Exam 17025
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ScribdTranslationsExam 17025
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ScribdTranslationsEXAMINATION 'INTERPRETATION OF THE ISO/IEC 17025:2017 STANDARD'
1. Is the ISO/IEC 17025:2017 standard a Quality Management System?
Yes, it is a Quality Management System and is managed as such.
Does the 2017 version of the standard allow for strikethrough in the records?
technicians?
In the new regulation, crossing out the data is no longer allowed, instead it must be
replace the wrong record, you must identify which is the original and which is the
modified and keep both versions to ensure traceability.
It is important for the laboratory to seek the mechanism that best fits.
to meet the requirement so that it does not become something exhausting and
to make the staff aware of writing the data correctly, whether they are
data is handled in physical or digital form.
What the regulation really seeks is for that 'data correction' to decrease.
substantially, because the strikethrough allows in some way for alteration
from the original data.
Can anyone file a complaint?
Yes, any interested party (laboratory clients, the authorities
regulatory, the organizations, the accreditation bodies, among
others) can file a complaint and the process of handling it must be
available whenever any interested party requests it (requirement 7.9.2) and the
The laboratory must be responsible for its proper management.
4. Is accreditation and certification the same thing?
Certification is a process in which it is evaluated whether a company, product,
service or process is in accordance with the requirements that were set out to understand.
For example, an ISO can be used for a certification process.
9001:2015
ISO 9001:2015 is a management system that provides good practices.
regarding quality, promoting standardization within the company,
risk mentality, process approach, among other aspects.
When seeking ISO 9001:2015 certification, the company must prove that its
Quality Management System meets the requirements set forth in that
standard. You must present evidence that demonstrates compliance with the
practices described in ISO 9001:2015.
On the other hand, accreditation is the process by which an organization
competent certifies the technical competence of a laboratory to provide
a service of testing, calibration and/or sampling. In the accreditations there is
also the evaluation of compliance with technical requirements of the process,
much deeper. While the certification only evaluates
the processes and management of the organization are carried out in the accreditation
Technical capacity tests, in order to verify that the laboratory is capable
to carry out what is intended to be done.
Therefore, the ISO/IEC 17025:2017 standard is accredit-able but not certifiable.
5. What is the difference between calibration and qualification?
Calibration determines the metrological characteristics of the equipment and is
carry out through direct comparison with measurement patterns, through a
uninterrupted chain of measurements and from this measurement we
determine an uncertainty through a calibration certificate.
While the rating has two components, the operational and the
performance. The operational assesses the correct functioning of the equipment and the
of performance evaluates the team when it is subjected to the load for which
It was designed, confirming that it maintains its specifications. y
characteristics.
6. How would the decision rule be applied when the result is issued?
for a laboratory with which we subcontract tests that do not
conducted in the laboratory?
If it is required that the result of a subcontracted test be compared
with a specification, the supplier must be asked to apply it
decision rule you have set for that essay, therefore, the
the laboratory must inform the testing provider with which specification
wants to be compared, the decision that is made will depend on the
uncertainty that he has defined and as it should be transmitted to the client.
7. What is the difference between aptitude tests and the
interlaboratory comparisons?
The aptitude tests consist of the individual performance of a
laboratory in conducting tests through comparisons
interlaboratory (e.g. satsfactorio/insatsfactorio), while the
interlaboratory comparisons refer to the organization, execution and
evaluation of essays on the same essay element, where they participate
two or more laboratories according to predetermined conditions.
8. Who takes over the direction of the laboratory?
It is important to note that one should not confuse 'the direction of the
"laboratory" with the "general manager of the laboratory". In the first case
it refers to the manager or the coordinator of a specific work group
(in the case of a larger organization), while in the second case,
refers to the one who would assume the functions of 'technical director' or as it
design the laboratory.
9. What is the relationship between BPLs and the ISO/IEC 17025:2017 standard or is it
the same?
It is not the same, since each one has its specific requirements. The BPLs
they are a quality system associated with clinical studies (OECD) that has
its specific principles and to the pharmaceutical quality laboratories
(INVIMA). In this last case, resolution 3619 of 2013 is a mix.
among the requirements of the ISO/IEC 17025:2005 standard and the WHO guidelines
for good manufacturing practices.
Therefore, one does not substitute the other, but they complement each other.
10.Can the quality and technical management functions be assumed by the
same person?
Requirement 5.6 of the standard states, 'The laboratory must have qualified personnel.'
that, regardless of other responsibilities, has the authority and the
necessary resources to carry out their tasks... therefore it could yes.
to make the same person, the issue lies in being able to perform
cability both functions and also it would be necessary to identify the risks
associated with impartiality, so that the decisions made are objective.
take from each of the positions, for the proper implementation of
the norm.
11. What is the difference between education, training, qualification and
technical knowledge?
To understand it better, let's put an example: Let's suppose that it
requires a person to determine metals by Atomic Absorption,
So the requirements would be:
Education: Industrial Engineer
Certification: Certificate in accordance with SNT-TC-1A
Technical knowledge: Knowledge in statistics, knowledge in
validation of methods.
Training: It is required to have the internal auditor course in the
ISO/IEC 17025:2017 standard
These, along with other requirements that are documented, is what determines the
staff competence for a specific laboratory activity.
12. Who can I accredit myself with:
The only organization recognized by multilateral agreement that grants
recognition, that is to say that accredits as the EMA (Mexican Entity of
Accreditation
What happens if the information is required by law and the client refuses?
to provide it?
One must take into account what the legislation expresses and in case of being
It is necessary to consult with a lawyer, as according to the type of information
it may be prohibited by law, however, if there is no prohibition, the
The laboratory's task is to inform the client what information needs to be provided.
provided, to whom and for what.
14. How can I define the calibration frequencies of a device?
The document ILAC G24:2007 establishes the methodologies for
define the calibration times of the equipment.
15. Any deviation or change to a reference method must be
validated?
Yes, as long as such deviation or change has been documented,
technically justified, authorized and accepted by the client.
16. Do testing procedures need to be physical?
It can be in the form that you provide and is facilitated to the laboratory, whether it is
physical or electronic, the important thing is that they are controlled by the SGC of
agreement with the compliance of the applicable requirements of this standard.
17. Is it always necessary to have a contract with the client?
A contract as such is not required when the laboratory issues a
quotation specifying the conditions and services to be provided and the
The customer accepts it, this is considered a contract between the parties. Any
modification made by either party, before or during the
the execution of the work must be recorded, accepted by the parties and
communicated to whom it may concern.
18. What does it mean to 'take viable actions to avoid adjustments not
"equipment forecasts" indicated in section 6.4.12?
It refers to the fact that some equipment (and those that allow it) must be sealed or
to safeguard against unauthorized changes, therefore, these
safeguards or measures must be designed and implemented in such a way
that its alteration is detected. For example, to establish writing measures
that prevent unauthorized changes to the application or software
programming. However, it should be clarified that not all teams are
susceptible to 'sealing' in some way, but the laboratory must
implement controls to prevent its alteration.
19. Is it mandatory to apply a decision rule to all results?
issued by the laboratory?
It is not mandatory, it is only when the client or an authority requires it for
evaluate the fulfillment of a result against a specification. For this reason
It is important from the proposal or the quotation that it is made clear how it
will manage and what is the decision rule to apply. This statement of
conformity must be given by competent and authorized personnel.
20. How often should aptitude tests and/or
interlaboratories?
If the organization granting recognition defines a frequency and some
conditions, these must be met. Otherwise, the laboratory from its
planning must consider the risk if you decide to do it at very intervals
prolonged.