ISO/IEC 17025

What is ISO/IEC 17025?

2010-07-10T07:40:00.001-07:00

Laboratory Testing and Analysis Control

2008-06-24T10:51:00.000-07:00

Control measures are necessary to identify sources of measurement error within the laboratory and to estimate their bias and variability (repeatability and reproducibility).

The following control measures could be implemented in the laboratory:
- function checks performed by the technician to check the validity of the sample and performance of the equipment
- control checks performed during the anlaysis or testing process. These checks are used to:
a. determine the performance of the analytical or testing system
b. quantitate the variability of results from the analysis or test in terms of precisison and accuracy.
The frequency of checks will be determined by ruggedness, precision, accuracy of the method, dependability of the technician, precision and sensitivity of the instrument, difficulty and time length of the test method.

The data from the check analyses or tests will be compared with that from the analyses or tests and tested for significant differences. Any significant differences will be reported to the Lab Director. The Quality Manager will prepare a regular report showing the percent of significantly different check analyses that occurred during that period and recommend corrective action.

Control charts should be set up and used to record results from selected function and control checks to determine when or if the testing or analytical process is out of control and to record the results of corrective action taken.

Function checks should be performed to verify the stability and validity of the sample and the performance of testing and analytical equipment. The testing or analytical technician will be provided with written performance specifications for each function check, accompanied by recommended action if the specifications are not met. Function checks are measurement specific.

Control checks should be performed during the analytical or testing process. These checks are made on all analyses or tests and intermittently after a specified number of procedures have been completed. Some control checks may be required as part of the routine analysis or test, and are performed by the analyst to determine the performance of the system. These control checks include the use of sample blanks to observe zero concentration drift, introduction of spiked samples to determine percentage of sample recovery during intermediate extraction steps, and processing of sample aliquots to observe within and between run variability for the entire analysis. Other control checks are performed by the analyst intermittently to quantitate analysis variability in terms of precision and accuracy. Control samples normally used for this purpose are sample aliquots to determine precision and standard reference materials to determine accuracy in addition to precision.

Results from selected function checks and control samples will be recorded on control charts to track events showing that the system is out of control; to indicate what part of the system is the source of the error; to provide an indication of the results of any corrective action taken. The QC Technician is responsible for the establishment and monitoring of any control charts needed for lab performance control.

Sampling - 5.7

2008-06-05T11:19:00.000-07:00

Sampling is integral to the measurement process and should be an important consideration in meeting the needs of the end user of the results. Sampling quality has not traditionally been thought to be part of measurement quality, but it is a key aspect. In fact, sampling frequently is a major contributor to measurement uncertainty. If sampling is not considered, the values of uncertainty estimates will often seriously underestimate the real uncertainty of the system.

Laboratories often do not sample materials outside of the lab. However, labs are still responsible for subsampling and homogenizing the sample to ensure that a representative test portion is used for analysis. If the samples are not collected correctly and subsampled properly, data obtained will not be indicative of the true concentration no matter how well the lab performs.

Labs sometimes assume that the samples they receive are homogenous and do not require a specific method to subsample the material to be tested. However, this assumption can result in problems. The lab shall have documented procedures for subsampling and/or homogenization to ensure that a representative test portion is used for analysis. Appropriate considerations should be made for multiphase and lable samples, aseptic handling, cross-contamination, and other issues to reduce the known errors associated with sample heterogeneity. Validation procedures should include all the steps normally undertaken within the lab., including any subsampling of test samples.

Purchasing - 4.6.1

2008-02-07T07:46:00.000-08:00

ISO/IEC 17025 requires that the laboratory has a policy and procedure for purchasing services and supplies that affect the quality of the tests.

Required Procedures - purchasing, receiving, and storing reagents and consumable materials must be available, so that the laboratory can clearly define requirements for the supplier. The laboratory must evaluate suppliers, and once reliability has been established, the lab can accept reports from the supplier. Purchasing documents are to be reviewed and approved for technical content prior to release. Procedures must also verify suitability of materials upon receipt. This verification may require more than one suitability test. In addition, storage and disposal procedures must exist.

Required Records - records prove that proper procedures for purchase and use of consumable materials were followed. Records provide processing history for the product as prepared solutions must be traceable to the original manufacturer's lot number. Records of the lab's evaluation and approval of suppliers must be established prior to purchase. Records include proper log into the system, as well as tests performed to establish suitability for use. Multiple records might be required for preparation of a consumable material.

Procedures for purchasing according to the ISO 17025 standard can be found at:

http://www.e-shoq.com/wst_page4.html

Measuring a block using a vernier caliper

2007-07-12T13:46:00.000-07:00

A good way to document your procedures is to make them into videos.

Implementing Continuing Improvement in the Lab

2007-06-20T10:43:00.000-07:00

Step 1 - define the need to improve:
Scenario - an audit and management review found that turnaround times from sample receipt through lab analysis to final reporting had increased over time but still met the quality objective of 10 business days. However, in several instances, customers had requested results in 7 business days. The reduction of turnaround times to 7 days and subsequent increase in productivity was identified to be made as a result of the management review process. Thus far the lab has determined current performance, established a need to improve, made a commitment, and defined the objective.
The next step is employing the lab staff to document the current process by using a flow diagram of the sample process and measuring the time between each step to determine the cause of the lab's current performance. In this instance, the lab discovered the bottlenecks were manual sample log-in and manual sample reporting with transcription errors in the data transfer process causing repeat work and delays.

Step 2 - find the solution:

Step 3 - implement the plan:

Step 4 - monitor the performance:

Nulab Quality Control

2007-05-03T08:55:00.000-07:00

Nulab is an FDA Registered laboratory that manufactures vitamins, minerals, antoxidants and other products with some proven health benefit. Quality Control is at the center of our manufacturing processes. We make products in the form of capsules, tablets, powders, liquids, single dosage paclets. effervescent wafers and chewing gum. (more)

Artillery manufacturing quality!?

2007-02-01T09:12:00.000-08:00

You can be the judge of this video and the importance of quality management in an artillery production facility.

No comment!

Communications in the laboratory

2006-12-19T11:36:00.000-08:00

Effective laboratory management is characterized by an efficient communication system that works top down and bottom up within the organization. Management makes sure that all concerned are aware of management system policies, objectives, plans and procedures, while seeking out and encouraging timely reports on program/project progress, improvement, and problems.

Methods for carrying out such communication activities include:
- in-house educational programs related to the quality management system
- management visits to the laboratory and associated work areas
- planned, periodic section meetings to discuss mutual problems, achievements, and customer concerns
- periodic publication of an in-house newsletter which includes articles related to laboratory performance
- use of timely and appropriate notices and posters on the laboratory bulletin board
- perform periodic employee opinion polls to elicit suggestions for improvement, bring to light problems that might otherwise go unnoticed, and uncover areas of customer dissatisfaction

Quality Manual - Table of Contents

2006-11-04T11:31:00.000-08:00

TABLE OF CONTENTS

Introduction
1.0 Scope
2.0 References
3.0 Terms and Definitions
4.0 Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
4.5 Subcontracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Customer
4.8 Complaints
4.9 Control of Nonconforming Testing and/or Calibration Work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews
5.0 Technical Requirements
5.1 Technical Requirements - General
5.2 Personnel
5.3 Accommodations and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling and Transportation of Test and/or Calibration Items
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results

Internal audits

2006-10-19T09:03:00.000-07:00

Internal audits are a critical requirement of ISO 17025:2005. The purpose of an internal audit for a lab is to verify that its operations continue to comply with the requirements of the management system. Section 4.14 of ISO 17025 specifies that internal audits are conducted “in accordance with a predetermined schedule and procedures” and “carried out by trained and qualified personnel.” No further information is provided by the standard on how to achieve an effective internal audit. Therefore, it is up to the lab to determine the procedure that best fits its needs.

Predetermined Schedule and Procedure

ISO 17025 does not specify the procedure to be used for a lab audit. However, other documents provide more specific guidance. APLAC provides a technical document on internal audits that can be found at www.aplac.org and is quite helpful. The important steps of an audit are planning, investigation, analysis, reporting, corrective action, and follow-up to determine the effectiveness of the corrective action. The investigation process involves gathering objective evidence by asking questions, observing activities, and examining facilities and records. The quality manager is responsible for planning and organizing audits.

