Iso Training

About This Course
Course Scope and Structure

This course is designed to provide an introduction to the third party Accreditation
process, and instruct the user on auditing their own laboratory to the requirements of
ISO/IEC 17025:2017.
The course is divided into the following main topics:

1. The Assessment Process: Part 1
3. Documentation Produced
4. After the Assessment
5. Assessor's Notes for ISO/IEC 17025
6. Requirements of ISO/IEC 17025 Section 4 -
General Laboratory Requirements
Organization Structure Requirements
Resource Requirements
Laboratory Process Requirements
Management System Requirements
11. Additional Requirements of Accreditation Bodies
Main topics are divided into several sub-topics.
To select a main topic, click the Main Topics link on the navigation panel at the left. After
selecting a main topics, you can choose from a list of associated sub-topics.
Testing
Before diving into course content, take the Pre-Test to check your current level of
knowledge. After working through the course, take the Post-Test to verify your increased
level of knowledge. After passing the Post-Test you will be able to print a certificate of
course completion.
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Introduction
The material contained in this course is for training purposes only. The content is not
About
intended to limit your laboratory to only the examples presented in the subject matter,
Objectives
Pre-Test nor to be all-inclusive of topics or questions presented.
Every effort has been made to achieve technical accuracy. Do not use this course as a
technical reference. Consult the latest accepted industry standards for specifications
Main Topics
relating to your specific application.
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Getting Started
Introduction:
This lesson is a comprehensive look at ISO/IEC

17025:2017 and its requirements from an auditing
perspective.
This lesson will provide critical insight on the

application of the requirements of this new
laboratory standard; you will also receive a review
of the typical third-party accreditation process.
The lesson will cover the requirements of the international conformity assessment standard as it is
applied to sampling, calibration, and testing laboratories.
It explains how to plan, conduct, and report the results of an internal audit of an ISO/IEC 17025:2017
conformant laboratory.
On completion, you will understand the requirements from a risk-based perspective, and understand
what behavior and actions are generally required in order to perform an internal audit of a laboratory
to the requirements of the standard.
Further detailed training would be required before performing assessments as a representative of an

accreditation body or other third-party auditing organization.
About This Course

This course is designed to provide an introduction to the third party Accreditation process, and
instruct the user on auditing their own laboratory to the requirements of ISO/IEC 17025:2017.

To select a main topic, click the Main Topics link on the navigation panel at the left. After selecting a
main topics, you can choose from a list of associated sub-topics.
Testing
Before diving into course content, take the Pre-Test to check your current level of knowledge. After
working through the course, take the Post-Test to verify your increased level of knowledge. After
passing the Post-Test you will be able to print a certificate of course completion.
Navigation
The course has built-in navigation in the form of the menu links, Next and Back buttons, and other
links.
The Next and Back buttons take you forward one screen or back one screen, respectively.
OJT Mentor
The OJT Mentor link, located on the navigation bar, is available to you at any time to ask questions
about the content of the course. Your question will be sent directly to WorkPlace Training subject
matter experts who will respond as quickly as possible. OJT Mentor requires a live Internet
connection.
Additional Features
The course includes a Glossary, Resources, a Course Map, and a Course Notes option all
accessible from the navigation panel at the left.
Please Note
The material contained in this course is for training purposes only. The content is not intended to
limit your laboratory to only the examples presented in the subject matter, nor to be all-inclusive of
topics or questions presented.
Every effort has been made to achieve technical accuracy. Do not use this course as a technical
reference. Consult the latest accepted industry standards for specifications relating to your specific
application.
Objectives
On completion of this course, users will be able to:
* Apply a risk-based approach to their laboratory's processes,
* Describe impartiality,
* Identify when a laboratory must have certain types of documentation,
* Discuss various means of implementing the requirements of the standard, and
* Verify, through appropriate audits, their laboratory's conformance to the requirements of the
standard.
Pre-Test
Question 1 of 23
How often must laboratories perform an internal audit?
Once per quarter
Once per year
Once per month
Whenever it schedules them
Question 2 of 23
When should a laboratory determine what parts of its operations will be undergo an internal audit?
During the management review
During the planning phase
During the initial business setup
During the board meetings
Question 3 of 23
A ___________ audit is when the laboratory is both the auditor and the auditee.
primary
compliance
self
first-party
Question 4 of 23
Which of the following is normally NOT included in audit assignment notifications?
Requirements to be audited against
People to interview / observe
Particular job files to review
Makeup of the audit team
Question 5 of 23
___________ is a word stated in the standard that indicates a requirement.
May
Shall
Should
Can
Question 6 of 23
___________ is a word stated in the standard that indicates the laboratory must write down or
document the results of a given activity.
Control
Monitor
Record
Track
Question 7 of 23
Audit findings include all of the following EXCEPT FOR...
Risks
Root Causes
Conformity evidence
Improvement Suggestions
Question 8 of 23
When must laboratories be ready to identify and address impartiality risks?
Once a year
All the time
During Management Reviews
Ahead of accreditation assessments
Question 9 of 23
All of the following could be used to meet confidentiality requirements EXCEPT FOR ...
Verbal promises of behavior

Employment contracts
Signed codes of conduct
Terms and Conditions with clients
Question 10 of 23
The laboratory's reported results normally discuss all of the following except _______________.
what laboratory performed the measurements
which measurement methods were used
what can be claimed in marketing literature
the measurement results from the testing/calibration
Question 11 of 23
An internal auditor's role is to:
Issue technical opinions
Recommend accreditation
Approve work for clients
Obtain evidence of conformity/non-conformity
Question 12 of 23
Which of the following topics does NOT require a procedure according to ISO/IEC 17025:2017?
Evaluation of calibration providers
Review of customer work requests
Risk analysis
Maintaining personnel competence
Question 13 of 23
Which of the following measures to control laboratory facilities is required to be implemented?

Special procedures for cleanliness and housekeeping
Access to areas affecting laboratory results
Procedures for personnel and lab safety
Air conditioning/heating systems
Question 14 of 23
Which of the following does NOT need to be accounted for when determining decision rules?
If measurement uncertainty is involved
If the conformity specification includes the rule
If the laboratory has a procedure for creating the rule
If the customer requested a statement of conformity
Question 15 of 23
Laboratory competence requirements must include all of the following except for...
Education
Employment history
Training
Experience
Question 16 of 23
ISO/IEC 17025 Section ____ contains general requirements relevant to a lab's management system.
4.1
8.2
5.2
6.6
Question 17 of 23
A team or technical auditor's primary focus should be ___________________.
reviewing training records of certain personnel
increasing profitability of the laboratory
to determine lab personnel competence in specific measurements
establishing traceability of the lab's standards and reagents
Question 18 of 23
For accredited laboratories, the preferred way to demonstrate metrological traceability is to...
Issue statements of traceability on their reports
Use the calibration lab that has the lowest costs
Use accredited calibration providers when available
Rely on OEM calibrations forever
Question 19 of 23
Which of the following is the most proper tool to use to determine when laboratory measurement
setups or results are out of tolerance?
internal audit (section 8.8)
quality check (section 7.7)
verification check (section 6.4)
risk assessment (section 8.5)
Question 20 of 23
All of the following items must be Validated except for...

Spreadsheet functions created by the lab
Commercial Software used without modification
Lab-developed test/calibration methods
Electronic LIMS systems
Question 21 of 23
After internal audits reveal a non-conformity, how long does a laboratory have to implement
corrective actions?
Up to 30 days
There is no defined timeframe
Up to 90 days
The lab must define this in a procedure
Question 22 of 23
When lab supplies purchased with technical requirements are received, _______________ is
required to conform to the standard.
a record showing the item met lab-defined requirements
a certificate of authenticity
a copy of the product's marketing specifications
a visual inspection
Question 23 of 23
Errors made in data recording must be ___________________.
covered with white out and corrected with date and identification
not obliterated and corrected with date and identification

erased or deleted and corrected with date and identification
scribbled out as necessary with date and identification
Assessment to the Requirements of ISO/IEC 17025
Main Topics
Select:
• The Audit Process: Part 1
• Documentation Produced
• After the Audit
• Auditor's Notes for ISO/IEC 17025
• ISO/IEC 17025 Section 4 - General Requirements
• ISO/IEC 17025 Section 5 - Structural Requirements
• ISO/IEC 17025 Section 6 - Resource Requirements
• ISO/IEC 17025 Section 7 - Laboratory Process Requirements
• ISO/IEC 17025 Section 8 - Management System Requirements
• Additional Requirements of Accreditation Bodies
Audit Process Part 1

Sub-Topics
Select:
• Introduction to the Audit Process
• Assignment
• Planning
• The Audit Process at a Glance
• The Checklist
• The Desk Audit
• Scheduling the Audit
• Agenda and Auditor Roles
Introduction to the Audit Process
An audit is the determination, by examination of objective

evidence, that a management system is in place,
documented, operational, and effective.
When auditing an organization for the purpose of

accreditation, additional requirements ensure that the
organization is competent to perform a specific set of
measurements listed on a document called the Scope of
Accreditation (SoA).
An accredited organization will therefore have an

operational management system and will also be judged competent to perform the calibration and/or
testing work on its Scope of Accreditation.
Judgment of competence is typically made by a third party Accreditation Body using assessors with
technical expertise in or related to the areas of work the laboratory performs.
An audit is carried out by an individual or a team. Often, more than one person is required because
of the range of auditor competence needed. If a team is deployed, one of the team members acts as
a lead auditor. The lead auditor is responsible for:
• Planning, organizing and directing the audit.

• Representing the team to the organization/department being audited.
• Leading the team in reaching conclusions.
• Preventing and resolving conflicts.
• Preparing, completing, presenting, and submitting the audit report.
All organizations operating under ISO/IEC 17025 are required to perform periodic internal audits,
with the purpose of verifying that the laboratory continues to competently and consistently operate in
accordance with:
• Its management system,

• The ISO/IEC 17025 requirements,
• The measurement methods it performs for its customers, and
• Any additional rules (such as those from an accreditation body or regulatory program)
It is common to hear that an internal audit cycle must be completed in a year, but this is not a
requirement of the ISO/IEC 17025 standard, even though for many labs it may be a best practice.
These audits should not just be a paperwork exercise.
In addition to finding that the laboratory's system documentation

contains all relevant requirements, the auditors must determine
that policies and procedures are actually implemented
consistently and correctly by the laboratory's personnel.
An internal audit is carried out in several phases.
Assignment
The laboratory's management system is required to have a documented

program devoted to internal audits. This section will indicate a frequency (or,
how often audits are performed) as well as the laboratory's chosen
requirements for responsibilities and preparation, performance, and
reporting needs that must be followed for each audit performed.
The ISO/IEC 17025 standard allows the laboratories to decide upon an audit
scope during planning, rather than pre-defining what areas of management
system and/or measurement activities are to be addressed at specific times.
There is no requirement to audit all areas of the laboratory in a single audit, nor to define a time
period within which all areas must be audited. Many laboratories find it more useful to conduct
smaller, more frequent audits, with a flexible approach to defining the Audit Scope.
Section 8.8 of the ISO/IEC 17025 standard goes into more detail on expectations for Internal Audits.
A schedule (also known as an agenda) should be prepared and followed for each audit, and possibly
for each area visited in a larger audit. Last-minute changes should be expected, as availability of
personnel and laboratory workload may prevent exact adherence to the plan.
While not commonly used in small and mid-sized laboratories, a formal audit assignment should
specify:
• the requirements (elements of the standard, parts of the management system, and
measurements) to be audited,
• the physical area within the lab (or field labs, mobile labs, or off-site work) to be visited,
• the technicians and managers to interview, and
• the makeup of the audit team.
A method of audit called the Process Audit looks at assessing the process (e.g. a Pressure
Calibration) where more than one element of the standard is assessed as the whole process is
reviewed by an assessor.
There are other audit methods as well, such as Departmental audits, Horizontal audits,
and Vertical audits, and laboratories should utilize different methods or combinations of methods to
most effectively achieve the goals of their audit program.
One person is chosen to lead the assessment and manage the process. This is the lead auditor.
Other members of the team, if there are any, are called technical auditors or team auditors. You may
also see Technical Experts, but their use and discretion over audit findings should be limited (refer
to ISO 19011:2018).
It is recommended, although not required by ISO/IEC 17025, that all auditors have explicit training in
management system auditing. Credentials such as ASQ Certified Quality Auditor are good evidence
of this training but are not required. Further training in laboratory measurement auditing and the
requirements of ISO/IEC 17025 (such as this lesson and its prerequisites) are also worthy of
consideration.
For more information on the requirements for Internal Auditors, refer to ISO/IEC 17025 Section 6.2.
It's also important that at least one member of the audit team
have technical expertise in the area being assessed. If no
laboratory measurement areas are being reviewed, technical
auditors are not needed.
Generally, even though most auditors have special

