A Review of Certification and its Impact on Regulatory Intervention (July 2021)
This paper explores the interplay between regulations and standards, and the value that third-party certification provides as means to ensure that food manufactured into the market in the Netherlands are safe for consumers. It draws on data from the results of audits of industrial food businesses by the regulator against the requirements of National and EU laws, which also records if the business is certified to one of the recognised Global Food Safety Initiative (GFSI) third-party certification programmes.
The data, which covers 5 years and 15,000 inspection audits, shows that sites operating to 3rdparty management systems perform better than non-certificated sites.
Recent Case Study
Improving Drinking Water Monitoring in Croatia
The accreditation supports monitoring of drinking water in Croatia through the accreditation of drinking water testing laboratories that are further authorised by the Croatian Ministry of Health (MoH) for drinking water monitoring. With its accredited laboratories, the Croatian Institute of Public Health (CIPH) coordinates monitoring. It is also one of the national contact points for SDG 6 as well as for UNECE – WHO/Europe Protocol on Water and Health, whose basic goal is to ensure access to water and sanitation for all.
Accreditation provides confidence in the technical competence of a laboratory to carry out drinking water analyses and as such ensures that the most appropriate methodologies and rigour are applied to the assessment process of drinking water safety.
This synergy of roles of CIPH on drinking water monitoring and SDG 6 gives an opportunity to identify the current public health needs of the population related to drinking water, anticipate future trends and provide preconditions for their effective management, with the main goal of assurance of safe drinking water delivery to all Croatian residents, as well as preserving and improving the health of the population.
Croatian National legislation on drinking water quality is based on the European Drinking Water Directive (DWD), which establishes the monitoring programme and parameters (microbiological, chemical and indicator) that need to be measured in order to protect human health from the adverse effects of any pollution of water for human consumption. However, on some levels Croatian legislation is stricter than DWD and also prescribes measurements of parameters that are not prescribed by the DWD but which are considered important to monitor by the national experts.
Public health laboratories (20) are authorised by the MoH to analyse samples taken at consumers’ taps as a part of monitoring programme that is defined by the CIPH and approved by the MoH. Laboratories need to be accredited according to the HRN EN ISO/IEC:17025 standard. In addition to methods that are accredited, it is possible to obtain authorisation from the MoH for additional methods if laboratories perform method validation, calculate measurement uncertainty and successfully participate in the proficiency testing schemes.
Conformity assessment of drinking water samples is extremely important for the protection of human health. When the conformity assessment is not prescribed by law, a binary statement for a simple acceptance rule according to ILAC-G8: 09/2019 Guidelines on Decision Rules and Statements of Conformity is applied.
Results and impact
Drinking water monitoring results indicate that drinking water quality supplied through public water supply systems is safe for 87.8% of Croatian residents. However, a small portion of residents (1.6%) are connected to small community water supply systems that deliver water that is very often microbiologically unsafe. Thus, in Croatia, as in many other countries, it has been shown that small systems carry the greatest public health risk.
Independent drinking water surveillance is essential for public health. Further associated activities in Croatia will aim to improve effective drinking water surveillance that will be aligned with risk-based principles, including prioritization of monitoring parameters and surveillance efforts based on water safety plan outcomes. The role of the accreditation is very important in this process since reliable analytical results are the basis for any risk-based approach that aims to assure drinking water safety and public health.
Magdalena Ujević Bošnjak, BSc, PhD, scientific assistant
Head of the Department for Water Safety and Supply
CROATIAN INSTITUTE OF PUBLIC HEALTH
Rockefellerova 7, HR-10000 Zagreb, Croatia, www.hzjz.hr
T. +385 1 4863 219 F. +385 1 4683 009
E. firstname.lastname@example.org M.+385 91 799 6068
Recent Case Study
Southern African Development Cooperation (SADC) Regional Laboratory Association (SRLA): OUR UNIQUE SUCCESS STORY
The SADC Regional Laboratory Association (SRLA) was established over a decade ago in order to support, assist and empower member states by providing them with a regional platform and voice. Furthermore, the SRLA promotes the importance of laboratories in the SADC economy; strengthens both management and technical capacity through training and interventions; builds and broaden skills of analysts; strengthens the capacity of food and water testing laboratories and assists members with accreditation in their respective laboratories.
Unique to the African landscape, the Mopane tree is hardy and can withstand the harsh African heat and often dry habitat. In order to flourish in a tough environment, its ‘butterfly’ leaves open and close to protect it from moisture loss. It is also resistant to termites but home to the Mopani worms after the rainy season and eaten as a staple food in some African cultures.
