ISO/IEC 17025

General Requirements for the Competence of

Testing and Calibration Laboratories

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ISO 17025

• Is an International Standard (published by the International Organization for

Standardization) that specifies the general requirements for the competence to carry out

tests and/or calibrations.

• There are 15 management requirements and 10 technical requirements.

• These requirements outline what a laboratory must do to become accredited.

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ISO/IEC 17025

ISO IEC• ISO (International Organization for

Standardization) is the world's largest

developer and publisher of International

Standards.

• The IEC (International Electrotechnical

Commission) is the world’s leading

organization for the preparation and

publication of International Standards for

all electrical, electronic and related

technologies.

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What does 17025 apply to?

• ISO 17025 applies to all organizations performing tests and/or calibrations.

• It applies to all laboratories regardless of the number of personnel or the extent of the scope

of testing and/or calibration activities covered by this International Standard

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17025 Contents

The ISO 17025 standard itself is comprised of 5 elements:

1. Scope

2. Normative References

3. Terms and Definitions

4. Management Requirements

5. Technical Requirements

Elements 4 and 5 contain the actual accreditation requirements.

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Contents

4. Management Requirements

(Requirements for lab environments)• 4.1. Organization• 4.2. Quality system• 4.3. Document control• 4.4. Review of contracts• 4.5. Subcontracting• 4.6. Purchasing• 4.7. Service to the client• 4.8. Complaints• 4.9. Control of non-conforming work• 4.10. Improvement• 4.11. Corrective actions• 4.12. Preventive actions• 4.13. Control of quality records• 4.14. Internal audits• 4.15. Management review

5. Technical Requirements

(Requirements for lab)• 5.1. General• 5.2. Personnel• 5.3. Accommodation• 5.4. Test methods and validation• 5.5. Equipment• 5.6. Measurement traceability• 5.7. Sampling• 5.8. Test items• 5.9. Quality control• 5.10. Report Introduction

Management Requirements

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Management Requirements

• Management requirements pertain to the

operation and effectiveness of the quality

management system within the laboratory.

• The requirements are similar to ISO 9001.

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4.1 Organization and management

This section of 17025 stresses the fact that :-

• The lab must have legally responsible.

• The lab must be organized so that it can carry out its work at permanent or temporary

facilities.

• The responsibilities must be carefully divided to avoid conflicts of interest.

• The lab must have management and technical personnel.

• Staff must be free from any undue pressures that could adversely affect the work.

• The lab must have policies for confidential of information .

• The lab must have an organizational chart that specifies the interrelationships of all

personnel.

• The lab must also have a technical manager and a quality manager.

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4.2 Management System

• Is a set of interrelated or interacting elements that

organizations use to direct and control how quality policies

are implemented and quality objectives are achieved.

• The laboratory shall

o Establish

o Implement

o Maintain

a management quality system.

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Quality policy

The quality policy statement shall be issued under the authority of top management.

• a) Lab management's commitment to good professional practice and to the quality of its

testing in servicing its customers;

• b) Statement of the laboratory's standard of service;

• c) The purpose of the management system related to quality;

• d) A requirement that all personnel concerned with testing activities within

the laboratory familiarize themselves with the quality documentation and implement the

policies and procedures in their work; and

• e) The laboratory management's commitment to comply with this International Standard and

to continually improve the effectiveness of the management system.

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Q policy

• Top management shall provide evidence of commitment to the development and

implementation of the management system and to continually improving its effectiveness.

• The quality manual shall include or make reference to the supporting procedures including

technical procedures. It shall outline the structure of the documentation used in the

management system.

• 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.

• Top management shall ensure that the integrity of the management system is maintained

when changes to the management system are planned and implemented.

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4.3 Document Control

• The laboratory shall

o Establish

o Implement

o Maintain

procedures to control all documents that form part of

its management system

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Document

Documents

information and its supporting medium

for examples:

• paper

• magnetic

• electronic or optical computer disc

• photograph

• master sample

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Document approval and issue

o All documents issued shall be reviewed and approved .

o A master list or an equivalent document control procedure identifying the current revision

status and distribution of documents in the management system .

o The procedure(s) adopted shall ensure that:

• a) authorized editions of appropriate documents are available at used locations.

• b) documents are periodically reviewed and, where necessary, revised .

• c) invalid or obsolete documents are promptly removed from all points .