knowledge of certain areas of the laboratory's operations, all
auditors on the team will participate in the entire process.
Planning
The lead assessor generally takes responsibility for advance planning.
The timing of the entire event needs to be compatible with work or production schedules for the
areas and people to be audited and, if the auditors are laboraotry employees, their availability as
well.
The people who are to be interviewed need to be notified, and a mutually agreeable time worked
out, sometimes in the presence of travel schedules and vacations.
The audit team usually will need a private working area with sufficient space for computers, papers,
record reviews, and the like.
Before and during the audit, the auditors will require access to all of the documents relevant to the
management system and the audit. These may include, but not be limited to:
• quality manual
• policies, procedures and forms
• instruction manuals for measurement equipment
• measurement methods
• job records from initial customer request through final reports
• personnel records of employees in the areas to be audited
• records of QC activities such as control charts
• proficiency testing results
• records of previous internal audits
• records of corrective actions, both "open" and "closed"
• records of risk mitigation and monitored
• records of management reviews
The Audit Process at a Glance
1. The auditors review evidence (reports, records, interviews, documents, data, etc.) to
determine the degree of conformance of the laboratory to all of the requirements being
audited.
2. The auditors discuss their findings with the auditee and prepare a written audit report.
3. This report may include a specific list of non-conformities which require corrective action.
4. The report may also include risks and/or opportunities identified by the auditors for the
laboratory to consider.
5. The lab performs a cause analysis on each non-conformity, and plans and implements the
necessary corrective action(s).
6. The audit team may be called upon to evaluate the effectiveness of the corrective action. This
may also be left to the next team to follow up in the area in question.
7. The entire documentation package is assembled when complete and filed with the appropriate
managers.
Note: During a third party assessment, such as might be performed by an accreditation body, the
assessment team is not always responsible for evaluating the corrective action results. The
assessment team may only be asked to review technical corrective actions, such as equipment
calibration data, uncertainty estimates, or method performance. The management system non-
conformities might be reviewed by accreditation body staff or by a manager or committee convened
for the purpose.
Audit Records
While not required, a checklist is frequently used by auditors and may be an

important tool.
Checklists can be set up in many ways, but frequently they list each requirement
of the standard, the laboratory's management system, and other special
requirements in the order in which they are to be reviewed.
Often, it will have blank spaces to allow the auditor to note what information or evidence was
observed, as well as the conclusion reached by the auditor.
For third party assessments, laboratories will typically be asked to provide a reference or link to their
management system documents in a checklist format. These references make finding and
evaluating the relevant management system documents fast and easy, and can greatly reduce the
time, cost, and effort to perform the assessment.
Since the laboratory is most familiar with its own system, these entries are far less important for
internal audits, and many laboratories omit these references from their own internal records.
When the checklist (or other form) is completed by the auditor with all positive and negative findings,
it constitutes the raw data from which the final audit report will be constructed, and must also be
permanently saved as part of the audit documentation.
Audit Preparation
Before the on-site visit for an audit, the lead auditor (and sometimes other team members) will
review some parts of the laboratory's management system documentation that are scheduled for the
upcoming assessment. This is sometimes called a "desk audit" because it can be done at the
auditor's desk.
Ideally, this part of the activity is done well in advance of the planned on-site audit to provide enough
time for review, note-taking, question preparation, and refresher readings.
Desk audits also focus on identifying any "gaps" or non-conformities in the existing procedures and
policies of the laboratory's management system.
This will also greatly facilitate a more efficient in-person audit since the auditors can focus on
reviewing implementation instead of papers.
Desk Audit
Check your Understanding
The focus of the desk audit is _________________________.
meeting appropriate staff
to observe over the shoulder test or calibration procedures

understand requirements and identify gaps in the management system
to write the quality manual
The "desk audit" also helps the lead auditor finalize and fine tune the audit plan. It helps determine
which areas to look at closely in case of questions.
Any gaps identified and corrected during this phase of the work should remain listed in the final audit
report, but should be listed as "closed" or "resolved." This should be written in such a way as to
identify what happened to close the deficiency, with wording such as:
"CLOSED 8/2/41 by modifications of policy 32-006, which is now at Revision G."
Any misunderstanding or confusion about policies or procedures should not be pursued during the
desk audit. It can be settled in person at the on-site visit.
Scheduling the Assessment
The lead auditor schedules time for the on-site work for the convenience of both the area being
audited and the audit team. It is important to leave enough time for:
• private meetings of the team,

• interim debriefing and technical discussions with the management and staff of the audited
area,
• assessors to write their observations and contributions to the final report, and
• official meetings such as the opening and closing meetings.
This means that the final schedule should total 1.5x the number of hours planned for actual
observations, interviews, and reviews of processes, equipment, and standards (or about 1 hour of
meeting/private work for every 2 hours of active auditing).
Full audits normally span several days. Therefore, the allotted time for the day should be divided in a
similar manner where there may be "mini" opening and closing meetings with key laboratory
personnel to brief them on the day's activities. During this time, any deviations to the audit plan due
to findings or unexpected problems should be.
Agenda and Auditor Roles

Before the time scheduled for the actual assessment visit, the lead auditor should send the
audit schedule (or agenda) to all concerned parties, including the management of the lab area
being assessed. The agenda ideally lists approximate times for each activity, what will be
done, and whose presence will be required.
The same communication should list the requirements of the assessment team — meeting space;
computers, printers, fax and copiers; and suggestions for meals and breaks.
This will enable the laboratory personnel being observed to prepare their schedules (including
availability of technicians and equipment) and facilities to minimize interruption of regular activities,
while still making effective use of the audit team's time.
The agenda for the audit should include all of the following except ______________.
the approximate times for each audit area to begin
what laboratory activity will be examined
examination of the lab's customer list
identity of laboratory personnel who need to be present
Post-Test
Question 1 of 23
A laboratory will seek accreditation as a means of demonstrating __________.
competence
certification
proficiency
its capabilities
Question 2 of 23
Conformance to ISO/IEC 17025 is determined by _____________________.

an auditor
an assessment
compliance
demonstrating competence
Question 3 of 23
A ___________ audit is when a laboratory itself is the customer.
primary
compliance
self
first-party
Question 4 of 23
Test and calibration reports of an accredited lab must only display results covered by the
______________, unless clearly indicated.
specifications
tolerances
scope
marketing data
Question 5 of 23
Must
Shall
Should
Will
Question 6 of 23
A(n)___________________ in a standard is prefaced with the word should.

example
requirement
recommendation
interpretation
Question 7 of 23
____________ written into a new standard, taken from previously written standards are called
normative references.
Examples
Requirements
Recommendations
Interpretations
Question 9 of 23
A desk audit might include all of the following except
over the shoulder observation of tests of calibrations
measurement uncertainty budgets

review of quality manual
draft scope of accreditation
Question 10 of 23
The final report discusses all of the following except _______________.
an overall impression of the quality and capabilities
which requirements of the standard were assessed

what was observed
Question 11 of 23
The deficiency report cites those specific items for which the laboratory must take __________.
responsibility for
out of their scope
preventative action
corrective action
Question 12 of 23
Paragraph 4.10 calls for the laboratory to have _____________ for corrective action.
a policy and procedure
recommendations
a root cause analysis
a schedule of appropriate fines
Question 13 of 23
A surveillance audit or partial evaluation is performed __________ the accreditation period.
at the beginning of
periodically during
at the end of
throughout
Question 14 of 23
The focus of the ___________ is first round deficiencies and corrective action.
surveillance audit
initial meeting
desk audit
second party audit
Question 15 of 23
The assessment agenda should include all of the following except ______________.
the approximate times for each activity

what will be done
whose presence will be required
Question 18 of 23
A laboratory scope shows ____________ that the lab is able to test or calibrate, along with the
range and uncertainty for each.
each instrument
the cost of each procedure

each parameter
the advertised specification and tolerances
Question 19 of 23
A ____________ is used to determine when a lab's test or calibration results are out of range.
test audit
proficiency test
root cause analysis
compliance report
Question 20 of 23
At the closing meeting, the assessment team may discuss all of the following except
_________________.
a reiteration of what steps must be taken by the Laboratory
the admonishment of any shortcomings found

what rights of appeal they have if they do not agree with any findings
offer thanks for the privilege of serving as the assessor
Question 21 of 23
If ___________ cannot be completed in 30 days, a plan, complete with milestones, promises what
will be done and when it will be presented.
a complaint follow up
corrective action
a proficiency test
Question 22 of 23
When lab supplies purchased with technical requirements are received, _______________ is the
proper documentation.
a certificate of analysis
a certificate of conformance
marketing specifications
a visual inspection
Question 23 of 23
covered with white out and reentered
crossed out, corrected alongside and initialed
erased, reentered and initialed
scribbled out as necessary
Glossary of Terms
A|B|C|D|E|F|G|I|K|L|M|N|O|P|Q|R|S|T|U|V
Accuracy, Accuracy of Measurement, Measurement Accuracy
Closeness of agreement between a measured quantity value and a true quantity value of a measurand.
Ampere
The SI unit of electric current defined as that constant current which, if maintained in two straight parallel conductors
of infinite length, of negligible circular cross-section, and placed 1 meter apart in vacuum, would produce between
these conductors a force equal to 2 x 10-7newton per meter of length.
Attribute Data
Data indicating the state of an attribute (e.g. True/Not True, On/Off, go/no go).
Availability
A measure of the degree to which an item is in an operable state at any time.
Bias, Measurement Bias
Estimate of a systematic measurement error.
Calibration
Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with
measurement uncertainties provided by measurement standards and corresponding indications with associated
measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a
measurement result from an indication.
NOTE: A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve, or
calibration table. In some cases, it may consist of an additive or multiplicative correction of the indication with
associated measurement uncertainty.
Calibration - what is it?
A fundamental concept in quality assurance is the calibration of measuring instruments. Calibration is a word which is
sometimes misunderstood. Calibration of an instrument means determining by how much the instrument reading is in
error by checking it against a measurement standard of known error.
A calibration is thus not usually associated with approval. It "only" gives information about the error of the equipment
with respect to an accepted reference value. As a consequence, it is up to the user to decide whether the equipment
is sufficiently good to perform a certain measurement. One possibility is to have the instrument certified.
Calibration Interval
The period of time between successive, scheduled calibrations for a given item of equipment.
Candela
The SI unit of luminous intensity defined as the luminous intensity, in a given direction, of a source that emits
monochromatic radiation of frequency 540 x 1012 hertz and that has a radiant intensity in that direction of 1/683 watt
per steradian.
Combined Standard Uncertainty
Standard measurement uncertainty that is obtained using the individual standard measurement uncertainties
associated with the input quantities in a measurement model.
Confidence Limits
Limits that bound a range of values that contains a particular value with a specified probability.
Correction
Compensation for an estimated systematic effect. The compensation can take different forms, such as an addend or
a factor, or can be deduced from a table.
Coverage Factor
Number larger than one by which a combined standard measurement uncertainty is multiplied to obtain an expanded
measurement uncertainty.
NOTE: A coverage factor is usually symbolized k.
Drift
A slow change of a metrological characteristic of a measuring instrument.
Equipment Parameter
An attribute of an item of equipment which can be characterized with an expected nominal value bounded by
performance specifications.
Error, Error of Measurement
Measured quantity value minus a reference quantity value.
NOTE 1: The concept of ‘measurement error’ can be used both
a) when there is a single reference quantity value to refer to, which occurs if a calibration is made by means of a
measurement standard with a measured quantity value having a negligible measurement uncertainty or if a
conventional quantity value is given, in which case the measurement error is known, and
b) if a measurand is supposed to be represented by a unique true quantity value or a set of true quantity values of
negligible range, in which case the measurement error is not known.
NOTE 2: Measurement error should not be confused with production error or mistake.
Expanded Uncertainty, Expanded Measurement Uncertainty
Product of a combined standard measurement uncertainty and a factor larger than the number one.
NOTE 1: The factor depends upon the type of probability distribution of the output quantity in a measurement model
and on the selected coverage probability.
NOTE 2: The term "factor" in this definition refers to a coverage factor.
NOTE 3: Expanded measurement uncertainty is termed "overall uncertainty" in paragraph 5 of Recommendation

