Chapter 6: Resource Requirements

1.1 General:

The laboratory has the personnel, facilities, equipment, systems,

and support services necessary to carry out its activities.

1.2 Personnel:
1. All laboratory personnel who can have an influence on the
laboratory activities, also the internal or external personnel
perform their work with integrity and efficiency in accordance
with the laboratory management system.
2. The laboratory documents the competency requirements for
each business that influences its activity outcomes, including
education requirements, Qualification, training, technical
knowledge, skills, and experiences.
3. The laboratory ensures that the personnel have the competence
to carry out the laboratory activities for which they are
responsible and they appreciate the importance of deviation and
its consequences.
4. The laboratory management informs each employee of his
duties, responsibilities, and powers, based on the pre-defined
job structure.
5. The laboratory should have a procedure (s) and keep records of:
A. Determine Necessary Competence:
The organization decides what specific competencies are needed
for a person to perform his job effectively. To determine employee
requirements for a specific job, by asking the following

questions:
1. What areas of job-specific knowledge should a person in this
position understand well?
 2. What manual, mental, or interpersonal skills should an
employee possess to do the job well?
3. What natural abilities or talents would a person have to be
effective in this field?

A properly defined job description can help with guiding this process. The
description should at least give a basic understanding of what is required and
how the employee qualifies for the job. After you have collected the answer to
those questions, the hiring process and training and development plans can
be created. Also, the selection of the right person will be a lot easier when
these requirements are clearly defined.

A.1 Ensure Competence:

The requirements mandate that everyone who affects the KIT (i.e., everyone
in the organization) must be competent. by separating four different variables
relating to competence:

❖ Education.
❖ Training.
❖ Skills.
❖ Experience.

Of course, it is pretty much up to the organization what they define as

competent, but it should be in line with the job description. Also be cautious
for inconsistencies. When someone is hired that doesn’t really fit the profile,
make sure the appropriate training is giving.

A.2 Take Action to Achieve Competence:

Once competency has been determined for all personnel affecting product
conformity, the organization must compare individuals to its competency
needs and identify where gaps exist. Options for dealing with a gap between
actual performance and required performance include:

❖ On-the-job training.
❖ Coaching and counseling.
❖ Independent study (traditional, audio, video, and internet-based).
 A.3 Keep Evidence:

The organization stresses the need to keep records as evidence of

competence. This can be accomplished on one or multiple records. The fewer
odd records, the better - especially if the records are kept on paper.

Examples of evidence include:

1. Job descriptions/postings (evidence of determination of competency).

2. Employee resume and certifications (evidence that competency was
met).
3. Training attendance and agendas (evidence that competency was
met).
4. Test results, certifications, performance evaluations (evidence that
actions were effective).

B. Delegate employees:

C. Monitor (control) the efficiency of employees:

▪ maintain current and accurate records associated with the
evaluation and maintenance of competencies. Before
undertaking any accreditation activities, personnel shall be
evaluated to demonstrate that they possess the appropriate
knowledge and skills based on the established competence
criteria. The evaluation shall be conducted using a
combination of two or more of these methods: examinations
(oral or written), review of records (employment, training,
etc.), feedback (surveys, personal references, complaints,
peer review), interviews and observations (practical tests,
witnessing of activity, etc.).

▪ developed procedures for periodically monitoring the

performance of all categories of personnel involved in the
performing and managing accreditation activities.
 ▪ The Quality Manager is responsible for maintaining updated
records of competence for all personnel involved in the
management and performance of accreditation activities.

1.3 Facilities and environmental conditions

Environmental requirements for calibration laboratories:

All test equipment and reference standards used in calibration laboratories are
affected by environmental changes in temperature, relative humidity,
barometric pressure, vibration and several other environmental conditions. The
laboratory needs to monitor, control and record those environmental conditions
that influence the measurement results. There should be a continuous
monitoring system that records those environmental conditions at specified
time intervals. The monitoring and control must also extend to encompass the
storage and handling of equipment within the laboratory.

