DAVID TREW CONSULTING LIMITED
Quality Management Systems (QMS)
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)