History
Early accreditation
Accreditation in South Africa started in 1980 with the formation of the National Calibration Service (NCS), later called the National Laboratory Accreditation Service (NLA). Initially the NCS, which was operated under the auspices of the CSIR, accredited laboratories only in the field of calibration.
In 1994 the NLA became an independent Section 21 company in line with international requirements pertaining to autonomy. From 1995 the NLA accredited testing laboratories, assuming responsibility for laboratories previously accredited under a South African Bureau of Standards (SABS) system.
The Department of Trade and Industry (DTI) had recognised the need to create a single national accreditation system as long ago as 1993, and the establishment of such a system was approved by Cabinet in late 1994.
During 1995 the newly independent NLA was contracted to create the South African National Accreditation System (SANAS). In July 1995 a working group was formed to finalise the organisational structure and constitution of SANAS. The new entity was registered as a Section 21 company in January 1996.
Founding of SANAS
SANAS was officially launched in August 1996. In December 1997, SANAS and the DTI agreed to recognize SANAS as the single national authority for the accreditation of test and calibration laboratories, inspection bodies, bodies for certification of quality and environmental management systems, product conformity certification bodies. The agreement also recognized SANAS as the national monitoring authority for GLP and GCP compliant facilities.
In 1998, SANAS became fully operational. with one division in charge of the accreditation of laboratories/inspection bodies and the other division handling the accreditation of all certification bodies.
On 1 May 2007 SANAS became a public entity. By the end of 2012, SANAS had accredited more than 1400 conformity assessment bodies in South Africa.
Entities certified by SANAS
Calibration laboratories and proficiency testing schemes
Calibration laboratories provide legal metrological traceability in South Africa. The laboratories form an integral part of the metrological chain whenever physical measurements are performed.
The calibration programme ensures that:
- the weights of the sugar, maize meal and flour purchased by consumers are correct.
- the accuracy of the equipment used for law enforcement, such as evidential breath analysers and speed measuring devices,
- the accuracy and traceability of measurements required within the IPAP priority sectors.
Proficiency testing is essential for the demonstration of the competency of a laboratory.
Testing laboratories
Testing laboratories provide objective evidence that a product or service offering conforms to certain customer requirements or specifications.
SANAS-accredited laboratories in the food safety sector play an important role in monitoring the quality of food for import and export purposes, as well as for the health and safety of the public at large. The testing programme also provides an accreditation service in the IPAP priority sectors and other industry sectors, including environmental monitoring, food safety, infrastructure and construction, agriculture and minerals.
Medical laboratories
Credibility of medical pathology laboratories is paramount to the health and safety of the patients who rely on the testing services provided by these laboratories. Laboratory tests are an integral part of the workup of any patient, and constitutes up to 80% of a physician’s diagnosis and treatment choice. It is therefore important that the results are reliable, as medical doctors base their diagnosis on such results.
GLP-compliant facilities
SANAS is the official OECD GLP monitoring authority. The main duty of the GLP monitoring authority is to monitor compliance with GLP Principles by conducting laboratory inspections and study audits.
The OECD principles of GLP were primarily developed to promote the quality and validity of test data used to determine the safety of chemicals and chemical products.
Forensic laboratories
Forensic laboratories are crucial to our criminal justice system as they provide very useful information that aid in the investigation and prosecution of crime through the scientific examination of physical evidence.
Veterinary laboratories and Good Clinical Practice (GCP)-compliant facilities
South Africa is no exception when it comes to the problems faced by the livestock industry worldwide. It is therefore important for the country to have a strong and competent veterinary laboratory industry to help with the diagnosis of diseases, especially emerging diseases such as Bovine spongiform encephalopathy and to test the safety of meat and other animal products.
Blood transfusion
The primary goal of a blood transfusion facility is the transfusion of safe units of blood. Accreditation plays a vital role in ensuring that the personnel involved in all the activities (such as donor registration, blood collection, testing, processing and storage) of a blood transfusion service are competent and that national and/or international standards are being adhered to.
Pharmaceutical
The South African pharmaceutical industry is regarded as the largest in Africa, constituting about 33% of all the pharmaceutical sales in Africa. The pharmaceutical or medicine industry is regarded as one of the best areas for business investment. Furthermore, it plays a vital role in fighting numerous diseases that are ravaging our country, such as TB, HIV and AIDS.
Inspection bodies
Inspection mainly operates within the regulatory domain where regulators and citizens need to be confident that inspection bodies, especially those inspecting health and safety issues in accordance with the Occupational Health and Safety (OHS) Act, are competent to do so. This also applies to bodies that are required to ensure the protection of consumers, such as the National Regulator for Compulsory Specification (NRCS) and those required under the IPAP, for example, nuclear inspection and measurement and verification agencies.
