White Paper

ISO/IEC 17025:2017
A Selection of Implementation Tools

Content

1. Introduction

2. Excerpts from ISO 17025:2017 Chapter 6 – Resource Requirements

2.1 Equipment Conformity

2.2 Status of Calibration

2.3 Activity Monitoring

2.4 Metrological Traceability

3. Excerpts from ISO 17025:2017 Chapter 7 – Process Requirements

3.1 Technical Records

3.2 Laboratory Information Management System Validation

3.3 Requirements of Laboratory Information Management System

4. Conclusion

5. References
 1. Introduction
White Paper ISO/IEC 17025:2017

Laboratories have to continuously provide high-quality services if they tend to be successful in the marketplace.
Using the ISO 17025 standard will assure quality improvement and consistency in an organization. ISO 17025 is
the only internationally accepted standard for laboratory quality systems that provides a globally accepted basis
for accreditation. The first version (ISO Guide 25) of this standard was published in 1999, by the International
Organization for Standardization (ISO). The second version was released in 2005, which is more aligned with the
ISO 9001:2000 standard regarding quality system words.

ISO 17025:2005 specifies the general requirements a laboratory has to meet if it is to be recognized as compe-
tent to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using
standardized methods, methods not covered by standardized methods, and laboratory-developed methods.

Developed jointly by ISO and IEC in the Committee on conformity assessment (CASCO), the 2017 version of
ISO/‌IEC 17025 will replace the 2005 version. The new version was published November 30 of 2017. Laborato-
ries already accredited to ISO/IEC 17025:2005 will need to transition their processes to the new version
within a three-year period, until November 30, 2020.

Over the years, ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Labora-
tories – has become the international reference for testing and calibration laboratories wanting to demonstrate
their capacity to deliver trusted results. However, the laboratory environment has changed dramatically since the
standard was last published, leading to the decision to revise the standard and integrate significant changes.
The revision was needed to cover all the technical changes, technical developments and developments in IT
techniques that the industry has seen since the last version.

With a stronger focus on information technologies, the standard now recognizes and incorporates the use of
computer systems, electronic records and the production of electronic results and reports. Modern-day labora-
tories work increasingly with information and communication technologies and hence a chapter on this topic was
developed.

In addition, the new version of the standard includes a chapter on risk-based thinking and describes the com-
monalities with the new version of ISO 9001:2015, Quality management systems – Requirements.

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 2. Excerpts from ISO 17025:2017 Chapter 6
– Resource Requirements

2.1 Equipment Conformity

ISO/IEC 17025:2017
Chapter 6.4 Equipment

6.4.4 The laboratory shall verify that equipment conforms to specified requirements before being
placed or returned into service.

6.4.5 The equipment used for measurement shall be capable of achieving the measurement accuracy
and/or measurement uncertainty required to provide a valid result.

MT Solution: Good Measuring Practices and GWP Recommendation

Good Measuring Practices by METTLER TOLEDO is a global program supporting you in laboratory and produc-
tion environments with quality assurance measures for weighing, titration, thermal analysis and pipetting, as
well as for determining density and the refractive index, pH and conductivity values, or melting and dropping/
softening point analysis.

The five steps of all Good Measuring Practices guidelines start with an evaluation of the measuring needs of your
processes and their associated risks. We also take into account regulatory requirements and norms relevant to
your industry. Good Measuring Practices provide straight forward recommendations for selecting, installing, cali-
brating and operating laboratory equipment and devices.

Good Weighing Practice (GWP) Recommendation

In testing labs, weighing is just one step in a whole process or analysis chain. However, weighing can strongly
influence the final result. A correctly selected, installed and validated balance is the foundation of any sample
preparation and subsequent analysis [1].

Standard 1: Metrological guidelines, such as OIML R76-1 and HB44, define the minimum requirements for an
approved weighing device. Considering that their purpose is just to set a legal framework to commercial trans-
actions, they lack the guidance you need for your specific process requirements.

Standard 2: Quality standards such as, ISO, GMP, GLP, USP, HACCP, GFSI based and others, require continuous
equipment monitoring. For example, ISO 9001 states: “Measuring equipment shall be calibrated or verified, or
both, at specified intervals…” Because of its generic scope, however, ISO does not give you any specific infor-
mation on its implementation.

