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Integrated management system and ISO certifications

Date of publication: 08-09-2023 Update date: 10-04-2026 🕒 7 min read

Global markets need global standards. The statement applies not only to thread sizes or units of measurement, but also to more complicated issues such as management methodology or laboratory research quality.

Everyone in the electronics industry (and other industries, too, for that matter) most probably has heard terms such as “ISO 9001” or “RoHS directive”. Even though not all of us are obliged to know detailed provisions of documents that define international standards, every engineer and technician should have at least a general knowledge of those regulations, especially if their work involves issues related to automation, electronics or distribution of electrotechnical devices. Thus, it is worth taking a moment to learn about some basic information on international certification – and that is why we have prepared an overview of the most popular standards in the electronic industry for all ambitious readers.

In this article, you can read about:

What is IMS?

IMS – an English acronym standing for Integrated Management System. It is a complex methodology related to the organization of work and processes in a company. Its details are described in documents developed by international institutions for standardization, such as ISO, i.e. The International Organization for Standardization, and sometimeslegislation (as in the case of the EU regulations). This system includes processes (e.g. manufacturing), procedures (documentation, disposal of waste etc.) or practices pursued in the company.

The most basic standard, applicable to various companies, regardless of their character, is ISO 9001. In the case of the electronics industry, we can list a few more important and popular certifications, which are described below. Together, they form a set of rules that ensure high quality and workplace economy, responsible material, power and waste policies and also personal data security. It needs to be highlighted here that local (national) OHS rules are not directly related to those regulations. A company or other organization that meets the requirements of a given standard, is granted a quality certificate by the certifying entity. The list of such accredited entities is usually published by the relevant state authorities.

ISO 9001 – the most popular among management standards

ISO 9001 is the most popular, and at the same time the most general certificate. It is granted in over 150 countries for management quality, including the management of production processes, human resources, finances and even marketing and sales. Its regulations put emphasis on the good of clients, purchasers and employees, but at the same time they give to the management staff freedom when it comes to developing the enterprise. According to ISO 9001, every aspect of business activity is a process, and the quality of management is considered as an action that is meant to ensure mutual compatibility of processes. It should be kept in mind that over the years ISO 9001 has undergone modifications (that’s why the names are 9001:2008, 9001:2015 etc.). An ISO 9001 certificate is granted for three years and doesn’t require an annual audit.

ISO 14001 and quality control

While ISO 9001 certificates focus on the internal activity of companies, ISO 14001 is related to products and services offered by them, which puts it closer to the common understanding of the term “quality certificate”. Similarly to other ISO standards, ISO 14001 doesn’t impose particular goals, but confirms that methods for effective attainment of production objectives are in place in the certified company. The focus here is on environmental protection, reducing the emissions of harmful elements and chemical compounds, economical utilization of resources and intermediate materials, taking care of proper recycling and storage of waste, and also minimizing energy consumption. Of course, these aspects will be particularly important in the electronics industry, where substances considered as harmful are often processed. This applies to manufacturers of consumer devices as well as suppliers of passive and semiconductor components.

RoHS directive – consumer security

The most important thing that needs to be highlighted is: RoHS certification applies to products, and not to companies.

Unlike the standards described above, RoHS is an EU directive, which is implemented in Member States via the regulations of competent executive authorities. This means that it is not voluntary, because failure to observe the directive is a punishable act. The RoHS regulations impose obligations on every manufacturer/importer who introduces electronic products to the EU market.

RoHS stands for Restriction of Hazardous Substances. The aim of the directive is to protect human health and natural environment from excessive amounts of certain elements and chemical compounds. Currently (May 2023), the list of restricted substances contains 10 items, e.g. mercury (Hg), cadmium (Cd), lead (Pb), some polymers (e.g. PBB, PBDE). While describing RoHS, some people make a common mistake and mention “excluding” these substances from the market. It is a misunderstanding, because the directive in fact provides for:

  1. acceptable concentration of restricted substances (in millionth parts, i.e. as PPM, and as percentages);
  2. numerous exceptions (e.g. photovoltaic cells, batteries, certain selected binders, metal alloys specified in the regulations).

At the same time, it needs to be remembered that the definition of devices that is provided in the regulations is very broad. In fact, it covers almost every electrical and electronic device. The obligation of verifying product’s RoHS compliance lies with the entity that introduces it to the EU market (it can be a manufacturer as well as an importer). The certificate is issued by accredited organizations, and in order to receive it, it is necessary to: make laboratory tests, have quality controls (management system) audited, make the necessary documentation. The certificate expires after five years.

