The Standardization Directorate of the Standards and Metrology Institute (SMI) is a Maltese independent body set up under the Malta Competition and Consumer Affairs (MCCAA) Act (ACT No. VI of 2011) entrusted with the coordination of standardization and related activities at various corporate, national, regional and international levels.  Its main functions are to make, adopt and publish standards in relation to any class, category or type of products and/or services. The Standardization Directorate of SMI is responsible to inform the public of new subjects included in its standards programme and of the preparation or amendment of a standard, unless such standard is an identical or equivalent transposition of an International or European Standard.  The aims of the Directorate are to promote the benefits of improvement in:

• The quality of goods and services; 
• The quality of life, safety, health and the protection of the environment;
• The efficient use of resources;
• Regional and international trade.

This will be achieved by applying internationally accepted standardization principles including giving precedence to international agreements, consensus, balanced participation, transparency, well-defined rules for drafting and presentation of standards, and by respecting the intellectual property rights of contributors to Standards.

The MCCAA is a full member of CEN, CENELEC and ETSI as from 3rd October 2001, 1st October 2001 and 26th March 2000 respectively. The MCCAA fully participates in General Assemblies, Administrative Boards, Technical Boards and other corporate advisory bodies as necessary to meet its international, European and national requirements.

What is standard? 

Standards are documents defining characteristics (for example, dimensions, safety aspects, performance requirements) of a product, process or service, in line with the technical/technological state-of-the art.

Standards are developed by experts representing the interested economic and social parties ”stakeholders” (producers, services providers, suppliers, users, consumers, public authorities, scientist/professional institutions, educational authorities…). According to the national standardization body’s procedures, they are organized in committees and subcommittees, or often in specific working groups who address the detailed technical content, which are competent for their specific area of work.

The standardization body has the responsibility to validate the standard in accordance with the procedures. It provides the infrastructure, proven and published procedures and project management for the standardization process; while standards content is chosen by the “external” experts.

Objectives of Standardization

Standardization activity includes defining performances of products, processes and services, so intervening in all the “life” phases of a product, from its design to its use and tertiary activities. Moreover, standardization also involves establishing product safety characteristics, so as to protect people coming in contact with it. Quality and safety are therefore two very important aspects that guide the standardization activity. Other important objectives of standardization include:

• Facilitating technical communication through the unification of symbols, codes and interfaces
• Increasing the cost-effectiveness of production and use by defining and unifying products and processes, performances and final inspection/testing modalities
• Promoting safety and environment protection
• Acting in the general interests of consumers and community.

Principles of Standardization

Five principles characterize the standardization process:

1. Consensus standards must be approved with the agreement of all the stakeholders.
2. Democratic legitimacy all interested parties have right to participate in the elaboration of standards and, above all, anybody can formulate observations during the period preceding the final approval.
3. Transparency the standardization body indicates the fundamental stages of the approval process of a standardization project, making the latter publicly available.
4. Voluntaries standards are mere reference, nobody is obliged to follow them. Their application is only discretionary except in cases concerning with the safety of people.
5. Coherence standards should not contradict each other.

Benefits of Standardization

Standards contribute to the overall quality and safety of a product or service. They assure compatibility and interchangeability, reduce unnecessary variety and increase the cost-effectiveness of processes and procedures. Standards help to protect the health of human beings, animals and the general environment. They create transparency in technical and technological issues by offering a common terminology. In areas of very rapid technological development standards may provide a basis for the assessment of potential future risks. Finally, the harmonization of standards is a substantial step towards the free international movement of goods.

Standardization activity is a decisive factor for the success of a single company and of the economy of a country. Who has the standard has the market. In other words, who contributes in developing standards will have more opportunities to access the market and in shorter times; who does not participate will be forced to meet requirements set by his own competitors, with few time at disposal and with high costs of adaptation.

Elaboration of Standards

Standards are prepared in six major phases:

1. Assessment and approval: The proposal for the elaboration of a new standard (or the revision of an existing standard) is assessed: Is there a real need for this standard? Is there sufficient support for the standard? Are the required material and human resources available?
2. Drafting of the standard: The work is allocated to a Technical Committee (TC) and/or working group. Very often there is an initial draft from the proposed or reference documents which are the basis the elaboration of the text. In the drafting phase the various stakeholders try to reconcile their diverging interest with view to coming to a solution which is acceptable to all them.
3. Public consultation of the draft standard: As soon as the text has the agreement of the TC, it is published as draft standard for public enquiry.
4. Review of comments: The comments received are considered by the responsible TC and taken into account for the final document. The TC not obliged to include all comments received. After the review of comments, the TC votes on the final draft.
5. Consensus: If consensus is established, the document is handed over for publication.
6. Publication of the standard: Once a standard is published, it is notified in the official channels (e.g. official Government Gazette) to give it the status of a national standard.

Standards, Technical Specifications and Technical Regulations

The difference between the definition of Standards, Technical Specifications and Technical Regulations can be found in MSA EN 45020:2007 "Standardization and related activities - General Vocabulary":
A standard is a “document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context”.
A technical specification is a "document that prescribes technical requirements to be fulfilled by a product, process or service"

Do note that:

• a technical specification may be a standard or another document prescribing technical requirements, the elaboration of which does not necessarily require the abidance of standardization principles such as consensus etc.;
• a regulation is a "document providing binding legislative rules that is adopted by an authority";
• a technical regulation therefore is a binding document prescribing technical requirements.

Standards and Law

Standards are based on the principle of voluntariness, which means that the application of standards is only discretionary (choice). However, as standards are drawn up by a method requiring the approval of all interested parties and are to the benefit of all, there exists a willingness among the parties concerned to apply them (self-regulation of the market).
Regulations, on the other hand, are legally binding for the citizens of the state. They are enacted by the legislative organs of the state according to procedures outlined in the constitution. These regulations are referred to as laws, decrees or legislation. There exist also acts that are issued by executive authorities. They may be directed either to the general public or to individuals.
National legislators tend to refer to technical data as contained in technical specifications forming part of regulations (laws, decrees, acts).
Two options are used on a national basis:

1. Reference to specific standards:

Reference in regulations can be made to specific standards.

• Exclusive reference:

Compliance with the standard referred to is the only way of compliance with the law or regulation. This kind of standard is defined as a mandatory standard.

• Indicative reference:

Compliance with the standard is one way (from several) of meeting the requirements of the regulation. Such a standard is not mandatory.

2. General reference to “state of the art”:

Non-specific references are made by legislators by referring to general clauses like the “state of the art”. In order to find out what the “state of art” comprises in a specific field, at a certain period of time, all technical specifications existing in this field have to be considered.

Standards are technical specifications; they even make up the biggest part of the codified technical specifications that exist in a country. Whether the “state of the art” has been met can only be judged by a technical expert in an individual case

European Standardization

Standardization is an integral part of the European Union’s policies to increase the competitiveness of enterprises and to remove barriers. This was confirmed by the European Parliament in 1999 and by the Council both in its Resolution of 28 October 1999 and its Conclusions of 1 March 2002 on the role of standardisation in Europe. At the same time, the Council invited the Commission to review the objectives, scope and needs of European standardisation policy. See more.

eLearning Tool for SMEs

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