Product Certification 14th April 2016

PRESENTATION TOPICS: What is accreditation & AB’s purpose Technical infrastructure & Levels of oversight Certification of Products Product scheme development Validation of schemes

The understanding of Product certification and the scheme currently under review, is to address the needs of consumers, users and, more generally, all interested parties by giving confidence regarding fulfilment of specified requirements to allow suppliers to demonstrate to the market that their product has been attested to fulfil specified requirements by an impartial third party body provide confidence for those with an interest in fulfilment of requirements, and sufficient value so that suppliers can effectively market products

Accreditation is the independent evaluation of conformity assessment bodies against recognised standards to ensure their impartiality and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in the calibration and test results, inspection reports and certifications provided.

Accreditation bodies are established in many countries with the primary purpose of ensuring that conformity assessment bodies are subject to oversight by an authoritative body.

SANAS is mandated by government through the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act (Act No.19 of 2006) to provide accreditation services in South Africa. SANAS’s primary role is to serve South Africans by providing a reliable, internationally recognised accreditation infrastructure to government, industry and the wider community.

ACCREDITATION SUPPORTS: Private Sector (Industry & community) Government Private Sector (Industry & community)

ACCREDITATION SUPPORTS: Government Client User Specification Body MRA (government-to-government Trade negotiations Private Sector

ACCREDITATION SUPPORTS: (Industry & community) Government GENERAL BENEFITS: - Independent confirmation or benchmarking tool - Recognition of competence (enhance acceptance) - Marketing benefits Private Sector (Industry & community) INTERNATIONAL BENEFITS - International recognition of competence due to MLA - Output acceptance in foreign markets (reduce risk) - Import/export (no duplication due to signatory status

LEVELS OF OVERSIGHT IAF – International Accreditation Forum Department of Trade & Industry SANAS – Accreditation Body Product Certification Body Manufacturer/Service provider LEVELS OF OVERSIGHT

Accreditation - evaluation against a standard/requirement ensuring impartiality & competence Accreditation bodies – Provides authoritative oversight

Role of SANAS SANAS creates an impartial and transparent mechanism for organisations to independently demonstrate their competence and facilitate the beneficial exchange of goods, services and knowledge and provide a service that is recognised as equitable to best international practice while reflecting the demographics of South Africa in all that we do. Within SANAS there are different programmes of which the Certification programme applies in the context of todays topic.

The role of SANAS under the DTI In South Africa, SANAS is one of the 4 institutions or bodies that form the Technical Infrastructure under the DTI DTI Financial & Small Business Development Agencies Regulatory Agencies Technical Infrastructure NRCS – Mandate to control National Regulatory activities & enforce compulsory regulations NMISA – Mandate to maintain & develop scientific standards of physical & ensure global measurement equivalence SABS - Mandate to develop, promote & maintain National & International Standards SANAS – Mandate to Accredit & facilitate Trade

ILAC / IAF Testing Inspection Certification ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021 ISO/IEC 17065 ISO/IEC 17024 …and more

Product Certification Personnel Certification ILAC / IAF Testing Inspection Certification ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021 ISO/IEC 17065 Management Systems Product Certification ISO/IEC 17024 Personnel Certification …and more

ILAC / IAF Testing Inspection Certification Management Systems – QMS/EMS/OHSAS ILAC / IAF Testing Product Certification –GlobalGAP/OAPP/PEFC Inspection Certification ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021 Personnel Certification – Training/ Auditor reg ISO/IEC 17065 Management Systems Product Certification ISO/IEC 17024 Personnel Certification …and more

ILAC / IAF Testing Inspection Certification ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021 ISO/IEC 17065 Purpose: Int. Trade IAF Recognised Int. private schemes ISO/IEC 17024 Purpose: Specific req. is fulfilled National Product schemes (Refer to slide 3) …and more

ISO/IEC 17065 International National SCHEME Note: International/National separation only used for explanatory purposes in this slide. ISO/IEC 17065 International National Many CB’s Participate Single CB (currently) Other Scheme Own Scheme Certification system is separate (external) to CB’s system Certification system forms part of CB’s Management System SCHEME The purpose of the scheme needs to be established in order to set the boundaries of applicability i.t.o participants, trade or quality statements, oversight authority and management thereof etc

