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Tutorial - Implementing ISO 17025 in Laboratories complaint definition iso

The date of this authorization should be recorded. The associated tasks should not be  performed before the authorization date. Accommodation and Environmental Conditions

This chapter has been included to ensure that the calibration and test area environment will not adversely affect the measurement accuracy. It includes five sections with information that is mostly common sense. One clause recommends having effective separation between neighboring areas when the activities therein are incompatible. An example would be to separate laboratories that analyze extremely low traces of a solvent from those which consume large quantities of the same solvent for liquid-liquid extraction.

Key points are:

Environmental conditions should not adversely affect the required quality of tests. This means, for example, that equipment should operate within the manufacturer’s specifications for humidity and temperature. The laboratory should monitor, control, and record environmental conditions. Special attention should be paid to biologic sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound, and vibration. Tests should be stopped when the environmental conditions are outside specified ranges. Areas with incompatible activities should be separated. Access to test and calibration areas should be limited to authorized people. This can be achieved through pass cards.. Test and Calibration Methods and Method Validation

Accurate test and calibration results can only be obtained with appropriate methods that are validated for the intended use. This chapter deals with the selection and validation of laboratory-developed and standard methods and measurement uncertainty and control of data.

Key points for accurate test and calibration results:

Methods and procedures should be used within their scope. This means the scope should be clearly defined. The laboratory should have up-to-date instructions on the use of methods and equipment.   If standard methods are available for a specific sample test, the most recent edition should be used. Deviations from standard methods or from otherwise agreed-upon methods should be reported to the customer and their agreement obtained. When using standard methods, the laboratory should verify its competence to successfully run the standard method. This can be achieved through repeating one or two critical validation experiments, and/or through running method specific quality control and/or proficiency test samples. Standard methods should also be validated if they are partly or fully out of the scope of the test requirement. Methods as published in literature or developed by the laboratory can be used, but should be fully validated. Clients should be informed and agree to the selected method. Introduction of laboratory-developed methods should proceed according to a plan. The following parameters should be considered for validating in-house developed methods: limit of detection, limit of quantitation, accuracy, selectivity, linearity, repeatability and/or reproducibility, robustness, and linearity. Exact validation experiments should be relevant to samples and required information. Sometimes, standard and in-house validated methods need to be adjusted or changed to ensure continuing performance. For example, the pH of a HPLC mobile phase may have to be changed to achieve the required separation of chromatographic peaks. In this case, the influence of such changes should be documented, and if appropriate, a new validation should be carried out.  Validation includes specification of the requirements and scope, determination of the characteristics of the methods, appropriate testing to prove that the requirements can be fulfilled by using the method, and a statement on validity.

Key points for measurement uncertainty:

The laboratory should have a procedure to estimate the uncertainty of measurement for calibrations and testing. For uncertainty estimation the laboratory should identify all the components of uncertainty. Sources contributing to the uncertainty can include the reference materials used, the methods and equipment used for sampling and testing, environmental conditions and personnel.

Key points for control of data:

Calculations used for data evaluation should be checked. This is best done during software and computer system validation. As an example, spreadsheet formulas defined by a specific user should be verified with an independent device such as a handheld calculator. Data transfer accuracy should be checked. Accuracy of data transfer between computers can be automatically checked with MD5 hash sums.  Computer software used for instrument control, data acquisition, processing, reporting, data transfer, archiving, and retrieval developed by or for a specific user should be validated. The suitability of the complete computer system for the intended use should also be validated. Any modification or configuration of a commercial computer system should be validated. Examples include defining report layouts, setting up IP addresses of network devices, and selecting parameters from a drop-down menu.  Electronic data should be protected to ensure integrity and confidentiality of electronic records. For example, computers and electronic media should be maintained under environmental and operating conditions to ensure integrity of data. Equipment Equipment that is performing well and properly maintained is a prerequisite for the ongoing accuracy of test and calibration results. This chapter deals with the capacity and quality of equipment. The whole idea is to make sure that the instrument is suitable for performing selected tests/calibrations and is well characterized, calibrated, and maintained.

