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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). 

  • Generating quality documentation

    1. Can I generate quality documentation and have at least two other people in the R&D group review and approve them?

    Yes, you can generate quality documentation on your situation. Design and development for medical devices have to deal with relevant regulations, product safety, and risk controls on product defects in addition to the usual application requirements, specification requirements, and end-customer needs. 

    Here is 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. 

    The following articles can be helpful:

    • What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
    • How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/

    2. Can Quality Manual be revised as often as needed to reflect our developing stages?

    Yes, the Quality manual can be revised as often as you need. The quality manual must be the reflection of your current state.

    For more information, please see the following links:

    • How to manage the Quality Manual according to ISO 13485:2016 requirements https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/
    • ISO 13485: How to write a short quality manual https://advisera.com/13485academy/knowledgebase/iso-13485-how-to-write-a-short-quality-manual/

    • Is dental software considered as a medical device?

      1. Is dental software considered as a medical device?

      According to the Medical device regulation MDR 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

      • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
      • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
      • the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
      • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations
      • and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

      So if you can define your software within this explanation, then it is a medical device. Each medical device must have the proper classification, and classification is determined by rules The rule that is applicable for software is Rule 11 which states the following:

      Rule 11

      Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

      • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
      • a serious deterioration of a person’s state of health or surgical intervention, in which case it is classified as class IIb.
      • Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

      All other software is classified as class I.

      For more information, please see the following:

      • EU MDR Annex 8 – classification rules https://advisera.com/13485academy/mdr/classification-rules/

      2. If yes do we need to approach Health Canada for Licensing as a medical device?

      Yes, each medical device, regardless of classification, must be registered in the local authority for medical devices, in your case Health Canada.