• d) obsolete documents retained for either legal or knowledge preservation purposes

are suitably marked.

Management system documents generated by the laboratory shall be uniquely identified.

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Document change

• Changes to documents shall be reviewed and approved .

• Where practicable, the altered or new text shall be

identified in the document .

• Amendments shall be clearly marked, initialed and dated.

• A revised document shall be formally re-issued as soon as

practicable.

• Procedures shall be established to describe how changes

in documents maintained in computerized systems are

made and controlled.

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Control of quality records

A record is a type of document. Which provide evidence that

activities have been performed or results have been achieved.

Records management addresses six key issues:

• identification

• storage

• protection

• retrieval

• retention

• disposition

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4.4 Review of requests, tenders and contracts

• The laboratory shall establish and maintain procedures and Its shall ensure that:-

o a) Including the methods to be used.

o b) The capability and resources to meet the requirements.

o c) the selected method is capable of meeting the customers 'requirements .

• Lab's personnel have the skills and expertise necessary for the performance of the tests .

• The review shall also cover any work that is subcontracted by the laboratory.

• The customer shall be informed of any deviation from the contract.

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4.5 Subcontracting of tests and calibrations

• Laboratory subcontracts work shall be placed with a competent

subcontractor.

• The laboratory shall gain the approval of the customer, preferably

in writing.

• 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.

• The laboratory shall maintain a register of all subcontractors and a

record of the evidence of compliance with this International

Standard for the work in question.

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4.6 Purchasing services and supplies

• The laboratory shall have a policy and procedure(s) for the

selection and purchasing of services and supplies.

• materials that affect the quality of tests and/or calibrations are

not used until they have been inspected.

• The laboratory shall evaluate suppliers of critical consumables,

supplies and services.

• These purchasing documents shall be reviewed and approved

for technical content prior to release.

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4.7 Service to the customer

• The laboratory shall be willing to cooperate with

customers in clarifying the customer's request and in

monitoring and witnessing of tests.

• preparation, packaging, and dispatch of test and/or

calibration items needed by the customer for

verification purposes.

• The laboratory shall seek feedback include customer

satisfaction.

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4.8 Complaints

• The laboratory shall have a policy and procedure for

the resolution of complaints received from customers

or other parties.

• Records shall be maintained of all complaints and of

the investigations and corrective actions taken by the

laboratory (see also 4.11).

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4.9 Control of nonconforming testing and/or calibration work

• The laboratory shall have a policy and procedures nonconforming tests.

• The policy and procedures shall ensure that:-

o a) the responsibilities and authorities for the management of nonconforming work are

designated and actions are defined and taken when nonconforming work is identified;

o b) an evaluation of the significance of the nonconforming work is made;

o c) correction is taken immediately.

o d) where necessary, the customer is notified and work is recalled;

o e) the responsibility for authorizing the resumption of work is defined.

• Where the evaluation indicates that the nonconforming work the corrective action

procedures shall be promptly followed.

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4.10 Improvement

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

• management review.

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4.11 Corrective action

• The laboratory shall establish a policy and a procedure and

shall designate appropriate authorities for implementing

corrective action when nonconforming work or departures

from the policies and procedures in the management

system or technical operations have been identified.

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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,

• equipment and its calibration.

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4.12 Preventive action

• 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.

• the preventive action might involve analysis of data, including

trend and risk analyses and proficiency-testing results.

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4.13 Control of records

The laboratory shall establish and maintain procedures for:-

• identification,

• collection,

• indexing,

• access,

• filing,

• storage,

• maintenance

• disposal

of quality and technical records. Records may be in any

media, such as hard copy or electronic media.

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4.14 Internal audits

• The laboratory shall periodically, conduct internal audits of its

activities to verify that its operations continue to comply with

the requirements of the management system and ISO 17025.

• Follow-up audit activities shall verify and record the

implementation and effectiveness of the corrective action taken.

• The cycle for internal auditing should normally be completed in

one year.

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4.15 Management reviews

• 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.

• A typical period for conducting a management review is once

every 12 months.

Technical Requirements

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5.1 General

Many factors determine the correctness and reliability of the tests and/or calibrations

performed by a laboratory.

• human factors (5.2);

• accommodation and environmental conditions (5.3);

• test and calibration methods and method validation (5.4);

• equipment (5.5);

• measurement traceability (5.6);

• sampling (5.7);

• the handling of test and calibration items (5.8).