1. Temperature Stability
The stability of the temperature during the time it takes to make a
measurement is an important aspect for calibration laboratories, and limits
should be established and maintained.
2. Relative Humidity
Relative Humidity greater than 60% can lead to rust or corrosion effects in
certain instruments such as Gage Blocks, where below 20%, electrostatic
discharge issues can cause problems with electrical measurements or the
handling of sensitive electrical components. Most calibration laboratories
should maintain a Relative Humidity Environment of between 30% to 50%
Relative Humidity to achieve the best balance.
3. Vibration
Vibrations that are present in the laboratory should not compromise the
validity of the measurement results or affect the life of standards and
associated equipment. Specific standards such as analytical balances and
surface plates should be isolated from vibration as much as possible by using
isolated pads or special vibration tables. Those items should also be located
away from laboratory foot traffic.
 4. Barometric Pressure
The barometric pressure can influence some mass and force measurements.
Weather fluctuations make it difficult to control the barometric pressure in a
laboratory environment. Accurate barometric pressure measurements are
required to apply any necessary corrections to the measurement results.
5. Electromagnetic Interference
Some electronic measurement equipment, especially used for RF and high
resistance measurements, are susceptible to interference from electrical and
magnetic fields. Sufficient shielding precautions, use of proper cables and
filtering should be observed to keep the interference to a level that will not
impact the measurement results.
6. Air Cleanliness and Airflow
A positive air-pressure differential between the inside of the laboratory and the
outside areas is an important factor to reduce the influx of dust into the
calibration laboratory. Air cleanliness limits can be critical for some calibration
laboratories, especially within the medical field. Tack mats located within the
entryway can also assist in reducing particles entering the laboratory.

A. Laboratory Management:

1. Ensures laboratory facilities meet the required environmental conditions,

including any needed separation of work areas to ensure that analyses and
calibrations will not be adversely affected within resources provided;

2. Ensures laboratory storage areas provide proper storage of samples,

reagents, microbiological media, chemicals, select agents, standards and
reference materials, and radioactive wastes and hazardous waste;

3. Ensures any additional laboratory conditions needed for specialized

analyses are met, including structural, equipment needs and procedures for the
handling and analysis of extremely hazardous materials within resources
provided;

4. Ensures additional resources needed are identified and procured;

5. Ensures scheduled cleaning and maintenance service of the laboratory
facility is accomplished;

6. Ensures a pest control program is in place;

7. Ensures modifications are made to the laboratory to accommodate new

equipment, so the equipment does not interfere with the environmental controls
in the laboratory;

8. Implements environmental control programs in the laboratory;

9. Performs continual laboratory surveillance to ensure proper conditions are

being met, and Recognizes when environmental conditions are not met and
adversely affect test or calibration results.

B. Staff:

1. Plans and conducts laboratory operations in designated areas;

2. Monitors and records environmental conditions in their areas;

3. Identifies and implements any environmental controls needed to

complete sampling, analysis and calibration, and ensure these

factors do not adversely affect the quality of the work.

4. Practices good housekeeping practices, and

5. Practices proper handling and storage of hazardous waste, as

defined in the Hazardous Waste Plan, so as not to adversely affect

laboratory operations.
c. Environment

A. The laboratories are designed to provide space, engineering controls, and

proper environmental conditions for optimal sample storage, sample handling,
analysis, and calibrations, in accordance with general laboratory practices,
safety, and applicable Federal, State and local regulations.

B. Facilities consist of laboratories, office areas, storage rooms, and

special purpose areas. Laboratories are sectioned by testing compatibility and

design capabilities. Floors in the laboratories are constructed from a material
that is resistant to most chemical spills and easily disinfected. Floors are clean,
dry, and in sound condition so there are no tripping hazards.

6.4 (Equipment):

The purpose of this procedure is to describe the process of for handling,

transport, storage, use and planned maintenance of equipment in order to
ensure proper functioning, to prevent contamination or deterioration and to
maintain metrological traceability.

This procedure applies to all equipment of every type and class that are used
in the laboratory.

Users of this procedure are managers, supervisors and technicians working as

employers in the laboratory or other personnel associated with the laboratory.

6.4.1 General Equipment:

Equipment purchased by [KIT] is capable of achieving the measurement
accuracy and measurement uncertainty required to provide valid results.
Laboratory management ensures that all equipment complies with specified
requirements before being placed into service.
 List of devices and equipment:

the device Duration of Calibration

# Serial No. Device location Notes
name calibration port

1.4.2 Handling procedure:

To keep track of items received for testing or calibration, along with their results,
[KIT] uses a Laboratory Information Management System so that test or
calibration items are secure and do not deteriorate, become damaged, or have
a risk of loss or contamination during handling, and to ensure that handling does
not jeopardize the validity of results provided to the customer.

