Changes in ISO 17025:2017

The older version of ISO 17025 was the second edition which was published in 2005. Since then, the market has undergone many changes. To meet these changes and to establish a harmonization among other existing international standards, ISO 17025:2005 was revised and upgraded to ISO 17025:2017. This updated standard is based on a new structure which aligns it with other existing ISO/IEC conformity assessment standards.

The changes in ISO 17025:2017 are:

  • A new topic on risk based thinking has been added which has enabled reduction in standard’s prescriptive guidelines and replaced them with performance based guidelines
  • Increased flexibility in the guidelines for documented information, procedures, organizational responsibilities and processes.
  • Update in the terminology.
  • Recognition and incorporation of computer systems, e-records, and production of electronic reports and results.
  • Addition of all laboratory activities in the scope of the standard which includes calibration, testing and sampling related with subsequent testing and calibration.

Eurotech Assessment and Certification Services Pvt. Ltd. conducts ISO 17025:2017 Upgradation and Internal Auditor Course at reasonable fees. Drop an e-mail at trg@eurotechworld.net  or call at +91-9316744482 to know more about this training.

ISO 17025:2017 and ISO 9001:2015

The difference between ISO 17025:2017 and ISO 9001:2015 is in the applicability of the standards. ISO 9001:2015 can be applied to all types of industries as its requirements are very generic, whereas ISO 17025:2017 is applicable only on calibration laboratories as its requirements are very specific as to what you need to implement in calibration laboratories.

ISO 17025:2017 explains that a Quality Management System is necessary for the proper functioning of a calibration laboratory, and then provides you with two options i.e. Option A and Option B.

If the laboratory has not implemented ISO 9001, then a minimum set of QMS requirements which are needed for the applicability of ISO 17025:2017, need to me fulfilled. This is referred to as Option A. On the other hand, Option B states that if you have a QMS which meets the requirements of ISO 9001:2015, then you have everything that you need.

However, it is important to note that while ISO 9001 implementation is nice to have, it is not required to comply with ISO 17025:2017.

iso 17025 and iso 9001

If you fulfill just the minimum requirements of ISO 17025:2017 instead of requirements of ISO 9001:2015, some of the things that will be missing from your QMS are:

  • Context of The Organization: ISO 17025 does not talk about identifying and specifying your interested parties, internal and external issues or about establishing the scope of our QMS.
  • Quality Objectives: ISO 9001:2015 has important improvement goals for the QMS which are not included in ISO 17025:2017.
  • Leadership: Although some leadership commitment is there, there is no listing of leadership commitments, including the quality policy, in ISO 17025:2017.
  • Monitoring and Measurement: While there are some requirements of monitoring and measurement in ISO 17025:2017, these do not address all of the requirements of ISO 9001:2015.
  • Some Support Processes: Though ISO 17025:2017 includes many support and resource requirements as it applies to calibration laboratories, but it does not include all the requirements from ISO 9001:2015. For example, it does not include requirements about organizational knowledge.

ISO 17025:2017 standard is basically a set of how – to instructions for calibration laboratories to address these requirements. This is the reason that Option B exists in the standard as some companies will find it helpful to implement all of ISO 9001:2015 requirements rather than just the minimum.

Eurotech Assessment and Certification Services Pvt. Ltd. conduct ISO 9001:2015 and ISO 17025:2017 Trainings as well as Certifications (Only of ISO 9001) at reasonable fees. Drop an e-mail at trg@eurotechworld.net or call +91-9316744482 to know more about these trainings.

Importance of ISO 17025:2017

An ISO 17025 accredited laboratory demonstrates that it is technically proficient and is able to produce accurate and precise test calibration data. Laboratory accreditation bodies use ISO 17025:2017 standard to assess the factors relevant to a laboratory’s ability to produce accurate, precise calibration data and tests, including:

  • Appropriate transportation and handling of test items
  • Maintenance of test equipment
  • Quality assurance of calibration data and tests
  • Quality of the sampling and testing environment
  • Appropriateness and validity of tests
  • Traceability of calibrations and measurements to national standards
  • Technical competence of staff

Why is it important to calibrate your instruments in an ISO 17025 Accredited Lab?

