Quality Management Systems for Laboratories ISO 17025:2017
ISO/IEC 17025:2017 previous revision of ISO 17025:2012 was updated through collaboration with the International Electrotechnical Commission (IEC) and released on November 29, 2017. It is often used in connection with ISO 15189 Medical Laboratories – Requirements for Quality and Competence for companies in the medical sector.
ISO/IEC 17025:2017 Standard is applicable to all laboratories engaged in Calibration, Verification, Sampling or Testing and applies to all small, medium, large, government or privately-owned Laboratories and other entities engaged in activities of Testing, and Calibration. ISO/IEC 17025 has established the requirements necessary to demonstrate ability to provide accurate and consistent results of tests and measurements performed.
ISO/IEC 17025 Standard and ISO 15189 Medical Laboratory Standard are used for laboratory accreditation for testing / calibration and medical testing. These two standards are Laboratory Accreditation Standards for generic testing / calibration and medical testing.
ISO/IEC 17025 helps laboratories ensure customers that they can produce services competently and consistently and includes requirements for identifying risks and the need for taking preventive actions to mitigate the risk and provide reliable services.
An experienced / reputable ISO/IEC 17025 consulting company is beneficial in successful accreditation achievement. Quality System Enhancement has over 27 years of experience as a premier consulting company to provide effective ISO/IEC 17025 training, to meet all requirements of ISO/IEC 17025 standard through gap analysis, creation of simplified documentation, implementation assistance, initial internal audit of system, corrective action assistance, and preparation for the ISO/IEC 1702 Accreditation Audit.
To prepare organizations for ISO/IEC 17025 Accreditation, QSE auditors provide extensive / comprehensive ISO/IEC 17025 internal audit reports and submits them to top management for appropriate and timely corrective actions.
ISO/IEC 17025 emphasizes total customer satisfaction related to laboratory testing & measuring equipment calibration, with accurate results using competent laboratory technicians. The ISO/IEC 17025 standard requires laboratory technicians use appropriate audit checklists to record test results with for comprehensive coverage of requirements. It is essential to conduct internal audits using ISO/IEC 17025 audit checklists to judge the effectiveness of the entire ISO/IEC 17025 quality management system in maintaining and retaining customer satisfaction related to laboratory testing / measuring equipment calibration.
The following are the basic requirements for ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories:
- ISO/IEC 17025:2017 focuses on safety by establishing a Safety Officer with defined responsibilities to ensure employees realize their responsibility for personal safety and the safety of others who can be impacted.
- ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
- ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
- Laboratory customers, regulatory authorities, organizations, and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories. (Source: ANSI)
- Structural Requirements with defined management structure roles, responsibilities and range of activities
- Resource requirements include personnel, facilities, and environmental conditions, equipment, metrological traceability, externally provided products & services.
- Process requirements which include review of requests, tendering, controls verification validation of methods and sampling.
- Management system requirements include control of management system documentation, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits, and management review. (Source: ISO/IEC 17025;2017 standard)
- All Laboratories engaged in Laboratory testing of need a Testing Quality ManagementSystem (TQMS)
- TQMS can assure customers / government that the facility has a robust system and can produce valid results on test services, saving and conserving Quality.
- ISO 17025:2017 Standard is an international standard dedicated to supporting safety ensuring TQMS for Laboratory Safety. The medical laboratories requiring to have a comprehensive TQMS and satisfying their customers/interested parties need ISO 17025 Accreditation to maintain safety.
- A good ISO 17025 consulting firm can provide a detailed explanation of the intent of the standard and build a safe laboratory system. The medical laboratories requiring to build a safe laboratory system needs ISO 17025 Accreditation.
- A comprehensive laboratory safety system creates confidence in end users, government, statutory and regulatory agencies and Laboratories seeking to provide answers to all questions from agencies must get ISO 17025 Accreditation.
- An ISO 17025 consulting firm provides the techniques for implementing the system. Hence any facility seeking comprehensive system must get certified.
