General Product Certification Process
Certification activities start when a design specification is available that describes what needs to be designed. From this description, applicable design requirements are collected. These design requirements consist of rules and standards from the own company, but covers also governmental rules and other international rules. For each requirement an owner is assigned to demonstrate the compliance.
For each requirement the means of compliance is determined which is described in a certification plan. The certification plan explains the logic on how to demonstrate compliance and what will be demonstrated. Arrange with the involved parties agreement on the certification plan. The involved parties are te company's experts and the involved authorities. Also customers can be involved.
A declaration of compliance for the product is given by the company who is the design responsible of the product. The declaration shows all data that has been used to show compliance with the requirements and gives the limitations for the applicable configuration. This declaration, a statement, is provided to parties for acceptance. As a result a certificate is issued by authorities and the product is released.
The certificate is archived and the compliance file is maintained. The maintenance consists of verifying the validity of the certificate and thus the declaration of compliance, when changes occur. These changes can be related to design requirements (product development) but can also be related to changes of the (international) rules.
Avoiding time delay in product certification
Basic problem in the product certification process is the time delay. Designing a product is an iterative process and always contains contradictive requirements. Besides, if the development time is long enough other requirements pop up or become more important then the first selected assumptions. The biggest problem that occur in the certification process is confusion. This confusion is delaying the process and can result in repeating submittals. How to avoid this?
- First suggestion for the engineering phase, to avoid problems later on in the compliance demonstration and acceptance phase, is therefore to officially freeze your design and report the most important requirements including the chosen values and assumptions. This can be seen as the boundary conditions of the design. This is important to judge the validity of the performed verification and tests on key characteristics.
- Second suggestion is to define a product-break-down structure. The essence is to make such a structure that it acts as a boundary in the design phase and impact of changes can be easily detected/discussed and accepted.
- Third suggestion is to number that structure in a systematic uniquely way and designate the design. Designating the design avoids confusion in the design projects that are running in parallel. The numbering, configuration identification numbering, helps to identify the exact design that has been or will be demonstrated since the design will evolve as a result of improved insight or demands.