The schedule for audits is determined by the lab. ISO 17025 suggests that an internal audit be completed within a year, but the suggestion is only a note. Notes are recommendations, rather than requirements. In fact it may make more sense for a lab to divide the audit into sections that can be periodically conducted throughout the year. Management may request an audit in addition to scheduled audits.

Trained and Qualified Personnel

Personnel must have sufficient technical knowledge of the operations that they are auditing and be trained in auditing techniques. Because a lab’s internal auditor is responsible for examining various aspects associated with equipment, the performance of tests/calibrations, and the issuing of results, it is required that the training and qualifications of the internal auditor be identified, documented, and evaluated. As a result, section 5.2 of ISO 17025 (e.g., formulation of goals, policy and procedure for identifying training needs, evaluation of the effectiveness of training administered, etc.) is applicable to the person designated as a lab’s internal auditor. Labs are expected to maintain records to demonstrate compliance with sections 5.2.1-5.2.5 as related to their internal auditor. The lab determines what training the internal auditor must have to perform a proper audit.

In addition, personnel are to be “independent of the activity to be audited,” but only “whenever resources permit.” If there is no alternative and it is not possible to have the audit conducted by independent personnel, then it must be demonstrated that an effective audit has been conducted. However, labs greatly benefit from a review by a trained individual independent of the testing performed. Thus, smaller labs choose to hire a consultant to conduct these audits.

Audit Findings

All audit findings must be recorded and prepared promptly so that the report is submitted to the facility as soon as possible. Nonconformities identified during an audit must be noted and the appropriate corrective action and the time frame for corrective action agreed upon with the lab. The auditor must check the effectiveness of corrective action as soon as possible after the agreed-upon time frame. Internal audit findings are an important part of the discussion at management review meetings.

Conclusion

ISO 17025 requires internal audits to verify that lab operations continue to comply with the requirements of the management system. It is up to the lab to put procedures in place to ensure an effective internal audit. These procedures result in an audit report that is an important tool for the lab and upper management to ensure that the lab complies with the management system.

Terms, Definitions, and References

2006-09-27T08:07:00.000-07:00

Definitions:

1. Accuracy: The closeness of agreement between the measured value and the accepted, “true,” or reference value. Accuracy is indicative of the bias of the measurement process. Accuracy is often evaluated by repetitively spiking the matrix or placebo with known levels of analyte standards at or near target values. The fraction or percentage of added analyte recovered from a blank matrix is often used as the index of accuracy. Added analyte, however, may not always reflect the condition of the natural analyte in the materials submitted for analysis. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E).

Accuracy: Closeness of agreement between a measured quantity value and a true quantity value of the measurand. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.13 without notes)

2. Audit: A systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled (ISO 9000:2000 3.9.1 without notes)

3. Bias: Systematic measurement error or its estimate, with respect to a reference quantity value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.19)

4. Certified reference culture: Microbiological; a reference culture certified by technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body; e.g., cultures used for verifying test systems, validation of methods; quality control of test media must be traceable to a type culture collection.

5. Certified reference material: A reference material, accompanied by documentation issued by an authoritative body and referring to valid procedures used to obtain a specified property value with uncertainty and traceability. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.14 without notes)

Certified reference material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body (ISO Guide 30:1992 2.2), e.g., NIST infant milk standards with established levels of vitamins.

6. Customer: Organization or person that receives a product. Example: Consumer, client, end-user, retailer, beneficiary and purchaser.

Notes:

A supplier can be internal or external to the organization.
(ISO 9000:2000 3.3.5)

7. Conformity assessment: Demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled.(ISO/IEC 17000:2004 2.1 without notes)

8. Controlled document: A document that is subjected to controls to ensure that the same version of the document and any revisions are held by or available to all personnel to whom the document is applicable.

9. Corrective action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.

Notes:

There can be more than one cause for a nonconformity.
Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
There is a distinction between correction and corrective action.
(ISO 9000:2000 3.6.5)

10. Correction: Action taken to eliminate a detected nonconformity.

Notes:

A correction can be made in conjunction with a corrective action.
A correction can be, for example, rework or regrade.
(ISO 9000:2000 3.6.6)

Correction: Modification applied to a measured quantity value, to compensate for a known systemantic effect (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.53 without notes)

11. Document: Information and its supporting medium. Examples: Record, specification, procedure document, drawing, report, standard.

Notes:

The medium can be paper, magnetic, electronic or optical computer disk, photograph or master sample, or a combination thereof.
A set of documents, for example specifications and records, is frequently called “documentation.”
Some requirements (e.g., the requirement to be readable) relate to all types of documents; however, there can be different requirements for specifications (e.g., the requirement to be revision controlled) and records (e.g., the requirement to be retrievable)
(ISO 9000:2000 3.7.2)

12. Empirical method: A method that determines a value that can only be arrived at in terms of the method per se and serves by definition as the only method for establishing the accepted value of the item measured.

13. Inspection: Examination of a product design, product, process or installation and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements.

Notes:

Inspection of a process may include inspection of persons, facilities, technology and methodology.
(ISO/IEC 17000:2004 4.3)

14. Intermediate precision: The precision of an analytical procedure expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).

Intermediate precision: Measurement precision under a ser of conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.24 without notes)

15. Internal audit: A formal review of the performance of a quality system conducted by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.

16. Laboratory: Body that calibrates and/or tests.

17. Laboratory control sample: See Quality control sample.

18. Limit of detection (LOD): The LOD is the smallest quantity of analyte that can be shown to be significantly greater than the measurement (random) error of the blank at a prescribed level of confidence (usually 95%). It is often taken as the blank value (or background) plus 3 times the standard deviation. When the LOD is calculated, it should be stated what definition and method are used. More rigorous definitions require consideration of false positives as well as false negatives. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

Limit of detection: Measured quantity value, obtained by a given measurement procedure, for which the probability of obtaining a false negative value is ß, given a probability of a false positive value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.19 without notes)

19. Limit of quantitation (LOQ): The LOQ is the smallest amount of analyte in a test sample that can be quantitatively determined with suitable precision and accuracy under previously established method conditions. The LOQ is a crucial parameter in assays of low levels of compounds and in the determination of impurities, contaminants, or degradation products. It is often taken as the blank value (or background) plus 10 times the standard deviation. When the LOQ is calculated, it should be stated what definition and method are used. A multiple, e.g., 2, 3, or 5, of LOQ is often used to establish a level of fortification in residue recovery studies.

The validation of LOD and LOQ is not required when the analyte is within the useful range of the assay. They are important in the determination of low levels of residues and contaminants for exposure estimates required in risk assessments and for surveys of low levels of analytes. Because LOD and LOQ are determined at the lowest useful ranges of the methods, which tend to be regions of poor accuracy and precision, they can be expected to vary considerably. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

20. Linearity: The ability of an analytical method to elicit test results that are directly, or by a well defined mathematical transformation, proportional to the concentration of analyte in samples within a given range (USP NF)

21. Measurement uncertainty: Parameter characterizing the dispersion of the quantity values being attributed to a measurand (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.27 without notes)

22. Non-conformity: The non-fulfillment of a requirement (ISO 9000:2000 3.6.2).

23. Pharmaceutical testing laboratory: Laboratory that performs tests on finished pharmaceutical products, ingredients, raw materials, in-process samples, and associated environmental samples.

24. Precision: It is a general term for the variability among repeated tests under specified conditions. Two types of precision, repeatability and reproducibility, have been found necessary and, for many practical cases, sufficient for describing the variability of a test method (1). Precision expresses the closeness of agreement (degree of scatter) among a series of measurements obtained from multiple testing of a homogeneous test sample under the method’s established conditions. It should be investigated with homogeneous test samples, representative of the matrixes to which the method will be applied and containing the expected range of analyte concentrations within these matrixes. If it is not possible to obtain homogeneous test samples, however, precision may be investigated using test samples artificially prepared in the laboratory to simulate the original test samples. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

Precision: Closeness of agreement between indications obtained by replicate measurements on the same or similar objects under stated specified conditions. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.16 without notes)

25. Proficiency testing: Proficiency testing is a program external to the laboratory that compares the analytical performance of a group of laboratories. Such external validation gives the laboratory and client assurance that the work performed in the laboratory is at least comparable to the analytical results produced by other laboratories. If formulated, homogeneous matrixes are used, and the program also provides information on the bias of individual laboratories. In proficiency testing, laboratories are not restricted as to what method will be used. Therefore, it does not provide information on method performance unless such information is specifically requested. In very large proficiency programs, sufficient information may often be provided so that conclusions may be reached regarding method performance as well as analyst and laboratory performance. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

26. Proficiency test sample: Test material with microorganisms or chemical analytes that is tested periodically by a number of locations to determine the proficiency of recovery, using statistical analysis where appropriate.

