ISO/IEC 17025, general requirements for the competence of testing and calibration laboratories, is the international reference for the testing and calibration of laboratories wanting to demonstrate their capacity to deliver trusted results. The international standard, published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), contains a set of requirements that enable laboratories to improve their ability to produce consistently valid results. The standard has been revised with significant changes. These revisions cover technical changes, technical developments and developments in IT techniques. Canadian laboratories have until the end of 2020 to conform to the revised ISO/IEC 17025 standard. More information on this change can be found below. Details on all the revisions to ISO/IEC 17025 can be found on the ISO website.
ISO/IEC 17025 Key Dates:
January 1, 2018 - September 1, 2018:
- Laboratories have the option of being assessed to ISO/IEC 17025:2005 or ISO/IEC 17025:2017
After September 1, 2018:
- All laboratories must be assessed to the new version.
September 1 – December 31, 2018:
- Laboratories may request to be re-assessed to ISO/IEC 17025:2005 only if there are valid, extenuating circumstances including, but not limited, to:
- Corporate/Group accreditation laboratories that are working on a consolidated approach to implementing the revised standard.
- Laboratories that hold two or more accreditations from different accreditation bodies, who are required to meet different transition and implementation plans developed by the accreditation bodies.
- When a laboratory requests that their system be assessed to ISO/IEC 17025:2005, the laboratory must submit a plan on how accreditation to the revised version of the standard will be attained by the deadline, taking into account that the laboratory must still be assessed to the revised version before the deadline (e.g. less than two years later)
January 1, 2019:
- All laboratories shall be assessed to the revised version of the standard.
ISO/IEC 17025:2017 – Frequently Asked Questions:
QUALITY SYSTEM / QUALITY MANUAL
Q1 – Will we need to rewrite our “Quality Manual” to be aligned with the new sections of 17025? If so, how will that be accomplished?
A – You will need to review your Quality Manual and add information on how your laboratory is addressing new processes found in the 2017 version of 17025. Existing processes may also need to be revised and updated.
Q2 – Will we need to redesign our “Quality System” so that it is aligned with the new sections of 17025? If yes, how?
A – You do not need to redesign your Quality System and/or Quality Manual to be aligned with the new sections of 17025. Not all laboratories have chosen to align their Quality Manual to the 2005 version, and this remains an acceptable practice.
Q3 – What are the consequences of the new numbering structure?
A – Although the format of the standard has changed, this does not mean that quality manuals need to be rewritten. If a laboratory has a documented system that works, the documentation will need to be edited, some new processes will need to be added and some other processes may need to be revised. However, there is no reason to rewrite the Quality Manual to follow the new format.
Q4 – Do laboratories still need a quality manual?
A – Technically, the standard does not specify the requirement for a Quality Manual. If a laboratory has a Quality Manual that is working for their system, it can be updated and maintained by the laboratory. Having a Quality Manual does not constitute a “non-conformance.” Not having a functional, documented quality management system does.
Q1 – What are the new or modified requirements, if any?
A – An answer to this question will be provided once the revised standard is published.
Q2 – Will there be a detailed clause-by-clause cross reference?
A – Once the revised version is published, ISO will then provide information that highlights the differences between the 2005 version and the newly revised version.
Q1 – Can you please describe the proposed transition period?
A – Accreditation bodies will have three years from the date that the revised standard is published to demonstrate that all accredited laboratories are meeting the revised standard. This means that laboratories must have an accreditation certificate that states conformance to the revised standard by a set deadline. So all assessments and resolution of any non- conformities will need to be done in advance of this three year timetable.
Q2 – Are there any guidelines to follow during the transition process?
A – The following guidelines are recommended:
- Purchase a copy of the revised standard as soon as it is available.
- Perform a gap analysis between the revised standard and the laboratory’s system.
- Incorporate any new or revised requirements into the system.
- If some of the requirements seem difficult to apply, do not hesitate to seek out assistance – contact your accreditation body, seek out training opportunities, etc.
- Be open to the fact that some of the revised requirements are new for everyone – accreditation bodies, assessors and laboratories. There will be “growing pains” and application of some requirements will evolve as people become familiar with the standard.
- Once the laboratory’s system is updated, the laboratory will need to define and develop a communication and training plan to ensure that laboratory staff are aware of new or changed requirements.
Q3 – How will assessments be carried out during the transition period?
A – This issue is still being worked on and has yet to be determined. While the reassessment dates of many laboratories will remain unchanged, some laboratories may be asked to alter their due dates to accommodate getting everyone transitioned on time.
Q4 – Will all related or standard-related documents, such as the recently updated CAN-P-1630, be revised? If yes, how soon will this take place?
A – Every accreditation body will have to update related documents. Laboratories will be updated with information as it becomes available.
Q5 – Will laboratories need a transition plan? If so, can it be audited?
A – Whether to have a transition plan or not is up to each accreditation body to decide. Both SCC and CALA see a lot of value in laboratories using a transition plan as a tool. Typically, transition plans can be subjected to an audit.
Q6 – Where and when can laboratories purchase the revised standard?
A –The revised standard is available on the SCC Standards Store for purchase.
Q7 – When a laboratory is reassessed in 2018, will it be assessed against ISO/IEC 17025:2005 or the revised standard?
A – A communication has been issued by SCC and CALA stating that reassessments using the revised standard will be optional until September 1, 2018. That being said, some laboratories may have difficulty meeting the 2020 deadline if their reassessment is carried out in late 2018 and they opt to be assessed to the 2005 version. Both accreditation bodies are planning to deliver assessments to the revised standard as early as 30 days after the date of publication. One year after the publication of the revised standard, it is expected that all laboratories will be assessed using the revised version.