Key points are:

Equipment should conform to specifications relevant to the tests. This means that equipment specifications should first be defined so that when conforming to defined specifications the equipment is suitable to perform the tests. Equipment and its software should be identified and documented. Equipment should be calibrated and/or checked to establish that it meets the laboratory’s specification requirements. Records of equipment and its software should be maintained and updated if necessary. This includes version numbers of firmware and software. It also includes calibration and test protocols. Calibration status should be indicated on the instrument along with the last and the next calibration dates.. Measurement 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:

Calibration of equipment should be traceable to the SI units. Traceability of laboratory standards to SI may be achieved through an unbroken link of calibration comparisons between the laboratory standard, secondary standard, and primary or national standard. If traceability to SI units is not possible, the laboratory should use other appropriate traceability standards. These include the use of certified reference material and the use of consensus standards or methods. Sampling

This chapter has been added to describe how to ensure that statistically relevant representative samples are taken and that all information on the sample and the sampling procedure is recorded and documented.

Key points for sampling:

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. Handling Test and Calibration Items This chapter describes how to ensure that sample integrity is maintained during transport, storage, and retention and that samples are disposed of safely.

Key points for handling test and calibration items are:

Test and calibration items should be uniquely identified. Sample transportation, receipt, handling, protection, storage, retention, and/or disposal should follow documented procedures. The procedures should prevent sample deterioration and cross-contamination during storage and transport. Assuring the Quality of Test and Calibration Results

This chapter describes how to ensure the quality of results on an ongoing basis through, for example, regular analysis of quality control samples or participation of proficiency-testing programs.

Key points are:

The validity of test results should be monitored on an ongoing basis. The type and frequency of tests should be planned, justified, documented, and reviewed. Quality control checks can include the regular use of certified reference materials, replicating tests or calibrations using the same or different methods, and retesting or recalibration of retained items. Reporting of Results

This chapter describes how test/calibration results should be reported. This is important for an easy comparison of tests performed in different laboratories. The chapter has some general requirements on test reports such as clarity and accuracy, but it also has very detailed requirements on the contents..

Test reports and calibration certificates should include:

The name and address of the laboratory.  Unique identification of the test report or calibration certificate (such as the serial number). The name and address of the client. Identification of the method. A description and identification of the item(s) tested or calibrated. Reference to the sampling plan and procedures used by the laboratory. The test or calibration results with the units of measurement. The name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate.  A statement on estimated uncertainty of measurement (for test reports ‘where applicable’).   When opinions and interpretations are included, documentation of the basis for the opinions and interpretations. Opinions and interpretations clearly marked as such on the test report or calibration certificate

Procedures to Implement Technical Requirements

The Labcompliance ISO 17025 Accreditation Package comes with a full set of procedures to easily implement technical requirements. To learn more about the package, click here

5. Recommendations for Implementation

Now that you have an overview of required management and technical controls, we will give recommendations on how to efficiently comply with some key requirements. The scope of this primer does not go into all the details and we cannot cover all requirements.

We will focus on topics that most likely are new to laboratories without a quality system. These include: specific organizational structure, formal equipment calibration and testing, measurement traceability and uncertainty. We try to balance the lack of detailed information by providing references to official guidelines, textbooks, and other literature. For example, EURACHEM/CITAC, EUROLAB and ILAC have developed guidance documents for measurement uncertainty and traceability in measurement (3-9). ISO has published a “Guide to the Expression of Uncertainty in Measurement” (10). A EURACHEM-UK working group has developed guidance for qualification of analytical instruments that was published in “Accreditation and Quality Assurance” (11). EUROLAB has published a technical report called “Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025:2005” (12). Huber has authored a textbook “Validation and qualification in Analytical Laboratories” and Thompson et al. gave recommendations for an “International Harmonized Protocol for Proficiency Testing of Chemical Analytical Laboratories” (14).

Help is also readily available from accreditation bodies. For example, A2LA has a “Policy on Measurement Traceability” (15) and LabCompliance provides a complete “ISO/IEC Accreditation Package” with a sample master plan, SOPs, forms, and checklists (2).  

Organizational Structure

ISO/IEC requires that organizational arrangements should be such that departments with conflicting interests do not adversely influence compliance with the standard. For example, finance and QA should operate independently from laboratory activities. Figure 2 gives an example of how this could be accomplished. Finance and QA do not report to laboratory management but rather to the director of the company.

Figure 2: Example for Organizational Structure (from Reference 2)


Each laboratory should have a plan for how to ensure adequate equipment function and performance before and during sample measurement. The main activities are calibration and checking to verify specified performance and maintenance. The extent of testing depends on the complexity and use of the equipment. Each laboratory should have processes for how calibration and testing is performed for different types of equipment.