Much like the Mopane tree, the SRLA started as a seed, grew roots and started to flourish in challenging and often tough environments – working together to bear fruit (legumes) to be enjoyed by all SADC member states.
The resilience of the SRLA members was demonstrated during the COVID-19 pandemic when the demand for the services of the members was critical and laboratories were declared as essential services.
In developing the Quality Infrastructure (QI) of the South African Development Community (SADC) member states (MSs) it became evident that there would be a large reliance on the services of testing and calibration laboratories in support of trade. In the mid 2000’s, inspired by the National Laboratory Association – South Africa (NLA-SA), twelve (12) SADC Member States initiated the formation of their own associations in order to mobilise support and capacity building opportunities for their more than 500 members.
The SRLA is incorporated as a “Not for Profit (NPC) company with a Board of Directors guiding strategy and the secretariat being the heart of the regional association is held by the NLA-SA.
The SRLA liaises with the members of the SADC Technical Cooperation Structures as described in the TBT Annex to the SADC Protocol on Trade especially during events to raise awareness of the role of standards, quality assurance, accreditation and metrology (SQAM) in facilitating trade during World Metrology Day (20 May), World Accreditation Day (09 June) and World Standards Day (14 October).
The SRLA members and the National Accreditation Focal Points (NAFPs) that represent Member States without their own National Accreditation Body (NAB) has formed a platform for the MS-NLAs and NAFPs to meet and exchange knowledge and experiences, as well as to identify potential synergies and linkages. The main areas of collaboration include training on quality management systems and technical capacity building; marketing and awareness-raising events on the importance of accreditation; and, the establishment of a harmonized database of CABs in the region.
The SRLA became a Stakeholder Member of the African Accreditation Cooperation (AFRAC) in March 2020. Furthermore, the SRLA interacts with the members of the Infra-African Metrology System (AFRIMETS) during the General Assembly meetings.
Whilst the SRLA’s main focus is the CABs in the various member states, it is recognized that SADC is an integral part of the continent and thus the SRLA has a long-term goal to bring CABs in the Pan-African context together in meaningful structure.
The strategy can be outlined by the following 5 objectives:
• To promote the importance of laboratories in the SADC economy;
• To strengthen both management and technical capacity through training and interventions;
• To build and broaden skills;
• To strengthen the capacity of food and water testing laboratories
• To assist members with accreditation in their respective laboratories
In June 2016, a Gap Assessment tool was developed where a survey was conducted to evaluate additional needs that may exist within the SADC region in the area of Testing, Calibration and
Medical laboratories. Then, in 2017, 2018 and 2019, three training courses were presented, namely
(a) Business and Strategic Plan Development Training
in order to upskill members to have a clear understanding of how to run their association sustainably, to draft a business plan and associated documents for each MS-NLA.
(b)Method Validation for Microbiology laboratory personnel
The objective of this training was to build technical capacity in the MS-NLA to supply microbiology training services to public and private sector microbiology testing laboratories in the Member State (MS), in particular Method Validation and Method Uncertainty for microbiology test methods for food and water. In addition, the training was aimed at preparing microbiology testing laboratories to comply with the requirements of ISO/IEC 17025
(c) Method Validation Analytical
The Method Validation (Analytical) training course provided candidates with a fundamental understanding of the importance of Quality Control and Quality Assurance in a laboratory, as well
as the reasons for conducting Method Validation. It provided, also, the tools for conducting Method Validation and the methodology for approaching this requirement. Candidates had
sufficient opportunity to reinforce the theoretical aspects with practical and hands-on assignments on a daily basis.
RESULTS AND IMPACT
To date, 339 individuals have been trained in the 5 different fields.
Business and Strategic Plan Development Training
• Value Proposition
• Business Model
• Marketing and Sales
• Budgeting and Financial Reporting
• Competitor Analysis
• Participation in the annual Test & Measurement Conference in South Africa
• Collaboration with National Accreditation Focal Points in SADC Member States and participation in the annual regional SADC Technical Cooperation Structures’ meetings
• Finance for Laboratory Managers Course developed and offered virtually
Best Performing SRLA Member
• The first SRLA award was made during the first virtual meeting held on 27 May 2020
National Laboratory Association-South Africa
Tel. +27 12 349 1500
Fax. +27 12 349 1501
Recent Case Study
Labels and ‘slogans’ on the sustainability of products and services: how to orientate yourself?