Standard 3: GWP® documents that the weighing equipment fulfills the measurement accuracy requirements on
the basis of on-site calibration and measurement uncertainty determination. This closes the gap left open by
OIML/HB44. Furthermore, GWP® helps you determine the specific methods and frequency of the regular cali-
bration and verification tests required by the quality standards (ISO, GMP, GLP, etc.).

A GWP® certification provides an audit trail, proving that you comply with both external requirements and your
(often more demanding) internal quality management (e.g. six sigma and lean manufacturing). GWP® helps you
build exact metrological standards while ensuring that your resources are invested only in appropriate activities.

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 2.2 Status of Calibration
White Paper ISO/IEC 17025:2017

ISO/IEC 17025:2017
Chapter 6.4 Equipment

6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labelled,
coded or otherwise identified to allow the user of the equipment to readily identify the status of
calibration or period of validity.

MT Solution: Unique Serial Numbers

All balances, analytical instruments, weights, sensors and measuring relevant accessories possess a unique
serial number. All products with a unique serial number can be tracked and traced back to when they were pro-
duced and – where applicable – tested or calibrated.
METTLER TOLEDO supports and fulfills all points mentioned above. Specifically, to support correct weight hand-
ling, WeightLink™ is a weight verification system for balance testing, which provides safe identification and full
traceability of the test weights used. It consists of test weights, a data matrix code (DMC) scanner and balance
firmware to read the information [2].

MT Solution: StatusLight

The StatusLight on METTLER TOLEDO analytical instruments or balances indicates with a green light that it is
safe to start weighing or measuring. Warnings are shown in yellow, errors in red. The StatusLight is linked di-
rectly with key parameters in the analytical instrument or balance – instrument status, service status, calibration
status and more. The lab personnel has the confidence of knowing that all acquired weighing or analytical re-
sults meet pre-defined process requirements and hence also the relevant regulations.

Using the StatusLight will help regulated laboratories to ensure that weighing and measuring operations are
under control. Most importantly, it will help reduce analytical errors that could lead to out-of-specification, out-of-
trend or out-of-expectation (OOS, OOT or OOE) results. Using this function helps save time and effort by avoiding
laboratory investigations caused by improper procedures.

Besides StatusLight, METTLER TOLEDO developed the following tools and functions to monitor and communicate
the status of calibration or period of validity. They will not be described in detail in this paper:
• SmartStand for pipette asset management
• Intelligent Sensor Management (ISM) for electrochemical sensors
• Calibration reminder for various products
• PC software LabX (centralized reminder) for all products that connect to LabX
• Service reminder on instruments

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 2.3 Activity Monitoring

ISO/IEC 17025:2017

6.4.13 Records shall be retained for equipment which can influence laboratory activities.
The records shall include the following, where applicable:

a) the identity of equipment, including software and firmware version;

b) the manufacturer's name, type identification, and serial number or other unique
identification;
c) evidence of verification that equipment conforms with specified requirements;
d) the current location;
e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date
of the next calibration or the calibration interval;
f) documentation of reference materials, results, acceptance criteria, relevant dates and the
period of validity;
g) the maintenance plan and maintenance carried out to date, where relevant to the
performance of the equipment;
h) details of any damage, malfunction, modification to, or repair of, the equipment.

MT Solution: LabX and STARe Compliance Modules

The METTLER TOLEDO software systems LabX and STARe capture full traceability to the instrument, method, and
analyst performing the work and incorporate full user rights management. A complete log and audit trail of all
user and system actions are maintained. All measurement and related data is maintained securely in the LabX or
STARe database for immediate or subsequent reporting or for automatic transfer to other lab systems.

All parameters of ISO/IEC 17025:2017 chapter 6.4.13 are supported. The criteria of this chapter are met provided
the original data like acceptance criteria or current location are maintained by the end-user at all times. When
complete, data can be analyzed in LabX or STARe on a networked PC in the lab or office, printed to a network
printer, saved as .pdf, or sent to the LIS as .csv, XML or via a web services API [3].

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 2.4 Metrological Traceability
White Paper ISO/IEC 17025:2017

ISO/IEC 17025:2017
Chapter 6.5 Metrological Traceability

6.5.1 The laboratory shall establish and maintain metrological traceability of its measurement
results by means of a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty, linking them to an appropriate reference.
NOTE 1 In ISO/IEC Guide 99, metrological traceability is defined as the “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”.