Preferably the whole range of equipment should be divided into a few categories such as A, B, and C, and calibration and/or verification tests should be associated with each category. Instruments in the simplest category (A) such as stirrers and mixers usually don’t need to be tested but only visually inspected. Category B instruments such as balances and pH meters should be calibrated according to manufacturer SOPs, and more complex instruments such as chromatography systems should be fully tested according to their intended use.

The following paragraphs contain recommendations for how to specify, test, and maintain analytical equipment for ISO/IEC 17025 compliance.

Documenting Specifications

ISO/IEC 17025 requires that equipment and software should comply with specifications that are relevant to the tests. Therefore, the first step in the process is to define and document the equipment specifications.

For simple equipment, such as balances and pH meters, the use of manufacturer specifications is recommended. For more complex equipment hardware, such as gas chromatographs or mass spectrometers, the manufacturer’s specifications can also be used. This is only recommended as long as all vendor-specified functions are required by the intended applications over the fully specified range. As an alternative, the user can define specifications according to the intended use of the instrument. Commercial software and computer systems typically provide more functionality than required by a specific user. Therefore, for computer systems, the user should define specifications according to the system use. A functional specifications list will help define user specifications. Selecting a Vendor A documented procedure and well-defined criteria should be used for selecting equipment suppliers. Useful criteria include:

Vendor’s equipment meets the user’s requirement specifications.

Vendor has leading position in the marketplace.

Equipment and software design, development, and manufacturing takes place in a quality system environment such as ISO 9001.

Vendor provides installation, familiarization, and training services.

Metrology-based calibration and functional testing services are performed through qualified engineers.

Vendor provides phone and onsite support in local language.

Installation and Documentation Installation can be performed by the vendor or by the user. Steps include:

Verify that the location meets the environmental specifications as defined by the vendor.

Install equipment hardware according to vendor specifications.

Install software and start-up according to vendor specifications.

Create documentation of hardware and software, such as vendor, product number, model number, serial number, and location.

Initial Testing for Calibration and/ or Performance Verification Equipment used for measurement should be tested before initial use to ensure acceptable performance. This is performed through calibration such as the mass of a balance, or through verification of specified performance characteristics such as the sampling precision of a gas chromatograph.

Steps for testing include:

Develop test procedures and test protocols.

Define acceptance criteria based on documented specifications.

Select and order traceable test tools, such as reference weights for calibration of a balance.

Make sure that test engineers have the appropriate qualifications to perform the tests.

Perform the tests and document test results.

Verify that acceptance criteria are met.

Label the equipment with the status, as well as the dates of last and next calibrations.

Maintain records of calibration and checks.

These tests can be performed by the vendor or by the user. Advantages of testing by the vendor can be demonstrated using the Agilent Functional Verification Service (FVS) for gas and high-performance liquid chromatography. This service was specifically developed to meet ISO/IEC 17025 requirements:

Agilent has decades of knowledge and experience with factory and field-testing of equipment. As a result, the test selection and sequence is optimized for the highest speed and lowest instrument downtime, without comprising accuracy or calibration specifications.

Agilent engineers bring along calibrated test tools that meet traceability requirements.

Agilent engineers also bring certificates to document qualification.

Agilent tests are combined with recommended preventive maintenance for all the critical functional components of the equipment.

Agilent provides global lab-to-lab consistency via standardized and well-recognized maintenance and verification testing protocols.

Agilent’s calibration and test certificates are globally recognized by internal auditors and official assessors.

Testing During Ongoing Use

Equipment characteristics and performance can change over time. Therefore, equipment quality programs should ensure that equipment is routinely tested on an ongoing basis.

The type and frequency of such tests depends on the equipment. For example, on a daily basis, balances can be checked with laboratory reference weights, and chromatographs can be checked using well-defined quality control samples.

In addition to the more frequent tests that only challenge a subset of all specifications, annual repetition of all initial tests is recommended to repeat all the initial tests as described above, for example, for chromatographs, once a year. A balance is also typically calibrated once a year by the vendor with calibrated and traceable standard weights.

Maintenance and Repair

The laboratory should have a maintenance plan to carry out preventive maintenance  activities and a procedure for unplanned repair to ensure ongoing performance and reliability.

Defective equipment should not be used for tests and calibration. Smaller devices should be taken out of the laboratory and bigger instruments should be clearly labeled as being defective. Specified functioning and performance should be verified after repair. Records of maintenance and repairs should be maintained. Software and Computer Systems

ISO/IEC 17025 requires computer systems and software used for acquisition, processing, recording, reporting, storage and retrieval of test and calibration data be validated when the software is developed, configured, or customized by the user.

