Module D/D1 context to legal requirements

Module D/D1 contains legal provisions that implement requirements to be audited. 

These are usually requirements that are not 100% clear, such as that you shall 'have a quality system that covers manufacturing, quality control e.t.c...' 

The regulation does not define specifically what this means in practice. The requirements of these Modules stem from a general EU decision on CE marking. 

This is specifically Decision 768/2008 and it can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008D0768 

The requirements are usually the same across different regulations/directives, thus they are generic. The result is thus that they leave room for interpretation. 

The question that thus often arises is how is interpretation of these requirements performed. Sometimes a coordination group of Notified Bodies, or another forum, will publish guidance in this regard. However often these do not adequately cover what the Notified Body will ask during an assessment, as they are generic and procedural. 

In this page what we want to do is explain, at hand of the legal requirements, some of the questions that will be asked by an auditor to establish compliance against the relevant requirements.

Note, the numbering in each regulation is different however the general principles for Module D and D1 are comparable. We used a neutral numbering structure below (incremental). The requirements from point 3 below onwards can be linked back to Module D's article 3.2 and Module D1 article 5 in Decision 768/2008. 

The below are not direct additional requirements from the regulation and they cannot be read as such. They are guidelines designed to support an auditor who is attempting to establish compliance with requirements that have grey areas. The below is just informative, if you have other ways to show compliance these questions can be discarded. Questions? Reach out to us and we are happy to clarify. 

1. The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

• What is your QMS policy for this and is there a procedure for establishment of the TD. 
• Risk assessment: Most important hazards and risks of the production process, are these identified and what is the risk management mechanism of the manufacturer?
• Actions to address these risks and integrate them into the production processes as part of the QMS system?
• Update of risk assessment: frequency, reports, responsibilty. Generally please describe how this is done or not depending on the nature of product development? 

2. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 5/10 years after the  product has been placed on the market.

• We will look for evidence that this complies.

3. The quality system shall cover the quality objectives and the organisational structure with responsibilities and powers of the management with regard to product quality.

• What is the organisational structure?
• What are the responsibilities and powers of the management with regard to product quality? Are they written?
• What is the quality policy of the organisation?
• Are there quality goals and objectives regarding the production of the product?
• How is it measured if the quality goals and objectives are reached and what is done with these measurements?
• How are the quality documents updated and dissipated?
• Are the roles, responsibilities and powers of the personnel written?
• Are the job descriptions complete and up to date?
• How do the new employees get to know the quality requirements pertaining to them and how is training covered in the organisation?
• Is there a regular management review at the company? How often? What is the procedure for this? If not, why?

4. The quality system shall cover the manufacturing, quality control and quality assurance techniques, processes and systematic actions.

• Are the design inspection and design verification techniques implemented, documented and how are they appropriate?
• How is the production managed, systemised, regulated and developed and does it guarantee compliance with FPR
• What are the working procedures that cover the production? Does this cover all production steps?
• What is the procedure for the handling and storage of incoming raw materials, prodcution phase, handling of semi finished products and finished products, storage of final end products? 
• Is there a regulated identification and traceability during the production? How is this managed?

5. The quality system shall cover the examinations and tests to be carried out before, during and after manufacture with a specified frequency.

• Is the handling of test equipment documented if the company does it internally or is quality managed implemented on the lab?
• Is there a register about the test equipment and/or testing suppliers and for what they are used and how they comply?
• Is there an identification system for the test equipment if used?
• Is the test equipment calibrated and checked regularly or how do you ensure quality of the lab?
• How are the test results reviewed and evaluated? What is the frequency, interval and quality.
• What is the procedure in case of nonconformity?
• What is the sampling procedure?
• What tests and examinations are carried out during the production? What is the frequency?
• What tests are carried out after the production? What is the frequency?
  
• Are there any harmonised standards used?
• How are the labels checked?
• Who is responsible for handling the nonconforming articles?
• Is the handling of nonconform articles recorded and what is done with this?

6. The quality system shall cover the manufacturer’s quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc

• How is the accessibility to the quality documents for the personnell handled, who has access?
• What is the procedure for handling of the documents? How are the documents identified? How are employee documents handled and stored and what qualification data is present?
• Are there form sheets for the inspection reports, calibration data, training records, training plan and an audit plan, etc.? In general quality records are not defined so judgement is left to a case-by-case basis using ISO 9001 as guidance.
• How are invalid documents handled?
• What is the procedure for filing and refusion?

7. The quality system shall cover the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

• Are there regulated and planned internal audits carried out? If no internal audits how is monitoring handled?
• How are the nonconformities, found during the internal audits/monitoring, handled? How is the monitoring and evaluation done?
• What are the means of monitoring and measuring of the effectiveness of the QMS?
• What is the procedure for the preventive and corrective actions?
• What are the key performance indicators of the QMS? Are these analysed? Are they recorded? If no KPI's how is effective operation of the QMS managed.

On request, we can provide you with a specific checklist to each register (EFCI Register/H2O Register) which you can use for self-assessments. Please send us an email for this.