- Consulting firm can provide auditing services to help the facility to verify the accuracy and adequacy of implementation. Companies hoping to have world class service and accuracy in their work must get ISO 17025 Accreditation.
- Internal Quality Audit is conducted by ISO 17025 consultants help the Laboratory find deficiencies in their implementation, make correction and take corrective actions. ISO 17025 Accreditation streamlines these processes. Laboratories desirous of having processes streamlined must get ISO 17025 Accreditation.
- An annual surveillance audit is conducted to ensure maintenance of an ISO 17025 Accreditation laboratory.
- Consulting firms provide distinction in documentation between repeatability and reproducibility of test results.
- ISO 17025:2017 Accreditation is renewable every three years.
- Process of ISO Accreditation starts with preparation of a Quality Management System. (QMS) and the process of ISO 17025 Accreditation starts with developing ISO 17025 Laboratory System.
- ISO Consultants assist in developing a comprehensive QMS to meet all requirements of ISO 17025 and 3rdParty Accreditation Body stage 1 audit requirements. The stage 1 audit from ISO 17025 Accreditation Bodies vary depending on the selected Accreditation Bodies which verifies the documented system meeting all ISO 17025 requirements or not.
- An ISO 17025 consulting firm provides the techniques for implementation, and trains the organization’s internal auditors to become competent to perform internal audits or provides ISO Internal AuditingServices to audit all processes, all ISO 17025 Standard requirements and effective implementation of ISO 17025 Standard.
- Laboratories need to initiate corrective actions and continual improvement is realized through control of nonconforming products / services.
- Laboratories need to implement the prepared QMS for a minimum of 3 months and gather adequate data and record to show as evidence.
- Management of Laboratories need to conduct one comprehensive management review of the entire Laboratory System and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO 17025 standard requirements not being fulfilled.
- Once the medical laboratory system is ready, one full cycle of Internal audits is performed and one Management review is conducted prior to inviting a Accreditation Body to perform ISO 17025 Accreditation Audit.
- Accreditation Bodies conduct Audit in 2 stages. During Stage 1, ISO audit evaluates the documentation system and basic requirements of meeting ISO 17025 Requirements.
- Accreditation Body returns for final audit where all ISO 17025 standard requirements are thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance.
- Once Accreditation Body is satisfied for compliance, the recommendation is sent to accrediting agencies to issue ISO 17025 Accreditation.
- QSE Consulting practice focuses on assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented Laboratory Management System (LMS) for achieving ISO 17025 Accreditation for Laboratories.
- QSE Consultants Laboratories to have a Laboratory Management System and associated documents/records to show as evidence of having implemented the system.
- QSE always follows a tried and tested 10 step disciplined path in preparing Laboratories for ISO 17025 Accreditation, which is insensitive to failure.
- QSE 17025 consultants assist Laboratories to prepare a comprehensive simplified documentationsystem to show as evidence of having a streamlined process that ensures quality product or service every time without fail.
- QSE ISO 17025 consultants help in identifying issues and concerns of all stake holders and take them in to account in preparing a QMS for ISO 17025 Accreditation.
- QSE’s ISO 17025 consultants provide training to assist Laboratories in matching competence of personnel assigned to tasks, methods to select providers who supply quality products and services.
- QSE’s ISO 17025 consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality.
- QSE’s ISO 17025 consultants assist organizations to identify all processes and facilitate in establishing process performance metrics or process performance indicators (Key Process Indicators = KPIs) to effectively monitor and measure organizations intended Goals and Objectives.
- QSE’s ISO 17025 Consulting services are required to assist organizations in building a comprehensive LMS to identify risks at every process and have steps to mitigate risk.
- Internal Quality Audits conducted by QSE’s ISO 17025 auditors and consultants, help the Laboratory to find all deficienciesin their implementation which are not normalcy found during organizations first party audits.
- QSE’s consultants assist in meeting “Annex SL, a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written.” which in turn meets ISO 17025 requirements.
- QSE’s ISO 17025 consultants provide ISO 17025 training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement.
