Use of the new international laboratory standard should assure greater consistency between laboratories, testing and calibration.
Daniel D. Hoolihan
Hoolihan EMC Consulting, Lindstrom, MN, USA
The First Edition of ISO/IEC 17025 was released in 1999 and the Second Edition was released in 2005. Both editions of 17025 rely heavily on an earlier version of a similar international document; ISO/IEC Guide 25:1990 – General Requirements for the Technical Competence of Testing Laboratories.
The Second Edition of 17025 was released in May of 2005 and its clauses reflect the material carried in ISO 9001:2000 – Quality Management Systems – Requirements. The Second Edition is considered to be a technical revision, and it replaces the First Edition in its entirety.
The International Laboratory Accreditation Cooperation (ILAC) body has set a transition period of two years from the date of publication of the new edition—that is, 12 May 2007—for accredited laboratories to comply with the new standard’s requirements.
The standard contains all requirements necessary for a calibration or a testing laboratory to show competence in its specific technical arena. It contains both management and technical requirements, and it is an essential piece of the complete program to assure a laboratory’s competence.
Accrediting bodies such as the United States Department of Commerce National Institute of Standards and Technology (NIST), National Voluntary Laboratory Accreditation Program (NVLAP), and the American Association for Laboratory Accreditation (A2LA) use ISO/IEC 17025 as a basis for accrediting EMC laboratories. It is a definite advantage for a lab to be accredited since its test results are more readily accepted by various government and commercial entities; for example, the use of a Declaration of Conformity for electronic products for United States Federal Communications Commission (FCC) approval.
General Philosophy of the Standard
The standard is split into two basic areas—management requirements and technical requirements. The management requirements are very similar to the requirements found in ISO 9001:2000. The technical requirements are what separate “17025” from “9001.”
Since the First Edition of 17025 referenced the predecessors of ISO 9001:2000—namely ISO 9001:1994 – Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation, and Servicing and ISO 9002:1994 – Quality Systems – Model for Quality Assurance in Production, Installation, and Servicing—it was evident that the Second Edition of 17025 would have to reflect the more modern version of ISO 9001.
It should be noted that ISO 9001:2000 was a MAJOR change to the ISO 9000 series of standards in that it replaced the second edition of ISO 9001:1994, and it incorporated both ISO 9002:1994 and ISO 9003:1994 – Quality Systems – Model for Quality Assurance in Final Inspection and Test into the comprehensive document.
Table of Contents
Comparing the Table of Contents of the first and second editions of 17025 is a quick way to see the major changes between the two standards.
Three key changes were made to the Table of Contents:
- Clause 4.2 is changed from “Quality system” to “Management system.”
- Clause 4.7 is changed from “Service to the client” to “Service to the customer.”
- Clause 4.10 has a new heading titled “Improvement.”
Additional changes were made to the Table of Contents; these were primarily printing in the Table of Contents the titles of clauses that were in the body of Edition 1 but had not been printed in the original Table of Contents. Details on those changes are given below and a comparison of the two “Tables” is given in Table 1.
NOTE – The subclause headings for the 1999 edition are shown in italicized form; they were not listed in the 1999 Table of Contents but they were evident in the body of the standard.
Table of Contents – Details
Heading 4.1 (Organization) remained the same. Heading 4.2 (Management system) changed as noted in the previous paragraph.
Heading 4.3 (Document Control) in the Table of Contents changed from a single entry to a single title plus three subheadings. The subheadings are:
- 4.3.1 General
- 4.3.2 Document approval and use
- 4.3.3 Document changes
Clause 4.4 (Review of Request, Tenders, and Contracts), Clause 4.5 (Subcontracting of Tests and Calibrations), and Clause 4.6 (Purchasing Services and Supplies) all remained the same from Edition 1 to Edition 2.
Heading 4.7 (Service to the customer) changed, as noted above. Both Clause 4.8 (Complaints) and Clause 4.9 (Control of Nonconforming Testing and/or Calibration Work) had no change in title from Edition 1 to Edition 2.
Clause 4.10, as indicated earlier, has a new heading called “Improvement.”