6.5.2 The laboratory shall ensure that measurement results are traceable to the International System
of Units (SI) through:
a) calibration provided by a competent laboratory; or
NOTE 1 Laboratories fulfilling the requirements of this document are considered to be
competent.

b) certified values of certified reference materials provided by a competent producer with stated
metrological traceability to the SI; or
NOTE 2 Reference material producers fulfilling the requirements of ISO 17034 are considered
to be competent.

c) d irect realization of the SI units ensured by comparison, directly or indirectly, with national or
international standards.

MT Solution: Full Traceability to SI

Metrological traceability is a property of a measurement result. It is defined in the International Vocabulary of

Metrology (VIM) [4] as the “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”.

In practice, metrological traceability is realized by the following elements:

• An unbroken chain of calibrations that relate the result to an accepted standard, usually the SI definition
of a unit
• The measurement uncertainty is calculated in every step and propagated to the next link of the chain
• Calibrations and measurements are done according to accepted procedures and documented in each step
• The competence of all bodies involved in the chain
• The maintenance of traceability by an appropriate management of recalibration Intervals

Calibrations by accredited laboratories are usually accepted per se as being traceable as a consequence of
international agreements. The advantage of traceability is the universal intercomparability of measurement re-
sults. Two weighing results for the same object are consistent with regards to their uncertainties if they are each
produced on calibrated balances, independent of location, operator, and time. In the field of weighing, the
“reference” from the above definition of traceability is the kilogram as defined in the International System of Units
(SI system). The definition of the kilogram has been defined for a long time by the mass of the International
Prototype of the Kilogram (IPK) [5], but from 2018 onwards, it will be an accepted set of physical constants [6].

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 3 Excerpts from ISO 17025:2017 Chapter 7
– Process Requirements
3.1 Technical Records

ISO/IEC 17025:2017

7.5.1 The laboratory shall ensure that technical records for each laboratory activity contain the results,
report and sufficient information to facilitate, if possible, identification of factors affecting the
measurement result and its associated measurement uncertainty and enable the repetition of the
laboratory activity under conditions as close as possible to the original. The technical records
shall include the date and the identity of personnel responsible for each laboratory activity and
for checking data and results. Original observations, data and calculations shall be recorded at
the time they are made and shall be identifiable with the specific task.

MT Solution: Data Integrity Support with LabX and STARe

For tasks performed on instruments connected to LabX or STARe:

A complete set of all relevant data belonging to a specific laboratory activity (typically called a task) are stored in
a secure SQL database and (if required) filled into a report.
These data include:
• All results including raw data from the measurements
• Information on used instruments and other resources, including serial number and calibration information
• Used methods including version and release status
• Date and time at creation
• Responsible users for all activities (e.g. calibration, task execution, data and result check)

If the sequence of system steps or events is important in a process, is this enforced by the system?
Sample analysis is performed in the appropriate sequence as specified in verified user defined methods. A work-
flow can be associated with a defined instrument attached to the system (e.g. a balance with the appropriate
operational mass range for the method). The workflow ensures that the analysis is completed in the correct se-
quence. Workflows can be linked to e-mail so that other users can be informed about progress or alerted if there
are potential problems. SOPs can be incorporated and when a procedure is run, the steps of the procedure ap-
pear on the screen to ensure that the procedure is executed correctly. Further, the electronic signature of records
can be defined to occur in the required sequence.

Can the system generate accurate and complete copies of records in both human readable and electronic
form for inspection by the FDA?
All records are stored in a secure SQL database. Copies of electronic records can be produce by users with
the appropriate security access. Records can be printed or exported as PDF files. Files can be automatically
exported to a specific directory on a write-protected disk.

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 3.2 Laboratory Information Management System Validation
White Paper ISO/IEC 17025:2017

ISO/IEC 17025:2017

7.11.2 The laboratory information management system(s) used for the collection, processing,
recording, reporting, storage or retrieval of data shall be validated for functionality, including the
proper functioning of interfaces within the laboratory information management system(s) by the
laboratory before introduction. Whenever there are any changes, including laboratory software
configuration or modifications to commercial off-the-shelf software, they shall be authorized,
documented and validated before implementation.
NOTE 1 In this document “laboratory information management system(s)” includes the
management of data and information contained in both computerized and
non-computerized systems. Some of the requirements can be more applicable to
computerized systems than to non-computerized systems.
NOTE 2 Commercial off-the-shelf software in general use within its designed application range
can be considered to be sufficiently validated.

