Voluntary Standards: A Guide to Global Compliance & Market Access

There is a global practice that for products and services with health or safety or environment implications, ‘standards’ are mandated by law for compulsory compliance. Food and Drugs are two ready examples which are heavily regulated be it USA or India or Bhutan. Environmental regulations are another example.

In addition, there is a whole world of voluntary standards – even in regulated sectors – be it food or healthcare. These are not obligatory and its up to the businesses to decide which standard they would adopt based on the benefits it brings to them. One ready example is ISO 9001 for quality management system – a hugely popular standard globally, first published in 1987 and arguably the most certified standard today. The annual survey conducted by the International Organization for Standardization (ISO) shows that there are 1.47 million certifications covering 2.32 million sites for ISO 9001.

In the developed economies, there is role clarity – that regulation is the responsibility of the governments while voluntary standards are driven by markets and stakeholders, chiefly industry. The national standards bodies in developed economies like USA or Europe are industry led and in the private or non-governmental sector.

This is not the case in developing economies where the industry or other stakeholders were, and are, not strong enough to sustain voluntary standardization and hence governments took the initiative to establish national standards bodies. India is a prime example where the government set up the Indian Standards Institution (ISI) as a non-profit Society, which is immortalized now through the popular ISI mark, in 1947 even before independence, and later transformed it into a statutory body by enacting the Bureau of Indian Standards Act in 1986.

Even before ISI came into being, India had established Agmark as a voluntary standards and certification system for agricultural commodities under the Agricultural Produce (Grading and Marking) Act, 1937. 

The national standards bodies in our neighbouring countries or gulf or Africa continue to be governmental although they produce voluntary standards.

The same applies to accreditation, the system for attesting the competence of conformity assessment bodies like inspection bodies, testing labs or certification bodies say for ISO 9001. In large parts of the world, it’s a voluntary activity even if owned by the government in developing countries whereas in many developed economies, these bodies are in private sector.

Accreditation whether as indicated above for conformity assessment or in education or healthcare is voluntary in developed economies and in private sector whereas in developing economies, it is initiated by the governments and housed in governmental institutions. However, a significant development in accreditation world was the in 2008 when the European Commission adopted a regulation 765/2008 to prescribe a single national accreditation body system. However, it continues to be largely a voluntary activity.

There is another feature which separates regulated and voluntary sectors.

Typically, there is a single regulator in a country or in a jurisdiction – we have the Food Safety and Standards Authority of India (FSSAI) for food and Central Drugs Standard Control Organization (CDSCO) or Telecom Regulatory Authority of India (TRAI) in telecom services or the state governments who have authority to regulate say healthcare sector among others.

However, in the voluntary sector, there are likely to be multiple initiatives since there is legally no bar on anyone developing standards.

Indeed, in India, we have this multiplicity present  – while BIS is the national standards body, a number of standards have been developed by the National Accreditation Board for Hospitals & Healthcare Providers (NABH) under the Quality Council of India even though  BIS standards exist or standards on Good Agricultural Practices (IndG.A.P.) or Good Hygienic Practices/HACCP (IndiaHACCP) have been developed by QCI even through BIS has standards on these subjects. Now the National Horticulture Board (NHB) has come up with its own BharatGAP standard adding to the multiplicity.

The same situation prevails globally – there is widely popular Germany based GlobalG.A.P. standard which is even a prerequisite for entering European market for Indian agricultural produce specified not by the governments but by the buyers. In fact, there are more than 300 plus private sustainability standards and certifications going around the world which can seen at StandardsMap and many of these affect Indian industry – especially in agrifood and textiles sectors. Without certification against such standards, they do not get entry into developed markets.

The point to understand is that in voluntary sector, there will be multiplicity and competition, sooner or later and one has to be prepared for it.

There is another aspect.

We aim for global acceptance and in the voluntary sectors around the world such initiatives have come up naturally in private space to endorse such standards or certifications/accreditations.

There is the Global Food Safety Initiative (Home - MyGFSI) which benchmarks food safety related standards or the Programme for the Endorsement of Forest Certification (PEFC - Programme for the Endorsement of Forest Certification) for forestry related standards or ISQua External Evaluation Association (ISQua EEA) which endorses hospital standards and accreditations.

It has to be understood that if India looks for global recognition or acceptance, the concerned institutions needs to subject themselves to such evaluations and benchmarking even if they are governmental, like BIS or QCI or in case of education NAAC or even regulators like NMC or NCIMS, but operate in voluntary space like accreditation.

It has to be remembered that even if it is a governmental institution, in the voluntary space, it has to play by the rules of voluntary sector.

Many governmental bodies have understood this yet some are not clear.

BIS is a statutory body and yet is a member of ISO which is a non-governmental, private body. If it wishes that its standards like on HACCP or GAP should have global acceptance, it has to be open to reaching out to say GFSI. The same applies to QCI where NABH is member of ISQua EEA, which is a private body, and the accreditation Boards, the National Accreditation Board for Certification Bodies (NABCB) and the National Accreditation Board for Testing and Calibration Laboratories (NABL), are members of International Accreditation Forum (The International Accreditation Forum) or International Laboratory Accreditation Cooperation (International Laboratory Accreditation Cooperation) both of which are non-profit but private bodies.

It is in the interest of the industry and the country that we prove our world class standards. conformity assessments and accreditations by accepting the challenge of such voluntary benchmarking or endorsement systems. That we should have a say in such platforms is a topic for another day! India’s record in international bodies in this area is not particularly distinguished.

As we aspire to be a developed economy in 2047 and recognizing that in terms of intellectual ability and expertise, we have developed significantly since the days Agmark or ISI was set up, it is time the government and all stakeholders from industry to trade to academicians to civil society recognize the separation of roles – government to focus on regulation leaving the voluntary space to non-governmental sector rather than launching voluntary initiatives. The need in fact is to regulate the voluntary sector which is fraught with risk of unethical practices be it ISO 9001 certification or organic certification or carbon market. At best, the government may benchmark the multiple voluntary initiatives based on a transparent, clearly defined essential criteria as it has done by making a provision in the Ecomark rules to recognize other ecolabels or Ministry of Ayush is initiating under its Ayush Quality Mark programme (Ayush Export Promotion Council). We will do well to remember that when government liberalized sectors such as telecom or insurance to allow private players, it also set up regulators to exercise oversight in these sectors.

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