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  • Roles and responsibilities of QMS coordinator

    With ISO 9001:2015 there is no longer a mandatory requirement for the existence of a function as Management representative or Coordinator for QMS 9001:2015. So, each organization is free to decide to have such a function and to design roles & responsibilities. As a suggestion I invite you to look for ISO 9001:2015 clause 5.1.1 and think about how you can help top management performing their duties with the management system. Other suggestion varies according to the size of the organization and its organization chart. For example, supervise:

    • corrective actions
    • management review, audits and performance monitorization
    • documents and records control

    You can find more information below:

  • Integrated approach of ISO 13485 and ISO 9001

    1.An Integrated approach of ISO 13485 and ISO9001 What should be focused on considering these 2 standards (These will be audited separately). For integrated approach, I am following Anenxure B of ISO 13485

    Yes, for integrated part you can follow Annex B of the ISO 13485:2016 standard. Be focused on the following:

    To strictly defined and state in Quality manual which requirements from ISO 13485:2016 are not applicable for your process and medical device. For example, if your medical device is not sterile, then requirements 7.5.5 Particular requirements for sterile medical devices and requirement 7.5.7 Particular requirement for validation of processes for sterilization and sterile barrier systems are not applicable for you.

    There are certain requirements in the ISO 13485 that need to have documented procedures, while there are no such strict requirements in the ISO 9001:2015. For example, you need to make a documented procedure for purchasing (requirement 7.4.1), the procedure for validation (7.5.6), the procedure for identification, and traceability (7.5.8 and 7.5.9).  

    For more information what ISO 13485 is, please see the article on the following link:

    For more information about Similarities and differences between ISO 9001:2015 and ISO 13485:2016, please see the article on the following link: https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

    2. How to pass ISO 9001 stage 1 and stage 2 audit?

    To pass ISO 9001 stage 1 and stage 2 audit, your organization must have a quality management system designed according to ISO 9001:2015 requirements and must be implemented and followed.

    3. A Regulatory procedure and form is required that will meet both the standards requirements

    You can add in your Quality manual cross-reference table for your Quality management system between ISO 9001:2015 and ISO 13485:2016.

  • DPO, e-mail and transfer of data to third countries

    If your company is under German law, you will apply German law and GDPR towards all your data processing activities no matter where your employees are located.

    From a GDPR point of view, data processed by employees must comply with GDPR requirements wherever your employees are located. Therefore, you should consider your employee as a German or EU employee and require following the same data policy of your organization. This happens because GDPR compliance is an obligation of the data controller who must assess that everyone in its organization complies with it.

    There are other aspects of the employment agreement (wage, illness, social security) which may differ from country to country, and for those, you should check with a labor lawyer.

  • ISO 9001 Paper procedures

    Yes, you are right. Please check ISO 9001:2015 clause 7.5.3.2 a). Organizations should have a way of controlling distribution of, or access to, relevant quality management system documents. If documents are on paper, I recommend using a matrix that relates document identification, version, location and who has access to it. If documents are on a digital support, I still recommend the use of a matrix to relate document identification, version, and who has access to it. This is critical to ensure that paper documents are updated whenever there is a change in version and that people is informed of the change (for paper and digital documents).

    You can find more information below:

  • Recommendations regarding EU-US Privacy Shield

    What recommendations would you suggest for a small/medium-sized business in light of the recent decision by the ECJ regarding the EU-US Privacy Shield?

    The recent decision of the European Court of Justice (ECJ) has a huge impact on data transfer between the US and the EU. You cannot transfer data based on the decision of adequacy of the US Privacy Shield. Therefore, you need to find another legal ground for data transfer. Standard Contractual Clauses can be a solution.

    The European Data Protection Board (EDPB) issued a FAQ on the implication on GDPR compliance of the ECJ solution and stated that the data controller must take additional measure to ensure the same level of protection of personal data assured by GDPR: https://edpb.europa.eu/news/news/2020/european-data-protection-board-publishes-faq-document-cjeu-judgment-c-31118-schrems_en

    The main issue is that the US data controllers are forced to comply with US law which prevails over Standard Contractual Clause and Binding Corporate Rules (which is a solution for large companies and in some case medium-sized companies).

    The EDPB concluded stating that the data controller should consider storing or processing data elsewhere than the US. 

    You can find more information about data transfer here:

    You can consider enrolling in our free EU GDPR Foundations Course

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