July 28, 2021 | Series 1 / No. 8
Self-Declaration is a wonderful way for the regulators to make the businesses accountable and responsible for the products they are releasing in the market. It enables the regulatory authority to reduce the product regulatory costs by avoiding the issuance of certificates, while increasing the ease of doing business.
To provide the necessary scale, bring speed and simplicity to the regulatory approval process, reduce costs, and simplify the business process, the EU decided to limit its scope to publishing and managing the laws (called directives) and underlying technical standards. The certification process was delegated to the Original Equipment Manufacturer (OEM).
This was a productivity improvement measure, where the European Union (EU) showed the path to the rest of the world. Many countries are now adopting this method for conformity assessment.
To comply with the requirements in the European Union (EU), companies are responsible for issuing a Declaration of Conformity (DoC) to state that the product meets all the requirements of the applicable directives and underlying harmonized technical standards. Businesses are typically launching multiple new products in the EU every year. When existing products undergo major design changes, they may require revision of the DoCs. Moreover, directives and/or underlying technical standards are constantly changing, which may necessitate retesting of the product and revision of the existing DoCs.
Following the footsteps of EU and more recently Australia, now several countries offer a DoC as a valid method of conformity assessment. Each one of them have their nuances, unique requirements and dependencies. Manual creation and maintenance of the self-declarations for different products and markets takes significant time and efforts.
Below are references of some markets offering Self-Declaration:
The manual process of creating, reviewing, approving, signing and sharing a DoC is repetitive in nature and requires collaboration among multiple stakeholders. Additionally, keeping track of changes in EU directives and underlying standards so that the latest and applicable directives and standards are used for the presumption of conformity, identifying the impacted products and DoCs due to these changes in directives and standards, and updating the DoCs to reflect the correct standards consume important time of valuable resources.
More and more countries are adopting DoC as a valid method of conformity assessment. The requirements, formats and languages of the DoC may vary from country to country. Therefore, a solution with a rule-based engine that facilitates automation in creation and maintenance of these country-specific DoCs (in the mandated language) is the need of the hour.
The solution should offer a workflow promoting the automation of the DoC generation process that includes creation, review, approval, digital signature, search and share. Additionally, the solution should promote a close collaboration with key stakeholders including, but not limited to, the Compliance professional, Compliance Manager, company authority responsible to authorize (sign), and Test Lab(s) responsible for providing the test reports as the supporting evidence to the DoC. Moreover, the solution should provision for associating the supporting records with the DoC so that it is easy to trace the evidence of product regulatory compliance in the future.
Lastly, continuous monitoring of the changing laws and underlying standards is a must so that the business can create a technically proper DoC, and can modify the existing DoCs if there is a change in the requirements.