The previous 4.10 heading was “Corrective action” and that has become Clause 4.11 in the Second Edition. Additional subclauses were added below 4.11, namely:
- 4.11.1 General
- 4.11.2 Cause Analysis
- 4.11.3 Selection and implementation of corrective actions
- 4.11.4 Monitoring of corrective actions
- 4.11.5 Additional audits
Clause 4.12 in the new edition is “Preventive action” which was Clause 4.11 in the First Edition.
Clause 4.13 (Control of records) was Clause 4.12 in the 1999 edition; two sub-clauses have been added:
- 4.13.1 General
- 4.13.2 Technical Records
- Clause 4.14 (Internal audits) was Clause 4.13 in the First Edition.
- Clause 4.15 in the Second Edition is “Management reviews.” Previously, it was Clause 4.14.
Looking at the Technical Requirements, the headings for 5.1 (General), 5.2 (Personnel), and 5.3 (Accommodation and environmental conditions) remained the same from Edition 1 to Edition 2.
The title for 5.4 (Test and calibration methods and method validation) remained the same but seven subclauses were added into the Table of Contents in the Second Edition. They are as follows:
- 5.4.1 General
- 5.4.2 Selection of methods
- 5.4.3 Laboratory-developed methods
- 5.4.4 Non-standard methods
- 5.4.5 Validation of methods
- 5.4.6 Estimation of uncertainty of measurement
- 5.4.7 Control of data
The title for Clause 5.5 (Equipment) remained the same from the 1999 edition to the 2005 edition.
The title of Clause 5.6 (Measurement traceability) has not changed in the Second Edition; however, there are three new subclauses listed:
- 5.6.1 General
- 5.6.2 Specific requirements
- 5.6.3 Reference standards and reference materials
Clauses titled 5.7 (Sampling), 5.8 (Handling of test and calibration items), and 5.9 (Assuring the quality of test and calibration results) remain constant between the two editions.
Major additions were made to the Table of Contents for Clause 5.10 (Reporting the results) in the Second Edition of 17025. A total of nine subclauses were added to the Clause 5.10 Table of Contents listing:
- 5.10.1 General
- 5.10.2 Test reports and calibration certificates
- 5.10.3 Test reports
- 5.10.4 Calibration certificates
- 5.10.5 Opinions and interpretations
- 5.10.6 Testing and calibration results obtained from subcontractors
- 5.10.7 Electronic transmission of results
- 5.10.8 Format of reports and certificates
- 5.10.9 Amendments of test reports and calibration certificates
The informative Annex A changed from a “Nominal cross-reference to ISO 9001:1994 and ISO 9002:1994” to a “Nominal cross-reference to ISO 9001:2000.”
The informative Annex B kept the same title from Edition 1 to Edition 2; “Guidelines for establishing applications for specific fields.”
The last item in the Table of Contents is Bibliography and both Editions of 17025 have a Bibliography.
The Forewords in both editions are basically the same.
The Second Edition added a new sentence to the first paragraph; “In the field of conformity assessment, the ISO committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides.”
A new stand-alone sentence was added to the Second Edition which states that “It (ISO/IEC 17025) was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations.”
The First Edition states that “This first edition of ISO/IEC 17025 cancels and replaces ISO/IEC Guide 25:1990” while the second edition states that “This second edition cancels and replaces the first edition (ISO/IEC 17025:1999), which has been technically revised.”
The introduction of the Second Edition added one new paragraph and significantly modified another paragraph from the First Edition.
The new paragraph states “The first edition referred to ISO 9001:2004 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001:2000.”
The significantly modified paragraph states “Conformity of the quality management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001.”
Clause 1 SCOPE
Clauses 1.1, 1.2 and 1.3 remain the same in Edition 2 of 17025. However, in Clause 1.4 some changes are made; the term “management system” is used, the term “customers” is used instead of “clients,” and a new sentence is added at the end. So, Clause 1.4 now reads:
“This International Standard is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities, and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. This International Standard is not intended to be used as the basis for certification of laboratories.”
Clause 1.4 also includes two notes which are new:
Note 1 – The term ‘management system’ in this International Standard means the quality, administrative and technical systems that govern the operations of a laboratory.
Note 2 – Certification of a management system is sometimes also called registration.