INC-1 (1980) (see the GUM) and simply "uncertainty" in IEC documents.
Expectation of the Measurable Quantity
The mean of a specified population of measurements.
Failure Rate
The total number of failures within an item population, divided by the total time expanded by that population, during a
particular measurement interval under stated conditions.
Failure Time
The time elapsed since calibration for the occurrence of an out-of-tolerance event.
Guardbanding
The practice of adjusting specification limits (pass/fail criteria) to account for the uncertainty associated with the
measurement.
IMTE
Inspection, Measuring and Test Equipment
Inspection
The measurement, investigation or testing of one or more characteristics of a product which includes a comparison of
the results with specified requirements in order to determine whether the requirements have been fulfilled.
International System of Units, SI
System of units, based on the International System of Quantities (ISQ), their names and symbols, including a series
of prefixes and their names and symbols, together with rules for their use, adopted by the General Conference on
Weights and Measures (CGPM).
NOTE: The SI is founded on the seven base quantities of the ISQ and the names and symbols of the corresponding
base units that are contained in the following table.
In-Tolerance
A condition in which measurement attributes value lies within documented performance specifications for the
attribute.
Kelvin
The SI unit of thermodynamic temperature defined as the fraction 1/273.16 of the thermodynamic temperature of the
triple point of water.
Kilogram
The SI unit of mass equal to the mass of the international prototype of the kilogram.
Laboratory Bias
The difference between the expectation of the test results from a particular laboratory and an accepted reference
value.
Maintainability
A measure of the ability of an item to be retained in, or restored to, a specified condition when maintenance is
performed using prescribed procedures and technician skill levels.
Mean-Time-Between-Failure (MTBF)
A basic measure of reliability for repairable items. The average time during which all parts of the item perform within
their specified limits, during a particular measurement period under stated conditions.
Mean-Time-Between-Maintenance (MTBM)
A basic measure of reliability for repairable systems. The average time between all system maintenance actions.
Maintenance actions may be for repair or preventive purposes.
Mean-Time-Between-Repair (MTBR)
A basic measure of reliability for repairable fielded systems. The average time between all systems maintenance
actions requiring removal and replacement of a box or subsystem.
Mean-Time-To-Failure (MTTF)
A basic measure of reliability for non repairable systems. Average failure free operating time, during a particular
measurement period under stated conditions.
Mean-Time-To-Repair (MTTR)
A basic measure of maintainability. The sum of corrective maintenance items divided by the total number of failures
within an item. The average time it takes to fully repair a failed system.
Measurand
Quantity intended to be measured.
NOTE 1: The specification of a measurand requires knowledge of the kind of quantity, description of the state of the
phenomenon, body, or substance carrying the quantity, including any relevant component, and the chemical entities
involved.
NOTE 2: In the second edition of the VIM and in IEC 60050-300:2001, the measurand is defined as the "quantity
subject to measurement".
NOTE 3: The measurement, including the measuring system and the conditions under which the measurement is
carried out, might change the phenomenon, body, or substance such that the quantity being measured may differ
from the measurand as defined. In this case, adequate correction is necessary.
NOTE 4: In chemistry, "analyte", or the name of a substance or compound, are terms sometimes used for
"measurand". This usage is erroneous because these terms do not refer to quantities.
Measurement
Process of experimentally obtaining one or more quantity values that can reasonably be attributed to a quantity.
NOTE 1: Measurement does not apply to nominal properties.
NOTE 2: Measurement implies comparison of quantities and includes counting of entities.

NOTE 3: Measurement presupposes a description of the quantity commensurate with the intended use of a
measurement result, a measurement procedure, and a calibrated measuring system operating according to the
specified measurement procedure, including the measurement conditions.
Measurement Standard
Realization of the definition of a given quantity, with stated quantity value and associated measurement uncertainty,
used as a reference.
EXAMPLE 1: 1 kg mass measurement standard with an associated standard measurement uncertainty of 3 µg.
EXAMPLE 2: 100 W measurement standard resistor with an associated standard measurement uncertainty of 1 µW.
Measuring Parameter
A parameter whose indicated or stated value is taken to represent a reference during measurement.
Meter
The SI Unit of length defined as the length of the path traveled by light in vacuum during a time interval of 1/299 792
458 of a second.
Metrological Traceability
Property of a measurement result whereby the result can be related to a reference through a documented unbroken
chain of calibrations, each contributing to the measurement uncertainty.
NOTE 1: For this definition, a "reference" can be a definition of a measurement unit through its practical realization, or
a measurement procedure including the measurement unit for a non-ordinal quantity, or a measurement standard.
NOTE 2: Metrological traceability requires an established calibration hierarchy.
NOTE 3: Specification of the reference must include the time at which this reference was used in establishing the
calibration hierarchy, along with any other relevant metrological information about the reference, such as when the
first calibration in the calibration hierarchy was performed.
NOTE 4 For measurements with more than one input quantity in the measurement model, each of the input quantity
values should itself be metrologically traceable.
Metrological Traceability Chain, Traceability Chain
Sequence of measurement standards and calibrations that is used to relate a measurement result to a reference.
NOTE 1: A metrological traceability chain is defined through a calibration hierarchy.
NOTE 2: A metrological traceability chain is used to establish metrological traceability of a measurement result.
NOTE 3: A comparison between two measurement standards may be viewed as a calibration if the comparison is
used to check and, if necessary, correct the quantity value and measurement uncertainty attributed to one of the
measurement standards.
Metrological Traceability to Measurement Unit, Metrological Traceability to a Unit
Metrological traceability where the reference is the definition of a measurement unit through its practical realization.
NOTE: The expression "traceability to the SI" means "metrological traceability to a measurement unit of the
International System of Units".
Metrology
Science of measurement and its application.
NOTE: Metrology includes all theoretical and practical aspects of measurement, whatever the measurement
uncertainty and field of application.
Mole
The SI unit of amount of substance. The mole is the amount of substance of a system which contains as many
elementary entities as there are atoms in 0.012 kilogram of carbon 12.
National Measurement Standard, National Standard
Measurement standard recognized by national authority to serve in a state or economy as the basis for assigning
quantity values to other measurement standards for the kind of quantity concerned.
Nominal Quantity Value, Nominal Value
Rounded or approximate value of a characterizing quantity of a measuring instrument or measuring system that
provides guidance for its appropriate use.
EXAMPLE 1: 100 ω as the nominal quantity value marked on a standard resistor.
EXAMPLE 2: 1 000 ml as the nominal quantity value marked on a single-mark volumetric flask.
NOTE: "Nominal quantity value" and "nominal value" are not to be confused with "nominal property value."
Outlier
Observations at either extreme of a sample of values which are so far removed from the main body of the sample that
their exclusion from the sample improves the validity or accuracy of the data.
Out-Of-Tolerance (OOT)
A condition in which a measured value of a measurement attribute lays outside the documented performance
specifications for the attribute.
Performance Specifications
Measurement attribute specifications which bound the range of values considered indicative of acceptable attribute
performance.
Precision, Measurement Precision
Closeness of agreement between indications or measured quantity values obtained by replicate measurements on
the same or similar objects under specified conditions.
NOTE 1: Measurement precision is usually expressed numerically by measures of imprecision, such as standard
deviation, variance, or coefficient of variation under the specified conditions of measurement.
NOTE 2: The "specified conditions" can be, for example, repeatability conditions of measurement, intermediate
precision conditions of measurement, or reproducibility conditions of measurement (see ISO 5725-3:1994).
NOTE 3: Measurement precision is used to define measurement repeatability, intermediate measurement precision,
and measurement reproducibility.
NOTE 4: Sometimes "measurement precision" is erroneously used to mean measurement accuracy.
Preventive Maintenance (Calibration)
The time associated with the performance of all required maintenance (calibration) both scheduled and unscheduled.
Process
A Process is a naturally occurring or designed sequence of operations or events, possibly taking up time, space,
expertise or other resource, which produces some outcome.
• Calibration or Testing is a process that produces a measurement.
Quality
Relates to all the characteristics that meet an expressed or implied need
Reference Measurement Standard, Reference Standard
An accepted value that serves as an agreed-on reference for comparison, and which is derived as:
• Measurement standard designated for the calibration of other measurement standards for quantities of a
given kind in a given organization or at a given location.
• Theoretical or established value, based on scientific principles.
• An assigned or certified value, based on experimental work of some national or international organization.
• Consensus or certified value, based on collaborative experimental work under the auspices of a scientific or
engineering group.
• When these are not available, the expectation of the measurable quantity.
Reliability
The probability that an item will perform its intended function for a specified interval under stated conditions.
Reliability Target
A specified level of measurement reliability commensurate with quality, cost and logistic objectives.
Repeatability, Measurement Repeatability
Measurement precision under a set of repeatability conditions of measurement.

Repeatability Condition of Measurement, Repeatability Condition
Condition of measurement, out of a set of conditions that includes the same measurement procedure, same
operators, same measuring system, same operating conditions and same location, and replicate measurements on
the same or similar objects over a short period of time.
NOTE 1: A condition of measurement is a repeatability condition only with respect to a specified set of repeatability
conditions.
NOTE 2: In chemistry, the term "intra-serial precision condition of measurement" is sometimes used to designate this
concept.
Reproducibility, Measurement Reproducibility
Measurement precision under reproducibility conditions of measurement.
Reproducibility Condition of Measurement, Reproducibility Condition
Condition of measurement, out of a set of conditions that includes different locations, operators, measuring systems,
and replicate measurements on the same or similar objects.
NOTE 1: The different measuring systems may use different measurement procedures.
NOTE 2: A specification should give the conditions changed and unchanged, to the extent practical.
Resolution
Smallest change in a quantity being measured that causes a perceptible change in the corresponding indication.
NOTE: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend on the
value of a quantity being measured.
Second
The SI unit of time defined as the duration of 9 192 631 770 periods of the radiation corresponding to the transition
between the two hyperfine levels of the ground state of the cesium 133 atom.
Stability
The ability of a measuring instrument to maintain constant its metrological characteristics with time
Standard Uncertainty
The result of a measurement expressed as a standard deviation.
Test Uncertainty Ratio (T.U.R.)
The ratio of the span of the tolerance of a measurement quantity subject to calibration, to twice the 95% expanded
uncertainty of the measurement process used for calibration.
NOTE: This applies to two-sided tolerances.
Testing
A technical investigation, e.g. as to whether a product fulfils its specified performance.

Tolerance Limits
Extreme values of an error permitted by specifications, regulations, etc., for a given measuring instrument, test or
measurement application.
Traceability--see Metrological Traceability
Traveling Measurement Standard, Traveling Standard
Measurement standard, sometimes of special construction, intended for transport between different locations.
EXAMPLE: Portable battery-operated caesium-133 frequency measurement standard.
Trueness, Measurement Trueness, Trueness of Measurement
Closeness of agreement between the average of an infinite number of replicate measured quantity values and a
reference quantity value.
NOTE 1: Measurement trueness is not a quantity and thus cannot be expressed numerically, but measures for
closeness of agreement are given in ISO 5725.
NOTE 2: Measurement trueness is inversely related to systematic measurement error, but is not related to random
measurement error.
NOTE 3: Measurement accuracy should not be used for "measurement trueness" and vice versa.
Type A Evaluation of Measurement Uncertainty, Type A Evaluation
Evaluation of a component of measurement uncertainty by a statistical analysis of measured quantity values obtained
under defined measurement conditions.
NOTE: For various types of measurement conditions, see repeatability condition of measurement, intermediate
precision condition of measurement, and reproducibility condition of measurement.
Type B Evaluation of Measurement Uncertainty, Type B Evaluation
Evaluation of a component of measurement uncertainty determined by means other than a Type A evaluation of
EXAMPLES: Evaluation based on information. —associated with authoritative published quantity values, —
associated with the quantity value of a certified reference material, —obtained from a calibration certificate, —about
drift, —obtained from the accuracy class of a verified measuring instrument, —obtained from limits deduced through
personal experience.
Uncertainty, Uncertainty of Measurement, Measurement Uncertainty
Non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based
on the information used.
NOTE 1: Measurement uncertainty includes components arising from systematic effects, such as components
associated with corrections and the assigned quantity values of measurement standards, as well as the definitional
uncertainty. Sometimes estimated systematic effects are not corrected for but, instead, associated measurement
uncertainty components are incorporated.
NOTE 2: The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a
specified multiple of it), or the half-width of an interval, having a stated coverage probability.
NOTE 3: Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by
Type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of
measurements and can be characterized by standard deviations. The other components, which may be evaluated by
Type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from
probability density functions based on experience or other information.
NOTE 4: In general, for a given set of information, it is understood that the measurement uncertainty is associated
with a stated quantity value attributed to the measurand. A modification of this value results in a modification of the
associated uncertainty.
Uncertainty Parameter
Associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be
attributed to the measurand.
• The parameter may be, for example, a standard deviation (or a given multiple of it), or the half-width of an
interval having a stated level of confidence.
• Uncertainty of measurement comprises, in general, many components. Some of these components may be
evaluated from the statistical distribution of the results of a series of measurements and can be characterized
by experimental standard deviations. The other components, which also can be characterized by standard
deviations, are evaluated from assumed probability distributions based on experience or other information.
• It is understood that the result of the measurement is the best estimate of the value of the measurand, and
that all components of uncertainty, including those arising from systematic effects, such as components
associated with corrections and reference standards, contribute to the dispersion.
UUT
Acronym for Unit Under Test.
Working Measurement Standard, Working Standard
Measurement standard that is used routinely to calibrate or verify measuring instruments or measuring systems.
NOTE 1: A working measurement standard is usually calibrated with respect to a reference measurement standard.
NOTE 2: In relation to verification, the terms "check standard" or "control standard" are also sometimes used.
Validation
Verification, where the specified requirements are adequate for an intended use. For example, a measurement
procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for
measurement in human serum. Also:
• Process by which an assembly of hardware components or software module are shown to function in a total
systems environment.
• Tests to determine whether an implemented system fulfills its requirements.
• The checking of data for correctness or for compliance with applicable standards, rules, and conventions.
Variable Data
Data indicating a numerical value of a parameter.
Verification
Provision of objective evidence that a given item fulfils specified requirements.
EXAMPLE 1: Confirmation that a given reference material as claimed is homogeneous for the quantity value and
measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
EXAMPLE 2: Confirmation that performance properties or legal requirements of a measuring system are achieved.
EXAMPLE 3: Confirmation that a target measurement uncertainty can be met.
NOTE 1: When applicable, measurement uncertainty should be taken into consideration.
NOTE 2: The item may be, e.g. a process, measurement procedure, material, compound, or measuring system.
NOTE 3: The specified requirements may be, e.g. that a manufacturer's specifications are met.
NOTE 4: Verification in legal metrology, as defined in International Vocabulary of Terms in Legal Metrology (VIML),
and in conformity assessment in general, pertains to the examination and marking and/or issuing of a verification
certificate for a measuring system.
NOTE 5: Verification should not be confused with calibration. Not every verification is a validation.
NOTE 6: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the
structure or properties of that entity or activity.
Course Map
The Audit Process: Part 1
• Assignment
• Planning
• The Checklist
• The Desk Audit
• The Opening Meeting