PRIVATE SECTOR AS per Slide 8 International National INTERNATIONAL BENEFITS - International recognition of competence due to MLA - Output acceptance in foreign markets (reduce risk) - Import/export (no duplication due to signatory status GENERAL BENEFITS: - Independent confirmation or benchmarking tool - Recognition of competence (enhance acceptance) - Marketing benefits The purpose of the scheme needs to be established in order to set the boundaries of applicability i.t.o participants, trade or quality statements, oversight authority and management thereof etc

GOVERNENTAL Client User Specification Body MRA (government-to-government Trade negotiations

ISO/IEC 17065 International National Many CB’s with their own mgt system 17065 Single CB With it’s own mgt system 17065 Additional Certification system requirements Minimal additions to Certification system requirements

CB’s management system Own scheme Other scheme CB’s management system Certification system

3.1 certification system 3.2 certification scheme 3.3 scheme owner rules, procedures and management for carrying out certification 3.1 certification system certification system (3.1) related to specified products, to which the same specified requirements, specific rules and procedures apply 3.2 certification scheme person or organization responsible for developing and maintaining a specific certification scheme (3.2) 3.3 scheme owner

SUMMARY ILAC / IAF Scheme Owner SANAS (AB) ISO/IEC 17011 ISO 17067 SANAS places great effort in ensuring ALL scheme are developed and include 17067 Scheme rules Certification Body ISO/IEC 17065 Scheme rules (incl QMS audits?) Manufacturer SANS Req. Client/Consumer

Typically, a conformity assessment scheme will contain the following elements:   The WHAT   The HOW   The WHO

  The WHAT of conformity assessment – identification of the subject of the conformity assessment, such as product, process, service system, person, installation, sample, batch or (emissions) data; and also the requirements, including any interpretations thereof, against which the assessment of the subject takes place, such as certification standard, product, system or process specifications, legal standards.  

The HOW of conformity assessment – the way in which the conformity assessment body establishes the conformity, such as audit or verification (on site) method, inspection (17020) protocols, test (17025) or assessment method, inspection instruction, examination method and the process or procedure descriptions required; if applicable, the way in which supervision takes place, such as control frequencies, content and scope of organisation/project-based surveillances and reassessments;  

  The WHO of conformity assessment – meaning the bodies that perform the assessments using the requirements, including any interpretations thereof, that apply to the conformity assessment body with regard to its organisation, procedures, personnel, equipment, reporting, certificates, etc.

The degree of detail in which the said elements are set out depends on the intended use of the scheme. A document that only describes one of the above aspects, such as a normative document or an interpretation document, will not be regarded as a scheme. It is important that all schemes be prepared by persons demonstrably competent in that capacity, covering both the technical field of expertise and the conformity assessment procedure used.

As a minimum, a conformity assessment scheme must contain the following:   Identification of the conformity assessment object such as a product, process, system, service, person,   The requirements, including any resulting interpretations, against which the object is compared such as the certification standard, product specifications, legal standards, etc.,   The method in which the conformity assessment body determines conformity such as audit programmes, testing methods inspection protocols etc.,    If applicable, the method of surveillance (including control frequencies, etc.),   The requirements, including any resulting interpretations, that apply to the conformity assessment body relating to their organisation, operating methods, personnel, equipment, reporting, certificates etc.,

Validation of conformity assessment schemes   Once developed, a conformity assessment scheme will have to be validated before being placed under accreditation. Validation at least means that a new or modified scheme has been tested in practice and that it has been demonstrated that the conformity assessment described in the scheme is feasible in practice and meets the intended results.

Validation of conformity assessment schemes (continued)   The main questions to be answered during scheme validation include, what is the purpose of the conformity assessment and is it achieved with this scheme? Is the conformity assessment described feasible in practice?. There must be evidence of market acceptance of the scheme prior to application to SANAS for accreditation. For new schemes, a conformity assessment body may use principles as described in 8.3 of ISO 9001:2015. The basis for this validation is to confirm continued reliability of a conformity assessment scheme.