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5.2 Personnel

The laboratory management shall ensure the competence of all who

• operate specific equipment,

• perform tests,

• evaluate results,

• sign test reports.

Personnel shall be qualified on the basis of appropriate education,

training, and experience.

• The laboratory shall have a policy and procedures for identifying

training needs and providing training of personnel.

• The laboratory shall maintain current job descriptions for

managerial, technical and key personnel.

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Job descriptions

The responsibilities with respect to :-

• performing tests;

• the planning of tests and evaluation of results;

• reporting opinions and interpretations;

• method modification and development and

validation of new methods;

• expertise and experience required;

• qualifications and training programmes;

• managerial duties.

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5.3 Accommodation and environmental conditions

Laboratory facilities and environmental conditions, shall be such as to facilitate:-

• correct performance of the tests.

• sampling undertaken at sites other than a permanent laboratory facility.

• monitor, control and record environmental conditions.

• prevent cross-contamination.

• Access to areas affecting the quality shall be controlled.

• ensure good housekeeping.

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5.4 Test and calibration methods and method validation

The laboratory shall use appropriate methods and procedures for all tests

within its scope which include:-

• Sampling,

• Handling,

• Transport,

• Storage and

• Sample preparation.

• The laboratory shall have instructions on the use and operation of all

relevant equipment

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Non-standard methods

The valid method should contain at least the following information:

• a) appropriate identification;

• b) scope;

• c) description of the type of item to be tested or calibrated;

• d) parameters or quantities and ranges to be determined;

• e) apparatus and equipment, including technical performance requirements;

• f) reference standards and reference materials required;

• g) environmental conditions required and any stabilization period needed;

• h) description of the procedure, including

• i) criteria and/or requirements for approval/rejection;

• j) data to be recorded and method of analysis and presentation;

• k) the uncertainty or the procedure for estimating uncertainty.

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Validation of methods

The laboratory shall validate non-standard methods

The techniques used for the determination of the performance of a method should be one of, or

a combination of, the following:

• calibration using reference standards or reference materials;

• comparison of results achieved with other methods;

• interlaboratory comparisons;

• systematic assessment of the factors influencing the result;

• assessment of the uncertainty of the results based on scientific understanding of

the theoretical principles of the method and practical experience.

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Estimation of uncertainty of measurement

• Testing laboratories shall have and shall apply procedures for estimating

uncertainty of measurement.

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Control of data

When computers or automated equipment are used the laboratory shall ensure that:

• a) computer software developed by the user is documented in sufficient detail and is

suitably validated as being adequate for use;

• b) protection procedures shall include, but not be limited to,

o integrity and confidentiality of data entry or collection,

o data storage,

o data transmission and

o data processing;

• c) computers and automated equipment are maintained to ensure proper functioning

and are provided with the environmental and operating conditions.

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5.5 Equipment

• The laboratory shall be furnished with all items of sampling,

measurement and test equipment required for the correct

performance of the tests and/or calibrations (including

sampling, preparation of test and/or calibration items,

processing and analysis of test and/or calibration data).

• Equipment shall be checked and/or calibrated before use.

• Equipment shall be operated by authorized personnel.

• equipment and its software shall be uniquely identified.

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Equipment Records

The records shall include at least the following:

• a) the identity of the item of equipment and its software;

• b) the manufacturer's name, type identification, and serial number

• c) checks that equipment complies with the specification

• d) the current location, where appropriate;

• e) the manufacturer's instructions:

• f) dates, results and copies of reports and certificates of all calibrations, adjustments,

acceptance criteria, and the due date of next calibration;

• g) the maintenance plan, and maintenance carried out to date;

• h) any damage, malfunction, modification or repair to the equipment.

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Equipment procedures

The laboratory shall have procedures for

• safe handling,

• transport,

• storage,

• use and planned maintenance

of measuring equipment .

Additional procedures may be necessary when measuring

equipment is used outside the permanent laboratory or sampling.

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General Requirements

• Equipment that has been subjected to overloading or mishandling ,It shall be

isolated to prevent its use or clearly labeled or marked as being out of service.

• all equipment under the control of the laboratory and requiring calibration shall be

labeled, coded.

• equipment goes outside the direct control of the laboratory, shall checked and

shown to be satisfactory before returned to service.

