How to create a List of Applied Standards (LoAS) for Product Groups

The List of Applied Standards (LoAS) identifies all the standards applied to, for example, a particular product group or technical documentation that support conformity assessments, audits and ongoing compliance verification.

Using templates to generate LoAS documents

Within meddevo we provide templates that are automatically populated with relevant data. This allows you to generate documents quickly and accurately, ensuring consistency and compliance. You can also create your own customised document templates. (Link: https://manual.dytab.net/en/article/create-a-new-writer-document-template).

Creating the "List of Applied Standards" for a Product Group

  1. Preconditions: Make sure your product group and it's applied regulatory requirements are approved.
  2. Go to the "Documents" collection either from the home screen or from the Collections menu**.**
  3. Click on "+ Add" to start creating a new document.
  4. Click on „Document Generation based on a Writer Template“ and select "PG - List of Applied Standards (eStandards)" from the drop down list.
  5. Under "Scoped Entry" select an approved product group for which the document will be generated. This step ensures that the correct applied standards are populated in the document.
  6. Generate the document: Click on "Generate" to generate the LoAS. The system will populate the document with data based on the selected template and scoped product group.

Handling Preconditions

  • If the applied regulatory requirements are not approved: You can still generate the document, but only with approved data. Entries in "Applicable Requirements" that are still in draft will be excluded from the document. To ensure a complete LoAS, make sure that all relevant entries are approved.
  • If the product group is not approved: You won’t find your product group in the „Scoped Entry“ selector and therefore can't generate the document. Check the approval status of the product group and resolve any issues before generating the LoAS.








 

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