FOR FURTHER INFORMATION, VISIT OUR WEBSITE www.sanas.co.za THANK YOU Contact email details John Ndalamo – JohnN@sanas.co.za Victoria Wagener – Victoriaw@sanas.co.za

Determination of characteristics, as applicable, by: a) testing Conformity assessment functions and activities within product certification schemes Types of product certification schemes   1a 1b 2 3 4 5 6 1 Selection: including planning and preparation activities, specification of requirements, e.g. normative documents, and sampling, as applicable x Determination of characteristics, as applicable, by: a) testing b) inspection c) design appraisal d) assessment of services or processes e) other determination activities, e.g. verification Review Examining the evidence of conformity obtained during the determination stage to establish whether the specified requirements have been met Decision on certification Granting, maintaining, extending, reducing, suspending, withdrawing certification Attestation, licensing a) issuing a certificate of conformity or other statement of conformity (attestation) b) granting the right to use certificates or other statements of conformity c) issuing a certificate of conformity for a batch of products d) granting the right to use marks of conformity (licensing) is based on surveillance (VI) or certification of a batch. Surveillance a) testing or inspection of samples from the open market b) testing or inspection of samples from the factory c) assessment of the production, the delivery of the service or the operation of the process d) management system audits combined with random tests or inspections

DESCRIPTION OF CONTENTS ELEMENTS DESCRIPTION OF CONTENTS Scheme type 1a In this scheme, one or more samples of the product are subjected to the determination activities. A certificate of conformity or other statement of conformity (e.g. a letter) is issued for the product type, the characteristics of which are detailed in the certificate or a document referred to in the certificate. Subsequent production items are not covered by the certification body’s attestation of conformity. The samples are representative of subsequent production items which could be referred to by the manufacturer as being manufactured in accordance with the certified type. The certification body may grant to the manufacturer the right to use the type certificate or other statement of conformity (e.g. letter) as a basis for the manufacturer to declare that subsequent production items conform to the specified requirements. Scheme type 1b This scheme type involves the certification of a whole batch of products, following selection and determination as specified in the scheme. The proportion to be tested, which can include testing of all the units in the batch (100% testing), would be based, for example, on the homogeneity of the items in the batch and the application of a sampling plan, where appropriate. If the outcome of the determination, review and decision is positive, all items in the batch may be described as certified and may have a mark of conformity affixed, if that is included in the scheme. Scheme type 2 The surveillance part of this scheme involves periodically taking samples of the product from the market and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. While this scheme may identify the impact of the distribution channel on conformity, the resources it requires can be extensive. Also, when significant nonconformities are found, effective corrective measures may be limited since the product has already been distributed to the market. Scheme type 3 The surveillance part of this scheme involves periodically taking samples of the product from the point of production and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment of the production process. This scheme does not provide any indication of the impact the distribution channel plays on conformity. When serious nonconformities are found, the opportunity may exist to resolve them before widespread market distribution occurs. Scheme type 4 The surveillance part of this scheme allows for the choice between periodically taking samples of the product from the point of production, or from the market, or from both, and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment of the production process. This scheme can both indicate the impact of the distribution channel on conformity and provide a premarket mechanism to identify and resolve serious nonconformities. Significant duplication of effort may take place for those products whose conformity is not affected during the distribution process. Scheme type 5 The surveillance part of this scheme allows for the choice between periodically taking samples of the product either from the point of production, or from the market, or from both, and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment of the production process, or audit of the management system, or both. The extent to which the four surveillance activities are conducted may be varied for a given situation, as defined in the scheme. If the surveillance includes audit of the management system, an initial audit of the management system will be needed. Scheme type 6 This scheme is mainly applicable to certification of services and processes. Although services are considered as being generally intangible, the determination activities are not limited to the evaluation of intangible elements (e.g. effectiveness of an organization’s procedures, delays and responsiveness of the management). In some situations, the tangible elements of a service can support the evidence of conformity indicated by the assessment of processes, resources and controls involved. For example, inspection of the cleanliness of vehicles for the quality of public transportation. As far as processes are concerned, the situation is very similar. For example, the determination activities for welding processes can include testing and inspection of samples of the resultant welds, if applicable. For both services and processes, the surveillance part of this scheme should include periodic audits of the management system and periodic assessment of the service or process.