• equipment, including both hardware and software, shall be safeguarded from

adjustments which would invalidate the test and/or calibration results

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5.6 Measurement traceability

The laboratory shall have an established programme and procedure for the

calibration of its equipment. which should include a system for:-

• selecting,

• using,

• calibrating,

• checking,

• controlling and

• Maintaining measurement

standards, reference materials.

• The laboratory shall have procedures for safe handling, transport, storage

and use of reference standards and reference materials.

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Reference (standards and materials)

Reference Material (RM)

• 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.

Certified Reference Material (CRM)

• A Reference Material, accompanied by a certificate, one or more of whose property values

are certified by a procedure which establishes its traceability to an accurate realization of the

unit in which the property values are expressed and for which each certified value is

accompanied by an uncertainty at a stated level of confidence.

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5.7 Sampling

• The laboratory shall have an available sampling plan and

procedures for sampling when it carries out sampling of

substances, materials or products for subsequent testing or

calibration.

• the customer requires deviations from the documented

sampling procedure, these shall be recorded in detail with

the appropriate sampling data and shall be included in all

documents containing results.

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Sampling Records

• The laboratory shall have procedures for recording relevant data

and operations relating to sampling,

• These records shall include :-

• the sampling procedure used,

• the identification of the sampler,

• environmental conditions ,

• diagrams or the sampling location.

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5.8 Handling of test and calibration items

The laboratory shall have procedures for:-

• transportation,

• receipt,

• handling,

• protection,

• storage,

• Retention,

• disposal .

of test and/or calibration items,

• The laboratory shall have a system for identifying sample.

• Upon receipt of sample, record any abnormalities or departures from

normal or specified conditions, as described in the test method.

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5.9 Assuring the quality of test and calibration results

• The laboratory shall have quality control procedures for monitoring the validity of

tests and calibrations undertaken.

• This monitoring shall be planned and reviewed and may include, but not be limited

to, the following:

• a) regular use of certified reference materials and/or internal quality control

using secondary reference materials;

• b) participation in interlaboratory comparison or PT programmes;

• c) replicate tests or calibrations using the same or different methods;

• d) retesting or recalibration of retained items;

• e) correlation of results for different characteristics of an item.

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5.10 Reporting the results

Test report shall include at least the following information:-

• a) title (e.g. “Test Report” or “Calibration Certificate”);

• b) the name ,address, and the location of the laboratory .

• c) unique identification of the test report , on each page an identification, and a clear

identification of the end of the test report;

• d) the name and address of the customer;

• e) identification of the method used;

• f) a description of, the condition of, and unambiguous identification of the sample(s) .

• g) the date of receipt of the test or calibration item(s);

• h) reference to the sampling plan and procedures used by the laboratory;

• i) the test or calibration results with, where appropriate, the units of measurement;

• j) the name(s), function(s) and signature(s) or equivalent identification of person(s).

Documentation

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Required documents for 17025

• Policies.

• Procedures.

• Files

• Job descriptions.

• Forms.

• Lists.

• Others.

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Policies

• POL-01: Quality Policy (4.2.2)

• POL-02: Confidentiality Policy (4.1.5.c)

• POL-03: Gifts and Gratuities Policy (4.1.5.b)

• POL-04: Internal Complaint Policy (4.1.5.b)

• POL-05: External Complaint Policy (4.8)

• POL-06: Laboratory Access Policy (5.3.3, 5.3.4)

• POL-07: Good Housekeeping Policy (5.3.5)

• POL-08: Use of Outside Support Services and Supplies Policy (4.6.1)

• POL-09: Acceptable Activities Policy (4.1.5.d)

• POL-10: Nonconforming Calibration Work Policy (4.9.1, 5.5.7)

• POL-11: Corrective Action Policy (4.10)

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Procedures

• PRO-01: Quality Documentation Maintenance and Distribution Procedure (4.3.1, 4.3.2, 4.3.3)

• PRO-02: Traceability Procedure (5.5.2, 5.6.1, 5.6.3.1)

• PRO-03: Work Flow Procedure (4.4, 5.4.1, 5.8.2, 5.8.3, 5.8.4)

• PRO-04: Equipment Maintenance Procedure (5.4.7)

• PRO-05: Feedback and Corrective Action Procedure (4.9.1, 4.10, 5.5.7)

• PRO-06: Complaint Procedure (4.8)