• The Tour
• Lead Auditor Roles and Responsibilities
• Technical Auditor Roles and Responsibilities
• Technical Interviews and Observations
• Proficiency Testing and Interlaboratory Comparisons
• Daily Meetings
• The Closing Meeting
Documentation Produced
• The Non-Conformity Report

• The Final Report
After the Audit
• Introduction
• Deficiencies and Corrective Action
• Review of Entire Final Package
• Auditor Follow Up
• Continuing Assignments
Auditor's Notes for ISO/IEC 17025
• Introduction
• Additional AB Rules and Requirements
• Reading the Standard
ISO/IEC 17025 Section 4 - General Requirements
• 4.1 Impartiality
• 4.2 Confidentiality
ISO/IEC 17025 Section 5 - Structural Requirements
• Organization Structure Requirements of ISO/IEC 17025
ISO/IEC 17025 Section 6 - Resource Requirements
• 6.1 General
• 6.2 Personnel
• 6.3 Laboratory Environment
• 6.4 Equipment
• 6.5 Metrological Traceability
• 6.6 External Services
ISO/IEC 17025 Section 7 - Laboratory Process Requirements
• 7.1 Review of Requests/Tenders/Contracts

• 7.2 Selection/Verification/Validation of Methods
• 7.3 Sampling
• 7.4 Handling of Customer Items
• 7.5 Technical Records
• 7.6 Measurement Uncertainty
• 7.7 Ensuring Validity of Results
• 7.8 Reporting Results
• 7.9 Complaints
• 7.10 Non-Conforming Work Events
• 7.11 Laboratory Information Management Systems
ISO/IEC 17025 Section 8 - Management System Requirements
• 8.1 General Management System Requirements

• 8.2 Management System Documentation
• 8.3 Control of Documents
• 8.4 Control of Records
• 8.5 Risks and Opportunities
• 8.6 Improvement
• 8.7 Corrective Actions
• 8.8 Internal Audits
• 8.9 Management Reviews
Additional Requirements of Accreditation Bodies
• Overview
• Traceability
• Work Performed in the Field
• Use of the Accreditation Body Name and Logo
• Requirements of ANSI/NCSL Z540.x
Course Map

Introduction
About
Assignment
Objectives
Pre-Test Planning
The Checklist
Main Topics The Desk Audit
Post-Test Scheduling the Audit
OJT Mentor? Agenda and Auditor Roles

The Opening Meeting
Glossary The Tour
Resources Lead Auditor Roles and Responsibilities
Course Map Technical Auditor Roles and Responsibilities
Course Notes
Technical Interviews and Observations
Proficiency Testing and Interlaboratory Comparisons
Daily Meetings
Exit Course The Closing Meeting
The Non-Conformity Report
The Final Report
After the Audit

Introduction
Deficiencies and Corrective Action
Review of Entire Final Package
Auditor Follow Up
Continuing Assignments
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measuring systems.
NOTE 1: A working measurement standard is usually calibrated with respect to a reference

measurement standard.
NOTE 2: In relation to verification, the terms "check standard" or "control standard" are also
sometimes used.
Validation
Verification, where the specified requirements are adequate for an intended use. For example, a
measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in
Introduction water, may be validated also for measurement in human serum. Also:
About
Process by which an assembly of hardware components or software module are shown to
Objectives
function in a total systems environment.
Pre-Test
Tests to determine whether an implemented system fulfills its requirements.
The checking of data for correctness or for compliance with applicable standards, rules, and
Main Topics conventions.
Post-Test Process by which an assembly of hardware components or software module are shown to
OJT Mentor? function in a total systems environment.
Variable Data
Glossary
Resources Verification
Course Map Provision of objective evidence that a given item fulfils specified requirements.
Course Notes
EXAMPLE 1: Confirmation that a given reference material as claimed is homogeneous for the
quantity value and measurement procedure concerned, down to a measurement portion having a
mass of 10 mg.
EXAMPLE 2: Confirmation that performance properties or legal requirements of a measuring system

Exit Course are achieved.
NOTE 2: The item may be, e.g. a process, measurement procedure, material, compound, or
measuring system.
NOTE 4: Verification in legal metrology, as defined in International Vocabulary of Terms in Legal

Metrology (VIML), and in conformity assessment in general, pertains to the examination and marking
and/or issuing of a verification certificate for a measuring system.
NOTE 6: In chemistry, verification of the identity of the entity involved, or of activity, requires a
description of the structure or properties of that entity or activity.
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Post-Test
Question 22 of 23
Introduction
When lab supplies purchased with technical requirements are received, _______________ is the proper
About
Objectives documentation.
Pre-Test
Main Topics a visual inspection
Post-Test
OJT Mentor?
Record Answer and Continue
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 2 of 23
Introduction
About
Objectives an auditor
Pre-Test an assessment
compliance
Main Topics
Post-Test Record Answer and Continue
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 1 of 23
competence
certification
proficiency
its capabilities
/
Question 3 of 23
primary
compliance
self
first-party
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Post-Test
Question 4 of 23
Introduction
Test and calibration reports of an accredited lab must only display results covered by the ______________,
About
Objectives unless clearly indicated.
Pre-Test
specifications
tolerances
scope
Main Topics marketing data
Post-Test
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 5 of 23
Introduction
About
Objectives Must
Pre-Test Shall
Should
Will
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 6 of 23
Introduction
About
Objectives example
Pre-Test requirement
recommendation
interpretation
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Question 9 of 23
A desk audit might include all of the following except _________________________________________.

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Question 8 of 23
_____________ allows accreditation bodies to add their own requirements in granting accreditation.
Guide 58
Guide 25
ISO 10012
Z-540
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Post-Test
Question 10 of 23
Introduction
About
Objectives an overall impression of the quality and capabilities
Pre-Test which requirements of the standard were assessed
what was observed
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 11 of 23
Introduction
About
Objectives responsibility for
Pre-Test out of their scope
preventative action
corrective action
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 13 of 23
Introduction
About
Objectives at the beginning of
Pre-Test periodically during
at the end of
throughout
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 14 of 23
Introduction
About
Objectives surveillance audit
Pre-Test initial meeting
desk audit
second party audit
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 15 of 23
Introduction
About
Objectives the approximate times for each activity
Pre-Test examination of the lab's customer list
what will be done
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 16 of 23
Introduction
ISO/IEC 17025 Element ____ contains information relevant to a labs quality system.
About
Objectives 3.1
Pre-Test 4.2
5.2
6.7
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 17 of 23
Introduction
The technical assessor's primary focus should be ___________________.
About
Objectives to observe training records
Pre-Test increasing profitability
to observe procedures
establishing traceability of reference standards
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 18 of 23
Introduction
A laboratory scope shows ____________ that the lab is able to test or calibrate, along with the range and
About
Objectives uncertainty for each.
Pre-Test
each instrument
each parameter
Main Topics the advertised specification and tolerances
Post-Test
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 19 of 23
Introduction
About
Objectives test audit
Pre-Test proficiency test
root cause analysis
compliance report
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 21 of 23
Introduction
If ___________ cannot be completed in 30 days, a plan, complete with milestones, promises what will be
About
Objectives done and when it will be presented.
Pre-Test
corrective action
a proficiency test
Main Topics a root cause analysis
Post-Test
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
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Post-Test
Question 23 of 23
Introduction
About
Objectives covered with white out and reentered
Pre-Test crossed out, corrected alongside and initialed
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Post-Test
Question 7 of 23
Introduction
____________ written into a new standard, taken from previously written standards are called normative
About
Objectives references.
Pre-Test
Examples
Requirements
Recommendations
Main Topics Interpretations
Post-Test
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Assignment
The laboratory's management system is required to

have a documented program devoted to internal
audits. This section will indicate a frequency (or,
how often audits are performed) as well as the
laboratory's chosen requirements for responsibilities
and preparation, performance, and reporting needs
that must be followed for each audit performed.
The ISO/IEC 17025 standard allows the laboratories

to decide upon an audit scope during planning,
rather than pre-defining what areas of management
system and/or measurement activities are to be
addressed at specific times.
There is no requirement to audit all areas of the laboratory in a single audit, nor to define
a time period within which all areas must be audited. Many laboratories find it more
useful to conduct smaller, more frequent audits, with a flexible approach to defining the
Audit Scope.
Section 8.8 of the ISO/IEC 17025 standard goes into more detail on expectations for
Internal Audits.
Back Next
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Assignment
A schedule (also known as an agenda) should be prepared and followed for each audit,
Introduction
and possibly for each area visited in a larger audit. Last-minute changes should be
About
expected, as availability of personnel and laboratory workload may prevent exact
Objectives
Pre-Test
adherence to the plan.
While not commonly used in small and mid-sized laboratories, a formal audit assignment
should specify:
Main Topics
Post-Test the requirements (elements of the standard, parts of the management system,
OJT Mentor? and measurements) to be audited,
the physical area within the lab (or field labs, mobile labs, or off-site work) to be
visited,
the technicians and managers to interview, and
Glossary the makeup of the audit team.
Resources
Course Map
A method of audit called the Process Audit looks at assessing the process (e.g. a
Course Notes
Pressure Calibration) where more than one element of the standard is assessed as the
whole process is reviewed by an assessor.
Exit Course
and Vertical audits, and laboratories should utilize different methods or combinations of
methods to most effectively achieve the goals of their audit program.
Back Next
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Assignment
One person is chosen to lead the assessment and manage the process. This is the lead
Introduction
auditor. Other members of the team, if there are any, are called technical auditors or
About
team auditors. You may also see Technical Experts, but their use and discretion over
Objectives
Pre-Test
audit findings should be limited (refer to ISO 19011:2018).
It is recommended, although not required by ISO/IEC 17025, that all auditors have
explicit training in management system auditing. Credentials such as ASQ Certified
Main Topics
Quality Auditor are good evidence of this training but are not required. Further training in
Post-Test
laboratory measurement auditing and the requirements of ISO/IEC 17025 (such as this
OJT Mentor?
lesson and its prerequisites) are also worthy of consideration.
For more information on the requirements for Internal Auditors, refer to ISO/IEC 17025
Section 6.2.
Glossary
Resources
Course Map Back Next
Course Notes
Exit Course
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Assignment
It's also important that at least one member

Introduction
of the audit team have technical expertise in
About
the area being assessed. If no laboratory
Objectives
Pre-Test
measurement areas are being reviewed,
technical auditors are not needed.
Generally, even though most auditors have

