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Documented checklist for SaMD

Here you can find  the general list of mandatory documents for ISO 13485:2016:

• List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

As a manufacturer of software, from that list you do not need the following:

• Arrangements for control of contaminated or potentially contaminated product (clause 6.4.2)
• Requirements for cleanliness of product (clause 7.5.2)
• Records of sterilization process (clause 7.5.5
• Procedure and records for validation of process for sterilization and sterile barriers systems (clause 7.5.7)
• Records of traceability and name and address of the shipping package consignee (clause 7.5.9.2)
• Procedure for preserving the conformity of product (clause 7.5.11)
• Records of rework (clause 8.3.4)

If you do not have any kind of service (repair) in your business, then even the following requirement is not applicable for you:

• Procedure and records for servicing of the medical device (clause 7.5.4)

Furthermore, each medical device software must be in compliance with the following standard:

• IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle processes — Amendment 1 https://www.iso.org/standard/64686.html

For more information on ISO 13485, please see the following links:

• 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/

• ISO 9001 Question

  ISO 9001:2015 prefers using the term non-applicability of clauses. Only clauses from section 8 may be considered as non-applicable.

  8.1 is very general and applicable to all organizations, 8.2 is about commercial activities, every organization has commercial activities. 8.3 is about design and development and it is applicable since it is your main service. 8.4 is about purchasing relevant to the service and it is applicable. 8.5 may be applicable to the service of technical supervision of the construction of the dams and it is also applicable to your design work. Your job is designing projects (both 8.3 and 8.5). You have quality control, check calculations, check test results and you sometimes have errors, mistakes, failures. So, clauses 8.6 and 8.7 are still applicable. I think that even subclause 8.5.3 is applicable once your customer may give you drawings, information where intellectual property or business secrets may be relevant.

  You may find more information below:

  • What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
  • 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/
     

• ISO 9001 In an educational institution

  Unfortunately, I have no experience of working with ISO 21001. Why is your organization deciding to implement a management system? If it is as a marketing tool I recommend ISO 9001 just because is the most well known in the general public. However, even working to get ISO 9001 certification, I recommend using ISO 21001 as a guideline.

  ISO published in 2003, IWA 2:2003 - Quality management systems - Guidelines for the application of ISO 9001:2000 in education, a document updated in 2007 by IWA 2:2007 - Quality management systems -- Guidelines for the application of ISO 9001:2000 in education. However, as far as I know this 2007 guideline has been widrawn.

  ISO published in 2018, ISO 21001:2018 - Educational organizations -- Management systems for educational organizations -- Requirements with guidance for use. ISO 21001:2018 is a management system standard that is partially aligned with ISO 9001:2015 for quality managent systems.

  • The following material will provide you information about a QMS in an education setting:
    ISO 9001 – Should universities implement ISO 9001? - https://advisera.com/9001academy/blog/2015/04/21/should-universities-implement-iso-9001/
  • free online training I SO 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/

   

   

• ISO 9001 Question

  Setup a project sponsor, a project manager and a project team. Determine the scope of the QMS, your organization may decide to include only certain lines of business. Ensure top management support, get training. Designing and implementing a quality management system (QMS) 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/
     

• ISO 9001 Pregunta

  La implantación de un Sistema de Gestión de Calidad sobre todo tiene beneficios en la empresa. Algunos de los más importantes son los siguientes: 

  - Una mejora de la credibilidad y de la imagen de la organización

  - Un incremento de la satisfacción del cliente

  - Una mejor integración de los procesos

  - Una mejora del compromiso de los empleados

  - Una mejora en la evidencia de la toma de decisiones

  - La creación de una cultura de mejora continua

  Es importante tener en cuenta que para obtener estos beneficios la implementación de ISO 9001:2015 debe contar con los recursos necesarios, tanto económicos como de personal. Por lo que estos costes deben de ser tenidos en cuenta antes de decirdirse por implementar un SGC en una organización.

