South Africa’s tragic reality is
that to date, the checks and balances required to implement successful
procurement, distribution and administration plans have all too often been
ignored.
Muhammad Ali, CEO of WWISE, an ISO training, consulting and implementation specialist, says he is all too aware of South Africa’s questionable track record in this regard.
“If the procurement process is not independently audited, most of the tenders are awarded to companies that have employees in the public sector who have a personal advantage of being awarded the tender,” he says.
“The full legal requirements of
the tender requirements are not always aligned, such as a valid tax clearance,
or accredited BBBEE certificate and even unaccredited ISO Certifications.”
The fact is, most organisations do
not have quality controls in projects aligned to ISO 9001, the standard that
defines the requirements for a quality management system.
“There is poor quality in
verifying documents and reports and validating the actual design,” says
Ali. “This can cause sub-standard work, which can impact clients requiring
services. Often legal requirements are simply bypassed.”
South Africa needs to change its thinking in terms of certifications, particularly when it came to an issue like vaccines.
“Laboratories need to consider accreditation with South African National Accreditation System (SANAS) or Southern African Development Community Accreditation Services (SADCAS) to ISO 17025 (testing and calibration of medical laboratories) and/or ISO 15189 (quality management competency for medical laboratories).
“This justifies that the laboratory providing tests and research on the vaccines are following the correct methodologies with no shortcuts on quality control,” says Ali.
In terms of eliminating corruption
within the various systems, ISO 20400 Sustainable Procurement is key.
This provides guidance to
organisations, independent of their activity or size, on integrating
sustainability within procurement,
Ali says: “ISO 20400
Sustainable Procurement is aligned to the Public Financial Management
Act. No ISO management system will be effective if the legal requirements
are not embedded in the policies and procedures of the organisation’s
systems.”
Another important apparatus is ISO
37001, which specifically is designed to tackle bribery. It assists an
organisation to identify and mitigate weaknesses with extra controls
“whether they are automated or verified and validated by two independent
bodies which are alternated regularly”.
Traditionally, the medical industry
has been strict in respect of medical devices and ensuring these meet
international standards.
ISO 13485 Quality Management in
Medical Devices is the most common medical device quality management standard
regulatory standard in the world.
Ali says: “The South African
Health Products Regulatory Authority (SAHPRA), Health Professional Council of
South Africa and South African Pharmacy Council, along with the department of
health and all its subsidiaries, have made it clear to any organisation looking
to trade with the public or private sector the ISO 13485 is a pre-requisite
before a licence is obtained for PPE and your laboratory is accredited to ISO
17025 and ISO 15189.”
He says he cannot stress enough that
entities implementing ISO management systems should not see them as a cost, but
an investment that allows for a structured approach in doing business.
“In
turn a culture of quality will be embedded among the employees and suppliers
and expectations will increase among clients. That drives continual
improvement.”
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