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ISO 9001 Implementation

Determine the scope of the quality management system (QMS), your organization may decide to include only certain lines of business.

Setup a project sponsor, a project manager and a project team. Ensure top management support, get training about the standard. Designing and implementing a quality management system implies being knowledgeable about ISO 9001:2015.

As a first step perform a Gap analysis, to determine the amount of work to be done - comparing what your organization already has in place versus ISO 9001:2015 requirements. From that GAP Analysis you can develop your Project Plan, listing what needs to be done, by whom, until when.

Then, an important step is to design a model of how your organization work as a set of interrelated processes. For example:

Decide how to describe and monitor those processes.

From there it is implementation in order to close the gaps found. Then, perform an internal audit and the management review. There you can decide if your organization is ready for a certification audit.

This is a very short description of the journey but below you can find more detailed information:

You can find more information below:

• Free Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
• Should you use a gap analysis in your ISO 9001 implementation? -https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/
• Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
• ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
• How to budget an ISO 9001 implementation project - https://info.advisera.com/9001academy/free-download/how-to-budget-an-iso-9001-implementation-project?utm_source=script-for-iso-9001-lead-implementer-course&utm_medium=downloaded-content&utm_content=lang-en&utm_campaign=free-downloads-9001
• Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
• Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

Procedure(s) for conformity assessment

The term "Conformity assessment" means the process demonstrating whether the requirements of the Medical device regulation EU MDR 2017/745 relating to a medical device have been fulfilled. Medical device manufacturers have to follow conformity assessment procedures before placing products on the market. With conformity assessment procedures manufacturers must prove compliance of the products with the essential requirements laid down in Medical Device Regulation.

However, there is no requirement in MDR that the conformity assessment procedure must be documented. In Article 52 - Conformity assessment procedures states that manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes 9 to 11.

• EU MDR Annex 9 - Conformity assessment based on a quality management system and assessment of the technical documentation
• EU MDR Annex 10 - Conformity assessment based on type examination
• EU MDR Annex 11 – Conformity assessment based on product conformity verification

Here you can find the direct links to the Annexes:

• EU MDR Article 52 – Conformity assessment procedure https://advisera.com/13485academy/mdr/conformity-assessment-procedures/
• EU MDR Annex IX https://advisera.com/13485academy/mdr/conformity-assessment-based-on-a-quality-management-system-and-assessment-of-the-technical-documentation/
• EU MDR Annex 10 https://advisera.com/13485academy/mdr/conformity-assessment-based-on-type-examination/
• EU MDR Annex 11 https://advisera.com/13485academy/mdr/conformity-assessment-based-on-product-conformity-verification/

• Strategy to assess if the change is a significant change

  When you have significant change for your medical device, you are obliged to report it to your Notify Body according to the guidelines from the practice guide that you have mentioned. Each Notify Body has its own templates for reporting the changes so you will need to fulfill them. Than the Notify body will decide, depending on the significance of the change, is additional audit necessary or not.

  In our documentation toolkit, we do not have that template for reporting the change since it is Notify body form. 

  Since we are talking here about the change of the medical device, then definitively you will have a change in your technical documentation (medical device file). Document change management is described in the procedure 00_Procedure_for_Document_and_Record_Control_Premium_EN, in section 3.5 Document updates and changes.

• Main challenge stat up companies face to comply with ISO 13485

  First, you need to educate yourself about ISO 13485, what kind of standard it is, what are the specific requirements in it. If any requirements in Clauses 6, 7, and 8 are not applicable due to the nature of the medical device, those requirements can be excluded.

  For example, if your medical device is not sterile, then requirements 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems are not applicable for you.

  If your medical device is software, then several more requirements are not applicable: 6.4.2 Contamination control; 7.5.2 Cleanliness of product, 7.5.9.2 Particular requirements for implantable medical devices. 

  Then you need to be sure that you have a medical device. ISO 13485:2016 is applicable for manufacturing medical devices. Definition what is a medical device you can find on the following link:

  • Medical device regulation MDR 2017/745 – Article 2 – Definitions https://advisera.com/13485academy/mdr/definitions/

  The next important step is to define your processes and to make all necessary documentation procedures and records. In that, very helpful can be a documentation toolkit. It is a set of pre-written templates, easy-to-use, fully compliant policies, procedures, and records. 

  You can find our ISO 13485:2016 documentation toolkit on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

  For more details, please see the following articles:

  • What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
  • How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
  • Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
  • How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

  • Clean room requirements standards for ISO 13485:2016

    ISO organization has following standards dedicated to clean rooms, outlining the practices and procedures required to manage the risk of contamination, and provide the framework for classifying and monitoring the cleanliness of the air in cleanrooms:

    • ISO 14644-1:2015, Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration https://www.iso.org/standard/53394.html
    • ISO 14644-2:2015, Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration https://www.iso.org/standard/53393.html.

    More information about managing the cleanliness of a product and contamination control according, you can find on the following link:

    • Managing cleanliness of a product and contamination control according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/07/04/managing-cleanliness-of-a-product-and-contamination-control-according-to-iso-134852016/

    Also, the following article may be useful:

    • Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/

    • Making evidence to RPO and RTO

      The Recovery Point Objective (RPO) and Recovery Time Objective (RTO) are identified and documented during the Business Impact Analysis.

      When identifying which impacts can occur to a business process due to a disruptive event, and how they evolve over time, you can gather evidence to support the definition of RPO and RTO.

      In the Business Impact Analysis toolkit you bought, there is a Business Impact Analysis Questionnaire you can use to document the information needed to define the RPO and RTO.

      This article will provide you a further explanation about RTO and RPO:

      • What is the difference between Recovery Time Objective (RTO) and Recovery Point Objective (RPO)? https://advisera.com/27001academy/knowledgebase/what-is-the-difference-between-recovery-time-objective-rto-and-recovery-point-objective-rpo/

      This material will also help you regarding RTO and RPO:

      • Book Becoming Resilient: The Definitive Guide to ISO 22301 Implementation https://advisera.com/books/becoming-resilient-the-definitive-guide-to-iso-22301-implementation/

    • ISO 9001 Mandatory Core Policies and Procedures

      In this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ - you can see that ISO 9001:2015 has no mandatory procedures. Concerning mandatory documents, the list is very small (the scope, the quality policy and the quality objectives). All the rest is up to each organization. Please consider that the list of mandatory records is larger.

      You can find more information about documents and records below:

      • How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
      • New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
      • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
      • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/