Focusing on sustainability grows business and attracts consumer confidence. This is why ethical claims have become more widespread in the market. But how can you tell if these claims are true and verified?
Businesses have long understood that focusing on sustainability grows business and attracts the trust of consumers, who are increasingly attentive to social and environmental issues. And ethical claims are the most immediate and effective tool for reaching the market.
But how can we tell if these claims are true and verified?
A first step forward was taken with the adoption and publication in Italian of the international technical specification UNI ISO/TS 17033 “Ethical claims and supporting information – Principles and requirements”, which represents an important tool to put order, both at terminological and procedural level, in such a delicate area for all organisations and which pertains to the sphere of communication and transparency towards the market and consumers.
In order to provide application guidelines on responsibility and sustainability of the requirements of UNI ISO/TS 17033, UNI – Italian Standardization Body and ACCREDIA – Italian Accreditation Body have published the “Prassi di Riferimento” UNI/PdR 102:2021 “Ethical claims of responsibility for sustainable development – Application guidelines to UNI ISO/TS 17033:2020” identifying the elements that an organisation must take into consideration when declaring an ethical assertion of responsibility for sustainable development.
The purpose of the Practice is to indicate to organisations a structured and shared path in the elaboration and declaration of ethical assertions that intend to focus on sustainability issues.
“The ethical claims of responsibility for sustainable development” – explains Elena Battellino of ACCREDIA, Project leader of the UNI/PdR – “allows to promote the demand and supply of those products, services, processes whose characteristics can stimulate, with the involvement of stakeholders according to the principle of materiality, a process of continuous improvement towards sustainability throughout the value chain. Through a structured process that includes the assessment of the distribution of sustainable development impacts between generations and the use of reporting tools already widespread on the market, the organisation can support the actions underlying the claim also with reference to the fundamental issues of the UNI ISO 26000 and the 2030 Agenda’s Sustainable Development Goals, attracting more investors also thanks to the availability of non-financial information”.
“When you look at advertising, it seems as if all companies and products have suddenly become sustainable. But is this true? Does the company itself say so, or has anyone verified these claims?” – comments Emanuele Riva deputy director general of ACCREDIA. “The verification and validation of the claim ensures that a statement is not only true and unambiguous, but that it covers all the elements relating to sustainability (i.e. social, environmental and economic aspects) that are most relevant to the reference context. Objective data, declared results and achieved objectives are verified. This is a strong tool to protect consumers, who can now trust what they are told when promoting a product. “No more false promises and fake news,” concludes Riva. “Now there is someone who, with competence, impartiality and method, will be able to verify advertising claims on sustainability.
Recent Case Study
Offer greater clarity to investors in their investment choices in favor of the development of a sustainable economy
Socially responsible investment (SRI) takes into account several themes such as social, ethical, environmental and governance criteria.
The accreditation issued by Cofrac – the French accreditation body – concerns certification bodies that are accredited to assess and certify, in the form of a label, good practices in socially responsible investment. This accredited certification provides greater clarity for institutional and individual investors wishing to participate in the development of a sustainable economy through their investment choices.
The promotion of this type of investment aims to encourage companies to integrate environmental, social and governance (ESG) criteria into their policies, and individuals to invest their savings in more ethical, socially responsible and environmentally friendly investments, without obscuring the expected financial return.
Adopting a socially responsible approach to investment becomes possible by investing in SRI funds that meet these criteria. The money collected by these funds is then directly invested in companies in the real economy that meet SRI criteria.
The French public authorities wish to encourage savers to invest their long-term savings in instruments of ecological transition. SRI label is also an element of attractiveness of Paris as a financial center.
The use of accreditation responds to a need for confidence in such investment funds. Mandatory since 2015, it accompanies the will of French public authorities to promote them.
Results and impact
Paris is at the forefront of socially responsible investment in Europe.
At 31 December 2020, 656 funds had received the SRI label, involving 98 management companies for a total outstanding amount of 350 billion euros.
Cofrac – Communication department
Recent Case Study
Improving Trust in Forensic Science
The accreditation supports public health systems in West Africa, especially with the COVID-19 pandemic. The Community of West African States (ECOWAS) has a regional standardization mechanism called ECOSHAM. The latter allowed the adoption of two regional standards, for the benefit of all member states, relating to hand sanitizers and barrier masks for use by the general public. The ECOWAS accreditation mechanism is based on the Ghanaian accreditation body GhaNAS, the Nigerian accreditation body (NiNAS) and the West African Accreditation System (SOAC) which covers eight member states. The three bodies are taking over in order to accredit the product certification services of the member states for certification schemes based on the two validated standards.
