ISO 17025: 2017 LABORATORY MANAGEMENT SYSTEM

ISO 17025: 2017 Laboratory Management System

ISO 17025:2017 specifies the requirements for the competence, impartiality, and consistent operation of laboratories.

  • ISO 17025: 2017 more closely aligns with ISO 9001: 2015 to promote risk-based thinking
  • Clearly defined standard/specification
  • Requires laboratories to take RISK into account when determining compliance.

ISO 17025: 2017 LABORATORY MANAGEMENT SYSTEM

What Has Changed in ISO 17025: 2017?

A decision rule is a ” rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement.”

When the customer requests a statement of conformity to a specification standard for the test or calibration (e.g., pass/fail, intolerance / out of tolerance), the specification or bar and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard. The decision rule shall be communicated to and agreed upon with the customer.

When a statement of conformity to a specification or a standard is provided, the Laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule used and apply the decision rule.

The Laboratory shall report on the statement of conformity, such that the statement identifies:

  1. a) to which results in the statement of conformity applies
  2. b) which specifications, standards, or parts thereof are ‘met’ or ‘not met.’
  3. c) the decision rule applied (unless it is inherent in the requested specification or standard)

Major changes in ISO 17025: 2017 Version

  • The risk-based thinking applied
  • Greater flexibility than the previous edition in requirements for process, procedure, documented information, and organization responsibilities
  • A definition of “Laboratory” has been added

History of ISO 17025

  • 1983: ISO / IEC Guide 38
  • 1985: ISO / IEC Guide 45
  • 1986: ISO / IEC Guide 49
  • 1990: ISO / IEC Guide 25
  • 1999: ISO / IEC 17025 1st Edition
  • 2005: ISO / IEC 2nd Edition
  • 2017: ISO / IEC 17025 3rd Edition
  • Why ISO / IEC 17025: 2017

Laboratory customer expects:

  • Accuracy of test / Calibration of results
  • Reliability – test / Calibration results accepted by the customer as they are
  • Timely response and reporting of results
  • ISO 17025: 2017 PROVIDES FRAMEWORKS TO MEET / EXCEED THESE EXPECTATIONS
  • Standard developed by International Organization for Standardization(ISO) and International Electro-Technical Commission (IEC)

What are the Benefits of ISO 17025: 2017?

The benefits of ISO 17025 are as follows

  • National & Recognition
  • Recognizes the technical competence of laboratory staff
  • Assures the client that results are technically valid
  • Provides Comparability in Measurement
  • Decision Makers can rely on test results
  • Improve staff motivation
  • Ensures better support in the event of a legal challenge
  • To assist in the development of new programs
  • To reduce technical barriers in trade
  • Saves money by getting it the right first time

ISO 17025: 2017Accreditation Process

ISO 17025: 2017 Accreditation Process is as follows

  • Application
  • Document review
  • Accreditation Assessment
  • Accreditation Result
  • Surveillance & Continual Assessment

What are the requirements of the ISO 17025 Standard?

There are two main clauses in ISO IEC 17025

  • Management Requirements
  • Technical Requirements

Management Requirements

Management requirements are related to the operation and effectiveness of the Quality Management System within the Laboratory. This clause has similar requirements to ISO 9001. Management Requirement covers the specifications and compliances to

  • Organization
  • Quality System
  • Review of Requests
  • Document Control
  • Subcontracting of Tests and Calibrations
  • Purchasing Services and Supplies
  • Service to Client
  • Complaints
  • Control of Non-Conforming Testing and Calibration Work
  • Corrective Action
  • Control of Records
  • Preventive Action
  • Internal Audits
  • Management Reviews

ISO 17025 Requirements in details

  • Management Requirements
  • Organization

The Laboratory must be legally identifiable

  • Identify and eliminate potential conflicts of interest within the overall organization
  • Identify and eliminate departures from the Quality Management System
  • Protect Confidential, proprietary information
  • Avoid activities that would diminish confidence in the Laboratory
  • Define the Organization of the Laboratory and inter-relationships within the Laboratory
  • Technically Competent Management
  • Quality Manager for the Laboratory
  • Appoint Deputies for key Managerial personnel

Quality System

Establish a quality system and document all the

  • Policies
  • Systems
  • Procedures
  • Instructions

Create a Quality Manual to include a Quality Policy statement

  • (Management commitment to good professional practice, standards of services, objective, personal requirements, management commitment to comply with ISO 17025)
  • Structure of documentation
  • Management roles and responsibilities
  • Ensure records are kept of all activities supporting your quality system

Document Control

  • White Procedures
  • SOPs
  • Work Instructions
  • Guidelines
  • Important to Plan, Executer, and Control test calibration activities
  • Control all procedures
  • Identify
  • Track all documents
  • Ensure document numbering
  • Revision number
  • Issue date / effective date on all the documents
  • Create and maintain Master List of Documents
  • Ensure that only authorized documents are in use
  • Periodically review all documents and revise as necessary
  • Remove invalid or obsolete documents from use immediately
  • Uniquely identify each quality system document
  • Define and control the document revision process
  • Control documents of external origin