Main Topics
special knowledge of certain areas of the
Post-Test
laboratory's operations, all auditors on the
OJT Mentor?
team will participate in the entire process.
Back Next
Glossary
Resources
Course Map
Course Notes
Exit Course
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Audit Preparation
Before the on-site visit for an audit, the lead auditor (and sometimes other team
members) will review some parts of the laboratory's management system documentation
that are scheduled for the upcoming assessment. This is sometimes called a "desk
audit" because it can be done at the auditor's desk.
Ideally, this part of the activity is done well in advance of the planned on-site audit to
provide enough time for review, note-taking, question preparation, and refresher
readings.
Desk audits also focus on identifying any "gaps" or non-conformities in the existing
procedures and policies of the laboratory's management system.
This will also greatly facilitate a more efficient in-person audit since the auditors can
focus on reviewing implementation instead of papers.
Back Next
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An audit is the determination, by

Introduction
examination of objective evidence, that
About
a management system is in place,
Objectives
Pre-Test
When auditing an organization for the

purpose of accreditation, additional
Main Topics
requirements ensure that the
Post-Test
organization is competent to perform a
OJT Mentor?
specific set of measurements listed on a
document called the Scope of
Glossary An accredited organization will therefore have an operational management system and
Resources
will also be judged competent to perform the calibration and/or testing work on its Scope
Course Map
of Accreditation.
Course Notes
Judgment of competence is typically made by a third party Accreditation Body using

assessors with technical expertise in or related to the areas of work the laboratory
Exit Course
performs.
Back Next
/
An audit is carried out by an individual or a team. Often, more than one person is
Introduction
required because of the range of auditor competence needed. If a team is deployed, one
About
of the team members acts as a lead auditor. The lead auditor is responsible for:
Objectives
Pre-Test
Planning, organizing and directing the audit.
Representing the team to the organization/department being audited.
Leading the team in reaching conclusions.
Main Topics
Preventing and resolving conflicts.
Post-Test
Preparing, completing, presenting, and submitting the audit report.
OJT Mentor?
Back Next
Glossary
Resources
Course Map
Course Notes
Exit Course
/
All organizations operating under ISO/IEC 17025 are required to perform periodic
Introduction
internal audits, with the purpose of verifying that the laboratory continues to competently
About
and consistently operate in accordance with:
Objectives
Pre-Test
Its management system,
The ISO/IEC 17025 requirements,
The measurement methods it performs for its customers, and
Main Topics
Any additional rules (such as those from an accreditation body or regulatory
Post-Test
program)
OJT Mentor?
It is common to hear that an internal audit cycle must be completed in a year, but this
is not a requirement of the ISO/IEC 17025 standard, even though for many labs it may
be a best practice.
Glossary
Resources
Course Map
Back Next
Course Notes
Exit Course
/
These audits should not just be a

Introduction
paperwork exercise.
About
Objectives In addition to finding that the laboratory's
Pre-Test
system documentation contains all relevant
requirements, the auditors must determine
that policies and procedures are actually
Main Topics
implemented consistently and correctly by
Post-Test
the laboratory's personnel.
OJT Mentor?
An internal audit is carried out in several
phases.
Glossary
Resources Back Next
Course Map
Course Notes
Exit Course
/
Sub-Topics
Introduction
Select:
About
Objectives
Pre-Test
Assignment
Main Topics
Planning
Post-Test
OJT Mentor?
The Checklist
Glossary
The Desk Audit
Resources
Course Map
Scheduling the Audit
Course Notes
Exit Course
/
Audit Records
While not required, a checklist is frequently used by

Introduction
auditors and may be an important tool.
About
Objectives Checklists can be set up in many ways, but
Pre-Test
frequently they list each requirement of the
standard, the laboratory's management system, and
other special requirements in the order in which they
Main Topics
are to be reviewed.
Post-Test
OJT Mentor? Often, it will have blank spaces to allow the auditor
to note what information or evidence was observed,
as well as the conclusion reached by the auditor.
Glossary
Resources Back Next
Course Map
Course Notes
Exit Course
/
Audit Records
For third party assessments, laboratories will typically be asked to provide a reference or
Introduction
link to their management system documents in a checklist format. These references
About
make finding and evaluating the relevant management system documents fast and easy,
Objectives
Pre-Test
and can greatly reduce the time, cost, and effort to perform the assessment.
Since the laboratory is most familiar with its own system, these entries are far less
important for internal audits, and many laboratories omit these references from their own
Main Topics
internal records.
Post-Test
OJT Mentor? When the checklist (or other form) is completed by the auditor with all positive and
negative findings, it constitutes the raw data from which the final audit report will be
constructed, and must also be permanently saved as part of the audit documentation.
Glossary
Resources Back Next
Course Map
Course Notes
Exit Course
/
Before the time scheduled for the actual assessment visit, the lead auditor should send
Introduction
the audit schedule (or agenda) to all concerned parties, including the management of the
About
lab area being assessed. The agenda ideally lists approximate times for each activity,
Objectives
Pre-Test
what will be done, and whose presence will be required.
The same communication should list the requirements of the assessment team —
meeting space; computers, printers, fax and copiers; and suggestions for meals and
Main Topics
breaks.
Post-Test
OJT Mentor? This will enable the laboratory personnel being observed to prepare their schedules
(including availability of technicians and equipment) and facilities to minimize interruption
of regular activities, while still making effective use of the audit team's time.
Glossary
Resources Back Next
Course Map
Course Notes
Exit Course
/
Introduction Check Your Understanding

About
Objectives
The agenda for the audit should include all of the following except
______________.
Pre-Test
Main Topics what laboratory activity will be examined

Post-Test
OJT Mentor? examination of the lab's customer list
Glossary
Resources
Course Map Back Next
Course Notes
Exit Course
/
The Desk Audit
Introduction Check Your Understanding

About
Objectives
Pre-Test

Main Topics
Post-Test understand requirements and identify gaps in the management
OJT Mentor? system
Glossary
Resources Back Next
Course Map
Course Notes
Exit Course
/
The Desk Audit
The "desk audit" also helps the lead auditor finalize and fine tune the audit plan. It helps
determine which areas to look at closely in case of questions.
Any gaps identified and corrected during this phase of the work should remain listed in
the final audit report, but should be listed as "closed" or "resolved." This should be
written in such a way as to identify what happened to close the deficiency, with wording
such as:
Any misunderstanding or confusion about policies or procedures should not be pursued

during the desk audit. It can be settled in person at the on-site visit.
Back Next
/
Planning

Introduction
About The timing of the entire event needs to be compatible with work or production schedules
Objectives for the areas and people to be audited and, if the auditors are laboraotry employees,
Pre-Test
their availability as well.
The people who are to be interviewed need to be notified, and a mutually agreeable time
Main Topics worked out, sometimes in the presence of travel schedules and vacations.
Post-Test
OJT Mentor? The audit team usually will need a private working area with sufficient space for
computers, papers, record reviews, and the like.
Back Next
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Planning
Before and during the audit, the auditors will require access to all of the documents
relevant to the management system and the audit. These may include, but not be limited
to:
quality manual
policies, procedures and forms
instruction manuals for measurement equipment
measurement methods
job records from initial customer request through final reports
personnel records of employees in the areas to be audited
records of QC activities such as control charts
proficiency testing results
records of previous internal audits
records of corrective actions, both "open" and "closed"
records of risk mitigation and monitored
records of management reviews
Back Next
/
The lead auditor schedules time for the on-site work for the convenience of both the area
being audited and the audit team. It is important to leave enough time for:
private meetings of the team,

interim debriefing and technical discussions with the management and staff of the
audited area,
assessors to write their observations and contributions to the final report, and
official meetings such as the opening and closing meetings.
This means that the final schedule should total 1.5x the number of hours planned for
actual observations, interviews, and reviews of processes, equipment, and standards (or
about 1 hour of meeting/private work for every 2 hours of active auditing).
Full audits normally span several days. Therefore, the allotted time for the day should be
divided in a similar manner where there may be "mini" opening and closing meetings
with key laboratory personnel to brief them on the day's activities. During this time, any
deviations to the audit plan due to findings or unexpected problems should be
communicated.
Back Next
/
1. The auditors review evidence (reports, records, interviews, documents, data, etc.)
Introduction
to determine the degree of conformance of the laboratory to all of the
About
requirements being audited.
Objectives
Pre-Test
2. The auditors discuss their findings with the auditee and prepare a written audit
report.
3. This report may include a specific list of non-conformities which require corrective
Main Topics
action.
Post-Test 4. The report may also include risks and/or opportunities identified by the auditors for
OJT Mentor? the laboratory to consider.
5. The lab performs a cause analysis on each non-conformity, and plans and
implements the necessary corrective action(s).
6. The audit team may be called upon to evaluate the effectiveness of the corrective
Glossary action. This may also be left to the next team to follow up in the area in question.
Resources 7. The entire documentation package is assembled when complete and filed with the
Course Map appropriate managers.
Course Notes
Note: During a third party assessment, such as might be performed by an accreditation

body, the assessment team is not always responsible for evaluating the corrective action
Exit Course
results. The assessment team may only be asked to review technical corrective actions,
such as equipment calibration data, uncertainty estimates, or method performance. The
management system non-conformities might be reviewed by accreditation body staff or
by a manager or committee convened for the purpose.
Back Next
/
Main Topics
Introduction
Select:
About
Objectives
Pre-Test
Main Topics
Post-Test
OJT Mentor?
After the Audit
Glossary
Resources
Course Map
Course Notes
Exit Course ISO/IEC 17025 Section 7 - Laboratory Process Requirements
/
This lesson is a comprehensive look at ISO/IEC 17025:2017 and its requirements from an auditing perspective.
This lesson will provide critical insight on the application of the requirements of this new laboratory standard; you will also receive
a review of the typical third-party accreditation process
/
Introduction
The lesson will cover the requirements of the international conformity assessment
Introduction
standard as it is applied to sampling, calibration, and testing laboratories.
About
Objectives It explains how to plan, conduct, and report the results of an internal audit of an ISO/IEC
Pre-Test
17025:2017 conformant laboratory.
Main Topics Back Next

Post-Test
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Introduction
On completion, you will understand the requirements from a risk-based perspective, and
Introduction
understand what behavior and actions are generally required in order to perform an
About
internal audit of a laboratory to the requirements of the standard.
Objectives
Pre-Test
Further detailed training would be required before performing assessments as a
representative of an accreditation body or other third party auditing organization.
Main Topics
Post-Test Back Next
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Getting Started
Introduction:
This lesson is a comprehensive look at ISO/IEC

17025:2017 and its requirements from an auditing
perspective.
This lesson will provide critical insight on the

application of the requirements of this new
laboratory standard; you will also receive a review
of the typical third-party accreditation process.
The lesson will cover the requirements of the international conformity assessment standard as it is
applied to sampling, calibration, and testing laboratories.
It explains how to plan, conduct, and report the results of an internal audit of an ISO/IEC 17025:2017
conformant laboratory.
On completion, you will understand the requirements from a risk-based perspective, and understand
what behavior and actions are generally required in order to perform an internal audit of a laboratory
to the requirements of the standard.
Further detailed training would be required before performing assessments as a representative of an

accreditation body or other third-party auditing organization.
About This Course

This course is designed to provide an introduction to the third party Accreditation process, and
instruct the user on auditing their own laboratory to the requirements of ISO/IEC 17025:2017.

