2 September 2024

5 need to knows about harmonized standards

The market is patiently waiting for the harmonized standards to be published. But it is good to know that the possible publication of the harmonized standards isn’t just sunshine and rainbows. There are important thing to consider when making use of harmonized standards.

  • 1

    Can you do a self-assessment?

    There are three things to check when you want to do a self-assessment based on a harmonized standard: (1) Does the directive or regulation allow you to do a self-assessment? (2) Can you sufficiently test according to the standard? And (3) does your company need quality assurance for testing?

  • 2

    Understand the scope

    Your product has to fit the scope of the harmonized standard, therefore. Check the harmonized standards scope and see if it fits the intended use of your product.

  • 3

    Save your results

    When market surveillance has found a potential non-conformity, they may ask you for the testing results of the testing you have performed. Not being able to comply with this may results in fines or market recalls.

  • 4

    Independence matter

    There are multiple levels of independence and some standards require different levels of independence. For example, it may be required to have testing done by a separate department of a separate entity. Kiwa performs testing as an accredited testing laboratory, meaning we are held to high quality and independence requirements by our accreditation body.

  • 5

    The impact of your signature

    When you sign your declaration of conformity, you are accountable for your product and market surveillance may verify if your product complies with applicable legislation. It carries significant legal and practical implication, including responsibility for the product’s safety, quality and market readiness.

  • A declaration of conformity from a notified body may also provide insurance through shared responsibility in case of a non-conformity. The quality assurance process of a notified body may provide enhanced market opportunities and serves as a major risk mitigation for your company, particularly for high-risk products.