Quality is an intrinsic part of all endeavours at the CPGR, forming part of our service processes, product development and communication. To generate outputs of the highest quality, the CPGR selected ISO 9001:2008 as the standard for its Quality Management System and has been certified to this standard by AfriCert in 2014.
In 2017 the CPGR has been successfully certified for the ISO 9001:2015 quality management standard. 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 system. 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 make a submission to SANAS for accrediting routine laboratory workflows in accordance with ISO 17025:2005 by the end of September 2017. 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.
Our initial application to SANAS will include routine testing for cytogenetics, cancer sequencing, tumour sequencing, NIPT (non-invasive prenatal testing) and HLA typing. We expect to undertake our first SANAS audit by the middle of 2018.
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 we will be much better equipped for operating in the dynamically changing and increasingly regulated omics’ eco-system.
It is our belief that the CPGR environment 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, we hope that it will contribute more effectively to the development of a bio-economy in South Africa.
For questions, don’t hesitate to contact Busiswa Kekana, CPGR’s quality manager and risk coordinator, who has led us through this journey in an expertly and successful fashion, at Busiswa.email@example.com.