27. Preventive action: Action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation.

Notes:

There can be more than one cause for a potential nonconformity.
Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.
(ISO9000:2000 3.6.4)

28. Quality assurance (QA): Part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000:2000 3.2.11).

29. Quality control (QC): Part of quality management focused on fulfilling quality requirements (ISO 9000:2000 3.2.10).

30. Quality control sample: A test portion sample with known contents of analytes to carry through the method to verify performance.

31. Quality management system: Management system to direct and control an organization with regard to quality (ISO 9000:2000 3.2.3).

32. Quality manual: A document specifying the quality management system of an organization (ISO 9000:2000 3.7.4 without notes).

Conmment:

The quality manual may cite other documentation relating to the laboratory’s quality arrangements.
33. Range: The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).

Comments:

For quantitative analysis, the working range for a method is determined by examining samples with different analyte concentrations and determining the concentration range for which acceptable uncertainty and precision can be achieved. The working range is generally more extensive than the linear range, which is determined by the analysis of a number of samples of varying analyte concentrations and calculating the regression from the results, usually using the method of least squares. The relationship of analyte response to concentration does not have to be perfectly linear for a method to be effective.” To demonstrate acceptable linearity, five different standards (plus a blank) that at a minimum encompass the anticipated analyte range plus modest upper and lower extensions are usually sufficient. Once the linear range has been established, two or three standards (plus a blank) are sufficient to define the day-to-day calibration line. More measurement standards will be required where linearity is poor. In qualitative analysis, it is commonplace to examine replicate samples and standards over a range of concentrations to establish at what concentration a reliable cut-off point can be drawn between detection and non-detection.
34. Reference culture (RC): A culture with characteristics sufficiently well established to be used to calibrate/verify test systems, and test media and to validate methods, e.g., cultures used for verifying test systems, and validation of methods; in addition to the use of “wild strains,” quality control of test media shall also be traceable to a type culture collection.

Comment:

For some analyses, such as screening tests for high consequence pathogens, Reference Cultures are not available to the testing laboratory. In this case, a culture with suitable properties should be used as a reference. The required properties of this culture should be characterized by repeat testing, preferably by more than one laboratory.
35. Reference material: A material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials (ISO Guide 30:1992 2.1 amended), e.g., USP Reference Material.

36. Reference standard: A measurement standard, designated for the calibration of working measurement standards for quantities of a given kind in a given organization or at a given location. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.6).

Comment:

Generally, this refers to recognized national or international traceable standards such as National Institute of Standards and Technology (NIST) thermometers and weights.
37. Repeatability (of results of measurements): Closeness of the agreement between the results of successive measurements of the same measurand carried out subject to all of the following conditions:

same measurement procedure
same observer
same measuring instrument, used under the same conditions
same location
repetition over a short period of time
(ISO Guide 30: 1992 A7)

Repeatability: Measurement precision under the set of repeatability conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.22)

38. Replicate tests: An analysis of a laboratory sample, Certified Reference Material, or Reference Material can be performed more than once; the result of each individual analysis is a replicate test result. The replication can occur at any step in the procedure from laboratory sample, to test sample, to test portion, to test solution, to aliquot.

Comment:

An analytical method final result can be the average of more than one interim value.
39. Reproducibility (of results of measurements) : Closeness of the agreement between the results of measurements of the same measurand, where the measurements are carried out under changed conditions such as:

principle or method measurement
observer
measuring instrument
location
conditions of use
time
(ISO Guide 30:1992 A.8)

Reproducibility: Measurement precision under reproducibility conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.26 without notes)

40. Requirement: Need or expectation that is stated, generally implied or obligatory. (ISO 9000:2000 3.1.2 without notes)

Requirement: Provision that conveys criteria to be fulfilled (ISO Guide 2:2004 7.5)

41. Review: Activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.

Note:

Review can also include the determination of efficiency. Example: Management review, design, and development review; review of customer requirements; and nonconformity review (ISO 9000:2000 3.8.7).
42. Robustness: A measure of an analytical method capacity to remain unaffected by deliberate variations in method parameters. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).

43. Ruggedness: The ruggedness of an analytical procedure is its ability to tolerate small variations in procedural conditions, which may include variation in volumes, temperatures, concentrations, pH, and instrument settings, without affecting the analytical result. It provides an indication of the applicability of the method in a variety of laboratory conditions. Ruggedness is not a quantitative parameter. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

44. Sample: Any material brought into the laboratory for analysis.

45. Sample handling: The manipulation to which samples are subjected during the sampling process, from the selection from the original material through the disposal of all samples and test portions.

46. Sample preparation: This describes the procedures followed to select the test portion from the sample (or subsample) and includes in-laboratory processing, mixing, reducing, coring and quartering, riffling, and milling and grinding.

47. Sampling: Provision of a sample of the object of conformity assessment, according to a procedure. (ISO/IEC 17000:2004 4.1)

Comments:

This is a procedure whereby a part of a substance, material or product is taken to be used for testing or calibration as a representative sample of the whole. In some cases, such as forensic analysis, the sample may not be representative but is determined by availability.
Sampling procedures should describe the selection, sampling plan, withdrawal, and preparation of a sample. The resulting sample represents a larger quantity such as a lot or batch and as such, in a statistical sense, is a portion where the potential exists for a sampling error due to the heterogeneity of the parent population.
The laboratory staff is often not involved in the sampling process, but analysts may be consulted concerning proper sample size or the use of appropriate preservatives, and they may be asked to provide suitably prepared containers. ISO 17025 requires that, where relevant, a statement to the effect that the results relate only to the items tested shall be made.

48. Segregate: To set apart; can represent setting apart by space and time. An example would be the separation (segregation) of samples and standards to avoid cross-contamination.

49. Selectivity: Refers to the extent to which the [analytical] method can determine particular analyte(s) in a complex mixture without interference from the other components in the mixture. A method that is [perfectly] selective for an analyte or a group of analytes is said to be specific. The applicability of the method should be studied using various samples, ranging from pure measurement standards to mixtures with complex matrices. In each case, the recovery of the analyte(s) of interest should be determined and the influences of suspected interferences duly stated. Any restrictions in the applicability of the technique should be documented in the method. The analytical community is moving towards the use of the word specificity.

50. Sensitivity: Describes the change in instrument response for a given concentration change. It is represented by the slope of the calibration curve and can be determined by a least squares procedure, or experimentally, using samples containing various concentrations of the analyte.

51. Specificity: The ability of a method to respond exclusively to the target analyte and not to any degradant, impurity, or other component of the matrix. Very few methods are absolutely specific, so the term “selectivity” is often used for this property. This parameter shows that the method can be used to quantitate the analyte without interference. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

Specificity: Ability to assess unequivocally the analyte in the presence of components which may be expected to be present. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).

52. System Suitability: An important concept designated as “systems suitability” has evolved in chromatographic and instrumental analyses to permit use of columns and instruments that may differ somewhat from each other and from the initial specifications. The desired output is defined in terms of such properties as the relative standard deviation of repeated injections of a standard solution, peak shape or symmetry, resolution from an internal standard or associated analyte, ratio of peak height to peak width at a specified fractional peak height, peak-to-noise ratio, sensitivity (signal intensity per unit concentration), and similar properties. Column and solvent composition or instrument settings may be adjusted to obtain acceptable output within predetermined parameters. In such cases, the system suitability specifications and the settings used to attain the desired output must be documented. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

System suitability tests: These tests are based on the “holistic” concept that the aggregate equipment assembly shall demonstrate performance characteristics to show that it is suitable for its intended use.