ISO/IEC 17025 accreditation proves that a laboratory has an acceptable quality management system in place and has the competence and ability to provide calibration and testing results. Accredited laboratories perform tests against ISO 17025 and the results are mutually acceptable between different regulatory and government organizations. The arrangement between accreditation bodies is that accredited member’s test results will meet the same minimum quality standard regardless of the accreditation body and that the calibration results would be recognized as if they had performed the calibration themselves.

Eurotech Assessment and Certification Services Pvt. Ltd. conducts ISO 17025:2017 Upgradation and Internal Auditor Courses. Drop an e-mail at trg@eurotechworld.net or call at +91-9316744482 to know about the course details.

Documentation Structure and Accreditation Procedure for ISO 17025:2017

4 Tier Documentation Structure Required For ISO/IEC 17025:2017

Accreditation Procedure

Eurotech ACSPL is pleased to announce ISO/IEC 17025:2017 training course to help you in getting familiar with the new standard and help you become updated with its Upgradation Course for Internal Auditor. Drop an e-mail at trg@eurotechworld.net to know more about these trainings. You can also call us at +91-93167-44482, 0172-4191128.

Are You Ready to Make the Transition?

As you all are aware that the new version of the ISO/IEC 17025 standard is has been released. As the final version has been published there is a three year phase in period which does not necessarily mean that can wait until the end of the three years to move to the new standard. Start your transition before it is too late.

How much time I have to conform to the new standard published?

New standard got published on 29th Nov, 2017 and mostly all accreditation labs are assessed every two years. For the first year after the new standard is published, laboratories can choose to be assessed to either the 2005 version of the standard, or the new version. 

One year after the standard is published; assessments will be done according to the new version of the standard. The reason for this is the two year cycle. The last assessment visit you have prior to the three year deadline is when you need to conform to the new standard.

Example: ISO/IEC 17025:2017 published in November 2017 all accreditation laboratories need to be as per new standard by November 2020. If your next assessment visit is July 2019 based on your assessment cycle your July 2019 assessment needs to be against the new standard. Otherwise your lab doesn’t meet the requirement to be accredited by Nov 2020.

How do I get ready for transition?

The main steps to make the transition are:

  • You need to conduct a gap analysis between your present quality management system and the requirements as per the new standard.
  • You need to decide on your timeline which must fit with your reassessment schedule.
  • Documentation has to be updated which means updates have to been done in current policies and procedures as required and additional any new policies and procedures have to be made.
  • You have to make communication and training plan
  • Apply the revised and new policies and procedures made as per the new standard.

Make sure that your lab continues to be as per the current standard up until the assessment against the new standard. 

Eurotech ACSPL is pleased to announce ISO/IEC 17025:2017 training course to help you in getting familiar with the new standard and help you become updated with its Upgradation Course for Internal Auditor. Drop an e-mail at trg@eurotechworld.net to know more about these trainings. You can also call us at +91-93167-44482, 0172-4191128.

Overview of ISO 17025:2017

ISO/IEC 17025 gives the general requirements for competence of testing and calibration laboratories.

ISO/IEC 17025:2017 is useful for any organization performing sampling, calibration or testing and desires reliable results. It includes all types of laboratories irrespective of the sector in which they operate i.e. public sector or private sector.

It is also useful for universities, research centers, regulators, government, organization involved in product certification, inspection bodies and other conformity bodies, that have a need to do testing, calibration or sampling.

With the help of this standard, laboratories can demonstrate their ability to operate competently and generating valid results, and promoting confidence in their working both nationally as well as internationally. It also facilitates cooperation between other bodies and laboratories by ensuring wider acceptance of results between countries. The certificates and test reports are accepted across the countries without any further testing. This improves international trade.

Recently ISO 17025:2005 was revised to become ISO 17025:2017. There have been many changes in technological and market environment since 2005. ISO 17025:2017 takes into consideration ISO 9001:2015 and covers vocabulary, technical changes and other developments in IT techniques.

Eurotech Assessment and Certification Services Pvt. Ltd. are conducting ISO 17025:2017 upgradation and internal auditor course in your area at reasonable fees. Drop an e-mail at trg@eurotechworld.net to know more about these trainings.