories, we have realized that it takes between five and ten months to build all the SG documents if you do it on your own.

Laboratories that have purchased the Accreditation Kit achieve it in less than a week, dedicating on average two hours a day.

 

Do you need specialized knowledge to edit the documents?

No. If you are part of the laboratory, whether as a quality leader, director, or analyst, you already have the necessary knowledge to edit the Accreditation Kit.

 

Once the payment is made, how is the Kit sent to me?

When the payment is validated, we send you an email with a link to download the Accreditation Kit, plus a couple of surprise gifts.

 

Can I see how the documents are designed?

On the Kit page, which you can see above, you have access to the demo of the documents (procedures and formats).

 

Who is LABBOTH?

We are a company specialized in the implementation of the ISO/IEC 17025 and ISO 15189 standards for all types of laboratories. Over the last 10 years, we have developed a unique methodology so that you can accredit your laboratory in record time, without spending so much money and without breaking your head; this unique methodology is within the ISO 15189:2022 Accreditation Kit.