Comment:

For chromatographic procedures this may involve measures of precision of replicate injections, column efficiency, peak tailing, etc.

53. Test: A technical operation that consists of the determination of one or more characteristics or the performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.

Comment:

The result of a test is normally recorded in a document sometimes called a test report or a test certificate.
Testing: Determiantion of one or more characteristics of an object of conformity assessment, according to a procedure. (ISO 17000:2004 4.2)

54. Testing laboratory: Laboratory that performs tests.

55. Test method: Specified technical procedure for performing a test.

56. Test portion: The actual material weighed or measured for the analysis.

57. Traceability Chain: Sequence of measurement standards and calibrations that is used to relate a measurement result to a stated metrological reference. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.42 without notes).

Traceability: Ability to trace the history, application or location of that which is under consideration. (ISO 9000:2000 3.5.4)

58. Trueness: The closeness of agreement between the average of an infinite number of replicate measured quantity values and a reference quantity value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.15 without notes)

Comments:

The measure of trueness is usually expressed in terms of bias.
Trueness has been referred to as “accuracy of the mean.” This usage is not recommended

59. Uncertainty: See Measurement uncertainty.

60. Validated method: The planned and documented procedure to establish the method’s performance characteristics. The performance characteristics or the validation parameters of the method determine the suitability for its intended use. They define what the method can do under optimized conditions of matrix solution, analyte isolation, instrumental settings, and other experimental features. The inclusion of particular validation parameters in a validation protocol depends on the application, the test samples, the goal of the method, and domestic or international guidelines or regulations, as applicable. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)

Comments:

Validation of a method establishes, by systematic laboratory studies that the method is fit-for-purpose, i.e., its performance characteristics are capable of producing results in line with the needs of the analytical problem. The important performance characteristics include: Selectivity and specificity (Description of the measurand), Measurement range, Calibration and traceability, Bias linearity, Limit of detection/limit of quantitation, Ruggedness, Precision. The above characteristics are interrelated, many of these contribute to the overall measurement uncertainty and the data generated may be used to evaluate the measurement uncertainty. The extent of validation must be clearly stated in the documented method so that users can assess the suitability of the method for their particular needs.
Examples of validated method can be obtained from specific organizations such as AOAC INTERNATIONAL.
61. Verification: Provision of objective evidence that a given item fulfills specified requirements, taking any measurement uncertainty into consideration.( ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.44 without notes)

Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled (ISO 9000:2000 3.8.4 without notes).

Comment:

In connection with the management of measuring equipment, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation, or specification peculiar to the management of the measuring equipment. The result of verification leads to a decision either to restore in service, perform adjustments, or repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed shall be kept on the measuring instrument’s individual record.
Terms and Definitions Bibliography

1.- ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition. (To be published)

2.-Conformity assessment –Vocabulary and general principles. ISO/IEC 170000:2004.

3.-Quality management systems –Fundamentals and vocabulary. ISO 9000:2000

4.-Terms and definitions used in connection with reference materials. ISO Guide 30:1992

5.-Standardization and related activities –General vocabulary. ISO Guide 2:2004

6.-Unates States Pharmacopoeia and National Formulary (USP/NF)

7.-International Committee of Harmonization (ICH): Validation of Analytical Procedures: Text and Methodology, Q2R.

8.-Official methods of Analysis of AOAC International 18th Edition, Appendix E

Reference:
AOAC INTERNATIONAL Quality Assurance Principles for Analytical Labs 3rd Ed, available for purchase from www.aoac.org

Brown, M.R.W., & Gilbert, P. (1995) Microbiological Quality Assurance, A Guide Towards Relevance and Reproducibility of Inocula, CRC Press, Boca Raton, FL

Eurachem: http://www.eurachem.ul.pt/

Eurachem Guide: Traceability in Chemical Measurement (2003)

Eurachem Guide: The Selection and use of Reference Materials (2002)

Eurachem Guide: Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002)

Eurachem Guide: Accreditation for Microbiological Laboratories (2002)

Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories (2000)

Eurachem Guide: Quantifying Uncertainty in Analytical Measurement, 2nd Edition (2000)

Eurachem Guide: The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics (1998)

Eurachem Guide: Harmonised Guidelines for the Use of Recovery Information in Analytical Measurements (1998)

Eurachem Guide: Quality Assurance for Research and Development and Non-routine Analysis (1998)

Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing

ICH: http://www.ich.org/cache/compo/276-254-1.html

International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use ICH Harmonised Tripartite Guideline VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)

ISO: http://www.iso.org/iso/en/ISOOnline.frontpage

ISO/IEC Guide 2:2004 Standardization and related activities –General Vocabulary

ISO/IEC 17025:2005, General Requirements for the Competence of Calibration and Testing Laboratories

ISO/IEC Guide 30: 1992, Terms and Definitions Used in Connection with Reference Materials

ISO 9000: 2000, Quality Management and Quality Assurance—Vocabulary

ISO 9001:2000, Quality management systems – Requirements

ISO 9004:2000, Quality management systems -- Guidelines for performance improvements

ISO/TR 10013:2001, Guidelines for quality management system documentation

ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing

ISO 10012:2003, Measurement management systems -- Requirements for measurement processes and measuring equipment

ISO/DGuide 99999, International vocabulary of basic and general terms in metrology (VIM) -- Third edition

USP United States Pharmacopeia

USP: http://www.usp.org/

EP European Pharmacopoeia

EP: http://www.pheur.org/site/page_628.php

CITAC: http://www.citac.cc/

Eurachem/CITAC Guide 2003 Traceability in Chemical Measurements. A guide to achieving comparable measurement results

LGC/VAM: VAM Guides can be downloaded from the VAM website http://www.vam.org.uk A user login is required but there is no charge.

LGC/VAM/2003/016, New Eurachem/CITAC guidance on traceability of chemical measurements: A paradigm for practical traceability

LGC/VVAM, Meeting the Traceability Requirements of ISO 17025, An Analyst's Guide 2nd Edition, November 2003

References on Sampling

Enell, J.W. (1984) J. Qual. Technol. 16, 168–171

Feder, P.I. (1975) J. Qual. Technol. 7, 53–58

Garfield, F.A. (1989) J. Assoc. Off. Anal. Chem. 72, 405–411

Horwitz, W. (1976) J. Assoc. Off. Anal. Chem. 59, 1197–1203

Horwitz, W. (1990) Pure Appl. Chem. 62, 1193–1208

ISO 7002:1986, Agricultural food products -- Layout for a standard method of sampling from a lot

ISO 8213:1986, Chemical products for industrial use -- Sampling techniques -- Solid chemical products in the form of particles varying from powders to coarse lumps

ISO 6206:1979, Chemical products for industrial use -- Sampling -- Vocabulary

ISO 2859-1:1999, Ed. 2 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 2859-2:1985, Ed. 1 Sampling procedures for inspection by attributes -- Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection

ISO 2859-3:2005, Ed. 2 Sampling procedures for inspection by attributes -- Part 3: Skip-lot sampling procedures

ISO 2859-4:2002, Ed. 2 Sampling procedures for inspection by attributes -- Part 4: Procedures for assessment of declared quality levels

ISO 2859-5:2005, Ed. 1 Sampling procedures for inspection by attributes -- Part 5: System of sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 2859-10:2006, Ed. 1 Sampling procedures for inspection by attributes -- Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes

ISO 3951-1:2005, Ed. 1 Sampling procedures for inspection by variables -- Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL (available in English only)

ISO 3951-2:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics (available in English only)

ISO 3951-5:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 5: Sequential sampling plans indexed by acceptance quality limit (AQL) for inspection by variables (known standard deviation) (available in English only)

Kratochvil, B., & Taylor, J.K. (1981) Anal. Chem. 53, 924A–938A

Kratochvil, B., Wallace, D., & Taylor, J.K. (1984) Anal. Chem. 56, 113R–129R

Smith, R., & James, G.V. (1981) The Sampling of Bulk Materials, The Royal Society of Chemistry (Analytical Sciences Monographs No. 8), London, UK

ILAC: http://www.ilac.org/

ILAC-G3:1994 Guidelines for Training Courses for Assessors

ILAC-G8:1996 Guidelines on Assessment and Reporting of Compliance with Specification

ILAC-G9:2005 Guidelines for the Selection and Use of Reference Materials

ILAC-G10:1996 Harmonised Procedures for Surveillance & Reassessment of Accredited Laboratories

ILAC-G11:07/2006 Guidelines on Assessor Qualification and Competence of Assessors and Technical Experts

ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers

ILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 1702

ILAC-G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing

ILAC-G20:2002 Guidelines on Grading of Non-Conformities

ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing

Additional Web Sites:

European Co-operation for Accreditation: http://www.european-accreditation.org/default_flash.htm

Standards Council of Canada: http://www.scc.ca/

A2LA: http://www.a2la.org

AIHA: http://www.aiha.org

ANSI: http://www.ansi.org

IAAC: http://www.iaac.org.mx (Inter-American Accreditation Cooperation)

4.11 Corrective Action

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4.11.3 Selection and implementation of corrective action

Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.

Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.

Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.

In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.

The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.

4.11 Corrective Action

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4.11 Corrective Action

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4.11.2 Cause analysis
Procedures for corrective action must start with root cause analysis.

Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include customer requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.

Root cause analysis (RCA) is a process designed for use in investigating and categorizing the root causes of events with safety, health, environmental, quality, reliability and production impacts. The term “event” is used to generically identify occurrences that produce or have the potential to produce these types of consequences. Simply stated, RCA is a tool designed to help identify not only what and how an event occurred, but also why it happened. Only when investigators
are able to determine why an event or failure occurred will they be able to specify workable corrective measures that prevent future events of the type observed.
Understanding why an event occurred is the key to developing effective recommendations. Imagine an occurrence during which an operator is instructed to close valve A; instead, the operator closes valve B. The typical investigation
would probably conclude operator error was the cause. This is an accurate description of what happened and how it happened. However, if the analysts
stop here, they have not probed deeply enough to understand the reasons for the mistake. Therefore, they do not know what to do to prevent
it from occurring again. In the case of the operator who turned the wrong valve, we are likely to see recommendations such as retrain the operator on the procedure,
remind all operators to be alert when manipulating valves or emphasize to all personnel
that careful attention to the job should be maintained at all times. Such recommendations do little to prevent future occurrences. Generally, mistakes do not just happen but can be traced to some well-defined causes. In the case of the valve error, we might ask, “Was the procedure confusing? Were the valves clearly labeled?
Was the operator familiar with this particular task?” The answers to these and other questions will help determine why the error took place and what the organization can do to prevent recurrence. In the case of the valve error, example recommendations might include revising the procedure or performing procedure validation to ensure references to valves match the valve labels found in the field. Identifying root causes is the key to preventing similar recurrences. An added benefit of an effective
RCA is that, over time, the root causes identified across the population of occurrences can be used to target major opportunities for improvement. If, for example, a significant number of analyses point to procurement inadequacies, then resources can be focused on improvement of this management system. Trending of root causes allows development of systematic improvements and assessment of the impact of corrective programs.

Although there is substantial debate on the definition of root cause, we use the following:
1. Root causes are specific underlying causes.
2. Root causes are those that can reasonably be identified.
3. Root causes are those management has control to fix.
4. Root causes are those for which effective recommendations for preventing recurrences can be generated.

Root causes are underlying causes. The investigator’s goal should be to identify specific underlying causes. The more specific the investigator can be about why an event occurred, the easier it will be to arrive at recommendations that will prevent
recurrence. Root causes are those that can reasonably be identified. Occurrence investigations must be cost beneficial. It is not practical to keep valuable manpower
occupied indefinitely searching for the root causes of occurrences. Structured RCA helps analysts get the most out of the time they have invested in the investigation.
Root causes are those over which management has control. Analysts should avoid using general cause classifications such as operator error, equipment failure or external factor. Such causes are not specific enough to allow management to make effective changes. Management needs to know exactly why a failure occurred before action can be
taken to prevent recurrence. We must also identify a root cause that management
can influence. Identifying “severe weather” as the root cause of parts not being delivered on time to customers is not appropriate. Severe weather is not controlled by management.

Root causes are those for which effective recommendations can be generated. Recommendations should directly address the root causes identified during the investigation. If the analysts arrive at vague recommendations such as, “Improve adherence to written policies and procedures,” then they probably have not found a basic and specific enough cause and need to expend more effort in the analysis process.

Four Major Steps
The RCA is a four-step process involving the following:
1. Data collection.
2. Causal factor charting.

3. Root cause identification.
4. Recommendation generation and implementation.

Step one—data collection. The first step in the analysis is to gather data. Without complete information and an understanding of the event, the causal factors and root causes associated with the event cannot be identified. The majority of time spent analyzing an event is spent in gathering data. Step two—Causal factor charting. Causal factor charting provides a structure for investigators to organize
and analyze the information gathered during the investigation and identify gaps and deficiencies in knowledge as the investigation progresses. The causal factor chart is simply a sequence diagram with logic tests that describes the events leading up
to an occurrence, plus the conditions surrounding these events.

Preparation of the causal factor chart should begin as soon as investigators start to collect information about the occurrence. They begin with a skeleton chart that is modified as more relevant facts are uncovered. The causal factor chart should
drive the data collection process by identifying data needs. Data collection continues until the investigators are satisfied with the thoroughness of the chart
(and hence are satisfied with the thoroughness of the investigation). When the entire occurrence has been charted out, the investigators are in a good position to identify the major contributors to the incident, called causal factors. Causal factors are those contributors (human errors and component failures) that, if eliminated, would have either prevented the occurrence or reduced its severity.
In many traditional analyses, the most visible causal factor is given all the attention. Rarely, however, is there just one causal factor; events are usually
the result of a combination of contributors. When only one obvious causal factor is addressed, the list of recommendations will likely not be complete.
Consequently, the occurrence may repeat itself because the organization did not learn all that it could from the event. Step three—root cause identification. After all the causal factors have been identified, the investigators begin root cause identification. This step involves the use of a decision diagram called the
Root Cause Map to identify the underlying reason or reasons for each causal factor.
The map structures the reasoning process of the investigators by helping them answer questions about why particular causal factors exist or occurred. The identification of root causes helps the investigator determine the reasons the event occurred so the problems surrounding the occurrence can be addressed. Step four—recommendation generation and implementation. The next step is the generation of recommendations. Following identification of the root causes for a particular causal factor, achievable recommendations for preventing its recurrence are then generated. The root cause analyst is often not responsible for the implementation of recommendations generated by the analysis. However, if the recommendations
are not implemented, the effort expended in performing the analysis is wasted. In addition, the events that triggered the analysis should be expected to recur. Organizations need to ensure that recommendations are tracked to completion.

4.11 Corrective action

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The lab must have a procedure for implementing corrective action when nonconforming work or departures from policies and procedures in the quality management system or technical operations have been identified. The procedure requires that appropriate authority be designated for the implementation of corrective actions. The procedure includes cause analysis, selection and implementation of corrective action, and monitoring of actions.

Interpretation:
This section deals with correcting a problem that has been evaluated to be either potentially repetitive or that there is a doubt on the procedures. The investigation is a root cause analysis that will ultimately root out all the potential causes of the problem allowing the lab the ability to evaluate different solutions and select the best one to implement to prevent recurrence. The correction of 4.9.1 (c) is the correction of the immediate problem, where the corrective action of 4.11 and the ensuing root cause analysis extends beyond the immediate problem corrected and considers related systems and processes.

4.10 Improvement

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The laboratory continually improves the effectiveness of its management system through the use of the:
- quality policy
- quality objectives
- audit results
- analysis of data
- corrective actions
- and management review

Interpretation:
This element was added to the 2005 revision of ISO 17025. The addition of this element was squeezed between "Control of nonconforming testing and calibration work" and "Corrective Action". The reason why it was included in the revision was to bring ISO 17025 in line with ISO 9001:2000.

A helpful resource on continual improvement is as follows:

4.9 Control of nonconforming testing and/or calibration work

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4.9.2
Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 must be be promptly followed.

Section 4.11 covers the new requirements for Corrective Actions.