To select a main topic, click the Main Topics link on the navigation panel at the left. After selecting a
main topics, you can choose from a list of associated sub-topics.
Testing
Before diving into course content, take the Pre-Test to check your current level of knowledge. After
working through the course, take the Post-Test to verify your increased level of knowledge. After
passing the Post-Test you will be able to print a certificate of course completion.
Navigation
The course has built-in navigation in the form of the menu links, Next and Back buttons, and other
links.
The Next and Back buttons take you forward one screen or back one screen, respectively.
OJT Mentor
The OJT Mentor link, located on the navigation bar, is available to you at any time to ask questions
about the content of the course. Your question will be sent directly to WorkPlace Training subject
matter experts who will respond as quickly as possible. OJT Mentor requires a live Internet
connection.
Additional Features
The course includes a Glossary, Resources, a Course Map, and a Course Notes option all
accessible from the navigation panel at the left.
Please Note
The material contained in this course is for training purposes only. The content is not intended to
limit your laboratory to only the examples presented in the subject matter, nor to be all-inclusive of
topics or questions presented.
Every effort has been made to achieve technical accuracy. Do not use this course as a technical
reference. Consult the latest accepted industry standards for specifications relating to your specific
application.
Objectives
* Apply a risk-based approach to their laboratory's processes,
* Describe impartiality,
* Verify, through appropriate audits, their laboratory's conformance to the requirements of the
standard.
Pre-Test
Question 1 of 23
How often must laboratories perform an internal audit?
Once per quarter
Once per year
Once per month
Whenever it schedules them
Question 2 of 23
During the management review
During the planning phase
Question 3 of 23
primary
compliance
self
first-party
Question 4 of 23
Question 5 of 23
May
Shall
Should
Can
Question 6 of 23
___________ is a word stated in the standard that indicates the laboratory must write down or
document the results of a given activity.
Control
Monitor
Record
Track
Question 7 of 23
Risks
Root Causes
Conformity evidence
Question 8 of 23
Once a year
All the time
Question 9 of 23

Question 10 of 23
Question 11 of 23
Issue technical opinions
Recommend accreditation
Question 12 of 23
Which of the following topics does NOT require a procedure according to ISO/IEC 17025:2017?
Evaluation of calibration providers
Review of customer work requests
Risk analysis
Maintaining personnel competence
Question 13 of 23

Special procedures for cleanliness and housekeeping
Access to areas affecting laboratory results
Question 14 of 23
If measurement uncertainty is involved
If the conformity specification includes the rule
Question 15 of 23
Laboratory competence requirements must include all of the following except for...
Education
Employment history
Training
Experience
Question 16 of 23
4.1
8.2
5.2
6.6
Question 17 of 23
Question 18 of 23
Question 19 of 23
Which of the following is the most proper tool to use to determine when laboratory measurement
setups or results are out of tolerance?
risk assessment (section 8.5)
Question 20 of 23

Spreadsheet functions created by the lab
Commercial Software used without modification
Question 21 of 23
After internal audits reveal a non-conformity, how long does a laboratory have to implement
corrective actions?
Up to 30 days
Up to 90 days
Question 22 of 23
When lab supplies purchased with technical requirements are received, _______________ is
required to conform to the standard.
a visual inspection
Question 23 of 23

Main Topics
Select:
• Documentation Produced
• After the Audit
• Auditor's Notes for ISO/IEC 17025
• ISO/IEC 17025 Section 4 - General Requirements
• ISO/IEC 17025 Section 5 - Structural Requirements
• ISO/IEC 17025 Section 6 - Resource Requirements
• ISO/IEC 17025 Section 7 - Laboratory Process Requirements
• ISO/IEC 17025 Section 8 - Management System Requirements
• Additional Requirements of Accreditation Bodies

Sub-Topics
Select:
• Assignment
• Planning
• The Checklist
• The Desk Audit
An audit is the determination, by examination of objective

evidence, that a management system is in place,
When auditing an organization for the purpose of

accreditation, additional requirements ensure that the
organization is competent to perform a specific set of
measurements listed on a document called the Scope of
An accredited organization will therefore have an

operational management system and will also be judged competent to perform the calibration and/or
testing work on its Scope of Accreditation.
Judgment of competence is typically made by a third party Accreditation Body using assessors with
technical expertise in or related to the areas of work the laboratory performs.
An audit is carried out by an individual or a team. Often, more than one person is required because
of the range of auditor competence needed. If a team is deployed, one of the team members acts as
a lead auditor. The lead auditor is responsible for:
• Planning, organizing and directing the audit.

• Representing the team to the organization/department being audited.
• Leading the team in reaching conclusions.
• Preventing and resolving conflicts.
• Preparing, completing, presenting, and submitting the audit report.
All organizations operating under ISO/IEC 17025 are required to perform periodic internal audits,
with the purpose of verifying that the laboratory continues to competently and consistently operate in
accordance with:
• Its management system,

• The ISO/IEC 17025 requirements,
• The measurement methods it performs for its customers, and
• Any additional rules (such as those from an accreditation body or regulatory program)
It is common to hear that an internal audit cycle must be completed in a year, but this is not a
requirement of the ISO/IEC 17025 standard, even though for many labs it may be a best practice.
These audits should not just be a paperwork exercise.
In addition to finding that the laboratory's system documentation

contains all relevant requirements, the auditors must determine
that policies and procedures are actually implemented
consistently and correctly by the laboratory's personnel.
An internal audit is carried out in several phases.
Assignment
The laboratory's management system is required to have a documented

program devoted to internal audits. This section will indicate a frequency (or,
how often audits are performed) as well as the laboratory's chosen
requirements for responsibilities and preparation, performance, and
reporting needs that must be followed for each audit performed.
The ISO/IEC 17025 standard allows the laboratories to decide upon an audit
scope during planning, rather than pre-defining what areas of management
system and/or measurement activities are to be addressed at specific times.
There is no requirement to audit all areas of the laboratory in a single audit, nor to define a time
period within which all areas must be audited. Many laboratories find it more useful to conduct
smaller, more frequent audits, with a flexible approach to defining the Audit Scope.
Section 8.8 of the ISO/IEC 17025 standard goes into more detail on expectations for Internal Audits.
A schedule (also known as an agenda) should be prepared and followed for each audit, and possibly
for each area visited in a larger audit. Last-minute changes should be expected, as availability of
personnel and laboratory workload may prevent exact adherence to the plan.
While not commonly used in small and mid-sized laboratories, a formal audit assignment should
specify:
• the requirements (elements of the standard, parts of the management system, and
measurements) to be audited,
• the physical area within the lab (or field labs, mobile labs, or off-site work) to be visited,
• the technicians and managers to interview, and
• the makeup of the audit team.
A method of audit called the Process Audit looks at assessing the process (e.g. a Pressure
Calibration) where more than one element of the standard is assessed as the whole process is
reviewed by an assessor.
and Vertical audits, and laboratories should utilize different methods or combinations of methods to
most effectively achieve the goals of their audit program.
One person is chosen to lead the assessment and manage the process. This is the lead auditor.
Other members of the team, if there are any, are called technical auditors or team auditors. You may
also see Technical Experts, but their use and discretion over audit findings should be limited (refer
to ISO 19011:2018).
It is recommended, although not required by ISO/IEC 17025, that all auditors have explicit training in
management system auditing. Credentials such as ASQ Certified Quality Auditor are good evidence
of this training but are not required. Further training in laboratory measurement auditing and the
requirements of ISO/IEC 17025 (such as this lesson and its prerequisites) are also worthy of
consideration.
For more information on the requirements for Internal Auditors, refer to ISO/IEC 17025 Section 6.2.
It's also important that at least one member of the audit team
have technical expertise in the area being assessed. If no
laboratory measurement areas are being reviewed, technical
auditors are not needed.
Generally, even though most auditors have special

knowledge of certain areas of the laboratory's operations, all
auditors on the team will participate in the entire process.
Planning
The timing of the entire event needs to be compatible with work or production schedules for the
areas and people to be audited and, if the auditors are laboraotry employees, their availability as
well.
The people who are to be interviewed need to be notified, and a mutually agreeable time worked
out, sometimes in the presence of travel schedules and vacations.
The audit team usually will need a private working area with sufficient space for computers, papers,
record reviews, and the like.
Before and during the audit, the auditors will require access to all of the documents relevant to the
management system and the audit. These may include, but not be limited to:
• quality manual
• policies, procedures and forms
• instruction manuals for measurement equipment
• measurement methods
• job records from initial customer request through final reports
• personnel records of employees in the areas to be audited
• records of QC activities such as control charts
• proficiency testing results
• records of previous internal audits
• records of corrective actions, both "open" and "closed"
• records of risk mitigation and monitored
• records of management reviews
1. The auditors review evidence (reports, records, interviews, documents, data, etc.) to
determine the degree of conformance of the laboratory to all of the requirements being
audited.
2. The auditors discuss their findings with the auditee and prepare a written audit report.
3. This report may include a specific list of non-conformities which require corrective action.
4. The report may also include risks and/or opportunities identified by the auditors for the
laboratory to consider.
5. The lab performs a cause analysis on each non-conformity, and plans and implements the
necessary corrective action(s).
6. The audit team may be called upon to evaluate the effectiveness of the corrective action. This
may also be left to the next team to follow up in the area in question.
7. The entire documentation package is assembled when complete and filed with the appropriate
managers.
Note: During a third party assessment, such as might be performed by an accreditation body, the
assessment team is not always responsible for evaluating the corrective action results. The
assessment team may only be asked to review technical corrective actions, such as equipment
calibration data, uncertainty estimates, or method performance. The management system non-
conformities might be reviewed by accreditation body staff or by a manager or committee convened
for the purpose.
Audit Records
While not required, a checklist is frequently used by auditors and may be an

important tool.
Checklists can be set up in many ways, but frequently they list each requirement
of the standard, the laboratory's management system, and other special
requirements in the order in which they are to be reviewed.
Often, it will have blank spaces to allow the auditor to note what information or evidence was
observed, as well as the conclusion reached by the auditor.
For third party assessments, laboratories will typically be asked to provide a reference or link to their
management system documents in a checklist format. These references make finding and
evaluating the relevant management system documents fast and easy, and can greatly reduce the
time, cost, and effort to perform the assessment.
Since the laboratory is most familiar with its own system, these entries are far less important for
internal audits, and many laboratories omit these references from their own internal records.
When the checklist (or other form) is completed by the auditor with all positive and negative findings,
it constitutes the raw data from which the final audit report will be constructed, and must also be
permanently saved as part of the audit documentation.
Audit Preparation
Before the on-site visit for an audit, the lead auditor (and sometimes other team members) will
review some parts of the laboratory's management system documentation that are scheduled for the
upcoming assessment. This is sometimes called a "desk audit" because it can be done at the
auditor's desk.
Ideally, this part of the activity is done well in advance of the planned on-site audit to provide enough
time for review, note-taking, question preparation, and refresher readings.
Desk audits also focus on identifying any "gaps" or non-conformities in the existing procedures and
policies of the laboratory's management system.
This will also greatly facilitate a more efficient in-person audit since the auditors can focus on
reviewing implementation instead of papers.
Desk Audit

understand requirements and identify gaps in the management system
The "desk audit" also helps the lead auditor finalize and fine tune the audit plan. It helps determine
which areas to look at closely in case of questions.
Any gaps identified and corrected during this phase of the work should remain listed in the final audit
report, but should be listed as "closed" or "resolved." This should be written in such a way as to
identify what happened to close the deficiency, with wording such as:
Any misunderstanding or confusion about policies or procedures should not be pursued during the
desk audit. It can be settled in person at the on-site visit.
The lead auditor schedules time for the on-site work for the convenience of both the area being
audited and the audit team. It is important to leave enough time for:
• private meetings of the team,

• interim debriefing and technical discussions with the management and staff of the audited
area,
• assessors to write their observations and contributions to the final report, and
• official meetings such as the opening and closing meetings.
This means that the final schedule should total 1.5x the number of hours planned for actual
observations, interviews, and reviews of processes, equipment, and standards (or about 1 hour of
meeting/private work for every 2 hours of active auditing).
Full audits normally span several days. Therefore, the allotted time for the day should be divided in a
similar manner where there may be "mini" opening and closing meetings with key laboratory
personnel to brief them on the day's activities. During this time, any deviations to the audit plan due
to findings or unexpected problems should be.

