ISO 17025:2017 is an international standard that sets a framework for laboratories involved in testing, sampling and calibration to produce reliable, consistent and technically valid results. The Standard is split into two key parts, the development of an effective management system, with requirements aligned to ISO 9001; and laboratory technical requirements, which covers staff competency & training, and method development & validation, ensuring the validity of laboratory generated results and reporting of those results.
Accreditation to ISO 17025 recognises the competency of a laboratory and demonstrates its adherence to robust testing methods. In addition, Accreditation allows organisations to:
- easily demonstrate reliability to potential customers, giving an advantage in tendering processes
- continually improve and maintain operational performance and processes through internal and external assessments (monitoring and evaluation)
- address possible risks and opportunities to continually improve the laboratory and its systems
- create cost effective right first-time testing methods thus reducing the amount of waste and re-testing required
- create a customer focused approach to the business, helping to retain business and create a can-do attitude within the laboratory
Bywater is Europe’s leading provider of ISO/IEC 17025 consultancy and training services and has laboratory experts across the country. Over the years we have helped hundreds of laboratories from a variety of industries and sectors to implement and improve their management systems, ways we have helped include:
Management briefings will usually take place before implementing ISO/IEC 17025, and will cover key elements of the Standard, including management system requirements and laboratory technical requirements. During this stage we can include an assessment of how the key clauses of the Standard could affect your laboratory.
It can be beneficial to have an assigned ‘project owner’ attend the management briefing. Their role would be to manage the implementation of a project, defining the scope and working to meet the requirements for ISO/IEC 17025. We can also pair a consultant with this ‘project leader’ to provide direct and remote support throughout the Accreditation process.
ISO/IEC 17025 Gap Analysis
A gap analysis is a crucial part of the accreditation process. It involves assessing the current laboratory system to the requirements of ISO/IEC 17025:2017, highlighting any areas of non-compliance. The results of the gap analysis can then be used to develop an implementation plan.
In this stage of the process, Bywater can train members of staff on the key requirements of ISO/IEC17025 and the process for a gap analysis in our ISO/IEC 17025 implementation training course, or alternatively we can use trained consultants to perform the analysis with a full report and suggested actions.
Developing Laboratory System Documentation
To achieve Accreditation and the desired aims of ISO 17025:2017 laboratories are expected to have documentation, which in summary are:
- Ability technically to get a valid result – this involves people, knowledge, equipment, supplies and process – the “getting it right”
- A system to ensure impartiality, consistency, reliability – the “once right……always right”
Often documentation of a system can be seen as a difficult and time-consuming task for laboratories proceeding with accreditation to ISO/IEC 17025. That’s why we offer complete consultancy solutions to guide organisations through the process, assigning experienced consultants to help you cut the jargon and assess what’s necessary for your organisation to become ISO/IEC 17025:2017 compliant.
ISO/IEC 17025 Auditor Training
Bywater are Europe’s largest providers for ISO/IEC 17025 compliance training. Our courses include an introduction to ISO/IEC 17025, an ISO/IEC 17025 internal auditor training course, and a CQI IRCA ISO/IEC 17025 Lead Auditor Training Course. The courses run at venues across the country including Coventry, Manchester, Leeds and London.
Before the Accreditation Body assessment takes place, organisations can benefit from performing a check themselves. This pre-assessment review will highlight any areas of possible non-conformity to support the next stage of the accreditation process. This is a service that Bywater can offer using our experienced Consultants, providing you with assurance that your organisation is ready for proceeding to the formal Accreditation Body assessment.
Continual Improvement of the ISO/IEC 17025 Laboratory System
Continual improvement underpins ISO/IEC 17025, not only for the management system but the competency of results too. The Standard sets a framework for using tools such as internal audits and management reviews for laboratories to set goals and recognise opportunities.
As well as assisting organisations with internal audits, Bywater can help organisations form an action plan to address findings and opportunities. Alternatively, we can offer training courses to help with staff development and company efficiency goals, please see below for more details.
Lean and Six Sigma Training – A combination of two methods; Lean, and Six Sigma, that have both been used effectively in a range of laboratories to create better workflows and reduce variation in results.
Calibration and Control of Measuring Systems Training Course – Based on the requirements of ISO/IEC 17025 this one-day workshop will identify the elements for an effective calibration system.
Measurement Uncertainty Training Course – This course will explore the importance of uncertainty and equip delegates with the required methodologies to calculate uncertainty budgets
Root Cause Analysis Training – Aimed to help organisations reduce undesired outcomes from reoccurring
To discuss your specific requirements please call our Training team on 0333 123 9001 or send us a message using the Contact Us button.