• PRO-07: Determining Calibration Intervals Procedure (5.6.1)

• PRO-08: Environment Recording Procedure (5.3.2)

• PRO-09: Suspect Equipment Procedure (5.5.7)

• PRO-10: Calibration Status Procedure (5.5.8)

• PRO-11: Equipment Acceptance Procedure (5.5.2)

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Procedures

• PRO-12: Certificate Preparation and Approval Procedure (5.4.7, 5.10.4.2, 5.10.5)

• PRO-13: Data Backup Procedure (4.1.5.c, 5.4.7)

• PRO-14: Consumable Material Procedure (4.6.1, 4.6.3)

• PRO-15: Electronic Transmission Procedure (4.1.5.c, 5.4.7, 5.10.7)

• PRO-16: Activity Evaluation Procedure (4.1.5.d)

• PRO-17: Externally Generated Quality Documentation Maintenance and Distribution Procedure

(4.3.1,

4.3.2, 4.3.3)

• PRO-18: Maintenance of Electronic Documents Procedure (4.3.3)

• PRO-19: Preventive Action Procedure (4.11)

• PRO-20: Record Control Procedure (4.12.1)

• PRO-21: Transport and Storage Procedure for Reference Standards and Reference Materials (5.6.3.4)

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Files

• Employee Personnel Files (General: 5.2.2, 5.2.5)

• Technical Manager Personnel File (4.1.5.g)

• Quality Manager Personnel File (4.1.5.g)

• Interlaboratory Comparison and Proficiency Test File (5.9)

• Audit Documentation File (4.13)

• Management Review File (4.14)

• Equipment File (5.5.1, 5.5.5, 5.5.6, 5.5.10)

• Outside Supplier File (4.6.4)

• Obsolete Documents File (4.3.2)

• Work Order File (4.4)

• Sub-Contractor File (4.5.4)

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Job descriptions

• Technical Manager Job Description (4.1.5.a, 4.1.5.f,

4.1.5.h, 4.2.4, 5.2.1, 5.2.4)

• Quality Manager Job Description (4.1.5.a, 4.1.5.f, 4.1.5.i,

4.2.4, 5.2.1, 5.2.4)

• Technician Job Description (4.1.5.f, 5.2.1, 5.2.4)

• Administrative Assistant Job Description (4.1.5.f, 5.2.1,

5.2.4)

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Forms

• Skills Matrix (5.2.2, 5.5.3)

• Field Calibration Approval Form

• Certificate Cover Page Form (5.10.1)

• Quality Documentation Update Form (4.2.1, 5.4.3)

• Quality System Training Form (4.2.1)

• Internal Training Form

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Lists

• Quality Document Master List (4.2.3, 4.3.2)

• Major Equipment List (5.5.4)

• Reference Measurement Standards List (5.5.4)

• Outside Support Services and Supplies List (4.6, 4.6.1)

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Others

Agendas

• Management Review Agenda (4.14, 5.2.1, PRO-16, PRO-19)

• Employee Annual Review Agenda (5.2.2)

• New Hire Introduction (Agenda) (4.1.5.c, 5.2.2)

Checklists

• Calibration Procedure Approval Checklist (5.4.4)

• Sample provided

• Empty form or file with layout provided

Accreditation

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Accreditation benefits

• Your laboratory will gain international recognition for its commitment to quality,

• you comply with an internationally recognized standard, thus easing the global exchange of

valuable information.

• Accreditation is an objective way to assure your customers that you have demonstrated

technical competence to provide reliable and accurate test or calibration results.

• third party accreditation body performs annual assessments to verify whether your system is

meeting all of the requirements of ISO/IEC 17025.

• Otherssssssssssssssssssssssssssssssssssssssssssssss.

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Accreditation Steps

• A laboratory must document a quality management system.

• A documented quality manual is a basic requirement on the road to laboratory accreditation.

• In addition, quality management procedures must be established for how the system is

maintained.

• Once the system is documented it must be implemented in the laboratory.

• It will also accompany the laboratory’s application for accreditation.

• The implementation period will require several months to establish the records that an

accreditation body will review at an accreditation audit.

• Finally, the laboratory undergoes the ISO17025 assessment by an accreditation body that is

certified to perform laboratory accreditation.

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Steps Towards ISO/IEC 17025 Accreditation

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Thanks