The CPGR has been successfully certified for the ISO 9001:2015 quality management standard in September 2017.
In achieving this, we have made significant progress in expanding our quality management approach:
The new 9001:2015 standard is a revised version of the previous 9001:2008 framework. Among others, it puts a greater emphasis on demonstrating that a coherent customer value chain is in place. In contrast to the precursor, it has a stronger focus on management of stakeholders and organisational change.
In preparation of the certification audit, we have moved to a new certification body, i.e. TÜV SÜD Management Service GmbH. TÜV is one of the most prominent certification bodies in Europe; working with them ensures that our approach is firmly grounded in international best practice, among others by having access to international assessors and other experts, if and when necessary.
In addition to the existing ISO 9001:2015 management system, which covers processes in all organisational domains, we are going to have routine laboratory workflows accredited in accordance with ISO 17025:2005. The 17025 standard is in many areas similar to the 9001 framework: it is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.
Furthermore, we are preparing the organisation for the implementation of the ISO 13485:2016 standard (which has also a large degree of overlap with ISO 9001:2015), which is more specific to the development of IVDs (In-vitro diagnostic products). This is anticipation of increased requirements for organisations involved in the development and/or provision of omics-based tests, either in-house or for external use, to work in compliance with increasingly tight global industry standards (such as CLIA, FDA or ISO).
Overall, this means that the organisation will be much better equipped for operating in the dynamically changing and increasingly regulated ‘omics’ ecosystem.
This will crate an environment that allows for an effective integration of the different stages of life science product development, from discovery-oriented research to new product development and clinical application, applying different quality standards, as applicable, along the journey.
Ultimately, it will contribute more effectively to the development of a bio-economy in South Africa.
For questions, contact Busiswa Kekana, CPGR’s quality manager and risk coordinator; or, download our certificate CPGR ISO 9001_2015 TUV certificate – September 2017