Verification laboratories
Verification laboratories fall under the domain of legal (trade) metrology, whose sole purpose is to protect consumers from unfair trade practices. These laboratories perform verifications on volume, mass and length measuring instruments to ensure reliable results.
Certification bodies
Certification is the activity of conformity assessment where the focus is on a system that forms the basic requirements to ensure that an organisation has the necessary self-regulating procedures and controls on factors that affect a product so that it is possible to provide the customer with confidence that the product falls within the specified requirements. Accredited certification bodies certify other organisations with regard to compliance to management systems with recognised standards, such as quality management system, environmental management system, food safety management system requirements, responsible tourism and greenhouse gas validation and verification. This programme, together with the Inspection Body Programme, is the key accreditation implementer for the attainment of the IPAP projects assigned to SANAS.
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely on such certification including listing on the certification body's website, to assure quality to the end user and that competing suppliers are on the same level.
The International Organization of Legal Metrology, is an intergovernmental organization that was created in 1955 to promote the global harmonization of the legal metrology procedures that underpin and facilitate international trade.
Accreditation is the independent, third-party evaluation of a conformity assessment body against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
IEC 61508 is an international standard published by the International Electrotechnical Commission consisting of methods on how to apply, design, deploy and maintain automatic protection systems called safety-related systems. It is titled Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems.
The Standards Council of Canada (SCC) is a federal Crown corporation with the mandate to promote voluntary standardization in Canada, where standardization is not expressly provided for by law, however certification to some standards could be required through regulation. Located in Ottawa, Ontario, SCC has a governing council of as many as 13 members and a staff of approximately 110. The organization reports to Parliament through the Minister of Industry.
The International Laboratory Accreditation Cooperation or ILAC started as a conference in 1977 with the aim of developing international cooperation for facilitating trade by promotion of the acceptance of accredited test and calibration results. In 1996, ILAC became a formal cooperation with a charter to establish a network of mutual recognition agreements among accreditation bodies that would fulfil this aim.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
The Bureau of Indian Standards (BIS) is the National Standards Body of India under Department of Consumer affairs, Ministry of Consumer Affairs, Food & Public Distribution, Government of India. It is established by the Bureau of Indian Standards Act, 2016 which came into effect on 12 October 2017. The Minister in charge of the Ministry or Department having administrative control of the BIS is the ex-officio President of the BIS. BIS has 500 plus scientific officers working as Certification Officers, Member secretaries of technical committees and lab OIC's.
British Approvals Service for Cables is an independent accredited certification body headquartered in Milton Keynes, United Kingdom. Here, the organization's dedicated testing laboratory also operates which is believed to be the largest of its type in Europe. BASEC was established in 1971 and principally provides product certification services for all types of cable and wire, ancillary products and management systems within the cable industry. The organization maintains operations throughout the world including Africa, Middle East, America, Asia and Europe.
Functional safety is the part of the overall safety of a system or piece of equipment that depends on automatic protection operating correctly in response to its inputs or failure in a predictable manner (fail-safe). The automatic protection system should be designed to properly handle likely human errors, systematic errors, hardware failures and operational/environmental stress.
The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body recognised by the British government to assess the competence of organisations that provide certification, testing, inspection and calibration services. It evaluates these conformity assessment bodies and then accredits them where they are found to meet relevant internationally specified standards.
NSF International is an American product testing, inspection and certification organization based in Ann Arbor, Michigan.
IEC 62443 is an international series of standards that address cybersecurity for operational technology in automation and control systems. The standard is divided into different sections and describes both technical and process-related aspects of automation and control systems cybersecurity. It divides the cybersecurity topics by stakeholder category / roles including: the operator, the service providers and the component/system manufacturers. The different roles each follow a risk-based approach to prevent and manage security risks in their activities.
eCOGRA is a London-based testing agency and standards organisation in the realm of online gambling. The company was established in 2003 in the United Kingdom at the behest of the online gaming industry as the first industry self-regulation system. eCOGRA is a testing laboratory, inspection body, and certification body, specializing in the certification of online gaming software and the audit of Information Security Management Systems.
The National Association of Testing Authorities, Australia (NATA) is the recognised national accreditation authority for analytical laboratories and testing service providers in Australia. It is an independent, not-for-profit organisation, governed by a board of directors that has representation from NATA members, industry, government and professional bodies.
The Testing, Inspection and Certification (TIC) sector consists of conformity assessment bodies who provide services ranging from auditing and inspection, to testing, verification, quality assurance and certification. The sector consists of both in-house and outsourced services.
The Department of Standards Malaysia is the National Standards Body and the National Accreditation Body, providing confidence to various stakeholders, through credible standardisation and accreditation services for global competitiveness. Governed by the Standard of Malaysia Act 1996, the Department of Standard Malaysia is an agency established on 28 August 1996 under the purview of Ministry of International Trade and Industry (MITI).
