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List of questions to ask your ISO/IEC 17025 consultant

Before deciding about hiring a consultant for your ISO 17025 implementation, consider these
questions and use them while talking to potential consultants. The consultant should demonstrate
clear value through their experience and skills, reputation, and adaptability.

General questions about the consultant:

1. Are they able to communicate clearly (written and verbal) in your language?
2. What is their experience with other standards besides ISO 17025?
3. What is the consultant’s reputation? Can they provide testimonials and references – what do
other consultants and clients say about them?
4. Is there any risk to business ethics, i.e., conflicts of interest, risk to impartiality, or unethical
practices?
5. Does the consultant have suitable computer skills?

ISO 17025 experience questions:

1. Do they have knowledge and experience with establishing an ISO 17025 management system
in your particular field/specialty laboratory program? Do they have the technical know-how
to assist you effectively?
2. What knowledge and experience does the consultant have in other ISO 17025 specialty
laboratory programs?
3. How many and what kind of laboratories have they assisted with ISO 17025?
4. How many ISO 17025 implementation projects were finished successfully in the last two
years?
5. How many customers were successful in achieving accreditation after the first initial
assessment?
6. What was the most complex ISO 17025 project managed? Can a brief description be
provided?
7. What are typically the most common challenges faced in ISO 17025 implementation projects,
and what approach was taken to resolve them?
8. What is the consultant’s educational path in ISO 17025, i.e., what training and certificates are
evident?
9. Does the consultant facilitate ISO 17025 management system and technical training? If yes,
how many courses have been provided, for how many people?
10. Has the consultant ever published any expert articles? How many, and where?
11. Has the consultant performed third-party audits and/or audits for an accreditation
body/certification auditor?
12. Can the consultant show you examples of risk assessment documentation created for
customers?

Implementation-specific questions:

1. What is the usual length of the implementation project? What does it depend on?

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 [organization name]

2. How would the consultant define the scope of the project in your case?
3. Can the consultant briefly describe the proposed process for the ISO 17025 implementation
project:
a. What are the proposed phases for implementation?
b. What is the proposed platform for collaboration and document management during
implementation?
c. Regarding the documentation that needs to be developed – what are the minimum
documents and records required?
d. Will the consultant use and provide document templates and assist the laboratory to
populate them, or write the procedures and design records from start to finish, for
the laboratory to check and verify?
4. What suggestions does the consultant have in regard to defining responsibilities to perform
particular tasks in the project?

Price:

1. What is the total price of services and payment structure? (Make sure they include
everything: project scoping, interviews, documentation development, training,
transportation costs, etc.)
2. What are additional services you will have to purchase from other providers?
3. What are the laboratory’s estimated resource costs (e.g., employee time, method validation
costs) for the project?

For more information, see: Comparison matrices for ISO/IEC 17025 implementation solutions.

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