Before the time scheduled for the actual assessment visit, the lead auditor should send the
audit schedule (or agenda) to all concerned parties, including the management of the lab area
being assessed. The agenda ideally lists approximate times for each activity, what will be
done, and whose presence will be required.
The same communication should list the requirements of the assessment team — meeting space;
computers, printers, fax and copiers; and suggestions for meals and breaks.
This will enable the laboratory personnel being observed to prepare their schedules (including
availability of technicians and equipment) and facilities to minimize interruption of regular activities,
while still making effective use of the audit team's time.
The agenda for the audit should include all of the following except ______________.
what laboratory activity will be examined
Post-Test
Question 1 of 23
competence
certification
proficiency
its capabilities
Question 2 of 23

an auditor
an assessment
compliance
Question 3 of 23
primary
compliance
self
first-party
Question 4 of 23
Test and calibration reports of an accredited lab must only display results covered by the
______________, unless clearly indicated.
specifications
tolerances
scope
marketing data
Question 5 of 23
Must
Shall
Should
Will
Question 6 of 23

example
requirement
recommendation
interpretation
Question 7 of 23
____________ written into a new standard, taken from previously written standards are called
normative references.
Examples
Requirements
Recommendations
Interpretations
Question 9 of 23
A desk audit might include all of the following except

Question 10 of 23
an overall impression of the quality and capabilities
which requirements of the standard were assessed

what was observed
Question 11 of 23
responsibility for
out of their scope
preventative action
corrective action
Question 12 of 23
Paragraph 4.10 calls for the laboratory to have _____________ for corrective action.
a policy and procedure
recommendations
a schedule of appropriate fines
Question 13 of 23
at the beginning of
periodically during
at the end of
throughout
Question 14 of 23
surveillance audit
initial meeting
desk audit
second party audit
Question 15 of 23
the approximate times for each activity

what will be done
Question 18 of 23
A laboratory scope shows ____________ that the lab is able to test or calibrate, along with the
range and uncertainty for each.
each instrument

each parameter
the advertised specification and tolerances
Question 19 of 23
test audit
proficiency test
root cause analysis
compliance report
Question 20 of 23
At the closing meeting, the assessment team may discuss all of the following except
_________________.
a reiteration of what steps must be taken by the Laboratory
the admonishment of any shortcomings found

what rights of appeal they have if they do not agree with any findings
offer thanks for the privilege of serving as the assessor
Question 21 of 23
If ___________ cannot be completed in 30 days, a plan, complete with milestones, promises what
will be done and when it will be presented.
corrective action
a proficiency test
Question 22 of 23
When lab supplies purchased with technical requirements are received, _______________ is the
proper documentation.
a visual inspection
Question 23 of 23
covered with white out and reentered
crossed out, corrected alongside and initialed
Glossary of Terms
A|B|C|D|E|F|G|I|K|L|M|N|O|P|Q|R|S|T|U|V
Accuracy, Accuracy of Measurement, Measurement Accuracy
Closeness of agreement between a measured quantity value and a true quantity value of a measurand.
Ampere
The SI unit of electric current defined as that constant current which, if maintained in two straight parallel conductors
of infinite length, of negligible circular cross-section, and placed 1 meter apart in vacuum, would produce between
these conductors a force equal to 2 x 10-7newton per meter of length.
Attribute Data
Data indicating the state of an attribute (e.g. True/Not True, On/Off, go/no go).
Availability
A measure of the degree to which an item is in an operable state at any time.
Bias, Measurement Bias
Estimate of a systematic measurement error.
Calibration
Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with
measurement uncertainties provided by measurement standards and corresponding indications with associated
measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a
measurement result from an indication.
NOTE: A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve, or
calibration table. In some cases, it may consist of an additive or multiplicative correction of the indication with
associated measurement uncertainty.
Calibration - what is it?
A fundamental concept in quality assurance is the calibration of measuring instruments. Calibration is a word which is
sometimes misunderstood. Calibration of an instrument means determining by how much the instrument reading is in
error by checking it against a measurement standard of known error.
A calibration is thus not usually associated with approval. It "only" gives information about the error of the equipment
with respect to an accepted reference value. As a consequence, it is up to the user to decide whether the equipment
is sufficiently good to perform a certain measurement. One possibility is to have the instrument certified.
Calibration Interval
The period of time between successive, scheduled calibrations for a given item of equipment.
Candela
The SI unit of luminous intensity defined as the luminous intensity, in a given direction, of a source that emits
monochromatic radiation of frequency 540 x 1012 hertz and that has a radiant intensity in that direction of 1/683 watt
per steradian.
Combined Standard Uncertainty
Standard measurement uncertainty that is obtained using the individual standard measurement uncertainties
associated with the input quantities in a measurement model.
Confidence Limits
Limits that bound a range of values that contains a particular value with a specified probability.
Correction
Compensation for an estimated systematic effect. The compensation can take different forms, such as an addend or
a factor, or can be deduced from a table.
Coverage Factor
Number larger than one by which a combined standard measurement uncertainty is multiplied to obtain an expanded
NOTE: A coverage factor is usually symbolized k.
Drift
A slow change of a metrological characteristic of a measuring instrument.
Equipment Parameter
An attribute of an item of equipment which can be characterized with an expected nominal value bounded by
performance specifications.
Error, Error of Measurement
Measured quantity value minus a reference quantity value.
NOTE 1: The concept of ‘measurement error’ can be used both
a) when there is a single reference quantity value to refer to, which occurs if a calibration is made by means of a
measurement standard with a measured quantity value having a negligible measurement uncertainty or if a
conventional quantity value is given, in which case the measurement error is known, and
b) if a measurand is supposed to be represented by a unique true quantity value or a set of true quantity values of
negligible range, in which case the measurement error is not known.
NOTE 2: Measurement error should not be confused with production error or mistake.
Expanded Uncertainty, Expanded Measurement Uncertainty
Product of a combined standard measurement uncertainty and a factor larger than the number one.
NOTE 1: The factor depends upon the type of probability distribution of the output quantity in a measurement model
and on the selected coverage probability.
NOTE 2: The term "factor" in this definition refers to a coverage factor.
NOTE 3: Expanded measurement uncertainty is termed "overall uncertainty" in paragraph 5 of Recommendation

INC-1 (1980) (see the GUM) and simply "uncertainty" in IEC documents.
Expectation of the Measurable Quantity
The mean of a specified population of measurements.
Failure Rate
The total number of failures within an item population, divided by the total time expanded by that population, during a
particular measurement interval under stated conditions.
Failure Time
The time elapsed since calibration for the occurrence of an out-of-tolerance event.
Guardbanding
The practice of adjusting specification limits (pass/fail criteria) to account for the uncertainty associated with the
measurement.
IMTE
Inspection, Measuring and Test Equipment
Inspection
The measurement, investigation or testing of one or more characteristics of a product which includes a comparison of
the results with specified requirements in order to determine whether the requirements have been fulfilled.
International System of Units, SI
System of units, based on the International System of Quantities (ISQ), their names and symbols, including a series
of prefixes and their names and symbols, together with rules for their use, adopted by the General Conference on
Weights and Measures (CGPM).
NOTE: The SI is founded on the seven base quantities of the ISQ and the names and symbols of the corresponding
base units that are contained in the following table.
In-Tolerance
A condition in which measurement attributes value lies within documented performance specifications for the
attribute.
Kelvin
The SI unit of thermodynamic temperature defined as the fraction 1/273.16 of the thermodynamic temperature of the
triple point of water.
Kilogram
The SI unit of mass equal to the mass of the international prototype of the kilogram.
Laboratory Bias
The difference between the expectation of the test results from a particular laboratory and an accepted reference
value.
Maintainability
A measure of the ability of an item to be retained in, or restored to, a specified condition when maintenance is
performed using prescribed procedures and technician skill levels.
Mean-Time-Between-Failure (MTBF)
A basic measure of reliability for repairable items. The average time during which all parts of the item perform within
their specified limits, during a particular measurement period under stated conditions.
Mean-Time-Between-Maintenance (MTBM)
A basic measure of reliability for repairable systems. The average time between all system maintenance actions.
Maintenance actions may be for repair or preventive purposes.
Mean-Time-Between-Repair (MTBR)
A basic measure of reliability for repairable fielded systems. The average time between all systems maintenance
actions requiring removal and replacement of a box or subsystem.
Mean-Time-To-Failure (MTTF)
A basic measure of reliability for non repairable systems. Average failure free operating time, during a particular
measurement period under stated conditions.
Mean-Time-To-Repair (MTTR)
A basic measure of maintainability. The sum of corrective maintenance items divided by the total number of failures
within an item. The average time it takes to fully repair a failed system.
Measurand
Quantity intended to be measured.
NOTE 1: The specification of a measurand requires knowledge of the kind of quantity, description of the state of the
phenomenon, body, or substance carrying the quantity, including any relevant component, and the chemical entities
involved.
NOTE 2: In the second edition of the VIM and in IEC 60050-300:2001, the measurand is defined as the "quantity
subject to measurement".
NOTE 3: The measurement, including the measuring system and the conditions under which the measurement is
carried out, might change the phenomenon, body, or substance such that the quantity being measured may differ
from the measurand as defined. In this case, adequate correction is necessary.
NOTE 4: In chemistry, "analyte", or the name of a substance or compound, are terms sometimes used for
"measurand". This usage is erroneous because these terms do not refer to quantities.
Measurement
Process of experimentally obtaining one or more quantity values that can reasonably be attributed to a quantity.
NOTE 1: Measurement does not apply to nominal properties.
NOTE 2: Measurement implies comparison of quantities and includes counting of entities.

NOTE 3: Measurement presupposes a description of the quantity commensurate with the intended use of a
measurement result, a measurement procedure, and a calibrated measuring system operating according to the
specified measurement procedure, including the measurement conditions.
Measurement Standard
Realization of the definition of a given quantity, with stated quantity value and associated measurement uncertainty,
used as a reference.
EXAMPLE 1: 1 kg mass measurement standard with an associated standard measurement uncertainty of 3 µg.
EXAMPLE 2: 100 W measurement standard resistor with an associated standard measurement uncertainty of 1 µW.
Measuring Parameter
A parameter whose indicated or stated value is taken to represent a reference during measurement.
Meter
The SI Unit of length defined as the length of the path traveled by light in vacuum during a time interval of 1/299 792
458 of a second.
Metrological Traceability
Property of a measurement result whereby the result can be related to a reference through a documented unbroken
chain of calibrations, each contributing to the measurement uncertainty.
NOTE 1: For this definition, a "reference" can be a definition of a measurement unit through its practical realization, or
a measurement procedure including the measurement unit for a non-ordinal quantity, or a measurement standard.
NOTE 2: Metrological traceability requires an established calibration hierarchy.
NOTE 3: Specification of the reference must include the time at which this reference was used in establishing the
calibration hierarchy, along with any other relevant metrological information about the reference, such as when the
first calibration in the calibration hierarchy was performed.
NOTE 4 For measurements with more than one input quantity in the measurement model, each of the input quantity
values should itself be metrologically traceable.
Metrological Traceability Chain, Traceability Chain
Sequence of measurement standards and calibrations that is used to relate a measurement result to a reference.
NOTE 1: A metrological traceability chain is defined through a calibration hierarchy.
NOTE 2: A metrological traceability chain is used to establish metrological traceability of a measurement result.
NOTE 3: A comparison between two measurement standards may be viewed as a calibration if the comparison is
used to check and, if necessary, correct the quantity value and measurement uncertainty attributed to one of the
measurement standards.
Metrological Traceability to Measurement Unit, Metrological Traceability to a Unit
Metrological traceability where the reference is the definition of a measurement unit through its practical realization.
NOTE: The expression "traceability to the SI" means "metrological traceability to a measurement unit of the
International System of Units".
Metrology
Science of measurement and its application.
NOTE: Metrology includes all theoretical and practical aspects of measurement, whatever the measurement
uncertainty and field of application.
Mole
The SI unit of amount of substance. The mole is the amount of substance of a system which contains as many
elementary entities as there are atoms in 0.012 kilogram of carbon 12.
National Measurement Standard, National Standard
Measurement standard recognized by national authority to serve in a state or economy as the basis for assigning
quantity values to other measurement standards for the kind of quantity concerned.
Nominal Quantity Value, Nominal Value
Rounded or approximate value of a characterizing quantity of a measuring instrument or measuring system that
provides guidance for its appropriate use.
EXAMPLE 1: 100 ω as the nominal quantity value marked on a standard resistor.
EXAMPLE 2: 1 000 ml as the nominal quantity value marked on a single-mark volumetric flask.
NOTE: "Nominal quantity value" and "nominal value" are not to be confused with "nominal property value."
Outlier
Observations at either extreme of a sample of values which are so far removed from the main body of the sample that
their exclusion from the sample improves the validity or accuracy of the data.
Out-Of-Tolerance (OOT)
A condition in which a measured value of a measurement attribute lays outside the documented performance
specifications for the attribute.
Performance Specifications
Measurement attribute specifications which bound the range of values considered indicative of acceptable attribute
performance.
Precision, Measurement Precision
Closeness of agreement between indications or measured quantity values obtained by replicate measurements on
the same or similar objects under specified conditions.
NOTE 1: Measurement precision is usually expressed numerically by measures of imprecision, such as standard
deviation, variance, or coefficient of variation under the specified conditions of measurement.
NOTE 2: The "specified conditions" can be, for example, repeatability conditions of measurement, intermediate
precision conditions of measurement, or reproducibility conditions of measurement (see ISO 5725-3:1994).
NOTE 3: Measurement precision is used to define measurement repeatability, intermediate measurement precision,
and measurement reproducibility.
NOTE 4: Sometimes "measurement precision" is erroneously used to mean measurement accuracy.
Preventive Maintenance (Calibration)
The time associated with the performance of all required maintenance (calibration) both scheduled and unscheduled.
Process
A Process is a naturally occurring or designed sequence of operations or events, possibly taking up time, space,
expertise or other resource, which produces some outcome.
• Calibration or Testing is a process that produces a measurement.
Quality
Relates to all the characteristics that meet an expressed or implied need
Reference Measurement Standard, Reference Standard
An accepted value that serves as an agreed-on reference for comparison, and which is derived as:
• Measurement standard designated for the calibration of other measurement standards for quantities of a
given kind in a given organization or at a given location.
• Theoretical or established value, based on scientific principles.
• An assigned or certified value, based on experimental work of some national or international organization.
• Consensus or certified value, based on collaborative experimental work under the auspices of a scientific or
engineering group.
• When these are not available, the expectation of the measurable quantity.
Reliability
The probability that an item will perform its intended function for a specified interval under stated conditions.
Reliability Target
A specified level of measurement reliability commensurate with quality, cost and logistic objectives.
Repeatability, Measurement Repeatability
Measurement precision under a set of repeatability conditions of measurement.