4.9 Control of nonconforming testing and/or calibration work

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It is clear that the work of the laboratory is the production of test data. Therefore, nonconforming work is test data that, for some reason, does not meet specifications. Test data may not meet specifications for a variety of reasons, including:
- discovery of defective test equipment
- errors in testing technique
- improper storage of test item
- improper test item preparation; and
- faulty environmental conditions during testing.

When it is discovered that nonconforming work exists, the lab must follow its established procedures to ensure that the deviation is evaluated for significance, and that the customer is notified where necessary. It may also be necessary to halt further work in that area until the problem is eliminated.

4.9 Control of nonconforming testing and/or calibration work

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4.9.1 (c)
The term "corrective action" in this clause actually means "remedial action" and does not mean the same as the "corrective action" in Section 4.11. Apparently this term in this clause was inadvertently not corrected by the ISO/IEC 17025 drafting committee. The final draft standard that was submitted for voting had the term remedial action in the clause.

4.9 Control of nonconforming testing and/or calibration work

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4.9.1 The lab must have a policy and procedure implemented for any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or requirements that have been specified by the customer.

The policy and procedure ensures:
- responsibilities and authorities for managing nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates) are defined and taken when nonconforming work is determined
- that an assessment of the significance of the nonconforming work is completed
- correction is immediate and any decision about the acceptability of the nonconforming work
- customers are notified when work is recalled
- that the resumption of work is explained

Identification of nonconforming work or management system problems or testing / calibration problems could be found at any stage within the management or technical operation. For example, through customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits.

4.9 Control of nonconforming testing and/or calibration work

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This section covers remedial action while section 4.11 covers corrective action.
Use the example of a balance past the calibration due date. The following would be the results of section 4.9 control of nonconforming testing and/or calibration work:
- stop using the balance
- check other balances to determine calibration status
- calibrated any balances past due
- review results of calibration: balances within calibration requires no recall on work while calibrations outside limits require notification of clients regarding recalls
- evaluate the significance to determine if this is potentially repetitive or related to a potential problem with procedures
- when the evaluation has confirmed that this is potentially repetitive or related to a system problem then initiate corrective action (i.e., a management system change beyond the remedial action of calibrating them). If there is no reason to suspect the recurrence of the problem then the nonconformity is closed and no further need for a corrective action.

The following requires corrective action:
- investigate all direct and indirect processes related to the maintenance of the balance calibration status: causes and potential causes of the problem
- determine the most likely cause or causes
- decide if any actions are needed to eliminate the causes
- undertake any action necessary to elminate these causes and to prevent such a mistake from recurring
- do necessary follow-up
- monitor for effectiveness
- close out the corrective action

Correction = remedial action = correcting the nonconformity

Corrective action = investigate related processes or systems to determine the root cause and eliminate

4.8 Complaints

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The lab must have a policy and procedure for the resolution of complaints received from customers. The lab must also keep records of all complaints which include investigations and corrective actions taken by the lab.

Interpretation: ISO 17025 does not provide many definitive requirements for complaints other than producing records of their investigation and resolution. It is not necessary for complaints to produce corrective actions. A complaint can begin by being founded or not. When it is founded, it usually implies that there is a t least a nonconformity: something needs to be done to correct a problem identified by a customer. Whether this problem is potentially repetitive or related to a systemic defect will lead to the need to initiate a corrective action. Also, complaints that are not founded can lead to identifying needs for improvement or initiating preventive action. The need to provide feedback to the customer on the outcome of the investigation should form an intrinsic element of a complaint handling procedure.

iso 17025

4.7 Service to the customer

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4.7.2 The lab seeks feedback from its customers. This feedback is used and analysed to improve the management system, testing and calibration activities and customer service.

Feedback = positive and negative

Interpretation: feedback could involve customer satisfaction surveys and review of test or calibration reports with customer. The requirement for analysis provides a critical element of management review. The surveys must be meaningful in covering the activities of the lab. This requirement properly implemented will provide a source for continual improvement of the management system.

iso 17025

4.7 Service to the customer

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4.7.1 A customer's request that involves monitoring the lab's performance with respect to the work performed will be accomodated by the lab. The lab will cooperate with the respective customer or their representatives. The lab must ensure that they maintain the confidentiality of their other customers.

Note - access to lab would involve witnessing the test or calibration being performed.
Good communication, advice and guidance in technical matters, and opinions and interpretations based on results are valued services for customers.
Communications on large projects should be done periodically throughout the work.
Delays or deviations should also be communicated to the customer.

Interpretations:
Careful consideration of potential implications must be addressed prio to providing customer access to the lab to address such items as protection of the confidentiality of all the lab's customers, including the confidentiality of test/calibation items that could belong to competing cusotmers or protected by legal implications.

This clause is also cross-referenced to ISO 9001:2000 clause 6.1 (b).

iso 17025

4.6 Purchasing services and supplies

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4.6.4 Suppliers of critical consumables, supplies and services that affect test/calibration quality must be evaluated by the lab. Records of the evaluation and an approved suppliers list are maintained.

Interpretation and ISO 9001 clause 7.4.2
The organization establishes effective and efficient processes to identify potential sources for purchased materials, to develop existing suppliers or partners, and to evaluate their ability to supply the required products in order to ensure the effectiveness and efficiency of overall purchasing processes.

Examples of inputs to the supplier control processes include:
- evaluation of relevant experience
- performance of suppliers against competitors
- review of purchased product quality, price, delivery performance and response to problems
- audits of supplier management systems and evaluation of their potential capability to provide the required products effectively and efficienty and within schedule
- checking supplier references and available data on customer satisfaction
- financial assessment to assure the viability of the supplier throughout the intended period of supply and cooperation
- supplier response to inquiries, quotations and tendering
- supplier service, installation and support capability and history of performance to requirements
- supplier awareness of and compliance with relevant statutory and regulatory requirements
- supplier's logistic capability including locations and resources
- suppliers's standing and role in the community as well as perception in society

Management should consider actions needed to maintain the organization's performance and to satisfy interested parties in the event of supplier failure.

iso 17025

4.6 Purchasing services and supplies

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4.6.3 Documents for purchasing items affecting lab quality must contain data describing the services and supplies ordered. Purchasing documents are reviewed and approved for technical content before release.

Interpretation:
Selection of physical measurement calibration sources for testing labs requires specific requirements to be met by applicant and accredited testing labs in the purchase of calibration services. Labs must develop and implement procedures that meet these requirements and make available for review the requirements to outside providers of traceability.

Accredited calibration labs must in addition comply with the respective national standards of their country.

Accredited test labs must have policies for specifying the details of their calibration needs to their suppliers of calibration services.

iso 17025

4.6 Purchasing services and supplies

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4.6.2 The lab must ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. These services and supplies used must comply with specified requirements. Records of actions taken to check compliance must be maintained.

ISO 9001:2000 Reference - clause 7.4.3
The organization must establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier's premises, the organization must state the intended verification arrangements and method of product release in the purchasing information.

iso 17025

4.6 Purchasing services and supplies

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4.6.1
POLICY and PROCEDURE must be in place for selecting and purchasing services and supplies.

The purchasing procedures for reagents and lab consumable materials must include details on:
- purchase
- reception
- storage

ISO 9001:2000 Interpretation Reference clause 7.4.1
Top management of the organization must ensure that effective and efficient purchasing processes are defined and implemented for the evaluation and control of purchased products, in order that purchased products satisfy the organization's needs and requirements, as well as those of interested parties.

Use of electronic linkage with suppliers should be considered in order to optimize communication of requirements.

To ensure the effective and efficient performance of the organization, management should ensure that purchasing processes consider the following activities:
- timely, effective and accurate identification of needs and purchased product specifications
- evaluation of the cost of purchased product, taking account of product performance, price and delivery
- the organization's need and criteria for verifying purchased products
- unique supplier processes
- consideration of contract administration, for both supplier and partner arrangements
- warranty replacement for nonconforming purchased products
- logistic requirements
- product identification and traceability
- preservation of product
- documentation, including records
- control of purchased product which deviates from requirements
- access to supplier's premises

iso 17025

- product delivery, installation or application history
- supplier development
- identification and mitigation of risks associated with the purchased product

Requirements for suppliers' processes and product specifications must be developed with suppliers in order to benefit from available supplier knowledge. The organization could also involve suppliers in the purchasing process in relation to their products in order to improve the effectiveness and efficiency of the organization's purchasing process. This could also assist the organization in its control and availability of inventory.