The norms and certifications listed above are used widely, actually in the whole electronics industry (and not only that, but this article is focused on it). However, in some specialist fields, you can find a few more popular standards, which are described below. If you work in the electric engineering or IT industry, it is worth learning some basic information about these regulations.

What IEC, DIN and EN acronyms stand for

In the electronics industry, the most common norms are described with acronyms: DIN, EN, IEC and ISO. They may be strictly connected with one another or even identical, but they are developed by independent institutions, each with a different scope of activity. “Independent” does not mean that they avoid working together. In practice, many standards are rooted in cooperation.

International norms are mainly developed by ISO (as mentioned above) and IEC ( International Electrotechnical Commission). The latter organization, as its name says, focuses only on electrical engineering and related fields (IT, electronics, power engineering). When it comes to DIN (German: Deutsches Institut für Normung ), it’s scope of activity is definitely wider and closer to ISO, but there is a crucial difference: even though some standards developed by DIN are globally recognized, they are in fact regulations made for the needs of German industry. The same applies to its US equivalent, ANSI ( American National Standards Institute ), which (as the only one of those mentioned here) remains a private organization. In the case of EN norms ( European Norm ), the situation is analogical, but here, they are granted by the international body, CEN ( European Committee for Standardization ), which is an association of standardization authorities from all EU Member States (to make it clear, DIN belongs to this group).

Personal data protection – ISO/IEC 27001

The ISO/IEC 27001 certificate refers to information security. It focuses on such aspects as business activities as personal data storage (both in terms of human resources and in reference to clients, users and third parties) and the administration of the ICT network, databases etc. The regulations of this norm are also applied to asset management and the continuity of asset management; physical and environmental security; compliance with international and local regulations. It also requires the enterprise to have clearly defined procedures in the case of unauthorized access to the information it stores. As it is associated with reliability and safety, every company providing Internet services makes sure to work in line with this standard.

Medical devices (ISO 13485)

ISO 13485 confirms that the company meets high standards of the designing, production, distribution and service of medical products. Importantly, the certificate also applies to the suppliers of electronic medical equipment (for encephalography, electrocardiography, defibrillation, etc.). The standard requires from the manufacturer that the device is designed according to certain specific procedures (including e.g. identification of risk and utility requirements) and is compliant with all relevant norms and regulations. ISO 13485 also describes the organization of the management of product and production quality control, and even of making documentation.

OSH regulations and ISO 45001 certification

When we talked about ISO 14001, we have already mentioned that the ISO norms do not apply to national and international OHS regulations. The same applies to ISO 45001, even though this standard is directly related to management security and safety. Nevertheless: it focuses on, how a company ensures compliance with the OHS requirements, and not on particular legal acts. For example: ISO 45001 requires that OHS training be organised for workers, but it does not impose, topics to be discussed.

In practice, the ISO 45001 certificate informs us that the certified company protects employees’ health in the full range prescribed by labour law, but also by e.g. introducing strictly defined procedures, clear identification of risks and hazards, creating internal rules and permanent verification of their effectiveness.

What standards are certification bodies subject to?

We have already mentioned the research and audits which are required in order to receive and maintain the certification. At the end, it is worth mentioning that perhaps the most strict standardization applies to the activity of accredited laboratories and controlling bodies. Documents such as ISO 19011 orISO 17021 precisely describe the way in which an audit is to be conducted, its course and reporting, but also some strict requirements for certification institutions. In the area of laboratory procedures, two other standards play the crucial role, namely IEC 62321 describing research methodology required by the RoHS directive; or ISO/IEC 17025 referring e.g. to making measurements and calibration of measurement devices.

Transfer Multisort Elektronik (TME) is one of the world’s largest global distributors of electronic components, electrotechnical parts, workshop equipment, and industrial automation. The catalog includes over 1,500,000 products from 1,300 leading manufacturers. TME’s modern logistics centers in Łódź and Rzgów (Poland), with a combined area of over 40,000 m², ship nearly 6,000 packages daily to customers in more than 150 countries.

TME also invests in the development of knowledge and skills of young engineers and electronics enthusiasts through the TME Education project, and supports the tech community by organizing the TechMasterEvent series, promoting innovation and experience exchange.

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