Handling of items received for testing procedure

Code:

Version:
Created by:

Approved by:

Date of version:

Signature:
 1.4.3 Test and Calibration Method Procedure:

The purpose of this procedure is to ensure that the correct test and calibration
methods are chosen to meet customer requirements; that those methods are
appropriate and the organization meets all of the requirements of ISO/IEC
17025:2017; and to ensure that when required, that verification and validation
are applied to tests and calibrations.

The Quality Manual, based on ISO 17025, is used to document the Lab
Quality Management System of an organization. In addition to describing the
organization’s structure, the manual states the general requirements of
impartiality and confidentiality and other specific requirements for structure,
resource, process and management.

[Link] CALIBRATION OF PRESSURE GAUGES, INSTRUMENTS

Inspection / calibration of pressure gauges is carried out with the equipment

developed and manufactured in L-plan.

Calibration methods and equipment satisfy the following requirements:

1. EA-10/17 EA Guidelines on the calibration of electromechanical

manometers, July 2002
2. DKD-R 6-1 Calibration of Pressure Gauges, 01/2003.
3. ISO / IEC 17025: 2005-General Requirements for the Competence of
Testing and Calibration Laboratories
4. Pressure gauges – Part 1: Bourdon tube pressure gauges –
Dimensions, metrology, Requirements and Testing
5. Pressure gauges – Part 3: Diaphragm and capsule pressure gauges –
Dimensions, metrology, Requirements and Testing.

[Link] Standard Thickness Gage Calibration

Purpose
The purpose of this procedure is to provide general instructions for the
calibration of standard thickness gages.

Scope
This general procedure shall be used in the absence of any specific
calibration procedure for standard thickness gages.
To eliminate or minimize the effects of certain error sources, coating thickness
meters may need to be calibrated for proper measurement.

As accuracy of an ultrasonic thickness gauge is highly related to the material

to be measured and the speed of sound in this material, the calibration report
must include the information regarding the reference material and the speed
of sound applied.

Calibration report and certificate requirements procedure

Code:
Version:
Created by:
Approved by:
Date of version:
Signature:

6.5 Metrological Traceability

Traceability of equipment to the same standard is a prerequisite for

comparability of test and calibration results. Ideally all measurements should
be traceable to International System of Units (SI). While this is typically possible
for physical measurements such as length (m) and weight (kg), this is more
difficult in chemical measurements.

Key points for traceability of calibrations:

• Sampling should follow a documented sampling plan and sampling procedure.

• The sampling plan should be based on statistical methods.

• The sampling procedure should describe the selection and withdrawal of

representative samples.

• The sampling location and procedure, the person who took the sample, and
any other relevant information about the sampling process should be recorded.
Chapter 7: Process requirements
 7.1 Review of requests, tenders and contracts:

The laboratory has a procedure for reviewing requests, bids and

contracts through a committee composed of the Quality
Department, the laboratory officer and the technician concerned.
However, this procedure takes into account the following:

▪ Study the bid, submit the quotation, and make contracts to

be submitted for signature by the administration.

▪ Requirements are defined, documented and understood.

▪ The laboratory has the capacity and resources to fulfill the

requirements.

▪ Appropriate methods or procedures are chosen and are

capable of meeting the client's requirements.

The laboratory ensures good communication with the client, making sure that
their needs are well met, but the client must also be informed if their methods
are inappropriate or outdated, or if their request cannot be completed because
it may jeopardize the safety of the laboratory.

1.2 Selection, Verification and Validation of Methods

1.2.1 Selection and verification of methods:

The laboratory uses methods and procedures appropriate to the activities and,
when necessary, to assess uncertainty as well as statistical methods for data
analysis. The laboratory ensures that the methods, procedures and supporting
documents are kept up to date and made available to all employees.

Based on ISO 17025: 2017, the lab is kept up-to-date with methods as
appropriate and when customers do not specify a method, the lab selects the
best and most recent valid version. The laboratory should communicate the
method they are using with the client.

The laboratory needs to keep verification records. Additionally, when style

development is required the development should be planned and assigned to
competent personnel. Periodic reviews of method development should be
undertaken.
 7.2.2 Selection and Validation of methods:

Method validation is the process used to confirm that the analytical procedure
employed for a specific test is suitable for its intended use. Results from method
validation can be used to judge the quality, reliability and consistency of
analytical results; it is an integral part of any good analytical practice. Analytical
methods need to be validated or revalidated.

laboratory shall use appropriate methods and procedures for all tests within its
scope.

Selection of methods

- methods must meet customer requirements.

– preference for standard methods (international/national standards).