Review of Requests, Tenders, and Contracts

  • Clearly Understand customer requirements and document all the inquiries
  • Keep records of review to check the capability of the Laboratory
  • Review sub-contracted work
  • Notify customer of any deviations from the Contract
  • Amend Contract as necessary, Repeat the review process, and ensure that amendments are communicated to all affected personnel

Subcontracting of Tests and Calibrations

  • Choose only competent sub-contractors who comply with ISO 17025
  • Notify the customers that sub-contractors are being used
  • Sub-Contractors must be approved by the customer whenever possible

Purchasing Services and Supplies

  • Evaluate suppliers of goods and services that are critical to the quality of testing and calibration
  • Ensure
  1. Supplier Registration
  2. Supplier Evaluation
  3. Supplier Re-Evaluation
  • inspects goods and services before use

Service to the Client

  • Understand the customer’s needs and keep them informed of delays or deviations
  • Seek feedback from the customer and utilize customer surveys

Complaints

  • Have a procedure for resolving complaints
  • Record all complaints and actions taken

Control of Non-Conforming testing/calibration work

  • Assign responsibility and authority for handling non-conforming work
  • Evaluate the significance of the non-conformity
  • Take Corrective Action
  • Notify the customer of non-conforming work

Corrective Action

  • Find the “root cause” of all non-conforming work produced by the Laboratory
  • Select and implement the action most likely to eliminate the cause of the problem
  • Corrective Action should be appropriate to the magnitude and risk of the problem
  • Monitor progress of the corrective action to ensure effectiveness
  • Document and implement any changes indicated by the corrective action
  • Schedule an audit of the Laboratory if the non-conformity brings laboratory integrity into question

Preventive Action

  • Identify needed improvements and potential non-conformities
  • Plan Preventive Action
  • Ensure Effectiveness of the preventive action

Control of Records

  • Keep records of the quality system and technical activity
  • Store the records suitably
  • Establish retention times
  • Keep complete records of calibration results made at the time of the test
  • Mistakes in recording results will be crossed out initialled but not erased.

Internal Audits

  • Audit the Laboratory’s activities at least annually
  • Auditors should be independent of the audited facility
  • Take timely corrective action if problems are found
  • Follow up on corrective action to ensure its effectiveness

Management Reviews

  • Laboratory executive management will periodically review the Laboratory’s quality system and activity
  • Maintain records like MRM Agenda, MRM Minuets, and MRM Action plan

Technical Requirements

  • Technical Requirements Covers the specifications and compliances to
  • Personnel
  • Accommodation and Environmental Conditions
  • Test and Calibration Methods and Method Validation
  • Equipment
  • Measurement Traceability
  • Sampling
  • Handling of Test and Calibration Items
  • Assuring the Quality of Test and Calibration Results
  • Reporting the Results

General

  • Many factors contribute to the correctness and reliability of tests and calibrations
  • The Laboratory must account for these factors

Personnel

  • Only Competent, qualified personnel can execute procedures
  • Formulate goals for the education, training, and skills of personnel
  • Identify training needs and provide training
  • Keep records of authorization, competence, qualifications, training, and experience of personnel
  • Maintain job descriptions for all personnel involved in test or calibrations

Validation of Methods

  • Validation requires objective evidence that the selected method meets the requirements
  • All tests and calibration must be validated
  • Record the results of validation and the procedure used for validation
  • The range and the accuracy of values obtainable from validated methods shall be relevant to customer’s needs

Selection of Methods

  • Use validated test methods that are suitable for the task and which meet the needs of the customer
  • Methods published in international standards are preferred
  • laboratory-developed methods may be used if they are validated

Laboratory-developed methods

  • The introduction of laboratory-developed methods will be planned
  • Effective communication will be ensured

Non-Standard Methods

  • Non-Standard methods will be approved by the customer and appropriately validated before use

Estimation of Uncertainty of Measurement

  • Calibration and testing laboratories will estimate the uncertainty of all measurements
  • Where rigorous uncertainty analysis cannot be done, all relevant uncertainty components will be identified, and a reasonable estimation of their magnitude will be made

Uncertainty estimates can be obtained in one of two ways:

  1. uncertainty estimates are obtained by the statistical analysis of data

For Example,

Repeatability may be estimated as the standard deviation of a set of repeated measurements.

  1. Uncertainty estimates are obtained by other means, such as finding the uncertainty of a calibration result on a calibration certificate or the uncertainty in the value of reference material from the material certification. In some cases, uncertainty estimates can be based on one’s knowledge and experience or the laws of physics, or from the knowledge about how a measuring instrument behaves

Procedure for Determining the Uncertainty

  • Determining what you are measuring
  • Determine units of measure
  • Obtain uncertainty of calibration standard or equipment used for test
  • Evaluate repeatability
  • Evaluate resolution/readability of all instruments
  • Identify and evaluate other sources of uncertainty
  • Prepare budget documentation
  • Evaluate reasonability of budget
  • Determine combined standard uncertainty
  • Determine expanded uncertainty at 95% level of confidence

