The ISO/IEC 17025 standard was issued initially by the International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC) in 1999 and it states the overall requirements for the testing ability and standardization laboratories. For calibration and testing laboratories purposes it holds imperative value at global level. Above 50,000 laboratories are qualified internationally. This standard has been revised twice from the time when it was started during 2005 and in November 2017. Now its third revision includes a number of substantial alterations and due to this reason laboratories and accreditation entities must be fully equipped in the same way.
A period of three year has been allocated for transition purposes in which laboratories can conduct a ISO 17025 transition to the 2017 version before the old version no longer is valid. In case of accreditation to this standard a laboratory makes it official that has got the required skill, fairness along with reliable setups at worldwide level. By means of getting ISO/IEC 17025 accreditation a laboratory validates its operations and shows ISO’s confidence in the working practices of the particular lab. The formation of ISO/IEC 17025 standard took place by the consensus of different laboratory experts along with various additional lab associations. Consequently we can say that any laboratory that has a desire to prove its competence for providing correct results along with the working techniques can utilize this standard.
All credited laboratories must design their management system in compliance with the standard’s new revision prior to the ISO 17025 transition audit by their accreditation body. The fact must be not overlooked that they will have to do so prior to the deadline on November 30, 2020. Each and every accredited laboratory will be obliged to conduct and complete an efficient ISO/IEC 17025:2017 transition irrespective of their existing accreditation status. Now this deadline does not mean that all laboratories must wait to introduce their ISO 17025 transition adjustments to be evaluated by their accreditation bodies. It is recommended all laboratories start this transition process as soon as it gets feasible. Now an important question is how the organizations are supposed to handle this ISO 17025 transition. It can be done by internal staff only or with the support from an ISO 17025 consultant which often provides some benefits.
ISO 17025 Transition Process
If the laboratory managements seek an efficient and successful transition then they must make sure to follow some important steps. First of all, at basic level they must buy the new ISO/IEC 17025:2017 standard which is available at different sources. The complete standard must be read comprehensively in order to understand the latest specifications for implementation purposes. In this context, we can reap the benefits of various training opportunities available at different platforms. A decision should be made regarding the overall time span for transition purposes which must not ignore the due time for the next review. In order to avoid any confusion the particular needs of the organization must be discussed with the relevant accreditation body.
Training of Laboratory Personnel
Furthermore, proper training should be provided to the laboratory personnel having key tasks and responsibilities for the ISO 17025 transition and implementation purposes. A thorough gap analysis must be done between the current quality system and the revised standard’s specifications to identify your areas which lack compliance. The documentation of the management system must be up to date and for this purpose every current policy and process will need updating were relevant. Likewise, it will also include the elimination or alteration or addition in the existing processes and policies. An effective communication and training strategy must be formed for every person related to the laboratory.
In order to be fully prepared and learn essential requirements the organization can consider the option of joining or attending seminars or conferences on the subject of ISO/IEC 17025:2017. It will provide the opportunity of raising your concerns in the presence of experts discussing the latest specification with the other professionals working in the same field. All laboratories have the ability to conduct an efficient ISO/IEC 17025:2017 transition before the end of 2020 by vigilant planning. In this way, besides fulfilling their ISO 17025 transition, they will also be able to enhance the existing management system and practices of their laboratory.
Moreover, an audit checklist of ISO/IEC 17025 is an essential component of the ISO audit for a laboratory. It can act as a handy instrument that can support for conducting audit competently and timely so that ISO/IEC 17025 accreditation can be acquired by the specific laboratory. During the time when ISO auditors visit your lab they will demand lots of documented information regarding the QMS, practices and their practical applications. In case an organization has a ready made ISO 17025 audit checklist, it can facilitate organizing audit function in a systematized approach.
If you are interested in support with the ISO 17025 transition, please feel free to contact us for a free consultation