MT Solution: On-site System Validation

METTLER TOLEDO has developed the software applications under the ISO 9001 quality system. LabX and STARe
Validation Manuals are available that describe the development process used by METTLER TOLEDO. This covers
a description of the organization, the software development procedures and quality management of METTLER
TOLEDO. In addition, there are Instrument Qualification and Operational Qualification protocols available for both
systems. The installation checker utility can be run at any time to generate a report of the system configuration
e.g. software version, operating system, software patches, database version, and IP address [3].
It is the responsibility of the laboratory to comply with company standards, but the LabX and STARe systems can be lev-
eraged to reduce the validation effort. The METTLER TOLEDO service staff is trained to support on site system validation.

3.3 Requirements of Laboratory Information Management System

ISO/IEC 17025:2017

7.11.3 The laboratory information management system(s) shall:

a) be protected from unauthorized access;

b) be safeguarded against tampering and loss;
c) be operated in an environment that complies with provider or laboratory specifications or,
in the case of non-computerized systems, provides conditions which safeguard the accuracy
of manual recording and transcription;
d) be maintained in a manner that ensures the integrity of the data and information;

MT Solution: User Management with Individual Rights

Both software systems, LabX and STARe support the implementation of chapter 7.11.3. the following way:
• User management with individual rights for: view, create, edit, delete, release, export
• Secure login for each user
• Audit trail to document each modification including responsible user and date and time
• Electronic signatures

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 Are all electronic records included in system backups? Can data generated from earlier software versions
be retrieved from an archive and viewed in its entirety?
All LabX records (methods, sample data, results, audit trail, user configurations) are stored in a SQL database.
This database can be backed up or archived manually or scheduled. Archived or backed up databases can be
viewed in the same user interface as the active database, as well as reports printed from this data. When a new
version of the software is released an upgrade routine is run to enable data to be accessed with the new version.
It is recommended to align backup and archive procedures with internal company IT policies.

Are modifications and alterations clearly discernible by the system user and auditor?
All modified records are marked as such and any modifications to records are displayed on screen as well as
logged automatically in an audit trail with user name, date and time of changes, as well as the reason for what
was changed.
All methods are stored together with their complete history. Any previous version of a method can be viewed
and/or retrieved at any time.
A record of all human interaction with the system in combination with the system initiated events is listed both in
the audit trail and the task reports. This shows at every state ’who did what and when’.

4 Conclusion
This white paper explains implementation solutions for four sub-chapters in ISO/IEC 17025 chapter 6
– Resource Requirements –, and for three sub-chapters in chapter 7 – Process Requirements. The selected
laboratory approaches describe choosing the appropriate equipment, implementing dedicated software solutions
and applying supporting services. Provided all systems in use are correctly installed and continuously qualified,
and all methods applied follow stringent user management and are correctly validated, METTLER TOLEDO
significantly contributes to reaching and maintaining ISO/IEC 17025 certification.

Since the ISO/IEC 17025:2017 standard lies more focus on information technologies, secure data management
and safe solutions around electronic records and the production of electronic results and reports gain in
importance. This white paper presents all relevant METTLER TOLEDO software solutions that speed up reaching
an audit-proof implementation as well simplifies the maintenance of information and communication systems.

5. References
• [1] Fritsch, K. (2013) GWP - the science-based global standard for efficient lifecycle management of
weighing instruments. NCSLI Journal of Measurement Science, 8 (3), 60–69.
• [2] Mettler-Toledo (2015), whitepaper: Secure Traceability in Balance Testing with Verified Weight
Identification
• [3] Mettler-Toledo (2013), whitepaper: Full Compliance for 21 CFR part 11 and EU Annex 11
• [4] J CGM 200:2012 (2012) International Vocabulary of Metrology – Basic and General Concepts and
Associated Terms, 3rd edn, Bureau International des Poids et Mesures, Sèvres.
• [5] 9th SI brochure (2016) Draft, Bureau International des Poids et Mesures, Sèvres.
• [6] W iley online dictionary, whitepaper: Weighing
http://onlinelibrary.wiley.com/doi/10.1002/14356007.b05_027.pub2/abstract

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