EUROLAB has developed a technical report with recommendations for “Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025:2005” (12). This report provides advice on validation steps for different software and system risk categories, as well as recommendations for how to ensure the security, availability, integrity, and confidentiality of electronic records.

The report divides software into five categories as listed in Figure 3 and described below::

Operating systems Firmware as built into automated equipment Standard software packages such as word processors and non-configurable computerized analytical systems Configured software packages such as Excel formulas and configurable computerized analytical systems Custom built softwa bzogjlec. outlet moncler milanore

Figure 3: Validation Activities for Software Categories (Simplified).

Measurement Traceability

ISO/IEC 17025 requires reference material used for calibration of measurement equipment to be traceable to SI Units, where possible. Typically, laboratories use their own internal reference material for calibration. Traceability of such material to SI units can be achieved through an unbroken chain of comparisons between laboratory reference material and SI units. An example is shown in Figure 4.

Figure 4: Traceability Chain of Laboratory Reference Material

Working standards are regularly compared with secondary standards by an accredited laboratory  These secondary standards are calibrated by a national metrology institute or an accredited reference laboratory. For this kind of comparison, the measurement uncertainty should be known and documented in calibration certificates so that the measurement uncertainty of the working standard can be estimated and reported.

This concept works well for physical measurement such as meter (m) for length, kilogram (kg) for mass, and Kelvin (K) for temperature. For this reason, reference balance masses, thermometers and thermocouples should be traceable to SI Units through an unbroken chain of comparisons performed by accredited laboratories and national metrology institutes..

For most reference material used for chemical measurements, traceability to SI units is very difficult and not practical. The traceability chain in Figure 4 ends at the lower level, at suppliers of standard reference material (NIST, for example), at suppliers of certified reference material, or at a company’s accredited metrology laboratory. When traceability to SI is not possible, ISO/IEC 17025 recommends the use of well-characterized certified reference material that is provided by a competent supplier. Alternative well-defined methods (also called primary or definitive methods) agreed upon by all parties can also be used to establish traceability. This topic has been discussed in different working groups. Detailed recommendations have been published by ILAC (7) and EURACHEM/CITAC (8).

X.R. Pan (17) suggested a classification scheme of reference material used for chemical measurements. The classification as described on the following page is well accepted in chemical laboratories.

Primary Reference Material

Also called primary standards. Developed by a national metrology laboratory. Certified by primary/consensus method. Traced back to SI units and/or verified by international comparison

Certified Reference Material

Also called secondary standards.   Derived from primary reference material with statement of uncertainty. Usually prepared by a specialized reference laboratory.  Certified by reference methods or comparison methods.   Recognized by national or otherwise specialized authoritative organization.

Working Reference Material

Also called internal reference material. Derived from certified reference material. Accuracy verified by well characterized and validated methods.

Measurement Uncertainty There is uncertainty associated with every test and calibration. For testing, this is due to errors arising at the various stages of sampling, sample preparation, measurement,  and data evaluation. In other words, whenever any quantitative measurement is performed, the value obtained is only an approximation of the true value. Users of the measurement data should have an idea of how much the reported result may deviate from the true value. ISO/IEC 17025 recommends reporting the results of quantitative measurement both as a single value and with the possible deviation from the true value. This is logical for any report with quantitative results. It is, for example, of no use if a report on a food sample states 0.1 percent of compound X, and the user of the data is still unsure whether this could be 0.05 or 0.4 percent due to the level of uncertainty.

An uncertainty statement provides the user with information on the approximate measurement tolerances and the expected limits within which the true value of the measurement, such as analyte concentration, is supposed to lie. Without documenting the uncertainty, although the analyst can estimate the level of uncertainty, the client or user of the data cannot.

Information on uncertainty is of particular importance if a specification limit is to be verified and reported. For example, if a purchasing agreement specifies that a product can only be released if compound X is below 0.5 percent, the test report may not contain a statement about compliance if the measurement results range including the measurement uncertainty is above 0.5 percent.

When parameters are claimed to be within a specified tolerance, the measurement values range, including the estimated uncertainty of measurement, shall fall within the specification limit.

ISO has published a “Guide to the Expression of Uncertainty in Measurement” (10). It establishes general rules for evaluating and expressing uncertainty in measurement across a broad spectrum of measurements.