Clause 1.6 has major changes; it now reads:
“If testing and calibration laboratories comply with the requirements of this International Standard, they will operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001. Annex A provides nominal cross-references between this International Standard and ISO 9001. This International Standard covers technical competence requirements that are not covered by ISO 9001.”
Notes 1 and 2 of 1.6 substituted the new ISO/IEC 17011 – Conformity Assessment – General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies for the superseded ISO/IEC Guide 58.
CLAUSE 2 NORMATIVE REFERENCES
The first paragraph of Clause 2 changed to:
“The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.”
The documents referenced include the new ISO/IEC 17000 – Conformity Assessment – Vocabulary and General Principles and the carry-over document VIM – International Vocabulary of Basic and General Terms in Metrology. The second edition deleted ISO 9001:1994, ISO 9002:1994, and ISO/IEC Guide 2 from the normative references.
CLAUSE 3 TERMS AND DEFINITIONS
In this short clause, the second edition substituted ISO/IEC 17000 for ISO/IEC Guide 2 and ISO 9000 for ISO 8402 in the one sentence and Note.
CLAUSE 4 MANAGEMENT REQUIREMENTS
Clause 4.1 Organization
Clause 4.1.2 changed by substituting “customer” for the word “client.” The clause now reads:
“It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard and to satisfy the needs of the customer, the regulatory authorities or organizations providing recognition.”
Clause 4.1.5, subclause a) changed and added a number of words. It now reads:
“(The laboratory shall) a) have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence 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 (see also 5.2);”
Clause 4.1.5 c) changed “clients’” to “customers’.”
Clause 4.1.5 i) changed “quality system” to “management system.”
Clause 4.1.5 k) is all new and says “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.”
Clause 4.1.6 is all new and it states “Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.”
Clause 4.2 Management System
The title of this clause changed from Quality System to Management System.
In clause 4.2.1, the phrase “quality system” was replaced by “management system.”
The opening paragraph in 4.2.2 was rewritten to read:
“The laboratory’s management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following:”
Clause 4.2.2 c) used to read “the objectives of the quality system” and now it reads “the purpose of the management system related to quality.”
Clause 4.2.2 e) in the first edition read “the laboratory management’s commitment to compliance with this International Standard;” the second edition adds the following words to the original phrase, “and to continually improve the effectiveness of the management system.”
The Note after 4.2.2 e) changed the phrase “clients’ requirements” to “customers’ requirements.”
Clause 4.2.3 is all new and it says “Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.”
Clause 4.2.4 is also all new and it states “Top management shall communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements.”
Clause 4.2.5 is the first edition’s clause 4.2.3 with the term “quality system” replaced with “management system.”
The second edition’s clause 4.2.6 is the first edition’s clause 4.2.4, and it reads “The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the Quality Manual.”
Clause 4.2.7 in the second edition is all new and it states “Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.”
Clause 4.3 Document Control
In clause 4.3.1 (General), the second edition replaces the words “quality system” with the words “management system.” Also, the last sentence in Note 2 is changed from “The control of records is covered in 4.12” to “The control of records is covered in 4.13.”
Clause 4.3.2 is “Document approval and issue.” The first sentence in clause 184.108.40.206 was changed from “All documents issued by personnel in the laboratory as part of the quality system shall be reviewed and approved for use by authorizing personnel prior to issue” to “All documents issued by personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorizing personnel prior to issue.”
Clause 220.127.116.11 changed the first sentence from “Quality system documents generated by the laboratory shall be uniquely identified” to “Management system documents generated by the laboratory shall be uniquely identified.”
Clause 4.4 Review of Requests, Tenders and Contracts
Clause 4.4.1 c) now reads “the appropriate test and/or calibration method is selected and is capable of meeting the customers’ requirements (see 5.4.2)” where the term “clients’” was replaced by “customers’.” The next clause now reads “Any differences between the request or tender and the contract shall be resolved before any work commences. Each contract shall be acceptable both to the laboratory and to the customer.” Again, the term “customer” was substituted for “client.”
In Note 1 of 4.4.1, the sentence “For internal clients, reviews of requests, tenders and contracts can be performed in a simplified way” was changed to read “For internal customers, etc.” Note 3 was changed to read “A contract may be any written or oral agreement to provide a customer with testing and/or calibration services” where “customer” was substituted for “client.”
