South African National Accreditation System
SANAS is an acronym for the South African National Accreditation System.
SANAS is recognised by the South African Government in Act 19 of 2006 as the single National Accreditation Body that gives formal recognition that Laboratories, Certification Bodies, Inspection Bodies, Proficiency Testing Scheme Providers and Good Laboratory Practice (GLP) test facilities are competent to carry out specific tasks.
SANAS accreditation certificates are a formal recognition that an organisation is competent to perform specific tasks.
SANAS is responsible for the accreditation of certification bodies for Quality Management Systems and Environmental Management Systems to ISO/IEC 17021(and the IAF interpretation thereof), laboratories (testing and calibration) to ISO/IEC 17025 and medical laboratories to ISO/IEC 17025 and/or ISO 15189 . Inspection Bodies are accredited to ISO/IEC/17020. GLP facilities are inspected for compliance to OECD GLP principles. Verification laboratoroes are accredited to SANS 10378.
About the South African National Accreditation System
On 1 May 2007 it became a public entity with the promulgation of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act (Act 19 of 2006).
SANAS has its office on the The DTI Campus, Sunnyside, Pretoria, South Africa. It is directed and legally represented by a board of directors whose members are appointed by the Minister of Trade and Industry.
SANAS operates in accordance with the requirements, criteria, rules and regulations laid down in the following documents:
– The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006) – The requirements of the international standard ISO/IEC 17011:2004, General requirements for bodies providing assessments and accreditation of conformity assessment bodies.
The Board delegates to the chief executive officer (CEO) of SANAS the responsibility to implement the SANAS strategic objectives.
Approval Committees make recommendation to the CEO concerning the granting and continuation of accreditation and GLP compliance.
SANAS Mission Statement
, conclude and maintain all international mutual recognition agreements on behalf of its two divisions (certification body accreditation and laboratory/inspection body accreditation), and to pursue international acceptance of all bodies accredited by SANAS.
To accredit organisations in accordance with internationally accepted criteria, and to comply itself with the international criteria.
To continually review and negotiate methods of reducing the cost of international trade through accreditation.
To advise national and international organisations on the conditions for accreditation and issues relating to accreditation.
To promote SANAS as the national accreditation body and to encourage the accreditation of laboratories/inspection bodies and certification bodies within the territory.
To ensure that there is consistency amongst laboratories/inspection bodies and certification bodies in all activities relating to accreditation and to embrace all appropriate fields of accreditation.
To vigorously participate in the activities of international bodies representing the interests of accreditation, particularly the IAF and ILAC. To maintain observer statusuii
To work closely with national government to ensure the continued and adequate support for accreditation activities and international acceptance.
History of the South African National Accreditation System
Accreditation in South Africa dates back to 1980 with the formation of the National Calibration Service (NCS), later 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 referred to as SABS 0259.
The government through 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 manage the establishment of this system, to be called the South African National Accreditation System (SANAS). During July 1995 a working group was formed to finalise the organisational structure and constitution of SANAS, and the new entity was registered as a Section 21 company in January 1996.
The new accreditation body was officially launched in August 1996. After much effort from the new SANAS board, a Memorandum of Agreement was signed with the DTI in December 1997, through which SANAS is now recognised 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. It is also recognised as the national monitoring authority for GLP and GCP compliant facilities. The DTI reserves the right to extend this recognition to encompass other areas of accreditation as and if these arise.
SANAS became fully operational during 1998 with two divisions in place, one for accreditation of laboratories/inspection bodies and the other, handling the accreditation of all certification bodies.
On 1 May 2007 it became a public entity with the promulgation of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act (Act 19 of 2006). By the end of 2012 SANAS has accredited more than 1400 conformity assessment bodies in South Africa.
The key accreditation scopes covered by SANAS’s accreditation provision responsibilities and their purpose.
1. Calibration laboratories and proficiency testing schemes Calibration laboratories provide legal metrological traceability in South Africa as stipulated in the Measurements Units and Measurement Standards Act (Act No. 18 of 2006). The laboratories therefore form an integral part of the metrological chain whenever physical measurements are performed, be these for trade, safety, scientific purposes, law enforcement or to ensure that South African manufacturers remain globally competitive. The calibration programme has an impact on the lives of ordinary South Africans, from ensuring that the weight of the sugar, maize meal and flour that is purchased is correct, to ensuring the accuracy of the equipment used for law enforcement, such as evidential breath analysers and speed measuring devices, and ensuring 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.
2. Testing laboratories Testing laboratories play an important role in economies by providing 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.
3. Medical laboratories Creditability 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.
4A. 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.
4B. 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. 4C. 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 (BSE – mad cow disease) and to test the safety of meat and other animal products.
4D. 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.
4E. 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.
5. 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.
6. 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 in accordance with the requirements of the Trade Metrology Act (Act No. 77 of 1973) and other related technical regulations to ensure reliable results.
7. 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.
8. Broad-based Black Economic Empowerment (B-BBEE) verification agencies In 2007, SANAS initiated the B-BBEE Verification Accreditation Programme, which supports government’s national objective to allow for a broader participation of previously disadvantaged people in the mainstream economy.
International recognition In support of its national accreditation activities, SANAS is a founding signatory of the multilateral recognition arrangements of both the International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF). These arrangements promote the global acceptance of technical test and calibration data, as well as certificates issued by certification bodies. In this regard, signatories to the ILAC and IAF arrangement are spread over 88 and 59 economies respectively. For South African trade, it implies the elimination of or reduction in the need for retesting or recertification to an importing country that is a signatory to the arrangement. In 2012, the multilateral recognition arrangement (MLRA) for inspection was officially launched under ILAC. SANAS was one of the first signatories to this agreement, allowing international recognition of the inspection results of South Africa’s accredited facilities.
Support for regional integration SANAS plays an important role in SADC by hosting the SADC Accreditation Secretariat and holding the regional coordinator position. The body is further currently assisting the newly established SADC Accreditation Services (SADCAS) by training assessors and partnering with that body. SANAS was also recently elected to host the secretariat for the newly established African Accreditation Cooperation (AFRAC), launched in support of an African technical infrastructure under the African Union.