Services

#1: Define current regulatory stage

Our first service will be an evaluation and determination of your current stage for working with regulatory requirements.

We will look at your company and interview management end employees, to get an idea of where you company is today and what we can offer.

The interview will cover:

• How committed your management is to work with compliance
• What kind of control/compliance mechanism does already exist in the company, e.g. a Quality Management System
• Who are your current customers and their location
• What are your potential new markets – if you plan for this
• What are the high-level regulatory requirements for all your products for current and potential new market

Based on above, Compliance Advise provide a suggestion for a Compliance and Governance System including a suggestion for a Compliance Policy. Further we will discuss next step and what you can, or will do yourselves, or what can be offered as a service from Compliance Advise.

Setup & sustain a compliance management system

#2: Set up the Compliance or Quality Managemet System

This service cover support to integrate “working with regulatory compliance” into your existing ISO 9001 Quality Management System. If you want to have a separate Compliance Management System, it can be set up in accordance with the ISO 19600 standard.

The compliance system will include the “compliance cycle”, which is a proposal for continuously working with compliance, covering:

• Continuously monitoring for regulatory changes or new regulatory requirements
• Information, internally, about regulatory requirements and relevant interpretations for your products and markets
• Implementation of the regulatory requirements.
• Evaluation of whether your products fulfil the new requirements and documentation of the products proof/evidence of compliance.

#3: Sustaining the Compliance or Quality Management System

This is typically taken care of internally but can also be offered as a service from Compliance Advise covering:

• Handling of regulatory non-compliances and the afterwards evaluation of occurrence
• Non-compliances should not occur often in a robust Compliance System and therefore – beside of evaluation of these – also regular audit of the systems efficiency will take place and necessary improvements will be suggested.
• Regular management reports will be offered as part of this service

Legal requirements for your products

#4: Identify regulatory requirements

This service cover a detailed analyze of your products and the applicable regulations for each market.

The detailed regulatory requirements will be identified based on the company’s entire product portfolio and markets, or it can be based on e.g. specific products for specific markets. As an example; an existing product is planned to be introduced on a new market.

The deliveries will cover:

• Listing top-level legal requirement, with reference (link) to the regulation and a summary of the regulatory requirements
• Listing the relevant standards used to prove compliance together with a high-level summary of the requirements
• A review of whether proof of compliance is documented, present and current
• A comparison between existing proof of compliance and applicable current regulations and standards
  • If proof of compliance is up-to-date, it is ensured that evidence are stored in a controlled way
  • If proof of compliance is lacking, Compliance Advise will propose – in cooperation with the company – a prioritized plan, based on risk, for how to implement, prove and proof compliance

Sustain compliance for your products

#5: Implement regulatory requirements

Based on identified requirements or information about changed requirements, this service cover:

• What are the requirements in the legislation
• How can the requirements be fulfilled by using applicable standards
• A discussions about how specifically, maybe new, regulatory requirements can be implemented for applicable products, e.g. in cooperation with external test-houses or 3rd party certification agencies
  • Some products must have a 3rd party approval before it can be sold. Compliance Advise can take care of this 3rd party approval on your behalf
• Ensuring that compliance evidence, called proof of compliance, is present

Implementation of the regulatory requirements are done in close cooperation with your development engineers, or if we talk about imported products, your manufacturers development engineers.

If needed, specific implementation can also be handled by Compliance Advise in cooperation with our external partners.

#6: Evaluate and document Proof of Compliance

This service is about evaluating test results or other documents showing whether your products fulfil the applicable regulatory requirements, or not and whether the documentation is enough proof for compliance.

• If proof of compliance is accepted, next step is to ensured that it is stored in a controlled way

The evaluation of the proof of compliance documentation is a continuously process and is initiated by changes or new regulatory requirements – not just by the initial evaluation. It could be a good process to annually do an evaluation. A product could have been changed without the regulatory requirements have changed and a regular evaluation will eliminate the risk of regulatory non-compliances.

#7: Monitor for regulatory changes

When selling a product, companies must fulfil all current regulatory requirements for the market where their products are sold.

To avoid the risk related to fines, recalls and product safety issues, companies must be aware of all the regulatory requirement changes introduced AFTER the first product was designed and launched.

The monitoring service give your continuously knowledge to changes in regulatory requirements for specific product

• Compliance Advise can monitor for the changes and give you alerts on regulations or standards
• Compliance Advise can also inform you about the details and make relevant interpretations for your products and markets.

#8: Inform about regulatory changes

This service is a more detailed information about changes

• More detailed information about what specifically is changed
• Support in interpretation of the new requirements for your specific products and markets
• Compliance Advise is established by Carsten Raunsgaard and bases close to Aarhus in Denmark.
• Compliance Advise offer its services in Denmark as well as globally.