Clause 4.4.2 was changed to read “Records of reviews, including any significant changes, shall be maintained. Records shall also be maintained of pertinent discussions with a customer relating to the customer’s requirements or the results of the work during the period of execution of the contract.” The term “customer” was substituted for “client.” This same substitution occurred one additional time in the Note following 4.4.2.
Clause 4.4.4 reads “The customer shall be informed of any deviation from the contract.” Again, the word “client” was deleted and “customer” substituted in the sentence.
Clause 4.5 Subcontracting of Tests and Calibrations
Clause 4.5.2 in Edition 2 reads “The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.” Again, “customer” was substituted for “client.”
Edition 2 of 17025 modifies Clause 4.5.3 to read “The laboratory is responsible to the customer for the subcontractor’s work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used.” Once again, “customer” was substituted for “client.”
Clause 4.6 Purchasing Services and Supplies
The Note in 4.6.3 was changed to read “The description may include type, class, grade, precise identification, specifications, drawings, inspection instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made.” The term “management system” was inserted for “quality system” in the sentence.
Clause 4.7 Service to the Customer
This main clause heading was changed from “Service to the Client.”
Clause 4.7.1 is all new and it states “The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer’s request and in monitoring the laboratory’s performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers.”
Notes 1 and 2 remain the same from Edition 1 to Edition 2 except the word “customer” is substituted for the word “client” several times.
Clause 4.7.2 is all new and it says “The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be used and analyzed to improve the management system, testing and calibration activities and customer service.”
The Note following 4.7.2 is all new and it states “Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with customers.”
Clause 4.8 Complaints
This two-sentence clause was changed to read “The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained or all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).” In this case, the word “customers” was swapped with “clients” and “4.11” replaced “4.10.”
Clause 4.9 Control of Nonconforming Testing And/Or Calibration Work
In clause 4.9.1, the term “customer” was substituted for the word “client” twice. Also, in the Note following 4.9.1, the expression “management system” was substituted for “quality system” two times.
In clause 4.9.2, the reference to clause 4.10 was changed to “4.11” to reflect the numbering change in the second edition.
Clause 4.10 Improvement
This is an entirely new clause in the second edition. It is one sentence that states “The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.”
Clause 4.11 Corrective Action
This clause stayed primarily the same; the term “management system” was substituted for “quality system” twice and the word “customer” was substituted for “client” twice.
In addition, a reference to clause 4.13 in 4.10.5 (Additional audits) in Edition 1 had to be changed to clause 4.14 in 4.11.5 (Additional audits) in Edition 2.
Clause 4.12 Preventive Action
The second sentence in 4.12.1 was modified to read: “When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement.”
Clause 4.13 Control of Records
No changes were made to the clause entitled “Control of Records.”
Clause 4.14 Internal Audits
The term “management system” was substituted for “quality system” twice in 4.14.1. Also, in 4.14.2, the term “customer” was substituted for “client” one time.
Clause 4.15 Management Review
The first sentence in 4.15.1 reads “In accordance with a predetermined schedule and procedure, the laboratory’s top management shall periodically conduct a review of the laboratory’s management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements.” The word “top” was substituted for “executive” and the phrase “management system” was substituted for “quality system.”
In the list of items that the management review should consider, the phrase “customer feedback” replaced the phrase “client feedback” from edition 1 and the phrase “recommendations for improvement” is entirely new to edition 2.
CLAUSE 5 TECHNICAL REQUIREMENTS
Clause 5.1 General
No changes were made to this major clause in 17025 in the second edition.
Clause 5.2 Personnel
In clause 5.2.1, Note 1 had a small change from “client” to “customer.” It now reads “In some technical areas (e.g., non-destructive testing) it may be required that the personnel performing certain tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification requirements. The requirements for personnel certification might be regulatory, included in the standards for the specific technical field, or required by the customer.”
Also, in clause 5.2.2, an all new sentence was added at the end of the clause that reads: “The effectiveness of the training actions taken shall be evaluated.”
Clause 5.3 Accommodation and Environmental Conditions
No changes were made to this major clause of 17025.