The organization must define the need for records of purchased product verification, communication and response to nonconformities in order to demonstrate its own conformity to specification.

4.5 Subcontracting of tests and calibrations

2006-05-09T12:50:00.000-07:00

4.5.4
The lab must maintain a Register of Subcontractors list. Records of compliance with ISO 17025 must be available.

Interpretation:
If a subcontractor is not accredited for the specific service, the lab must ensure that qualified and trained personnel conduct an onsite assessment of the subcontractor's facilities and must conduct regular reassessments, or otherwise ensure to the accreditation body's satisfaction the adequate competence of the subcontractor. The lab must retain records of training and qualifications of the personnel that conduct such assessments. Such an on-site assessment must cover at least all the elements of ISO 17025. Evidence of this assessment as well as findings and their resolution, must be available for review. Evidence of compliance to ISO 17025 is not applicable in the case of customer or regulator specified subcontractors.

iso 17025

4.5 Subcontracting of Tests and Calibrations

2006-05-05T16:57:00.000-07:00

4.5.3
The lab is responsible for the subcontractor's work.

Subcontractor competence could be demonstrated through:
- accreditation
- registration
- certification
- check sample / proficiency sample results
- audit results

iso 17025

4.5 Subcontracting of Tests and Calibrations

2006-05-04T16:39:00.000-07:00

4.5.2 Customer Approval
Customers must be advised in writing when any portion of their work is subcontracted to another laboratory.

Note:
It is not a requirement that the lab identify to whom they had subcontracted a test or the name of the subcontractor. Under the requirement of this section, the lab must however inform their clients of their intent to subcontract prior to having the work subcontracted. Records of client consent must be retained.

An ISO 17025 accreditation for a specific scope of capabilities and for a specific site. The requirements for subcontracting actually apply in principle only to the subcontracting of an accredited test/calibration. The subcontracting of accredited tests/calibrations should not be confused with subcontracting of other tests and work. Organizations routinely subcontract work for a variety of reasons and when this work is not an accredited test/calibration, the conditions of ISO 17025 section 4.5.1 do not actually apply as far as accreditation requirements are concerned.

Examples of activities and work that are not considered subcontracting:
- calibration of measurement or test equipment when the lab is not accredited for calibrations
- outsourcing part of a test/calibration for which the lab is not accredited

These examples would essentially be considered purchasing and in the case of the second point the accrediting body would not be reviewing the activity. The first item would be reviewed under the requirements of 4.6 Purchasing and 5.6 Traceability.

ISO 17025 views subcontracting much more formally than what most organizations normally practice. When an organization has different subcontracting practices than those required by ISO 17025, then different procedures are required with a clear distinction within the procedures as to when the ISO 17025 procedures apply.

When a lab is subcontracting an accredited test/calibration (for whatever reason) to another lab that is part of the same legal entity and is accredited for the specific test being subcontracted, the accrediting body does not consider the movement of this test/calibration item between such facilities as subcontracting. The test/calibration report produced will however need to be identified to the facility that conducted the test/calibration. The requirements of ISO 17025 section 5.8 Handling of Test and Calibration Items applies.

iso 17025

4.5 Subcontracting of tests and calibrations

2006-05-01T12:23:00.000-07:00

4.5.1
Competent subcontractors must be utilized when a laboratory must subcontract work out.

Interpretation:
When a lab never performs a test/calibration, it cannot be granted accreditation for that test/measurement.

When a lab subcontracts a test or calibration for which they are accredited, such as to meet peak demands, preference is given to ISO 17025 accredited labs. The requirements for subcontracting in section 4.5 of ISO17025 must be applied. Refer to interpretative note section 4.5.4. Records of review of the scope of accreditation of the service provider must be available.

When a testing lab subcontracts calibrations for which they are not accredited, this is not considered subcontracting and requirements of sections 4.6 and 5.6 of ISO 17025 are applied to these purchases for purposes of accreditation.

When a testing lab subcontracts calibrations for which they are not accredited or when a calibration lab subcontracts calibrations for which they are not accredited then the requirements of section 4.5 of ISO 17025 may be applied at the lab's discretion. However, these subcontracted tests or calibrations are outside the scope of accreditation.

iso 17025

4.4 Review of Requests, Tenders, and Contracts

2006-04-26T20:03:00.000-07:00

4.4.5
Once testing/calibration work has commenced and the contract needs to be amended, the same contract review process must be repeated.
Amendments are communicated to all affected personnel.

iso 17025

4.4 Review of requests, tenders and contracts

2006-04-21T05:57:00.000-07:00

4.4.4
Any deviation from the contract must involve communication to the customer.

iso 17025

4.4 Review of requests, tenders and contracts

2006-04-20T11:29:00.000-07:00

4.4.3
Subcontracted work by the lab must also be reviewed.

iso 17025

4.4 Review of Requests, Tenders, and Contracts

2006-04-19T17:58:00.000-07:00

4.4.2

The lab must maintain records of request, tender and contract review. This would also include any significant changes and discussions with the customer.

iso 17025

4.4 Review of requests, tenders and contracts

2006-04-18T13:11:00.000-07:00

4.4.1

The lab must establish and maintain a PROCEDURE for the review of requests, tenders and contracts.

Policies and procedures ensure the:
- methods to be used are adequately defined, documented and understood
- lab has the capability and resources to meet the requirements
- appropriate method is selected and capable of meeting customer requirements

Differences between the request/tender and contract are resolved before work starts.

Bottom line:
The contract must be acceptable to the lab and customer.

iso 17025

4.3 Document Control / 4.3.3 Document Changes

2006-04-14T13:58:00.000-07:00

4.3.3.4

Computerized Documents
Documents in computerized systems also have to be controlled.

4.3 Document Control / 4.3.3 Document changes

2006-04-11T12:55:00.000-07:00

4.3.3.3

Amendments by Hand - the lab must decide on a policy for whether to allow hand-written amendments or not.

If these are allowed they must be clearly marked, initialled and dated.

It is suggested that a formal document be formally re-issued ASAP.

iso 17025

4.3 Document Control / 4.3.3 Document Changes

2006-03-24T11:34:00.000-08:00

4.3.3.2

Altered or new text must be identified in management system documents.

Interpretation:
One of the most common ways of identifying revised text in at document is to place a bar in the left hand margin of the hard copy text.
When you are displaying PDF documents through Adobe Acrobat, it is good practice to change the colour of the changed text so that it stands out to the user.

iso 17025

4.3 Document Control / 4.3.3 Document Changes

2006-03-23T11:34:00.000-08:00

When documents are revised they require the same review and approval process that they were originally issued through.Those doing the review and approval will be knowledgable and have access to the pertinent background information.

iso 17025

4.3 Document Control / 4.3.2 Document Approval and Issue

2006-03-22T16:34:00.000-08:00

4.3.2.3
Management system documents must be uniquely identified. This will include:
- date of issue
- revision identification
- page numbering
- total number of pages (or a mark to signify the end of the document)
- issuing authority

iso 17025

4.3 Document Control / 4.3.2 Document Approval and Issue

2006-03-21T06:22:00.000-08:00

4.3.2.2
The document control procedure must ensure:
- documents are authorized and available in the appropriate locations
- documents are periodically reviewed and/or revised to ensure they still meet the needs of the lab
- obsolete documents are promptly removed
- obsolete documents are suitably marked when retained for either legal or knowledge preservation

iso 17025

4.3 Document Control / 4.3.2 Document Approval and Issue

2006-03-20T07:02:00.000-08:00

4.3.2.1
Management system documents must be reviewed and approved for use by authorized personnel prior to use.
The lab must have a Master List or a document control procedure that identifies the current revision status and distribution of documents.
The purpose for this is to ensure that invalid and/or obsolete documents are not used in the laboratory.

iso 17025

4.3 Document Control / 4.3.1 General Requirements

2006-03-17T06:46:00.000-08:00

All documents in the management system (internally generated or external sources) must be controlled through standard procedures. These documents include:
- regulations
- standards
- normative documents
- test and/or calibration methods
- drawings
- software
- specifications
- instructions
- manuals

Interpretation:
Document - policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. They could be hard copy, electronic, digital, analog, photographs or written.

iso 17025

4.3 Document Control

2006-03-15T06:23:00.000-08:00

Document control within the ISO 17025 standard will cover the following
- General requirements
- Document approval and issue
- Document changes

iso 17025

4.2 Management System / 4.2.7 Maintenance

2006-03-14T07:47:00.000-08:00

It is the responsibility of top management to maintain the changes to the management system.

iso 17025

4.2 Management System / 4.2.6 Technical Management and Quality Manager

2006-03-13T11:46:00.000-08:00

The responsibilities of technical management and the Quality Manager are defined in the Quality Manual.

iso 17025

4.2 Management System / 4.2.5 Structure of Management Structure

2006-03-10T11:49:00.000-08:00

The quality manual must outline the structure of the management system.