- QSE’s ISO 17025 consultants assist organizations to effectively control documented information (Documents and Records) related to changes, conducting ISO management review meetings covering all management review inputs. (as per ISO 17025 requirements)
Including the trends to be monitored, internal audit results are fully addressed, risk related activities identified/assessed/mitigated, root-cause, identified and analysis is fully applied.
- QSE’s ISO 17025 consultants ensure that Accreditation is achieved with no or minimum nonconformities first time around.
- 1stParty Audit: Audits performed by a team within the facility is called 1st Party Audit.
- 2ndParty Audit: Audits performed by organizations on their suppliers is called 2nd Party Audit.
- 3rdParty Audit: Audits performed by Accreditation Bodies is known as a 3rd party audit.
3rd Party audit Accreditation Bodies (Accredited by International Accreditation Forum =IAF) perform the audits on the organizations to grant ISO 17025 Accreditations with demonstrated evidence of conformity to all the requirements of ISO 17025:2017.
3rd Party audit is conducted by Accredited Certifying Bodies accredited by ISO and are signatories to IAF and MLA.
- QSE has over 27 Years of standing in the field of Consulting, Auditing and Training for any ISO Standard, Sector Specific Standard, AISC standard or Food Safety
- QSE has helped over 800 Laboratories to earn their ISO 17025 Accreditation s and other Accreditations.
- All QSE’s ISO17025 laboratories pass ISO 17025 Accreditation Audits with no or minimum nonconformities.
- Over 98 % of QSE customers pass ISO Accreditation Audits with nil nonconformity first time around. QSE has a 100 % success rate in obtaining Accreditation s for its customers.
- Unlike our competitors, QSE has a unique, comprehensive, evidence based, simplified single level, documentation system which is easy to implement and provides evidence for implementation to earn ISO 17025 Accreditation.
- QSE’s designed templates are tried and tested for accuracy and correctness and provide objective evidence during internal audits and ISO Accreditation audits
- QSE’s ISO 17025 simplified system is evidence based, and it is easy to implement, easy to use and easy to audit.
- QSE ‘s evidence-based system with proven lists, forms and tables results in ISO 17025 Accreditation with minimum or no nonconformities.
- QSE only engages competent ISO 17025 auditors to conduct internal audits or supplier audits.
The benefits of implementing ISO 17025:2017 management systems are diverse and are seen in all departments of your company. The following are some of the benefits that you should take into consideration:
- An ISO 17025:2017 Accreditation promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
- Promotes a strong degree of consistency in compliance to laboratory laws and legislation both from an international and national perspective.
- ISO 17025:2017 Accreditation helps Improvement in Safety and Quality.
- ISO 17025:2017 Accreditation is a powerful marketing tool that brings your organization long-term Global Recognition.
- ISO 17025:2017 Accreditation helps Improvement in Business Opportunities
- ISO 17025:2017 Accreditation enhances consumer confidence through Problem Solving and Continual Improvement.
- Through ISO 17025 Internal Auditing provides an effective management tool to run any business considering from “Quote to Cash” processes for enhancing consumer confidence.
- ISO 17025:2017 Accreditation is fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
- TheISO 17025:2017 Accreditation program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of activities in the labs.
- ISO 17025:2017 Accreditation ultimately promoted the growth of customer satisfaction in organizations involved in laboratory testing to ensure safety.
QSE has assisted over 700 organization in obtaining ISO and other Accreditations, contact details can be furnished on demand for any accreditation.
Frequently Asked Questions
All laboratories engaged in taking measurements conducting testing and reporting, conducting calibrations and reporting must get certified to ISO 17025 for global recognition and to earn customer confidence
The main feature auditors look for is the reproducibility and repeatability of the results. Honest in reporting and evidence based records for all reports the laboratory submits to their customers
Cost of certification depends on the size of the laboratories, number of people working several processes engaged in the laboratory, extent of training required for employees and please contact QSE with details and a formal quote submitted in less than 48 hours giving all details