EURACHEM has produced an excellent document containing great detail about how the concepts of the ISO guide can be applied in chemical measurement (4). The whole process of measurement uncertainty is schematically shown in Figure 5. The basic ideas are explained in this primer, but for more detailed information, readers are encouraged to study the EURACHEM document (4).

The concept of evaluating uncertainty is fairly straightforward. It requires a detailed knowledge of the nature of the items being measured and of the measurement method, rather than an in-depth understanding of statistics.

Figure 5: Estimating Measurement Uncertainty

Develop the specifications by writing a clear statement of exactly what is to be measured and the relationship between this and the parameters on which it depends. For example, if the measurement temperature has an influence on the result, the measurement temperature should also be defined. Develop a workflow diagram for the entire, sample collection, sample preparation, calibration, measurement, data evaluation, and data transcription process (see Figure 1 for analytical sample testing). Identify and list sources of uncertainty for each part of the process or for each parameter. Possible sources for errors may be derived from non-representative sampling, operator bias, a wrongly calibrated instrument, lack of ideal measurement conditions, chemicals with impurities, and errors in data evaluation. Estimate and document the size of each uncertainty, for example, as standard deviations or as RSDs. The data should be gathered from a series of measurements. Where experimental evaluation is impossible or impractical, the individual contributions should be estimated from whatever sources are available. Sources for this kind of estimation can be found in the supplier’s information or in the results of inter-laboratory studies or proficiency testing.
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(For the business server line from Hewlett-Packard, see HP 9000 .)

ISO 9000 is a series of standards, developed and published by the International Organization for Standardization ( ISO ), that define, establish, and maintain an effective quality assurance system for manufacturing and service industries. The ISO 9000 standard is the most widely known and has perhaps had the most impact of the 13,000 standards published by the ISO. It serves many different industries and organizations as a guide to quality products, service, and management.

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An organization can be ISO 9000-certified if it successfully follows the ISO 9000 standards for its industry. In order to be certified, the organization must submit to an examination by an outside assessor. The assessor interviews staff members to ensure that they understand their part in complying with the ISO 9000 standard, and the assessor examines the organization's paperwork to ensure ISO 9000 compliance. The assessor then prepares a detailed report that describes the parts of the standard the organization missed. The organization then agrees to correct any problems within a specific time frame. When all problems are corrected, the organization can then be certified. Today, there are approximately 350,000 ISO 9000-certified organizations in over 150 countries.

The Technical Committee (TC) behind ISO 9000 is TC 176.

This was last updated in September 2005 Continue Reading About ISO 9000 provides more information and a directory of accreditation bodies, auditors, and consultants. Grossi Business Systems explains ISO 9000. Related Terms Data Center Infrastructure Efficiency (DCiE) Data Center Infrastructure Efficiency (DCiE) is a metric used to determine the energy efficiency of a data center. The metric, ... See complete definition IBM System z Application Assist Processor (zAAP) The IBM System z Application Assist Processor (zAAP) is a specialty engine that provides a performance environment for Web-based ... See complete definition legacy application A legacy application (legacy app) is a software program that is outdated or obsolete. See complete definition Dig Deeper on IBM system z and mainframe systems All News Get Started Evaluate Manage Problem Solve IBM to debut z Systems mainframe with beefed-up security IBM Machine Learning for z/OS deepens mainframe data analysis Manage and optimize IBM z Systems software costs Mainframe tools for better monitoring, capacity planning and more Load More IBM to debut z Systems mainframe with beefed-up security Mainframe programmers can be young, cool and relevant Mainframe applications may not be as secure as you think IBM delivers Linux mainframes to the open source world Load More Curiosity didn't kill the mainframe systems programmer What can I do to gain Java skills and leave mainframe programming? Learn mainframe SIMD instructions for the IBM z13's processor Five COBOL interview questions to land a new job Load More Mainframe tools for better monitoring, capacity planning and more The CICS mainframe program leans toward cloud, DevOps with TS 5.3 Simplify mainframe storage management with IBM SMFLIMxx Three types of mainframe monitoring tools to track performance Load More IBM Machine Learning for z/OS deepens mainframe data analysis Manage and optimize IBM z Systems software costs Mainframe capacity planning takes on unpredictable workloads Thread safety isn't the only way to boost mainframe performance Load More Optimize mainframe processor performance with vertical polarization Mainframe capacity planning takes on unpredictable workloads Thread safety isn't the only way to boost mainframe performance Address common problems in mainframe testing concepts Load More PRO+ Content Find more PRO+ content and other member only offers, here.


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