Interpretation:
For example,
Tier 1 - Quality Manual
Tier 2 - Technical procedures and support procedures (often called standard operating procedures...sops)
Tier 3 - Record keeping documents

iso 17025
iso 17025 quality manual

4.2 Management System / 4.2.4 Communication of Requirements

2006-03-08T20:21:00.000-08:00

The following requirements are communicated by top management to the laboratory:
- importance of meeting customer requirements
- statutory requirements
- regulatory requirements

iso 17025

4.2 Management System / 4.2.3

2006-03-07T10:26:00.000-08:00

There must be proof that top management are committed to the development and implementation of the management system and to continually improve its effectiveness.

Interpretation: if you write all your policies and procedures you have the proof. If you follow Section 4.10 and 4.15 of the standard then you have continually improved the management system. This clause is slightly redundant.

iso 17025

4.2 Management System / 4.2.2 Quality Policy Statement (continued)

2006-03-06T09:16:00.000-08:00

The quality policy statement must include:
- lab management's commitment to good professional practice and quality of its testing/calibration service
- a statement from management about the lab's standard of service
- the purpose of the management system
- a requirement for all personnel to be familiar with the management system policies and procedures related to their job
- and a statement of management's commitment to comply with ISO 17025 and continually improve the effectiveness of the management system.

A copy of the ISO 17025 standard can be obtained from:
http://www.17025-standard.com/

iso 17025

4.2 Management System / 4.2.2 Quality Policy Statement

2006-03-02T12:51:00.000-08:00

The lab's management system policies (including a quality policy statement) are defined in a Quality Manual.

A sample of a Laboratory Quality Manual can be viewed at:
http://www.e-shoq.com/wst_page9.html

See www.e-shoq.com for more details.

iso 17025

4.2 Management System / 4.2.1 Management System Documentation

2006-03-01T15:23:00.000-08:00

1. Establish
2. Implement
3. Maintain

The lab must establish, implement, and maintain a management system for their testing and calibration activities.

This includes:
- policies
- systems
- programmes
- procedures
- instructions

The system must be communicated, understood, and implemented.

See the following for more info:
http://www.aoac.org/pubs/iso17025.htm

iso 17025

4.1 Organization / 4.1.6 Communication

2006-02-27T12:26:00.000-08:00

Communicaton processes must be established within the lab by top management.
The communication of the management system must be effective.

4.1 Organization / 4.1.5 (k) Awareness

2006-02-24T17:01:00.000-08:00

The lab must ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.

4.1 Organization / 4.1.5 (j) Managerial Substitutions

2006-02-23T18:46:00.000-08:00

The lab must designate deputies for key personnel to fulfill the key personnel's duties in their absence.

Interpretation: at least one deputy for each key role be pre-designated in case of emergencies.

4.1 Organization / 4.1.5 (i) Quality Manager

2006-02-21T07:10:00.000-08:00

The lab must appoint a member of staff as quality manager. Their responsibilities as quality manager will include ensuring that the management system related to quality is implemented and followed at all times. The quality manager must have direct access to the highest level of management at which decisions are made on lab policy and resources.

4.1 Organization / 4.1.5 (h) Technical Management

2006-02-20T09:01:00.000-08:00

The lab must have technical management in place with responsibility for technical operations and authority to provide resources needed to ensure the required level of quality in the lab.

4.1 Organization / 4.1.5 (g) Supervision

2006-02-18T19:16:00.000-08:00

The lab must provide adequate supervision of testing or calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results.

4.1 Organization / 4.1.5 (f) Responsibility and Authority

2006-02-14T12:21:00.000-08:00

The responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting quality must be specified.

4.1 Organization / 4.1.5 (e) Org Chart

2006-02-02T19:08:00.000-08:00

The laboratory structure must be defined. Also, relationships between management, technical operations, support services, and the quality management system must be shown. Possibly through an org chart.

Interpretation: a simple box and line chart showing reporting relationship. Easily prepared in Powerpoint.

4.1 Organization / 4.1.5 (d) Operational Integrity

2006-02-01T20:41:00.000-08:00

The lab must stay away from any activity that would diminish confidence in its competence, impartiality, judgment, or operational integrity.

4.1 Organization / 4.1.5 (c) Customer Confidentiality

2006-01-31T19:13:00.000-08:00

Confidential information and proprietary rights of the customer must be protected. This includes electronic storage and transmission of results.

4.1 Organization / 4.1.5 (b) Undue Pressure

2006-01-30T13:34:00.000-08:00

Lab employees should sign a conflict of interest statement to ensure that management and personnel are free from undue pressures and influences including:
- internal or external
- commercial
- financial
- anything that may adversely affect the quality of their work

The lab can also meet this requirement by having a specific policy on the matter, or a code of ethics, employment contracts, and arrangements to relieve internal pressures from excessive workloads.

4.1 Organization / 4.1.5 (a) Management and Technical Personnel

2006-01-27T18:54:00.000-08:00

A commitment by the lab the lab to have managerial and technical personnel in place who have the authority and resources needed to carry out their duties, including implementation, monitoring, and improvement of the management system.
Personnel must identify the occurence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures.

4.1 Organization / 4.1.4 Potential Conflicts of Interest

2006-01-26T13:32:00.000-08:00

When the lab is part of an organization that does other things besides testing or calibration, key personnel in that organization that influence the lab must have their responsibilities defined in order to identify potential conflicts or interest.

4.1 Organization / 4.1.3 Scope of Management System

2006-01-25T18:18:00.000-08:00

ISO 17025 is a generic standard covering all types of testing and calibration laboratories. Hence, the laboratory must describe what the management system actually covers.

Permanent facility?
Satellite locations?
Temporary or mobile facilities?

This description will allow the accreditation body to identify and assess what will actually be accredited.

4.1 Organization / 4.1.2 Lab requirements

2006-01-24T08:05:00.000-08:00

4.1.2 Lab requirements
To follow ISO 17025 and satisfy customer needs, regulatory authorities, or accrediting bodies.

Interpretation...it is what it is!

4.1 Organization / 4.1.1 Legal identification

2006-01-23T12:17:00.000-08:00

4.1 Organization
4.1.1 Legal identification
ISO 17025 requires that the lab be held legally responsible.

This has been interpreted and accepted by accreditation bodies as "Legal Identification" or "identifiable under law".
Essentially, the laboratory or organization needs to be able to state their business name and place of business so that the accreditation body can ensure control over the status of accreditation. In the end the accreditation covers a distinct organization and is limited to that entity. If "corporate" boundaries are not clear and distinguishable, the labortory is not legally identifiable.

Section 4 - Management Requirements

2006-01-20T19:24:00.000-08:00

Section 4 of ISO 17025 outlines all of the management requirements of the standard. Essentially it is ISO 9001 for testing or calibration laboratories. There are 15 sub-sections under management requirements. These are:
4.1 Organization
4.2 Management system
4.3 Document control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews

iso 17025

ISO 17025

2006-01-19T12:53:00.001-08:00

ISO 17025 is the recognized international standard to which testing and calibration laboratories become accredited. In an effort to speed up the process of developing a quality management system, a laboratory should consider utilizing a template. The ISO 17025 Quality Manual Template can be located at www.e-shoq.com