Control of Data

  • Calculations and data transfers shall be systematically checked
  • Validate and document all software written by laboratory personnel
  • Protect the data generated in the Laboratory
  • Maintain the computers to ensure the integrity of test and calibration data

Equipment

  • Provide equipment that is capable of achieving the required accuracy
  • Calibrated equipment before use
  • Only authorized personnel will operate equipment
  • Maintain a calibration record for each piece of equipment
  • Protect and maintain equipment
  • Remove defective or questionable equipment from use
  • Examine the effect of having used defective or questionable equipment
  • Update software to reflect changes in equipment parameters or correction factors
  • Calibration status will be displayed on all equipment
  • Prevent unauthorized adjustment of the equipment

Measurement Traceability

  • Calibrate equipment before use
  • All equipment must have traceability to national/international standards
  • Reference standards shall be calibrated by a suitable agency

Sampling

  • If sampling is employed, the sampling plan must be statically justified
  • Follow procedures for sampling and record the results

Handling of Test and Calibration Items

  • Protect Calibration / Testing items
  • Identify all items to prevent confusion with similar items
  • On receipt of an item, inspect it for damage, abnormality, and suitability for testing
  • Provide safe storage facilities

Assuring Quality of Test and Calibration Results

  • Monitor and ensure the validity of tests and calibrations through certified reference materials
  • Participation in inter-laboratory comparisons or proficiency testing programs and calculate Z Score
  • Z score should be less than 2
  • Replicate tests or calibrations using the same or different methods
  • Re-testing or Re-Calibration of retained items
  • Correlation of results for different characteristics of an item

Reporting Results

ISO 17025 is quite specific about what must appear on reports from the Laboratory but also has a general requirement that the information must be reported

  • Accurately
  • Clearly
  • Unambiguously
  • Objectively

It must also be by any specific instructions in standard test or calibration methods specifications. There is a relaxation of this if a laboratory is reporting within its organization or in the case of a specific written agreement with a client. In these circumstances, the report may be abbreviated. Nonetheless, all of the information required by the standard report format must still be available within the Laboratory. Usually, the written agreement with the clients to report in an abbreviated form should be concluded as a part of the contract review.

Requirements for tests and calibration reports differ slightly, but the following are common factors.

  • A Title (Test Report, Calibration Certificate, Test Certificate, Calibration Report) appropriate terms, and there is no compulsion to use these specific terms
  • The name and the address of the Laboratory
  • The name and the address of the client
  • A serial number or similar unique identification for the report on each page
  • Identification details of samples and calibration items
  • Date of receipt of the item or dates of testing and calibrations
  • Validity of results to be done within a specific time
  • Identification of the method
  • sampling plan or method data
  • A note of deviations from a standard method and environmental conditions bear upon the results
  • The test or calibration results with units
  • Name, position, signature, and date of issue of the report
  • Identified as having authority to release data
  • Statement- only apply to the items tested or calibrated
  • Preferably, A Statement shall not be reproduced without the written permission
  • The Uncertainty of measurement in the calibration report
  • Evidence of traceability require details of the references used and cross-reference to their calibrations
  • Unless there is a legal requirement, carry any recommendations on a re-calibration interval or date

Why Choose TUV Austria Bureau of Inspection & Certification For Implementing ISO 17025 Requirements

Some of the leading international accreditation bodies have awarded TUV Austria Bureau of Inspection & Certification with the accreditation to offer certification to a vast range of industry sectors. For certification services, TUV Austria BIC is the preferred brand across multiple industry sectors.

Local Regulatory authorities like The Pakistan National Accreditation Council (PNAC)The Pakistan Engineering Council (PEC) also recognizes TUV Austria Bureau of Inspection & Certification as a leading certification and inspection body in Pakistan. TUV Austria BIC has earned global respect instead of its approach and service quality through its highly trained and experienced Consultants. Our professional auditors work with clients to guarantee that the requirements are successfully maintained and continuously improved to be up to customers’ expectations and the law.

In Addition, to ISO 17025:2017 Audits we also offer a range of complimentary services:

FAQ’s

What is ISO 17025 Laboratory Accreditation?

Accreditation to ISO 17025 means “Formal Recognition” by a National or International Body that is testing or calibration laboratory is competent to carry out specific tests or calibrations or sampling activity for subsequent test or calibration.

In other words, it is recognition of the lab’s competence and capability by a national or international body.

Why Accreditation of Laboratory is required?

If the laboratory is part of a parent manufacturing organization, then laboratory-related accountability is primarily confined to the validity and traceability of results produced by the laboratory and not to the further decision-making process in the parent company in their quality control activity after getting the results of the laboratory.

What are the Important Aspects of Laboratory Accreditation?

There are two important aspects of laboratory accreditation

  1. Validity – (or Reliability) of test or calibration results
  2. Traceability – of results to SI unit (System International Unit)

Who Can Avail ISO 17025?

Any Organization conducting Laboratory activities/operations

  • Testing Laboratory
  • Calibration Laboratory

What are the Focus Points to Implement ISO 17025?

  • Standardizing the Laboratory needs and its processes
  • Equipment and Calibration Procedure
  • Resource Requirements
  • Management Information System
  • Calibration Report and Certificate Requirements.

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