Repeatability Condition of Measurement, Repeatability Condition
Condition of measurement, out of a set of conditions that includes the same measurement procedure, same
operators, same measuring system, same operating conditions and same location, and replicate measurements on
the same or similar objects over a short period of time.
NOTE 1: A condition of measurement is a repeatability condition only with respect to a specified set of repeatability
conditions.
NOTE 2: In chemistry, the term "intra-serial precision condition of measurement" is sometimes used to designate this
concept.
Reproducibility, Measurement Reproducibility
Measurement precision under reproducibility conditions of measurement.
Reproducibility Condition of Measurement, Reproducibility Condition
Condition of measurement, out of a set of conditions that includes different locations, operators, measuring systems,
and replicate measurements on the same or similar objects.
NOTE 1: The different measuring systems may use different measurement procedures.
NOTE 2: A specification should give the conditions changed and unchanged, to the extent practical.
Resolution
Smallest change in a quantity being measured that causes a perceptible change in the corresponding indication.
NOTE: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend on the
value of a quantity being measured.
Second
The SI unit of time defined as the duration of 9 192 631 770 periods of the radiation corresponding to the transition
between the two hyperfine levels of the ground state of the cesium 133 atom.
Stability
The ability of a measuring instrument to maintain constant its metrological characteristics with time
Standard Uncertainty
The result of a measurement expressed as a standard deviation.
Test Uncertainty Ratio (T.U.R.)
The ratio of the span of the tolerance of a measurement quantity subject to calibration, to twice the 95% expanded
uncertainty of the measurement process used for calibration.
NOTE: This applies to two-sided tolerances.
Testing
A technical investigation, e.g. as to whether a product fulfils its specified performance.

Tolerance Limits
Extreme values of an error permitted by specifications, regulations, etc., for a given measuring instrument, test or
measurement application.
Traceability--see Metrological Traceability
Traveling Measurement Standard, Traveling Standard
Measurement standard, sometimes of special construction, intended for transport between different locations.
EXAMPLE: Portable battery-operated caesium-133 frequency measurement standard.
Trueness, Measurement Trueness, Trueness of Measurement
Closeness of agreement between the average of an infinite number of replicate measured quantity values and a
reference quantity value.
NOTE 1: Measurement trueness is not a quantity and thus cannot be expressed numerically, but measures for
closeness of agreement are given in ISO 5725.
NOTE 2: Measurement trueness is inversely related to systematic measurement error, but is not related to random
measurement error.
NOTE 3: Measurement accuracy should not be used for "measurement trueness" and vice versa.
Type A Evaluation of Measurement Uncertainty, Type A Evaluation
Evaluation of a component of measurement uncertainty by a statistical analysis of measured quantity values obtained
under defined measurement conditions.
NOTE: For various types of measurement conditions, see repeatability condition of measurement, intermediate
precision condition of measurement, and reproducibility condition of measurement.
Type B Evaluation of Measurement Uncertainty, Type B Evaluation
Evaluation of a component of measurement uncertainty determined by means other than a Type A evaluation of
EXAMPLES: Evaluation based on information. —associated with authoritative published quantity values, —
associated with the quantity value of a certified reference material, —obtained from a calibration certificate, —about
drift, —obtained from the accuracy class of a verified measuring instrument, —obtained from limits deduced through
personal experience.
Uncertainty, Uncertainty of Measurement, Measurement Uncertainty
Non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based
on the information used.
NOTE 1: Measurement uncertainty includes components arising from systematic effects, such as components
associated with corrections and the assigned quantity values of measurement standards, as well as the definitional
uncertainty. Sometimes estimated systematic effects are not corrected for but, instead, associated measurement
uncertainty components are incorporated.
NOTE 2: The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a
specified multiple of it), or the half-width of an interval, having a stated coverage probability.
NOTE 3: Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by
Type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of
measurements and can be characterized by standard deviations. The other components, which may be evaluated by
Type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from
probability density functions based on experience or other information.
NOTE 4: In general, for a given set of information, it is understood that the measurement uncertainty is associated
with a stated quantity value attributed to the measurand. A modification of this value results in a modification of the
associated uncertainty.
Uncertainty Parameter
Associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be
attributed to the measurand.
• The parameter may be, for example, a standard deviation (or a given multiple of it), or the half-width of an
interval having a stated level of confidence.
• Uncertainty of measurement comprises, in general, many components. Some of these components may be
evaluated from the statistical distribution of the results of a series of measurements and can be characterized
by experimental standard deviations. The other components, which also can be characterized by standard
deviations, are evaluated from assumed probability distributions based on experience or other information.
• It is understood that the result of the measurement is the best estimate of the value of the measurand, and
that all components of uncertainty, including those arising from systematic effects, such as components
associated with corrections and reference standards, contribute to the dispersion.
UUT
Acronym for Unit Under Test.
Working Measurement Standard, Working Standard
Measurement standard that is used routinely to calibrate or verify measuring instruments or measuring systems.
NOTE 1: A working measurement standard is usually calibrated with respect to a reference measurement standard.
NOTE 2: In relation to verification, the terms "check standard" or "control standard" are also sometimes used.
Validation
Verification, where the specified requirements are adequate for an intended use. For example, a measurement
procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for
measurement in human serum. Also:
• Tests to determine whether an implemented system fulfills its requirements.
• The checking of data for correctness or for compliance with applicable standards, rules, and conventions.
Variable Data
Verification
Provision of objective evidence that a given item fulfils specified requirements.
EXAMPLE 1: Confirmation that a given reference material as claimed is homogeneous for the quantity value and
measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
EXAMPLE 2: Confirmation that performance properties or legal requirements of a measuring system are achieved.
NOTE 2: The item may be, e.g. a process, measurement procedure, material, compound, or measuring system.
NOTE 4: Verification in legal metrology, as defined in International Vocabulary of Terms in Legal Metrology (VIML),
and in conformity assessment in general, pertains to the examination and marking and/or issuing of a verification
certificate for a measuring system.
NOTE 6: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the
structure or properties of that entity or activity.
Course Map
• Assignment
• Planning
• The Checklist
• The Desk Audit
• The Opening Meeting

• The Tour
• Lead Auditor Roles and Responsibilities
• Technical Auditor Roles and Responsibilities
• Technical Interviews and Observations
• Daily Meetings
• The Closing Meeting
• The Non-Conformity Report

• The Final Report
After the Audit
• Introduction
• Deficiencies and Corrective Action
• Review of Entire Final Package
• Auditor Follow Up
• Continuing Assignments
• Introduction
• Additional AB Rules and Requirements
• Reading the Standard
• 4.1 Impartiality
• 4.2 Confidentiality
• Organization Structure Requirements of ISO/IEC 17025
• 6.1 General
• 6.2 Personnel
• 6.3 Laboratory Environment
• 6.4 Equipment
• 6.5 Metrological Traceability
• 6.6 External Services
ISO/IEC 17025 Section 7 - Laboratory Process Requirements
• 7.1 Review of Requests/Tenders/Contracts

• 7.2 Selection/Verification/Validation of Methods
• 7.3 Sampling
• 7.4 Handling of Customer Items
• 7.5 Technical Records
• 7.6 Measurement Uncertainty
• 7.7 Ensuring Validity of Results
• 7.8 Reporting Results
• 7.9 Complaints
• 7.10 Non-Conforming Work Events
• 7.11 Laboratory Information Management Systems
• 8.1 General Management System Requirements

• 8.2 Management System Documentation
• 8.3 Control of Documents
• 8.4 Control of Records
• 8.5 Risks and Opportunities
• 8.6 Improvement
• 8.7 Corrective Actions
• 8.8 Internal Audits
• 8.9 Management Reviews
• Overview
• Traceability
• Work Performed in the Field
• Use of the Accreditation Body Name and Logo
• Requirements of ANSI/NCSL Z540.x
Objectives

Introduction
About * Apply a risk-based approach to their laboratory's processes,
Objectives
Pre-Test * Describe impartiality,

Main Topics
Post-Test
OJT Mentor? * Verify, through appropriate audits, their laboratory's conformance to the requirements
of the standard.
Glossary
Resources
Next
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 22 of 23
When lab supplies purchased with technical requirements are received, _______________ is required to conform to the standard.

a visual inspection
/
Pre-Test
Question 2 of 23
Introduction
About
Objectives During the management review
Pre-Test During the planning phase
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 3 of 23
Introduction
About
Objectives primary
Pre-Test compliance
self
first-party
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 4 of 23

/
Pre-Test
Question 5 of 23
Introduction
About
Objectives May
Pre-Test Shall
Should
Can
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 7 of 23
Introduction
About
Objectives Risks
Pre-Test Root Causes
Conformity evidence
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 8 of 23
Once a year
All the time
/
Pre-Test
Question 9 of 23

/
Pre-Test
Question 10 of 23

/
Pre-Test
Question 11 of 23
Introduction
About
Objectives Issue technical opinions
Pre-Test Recommend accreditation
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 13 of 23
Introduction
About
Objectives Special procedures for cleanliness and housekeeping
Pre-Test Access to areas affecting laboratory results
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 14 of 23
Introduction
About
Objectives If measurement uncertainty is involved
Pre-Test If the conformity specification includes the rule
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 16 of 23
4.1
8.2
5.2
6.6
/
Pre-Test
Question 17 of 23

/
Pre-Test
Question 18 of 23

/
Pre-Test
Question 19 of 23
Introduction
Which of the following is the most proper tool to use to determine when laboratory measurement setups or
About
Objectives results are out of tolerance?
Pre-Test
Main Topics risk assessment (section 8.5)
Post-Test
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 20 of 23
Introduction
About
Objectives Spreadsheet functions created by the lab
Pre-Test Commercial Software used without modification
Main Topics
OJT Mentor?
Glossary
Resources
Course Map
Course Notes
Exit Course
/
Pre-Test
Question 21 of 23
After internal audits reveal a non-conformity, how long does a laboratory have to implement corrective actions?
Up to 30 days
Up to 90 days
/
Pre-Test
Question 23 of 23

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About This Course

Course Scope and Structure

The course is divided into the following main topics:

Main topics are divided into several sub-topics.

Main Topics OJT Mentor

Glossary Additional Features

This lesson is a comprehensive look at ISO/IEC

This lesson will provide critical insight on the

Further detailed training would be required before performing assessments as a representative of an

About This Course

The course is divided into the following main topics:

1. The Assessment Process: Part 1

Main topics are divided into several sub-topics.

On completion of this course, users will be able to:

* Apply a risk-based approach to their laboratory's processes,

* Identify when a laboratory must have certain types of documentation,

* Discuss various means of implementing the requirements of the standard, and

How often must laboratories perform an internal audit?

Once per quarter

Once per year

Once per month

Whenever it schedules them

During the planning phase

During the initial business setup

During the board meetings

Which of the following is normally NOT included in audit assignment notifications?

Requirements to be audited against

People to interview / observe

Particular job files to review

Makeup of the audit team

___________ is a word stated in the standard that indicates a requirement.

Audit findings include all of the following EXCEPT FOR...

When must laboratories be ready to identify and address impartiality risks?

All the time

During Management Reviews

Ahead of accreditation assessments

Verbal promises of behavior

Signed codes of conduct

Terms and Conditions with clients

what laboratory performed the measurements

which measurement methods were used

what can be claimed in marketing literature

the measurement results from the testing/calibration

An internal auditor's role is to:

Issue technical opinions

Evaluation of calibration providers

Review of customer work requests

Maintaining personnel competence

Which of the following measures to control laboratory facilities is required to be implemented?

Access to areas affecting laboratory results

Procedures for personnel and lab safety

Air conditioning/heating systems

If measurement uncertainty is involved

If the conformity specification includes the rule

If the laboratory has a procedure for creating the rule

If the customer requested a statement of conformity

A team or technical auditor's primary focus should be ___________________.

reviewing training records of certain personnel

increasing profitability of the laboratory

to determine lab personnel competence in specific measurements

establishing traceability of the lab's standards and reagents

Issue statements of traceability on their reports

Use the calibration lab that has the lowest costs