Clause 5.4 Test and Calibration Methods And Method Validation
In clause 5.4.1 – General, the last sentence in the second paragraph was changed to read “Deviation from test and calibration records shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.” Again, the word customer was substituted for client.
In clause 5.4.2 – Selection of methods, the word “customer” is swapped with the word “client” five times.
No changes were made to clause 5.4.3 – Laboratory-developed methods. However, in clause 5.4.4 – Non-standard methods, the first sentence was changed to read “When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the test and/or calibration.” Again, the word “customer” is being substituted for the word “client” from Edition 1 of 17025.
In clause 5.4.5 – Validation of records, the word “customer” is substituted for “client” in two locations. The first time it occurs is in the first paragraph of 18.104.22.168, and the second time it occurs is in Note 2 of 22.214.171.124.
In clause 5.4.6 – Estimation of uncertainty of measurement; the word “customer” is swapped for the word “client” in Note 1 of 126.96.36.199.
Clause 5.5 Equipment
No changes were made to this major clause of 17025.
Clause 5.6 Measurement Traceability
No changes were made to this major clause of 17025.
Clause 5.7 Sampling
Clause 5.7.2 was revised to read “Where the customer requires deviations, additions or exclusion from the documented sampling procedure, these shall be recorded in detail with the appropriate sampling data and shall be included in all documents containing test and/or calibration results, and shall be communicated to the appropriate personnel.” Once again, the word “customer” was swapped for the word “client.”
Clause 5.8 Handling of Test and Calibration Items
The word “customer” is substituted for “client” in 5.8.1 and 5.8.3.
Clause 5.8.1 in Edition 2 reads “The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interest of the laboratory and the customer.”
Clause 5.8.3 in Edition 2 of 17025 reads “Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, shall be recorded. When there is doubt as to the suitability of an item for test or calibration or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.”
Clause 5.9 Assuring the Quality of Test and Calibration Results
Clause 5.9.1 is a new clause number that contains all the information contained in clause 5.9 of the first edition.
Clause 5.9.2 is all new to edition 2 and it says “Quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported.”
Clause 5.10 Reporting the Results
Clause 5.10.1 – General was revised in the second edition to include the word “customer” in four different locations, thus, the word “client” was deleted and the word “customer” inserted in its place.
In clause 5.10.2 – Test Reports and Calibration Certificates, item d) reads “the name and address of the customer.” Previously it read, “the name and address of the client.”
Clause 5.10.3 – Test Reports has in its clause 188.8.131.52 c) the phrase “customer’s instructions” and 184.108.40.206 e) the statement “additional information which may be required by specific methods, customers or groups of customers.” Again, the word “customer” was substituted for “client” from Edition 1.
In clause 5.10.4 – Calibration Certificates, under clause 220.127.116.11, we have the following words: “A calibration certificate (or calibration label) shall not contain any recommendation on the calibration interval except where this has been agreed with the customer. This requirement may be superseded by legal regulations.” The word “customer” replaced the word “client.”
In clause 5.10.5 – Opinions and Interpretations, we have in Note 3 the following: “In many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the customer. Such dialogue should be written down.” Again, the word “customer” was substituted for “client.”
The changes from Edition 1 to Edition 2 of ISO/IEC 17025 occurred mainly in Clause 4 – Management Requirements and were intended to bring the latest edition of 17025 into agreement with ISO 9001:2000 – Quality Management Systems – Requirements. There is more emphasis on the quality mantra of “continuous improvement” as evidenced by the one entirely new clause in the Second Edition; 4.10 – Improvement. Use of the new international laboratory standard should assure greater consistency between laboratories, testing and calibration, around the world.
ABOUT THE AUTHOR
Daniel D. Hoolihan is past president of the IEEE EMC Society. He has been a member of the Board of Directors of the EMC Society since 1987 and has held several leadership positions in the society. Dan is also active on the ANSI Accredited Standards Committee on EMC, C63 as chairman of the Subcommittee 6 on Laboratory Accreditation and Subcommittee 8 on EMC and Medical Devices. He served as the vice president of the Minnesota operation of TÜV Product Service, Inc. from 1994 to 1999. He can be reached at hoolihan @emcxpert.com.