The issue of the quality of masks and hand sanitizers has become central around the world in the fight against COVID-19. Ensuring that populations will be protected will depend on ensuring the quality of preventive control means, in particular masks and hand sanitizers solutions, namely standardization to set the performance / conformity criteria of products, conformity assessment to ensure that the criteria are met by the producing companies and the accreditation to guarantee the entire system by validating the competence of conformity assessment bodies.
NiNAS and SOAC have opened new accreditation programs including ISO IEC 17065 in order to meet the expectations of product certification services in their respective member states: Nigeria for NiNAS, (Benin Burkina Faso Côte d’Ivoire, Guinea Bissau, Mali, Niger, Senegal , Togo) for SOAC a multi economy AB. Within the region, at least three certification bodies have already started certification of masks nationwide with country brands. With the regional approach, the regional ECOQMARK Brand will be highlighted. NiNAS and SOAC, and later GhaNAS’ accreditation can thus validate a regional certification scheme based on two standards adopted by all member states: ECOSTAND 82 on barrier masks for general public use and ECOSTAND 83 standard on the quality of products for hand sanitizers.
Results and impact
There is a significant added value in accreditation in the area of SDG 3 “Health and Well-being” when it allows certification services to be accredited for the control of essential products that protect populations from the pandemic. Indeed, West Africa has an average of 386 million, including at least 20 million people over 60 (2005 data) who constitute the most vulnerable age group.
Recent Case Study
Energy management system certification supports environment-friendly and resource-conserving society in China
Energy management system certification is technical support for building an “environment-friendly and resource-conserving” society in China. The national standard Energy management system—Requirements (GB/T 23331-2012/ISO 50001:2011) was published on December 31, 2012, and took effect on October 1, 2013.
Altogether 6303 energy management system certificates have been issued for 6028 organizations in China by the end of 2020. Energy management system certification can not only prove effective operation of the system within an organization, but also help the organization to improve energy performance in terms of energy efficiency, use and consumption, contribute to conservation and rational utilization of energy, reduce production (service) and operation cost, and remain competitive when energy resource price constantly rises. It can also help form the concept and self-discipline mechanism of energy conservation and emission reduction to meet the requirements of national energy consumption index.
By the end of 2020, China had 68 energy management system certification bodies, 33 of which were accredited by China National Accreditation Service for Conformity Assessment (CNAS).
Recent Case Study
Forensic unit accreditation improves social governance level in China
The results of forensic identification concern the realization of judicial fairness and protection of citizens’ legitimate rights. In 2005, China issued the Decisions on Forensic Identification Management Problems. In the Decisions, Article 5 clearly stipulates that the forensic units engaged in forensic medicine, material evidence, and audio-visual material identification shall “have the testing laboratory with China Metrology Accreditation or laboratory accreditation by law for forensic identification within the scope of services”.
The Ministry of Justice, the Ministry of Public Security and the Supreme People’s Procuratorate of China have promulgated relevant administrative measures and put forward the same requirements for judicial expertise institutions. As a result, to obtain accreditation qualifications have become one of legal accesses for forensic units in China.
On the basis of ISO/IEC 17025 and ISO/IEC 17020, China National Accreditation Service for Conformity Assessment (CNAS) established forensic unit accreditation scheme to improve their credibility. In 2003, CNAS issued the first forensic unit accreditation certificate.
By the end of 2020, CNAS has accredited 461 forensic units, covering areas of forensic medicine, material evidence, and audio-visual material identification and electronic evidence. The 10 national level forensic units have all been accredited in China.
Recent Case Study
CNAS medical laboratory accreditation supports good health and well being
Medical laboratories play an important role in the evaluation of human health status, the correct diagnosis, treatment and prognosis of diseases. The quality and technical level of medical laboratory are directly related to the health and well-being of the public.
China National Accreditation Service for Conformity Assessment (CNAS) issued the first medical laboratory accreditation certificate in August 2005. By the end of December 2020, CNAS has accredited 453 medical laboratories. Accreditation has been recognized by medical laboratories in China as an important tool to improve quality and technical ability. In December 2007, CNAS successively signed the mutual recognition agreements with Asia-Pacific Laboratory Accreditation Cooperation (APLAC) and the International Laboratory Accreditation Cooperation (ILAC) on medical laboratory accreditation. China Accreditation will continue to make greater contributions to the construction of a healthy China.