  Estos materiales pueden ayudarle a entender el impacto de un SGC en una empresa:

  - Benefits of ISO 9001 implementation for small businesses: https://advisera.com/9001academy/blog/2018/09/17/benefits-of-iso-9001-implementation-for-small-businesses/

  - Seis beneficios clave de la implementación de ISO 9001: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/seis-beneficios-clave-de-la-implementacion-de-iso-9001/

  - Curso gratuito en línea - Fundamentos de la norma ISo 9001:2015:  https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

  - Libro - ISO 9001:2015 through practical examples:  https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

• Preparing Medical Device File

  Technical documentation necessary for the medical device file is described in the Medical device regulation EU MDR 2017/745 in Annex 2 – Technical documentation and EU MDR Annex 3 – Technical documentation for post-market surveillance.

  We in our ISO 13485 & MDR Documentation toolkit prepared the obligatory procedures and reports. Other test reports depend on the type of medical device and it was not possible to standardize it. 

  On the following link you can see the preview of those documents:

  • Procedure for clinical evaluation and related documents https://advisera.com/13485academy/documentation/procedure-for-clinical-evaluation/
  • Procedure for post-market surveillance and related documents https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/

  • Technical documentation procedure and related documents https://advisera.com/13485academy/documentation/technical-file-procedure/

  For more information, see:

  • EU MDR 2017/745 in Annex 2 – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
  • EU MDR Annex 3 – Technical documentation for post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

  • ISO 9001 Pregunta

    El contexto de la organización es un requisito de ISO 9001 en el que se requiere que una organización  considere las cuestiones internas y externas que pueden impactar a sus objetivos estratégicos y a la planificación del SGC. Para cumplir con este requisito, debe de centrarse sólo en las cuestiones que pueden afectar a la satisfacción del cliente y a la entrega de la calidad del producto o servicio.

    El contexto interno tiene que ver con la cultura, las creencias, los valores, o principios dentro de la organización, así como la complejidad de los procesos y la estructura organizativa.

    Por otra parte,el contexto externo está relacionado con cuestiones derivadas del entorno social, tecnológico, ambiental, ético, político, legal, y entorno económico de la organización.

    Para llevar acabo un análisis de este contexto puede realizar un análisis DOFA de debilidades, oportunidades, fortalezas y amenazas o/y un análisis “PEST” (Política, Económico, Social, Tecnológico).

    Respecto a las partes interesadas sólo es necesario identificar aquellas qye tendrán un impacto en la capacidad de la organización para proporcionar productos y servicios para satisfacer constantemente las necesidades del cliente y los requisitos legales. Esto incluye: proveedores, consumidores, uniones de trabajadores, docios, empleados, gobiernos y ONGs, etc.

    Estos materiales pueden ayudarle a entender el contexto de la organización y las partes interesadas:

    - Cómo identificar el contexto de la organización en ISO 9001:2015: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/como-identificar-el-contexto-de-la-organizacion-en-iso-90012015/

    - How to determine interested parties and their requirements accoding to ISO 9001:2015: https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/

    - Curso gratuito en línea - Fundamentos de la norma ISo 9001:2015:  https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

    - Libro - ISO 9001:2015 through practical examples:  https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

  • Difference (implementation-wise) between ISO 13485 and ISO 9001

    There is no difference in the implementation process between ISO 9001 and ISO 13485. Those two standards can run together. However, since ISO 13485:2016 does not have a high level structure as ISO 9001:2015 does, you just need to take into consideration the numbering of the requirements. At the end of the ISO 13485:2016, in Annex B you can find Correspondence between ISO 13485:2016 and ISO 9001:2015. 

    On the following links you can find some useful articles:

    • Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
    • Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

    • Number of procedures required by ISO 13485:2016

      The number of procedures depends on the type of your medical device. Requirements in the standard are prepared for all types of medical devices, so not all requirements are applicable for each medical device. 

      On the following link, you can find the list of mandatory documents from ISO 13485 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

      Of course, if you do not have certain processes (for example sterilization, or your product is not software), then there is no need to prepare and have those documents in your quality management system.

      Furthermore, I would like to point out that these are mandatory documents and definitely some additional documents can be necessary (for example: some policies, organizational charts, some plans and so on).