– laboratory shall confirm that it can properly operate standard methods

before introducing the tests.

– laboratory-developed methods may be used if they are validated .

The laboratory retains the following records of validation:

❖ The validation of the procedure used.

❖ Specification of the requirements.
❖ Determination of the performance characteristics of the method.
❖ Results obtained.
❖ A statement on the validity of the method.
 7.3 Sampling Procedure

The purpose of this procedure is to describe the process of regular sampling of

a smaller set of materials or fractions selected under controlled conditions using
statistically valid methods.

Main points of sampling:

• Sampling should follow the sampling plan and documented sampling

procedures.

• The sampling plan should be based on statistical methods.

• Must describe the check and withdrawal sampling procedure from

representative samples.

• The location and procedure for sampling, the person taking the sample, and
any other information relevant to the sampling process must be recorded.

When sampling, the laboratory must maintain appropriate records of the

samples. These records should include, where applicable:

❖ References to the sampling method.

❖ Date and time of sampling.
❖ Data for identifying and describing the sample.
❖ Individuals performing the sample.
❖ Environmental conditions or transportation conditions.
❖ Charts or other equivalent means for determining the sampling site.
❖ Deviations and additions or exceptions to the sampling method and the
sampling plan.

7.4 Handling of test or calibration items

The laboratory carries out a procedure to transport, receive, handle, protect,

store, retain, dispose of or return test or calibration items. This includes all
provisions necessary to protect the integrity of the test item or calibration, and
to protect the integrity of the test or calibration item, and in the interest of the
laboratory and the customer, the laboratory takes precautions to avoid
deterioration, contamination, loss, or damage to the item during handling,
transportation, storage, preparation for testing or calibration.
Additionally, the laboratory:

1. Defines handling instructions.

2. It contains a system for unambiguous identification of test or calibration

items.

3. Make sure not to confuse the items.

4. Score any deviations.

The laboratory consults with clients if there is any doubt about the suitability
of an item for titration testing, or if the item does not conform to the
description provided. If requested by the client, the laboratory must include
a disclaimer in the report indicating results that may be affected by the
deviation.

7.5 Technical records

Ensure that the technical records of all laboratory activities contain the results,
report and information in order to facilitate and identify the components affecting
the measurement results and associated uncertainty in measurement, and to
enable the repetition of laboratory activities under conditions as close as
possible to the original. When you keep records, you must include the date and
identify the personnel responsible for laboratory activities. Records shall
include original notes, statements and accounts, and be recorded at the time of
their preparation. If changes are made, these modifications should be reverted
to previous versions or to the original notes. It maintains all files, including the
original and the modifications, including the date of change, amended aspects,
and the personnel responsible for any modifications.
 7.6 Evaluation of measurement uncertainty

It is important to understand where the uncertainty comes from. Therefore, the

laboratory identifies contributions to the uncertainties. By looking at all
important contributions, even those arising from sampling.

When performing a calibration, the laboratory evaluates its equipment for

uncertainty. When performing the test, the uncertainty has to be assessed. If
the test method excludes the accurate assessment of measurement
uncertainty, laboratories should make estimates of uncertainty based on an
understanding of theoretical principles or from practical experience.

7.7 Ensuring the validity of result

7.7.1 The laboratory should have a procedure for monitoring the validity of the
results. As an ISO / IEC 17025: 2017 certified tester, ensuring that the results
are correct should be a top priority. One of the goals of validity is the ability to
identify trends using statistical techniques. To fulfill the requirements, the
laboratory must develop a procedure to monitor the validity of its results. The
main goal is to understand if a system or process is ineffective so that you can
take preventive action. Aptitude Test is now more important than ever and it's
covered in 7.7.2.

The procedures required to monitor the validity of the results:

1. Use of reference materials or quality control materials.

2. The use of alternative devices that have been calibrated to obtain sequential
results.

3. Perform a functional check of the testing and measuring equipment.

4. Use of verification standards or work standards with quality control charts.

[Link] checks or titrations using the same or different methods.

6. Recheck or calibrate held materials.

7. Connect the results.

8. Review the results of the reports.

7.7.2 The laboratory should monitor its performance by comparing its results
with those of other laboratories, whenever available and appropriate.

This may be accomplished through:

a. Participate in technical aptitude tests.

b. Take part in cross-comparisons other than aptitude tests.

7.7.3 Data on monitoring activities should be analyzed and used to control and
improve laboratory activities whenever possible.

7.8 Reporting of results