This service is targeted at laboratories seeking accreditation for the first time.
Clause 8.1 of the ISO 17025:2017 International Standard requires the laboratory to establish a quality management system suitable for its needs, which underpins all of its operations. For a laboratory seeking accreditation developing a documented quality management system is one of the first activities that needs to be carried out.
A laboratory’s operations will be assessed against its quality systems and quality management procedures and will often attract the most scrutiny from inspectors during client and compliance audits.
A quality Management system typically consists of a quality manual, with discusses how the laboratory will conform to each of the requirements of the International Standard, and a collection of documented policies and procedures that explain how the laboratory will perform the required tasks in a constant manner. These are focused on providing a high level of assurance that all testing or calibration activities are consistanly performed in such a way as to provide a high level of confidence that the results are both accurate and precise and are also reliable and trustworthy.
To discuss your specific needs please click on the link below:
Creating a quality management system that is both suitable for your laboratory’s needs and meets the requirements of the ISO 17025:2017 International Standard is a significant undertaking, which requires both a clear understanding of the International Standard, together with experience of laboratory operations.
Although a chemist by profession, I have extensive experience in developing quality management systems which conform to the requirements of the ISO/IEC 17025:2017 International Standard in any discipline.
With over 25 years of laboratory experience and over five years of consultancy experience, I can develop a QMS suitable for your laboratory’s needs and prepare the associated documents for a fixed price.
The objective of this package is to achieve a successful first stage review by the accrediting body.
The overall process consists of:
Two day on site gap analysis and report (can be longer if needed)
Preparation of quality manual, set of quality policies, procedures and forms
Preparation of test or calibration methods for which the laboratory is seeking accreditation
Two day on site review of draft documents (can be longer if needed)
Proofreading of all documents
Presentation of documents in both electronic and hard copy format
Two day preassesment audit
Attendence at assessment (subject to acceptance by the accrediting body)