All You Should Know About Certifications as a CRO

You might have a product that needs to have certain characteristics before going on the market. Then, maybe you have to go through a certification process?

Certifying your product tells your customers that you:

• Have met standards that have been established and verified.
• Are dedicated to maintaining quality in your work.

If you are in need of clarification about the process of certification and the role of certification providers, you are in the right place.

What are the standards?

You probably wonder who establish the standards at first. Here are the answer for Europe and the international level.

In Europe:

The European Committee for Electrotechnical Standardization (CENELEC) is a European regional standards’ organization. Together with the European Committee for Standardization (CEN), and the European Telecommunications Standards Institute (ETSI), they compose the European Standards Organizations. Only standards developed by CEN, CENELEC, and ETSI are recognized as “European Standards”.

The latest lists of references of harmonized standards and other European standards published are available on the website of the European Commission.

The standards for all these categories are available:

• Chemicals.
• Conformity assessment and management systems.
• Construction.
• Consumers and workers protection.
• Electric and electronic engineering.
• Healthcare engineering.
• Measuring technology.
• Mechanical engineering and means of transport.
• Services.
• Sustainability.

EU’s harmonization legislation is mainly managed by Directorate-General for Internal market, Industry, Entrepreneurship, and SMEs.

Internationally:

The International Organization for Standardization is a non-governmental organization.

• It is the world’s largest developer of voluntary international standards.
• And it facilitates world trade by providing common standards between nations.
• Thousands of standards have been set. They cover a lot of areas from manufactured products and technology to food safety, agriculture, and healthcare.
• Use of the standards supports for the creation of products and services that are safe, reliable and of good quality.

Why certification proves you met the standards?

A Certification is a useful tool that, by demonstrating that your product or service meets the expectations of your customers, strengthens your credibility. In some sectors, it is even a legal or contractual obligation.

Product certification is a common type of certification. It is intended to discover if a product meets minimum standards. It is similar to quality assurance.

Example of the European CE marking

The letters “CE” appear on many products on the market in the European economic area (EEA). It means that products have been assessed to meet high safety, health, and environmental protection requirements.

A manufacturer acknowledges that the product meets all the legal requirements when marking it with “CE”. It means that the product can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA. In fact, all companies are accountable to the same rules so it supports fair competition.

Example of international standards

ISO certifications are references that concern quality management. The International Organization for Standardization defines ISO certification as “a procedure in which a third party gives written assurance that a product, process or service conforms to the requirements specified in a repository. “

ISO certification ensures compliance of either a product, a service, an organization or a process. Find below a few examples of common ISO certification terminology.

ISO standards	Area of action
ISO 9000	Quality management systems and their terminology
ISO 9001	The requirements of quality management systems, the obligations of certified companies.
ISO 9004	Quality Management Guidelines for Continuous Improvement.
ISO 10011	Guidelines for carrying out quality control audits.
ISO 14001	Guidelines for Respecting the Environment.

How to get your certification?

Certification is used to determine whether individuals are knowledgeable enough in its activity to be labeled “competent to practice”.

To display certification claims in marketing materials you have to be certified and you need to go through a certain process.

First, you have to request the certification to certification providers. We will get back to this later. You go through a review of the certification criteria. You should seek clarification with experts. And, you prepare the self-assessment materials.

Then you have to be reviewed by the certification provider. Your self-assessment responses have to be clarified and it takes several weeks.

After that, you receive the certification decision. The certification letter still valid for a year. You can apply for an additional term, or product versions, up to 3 years.

Who can provide certification?

ISO can deliver ISO-related certifications and CENELEC and ETSI deliver European standards-related certifications. They have their prerogatives.

Some companies can deliver certifications on behalf of standard organizations.

Some suggestions for choosing a certification provider:

• Evaluate several certification providers, not just one.
• Determine whether the certification provider is implementing the appropriate standard.
• Ask if the organization is accredited: it is not mandatory, an organization that is not accredited can be perfectly reliable. Nonetheless, it is an independent confirmation of competence.

What is important to know is that certification is very a significant argument for customers, and sometimes mandatory.

The standards help businesses increase productivity and minimizing errors and waste. But, they also serve to safeguard consumers and the end-users of products and services.

There’s a specific process to go through to get yours. And if you are looking to find the names of accredited certification provider, you can contact the national accreditation structure in your country or go to the International Accreditation Forum.

You can also check-out our certification providers listed on Scientist