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Competence, Training & Awareness

Your organization must be consistent. If your organization considers eco-friendly design solutions capabilities to be relevant, either to your business or to the relationship with the environment, then it makes perfect sense that this is an internal competence. In that case, that competence will be assessed in that clause.

You can find more information in the following links:

• ISO 14001 Competence, Training & Awareness: Why are they important for your EMS? - https://advisera.com/14001academy/blog/2014/11/26/iso-14001-competence-training-awareness-important-ems/
• Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

Implementing QMS in a small factory

Smaller organizations (up to 50 employees) usually implement the standard in up to 8 months. When using our Documentation Toolkit, normally: companies of up to 10 employees - usually implement the standard in up to 3 months and companies of up to 50 employees - usually implement the standard in up to 6 months.

You can find detailed information about how to plan and implement a quality management system in the following links:

• 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
• 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 webinar on demand - How to use a Documentation Toolkit for the implementation of ISO 9001 - https://advisera.com/9001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-9001-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/

Becoming a better-accredited auditor

If you are already a certified auditor, you can try to become better by performing more audits and reflecting about what went well and what can be improved. You can look for training to become lead auditor or improve areas where are your weak points.

You can find more information in the following links:

• ISO 9001:2015 Lead Auditor Training Course - https://advisera.com/training/iso-9001-lead-auditor-course/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

Corrective action and communication logs

I see organizations that start a new log every year and I see organizations that continue to use the same log year after year. It is up to each organization. Continuing to use the same log year after year, particularly on a digital format, allow you to easily look for trends.

Please check this information below with more detailed answer:

• How to structure ISO 14001 documentation - https://advisera.com/14001academy/blog/2016/11/28/how-to-structure-iso-14001-documentation/
• Free on-line training – ISO 14001:2015 Foundations- https://advisera.com/training/iso-14001-internal-auditor-course/
• Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

Steps for obtaining CE certification or CE Mark

First, you need to define under which regulation you want and can certify your medical device: MDD 93/42/EEC or MDR 2017/745. Then you need to define which class your face masks are. Rules to define it, you can find on the following links:

• EU MDR Annex 8 Classification rules https://advisera.com/13485academy/mdr/classification-rules/
• Classification rules under the MDD you can find in Annex IX

Then you need to prepare the Technical documentation. Which documents are necessary to be in Technical file under the MDD you can find in Annex 1. Required technical documentation under the MDR you can fin in the

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

For more information about MDR, please see the following articles:

• EU MDR Easy-to-understand basics https://advisera.com/13485academy/what-is-eu-mdr/
• How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/

• Requirement for ISO 13485 of procedure of Human resources and another procedure of Infrastructure and working environment

  1. Hi, if we have few employees (8) with many outsourced freelancers, and we don't own the working place, is it required for ISO13485 a procedure of Human resources and another procedure of Infrastructure and working environment?

  According to the ISO 13485:2016 requirement 6.2 Human resources, for all personnel that performs work that affects product quality you need to document competencies, training needed, and description of how you will ensure the awareness of the employees. Therefore, you need a Human resource procedure for your 8 employees, but also for all freelancers because you need to state the criteria how will you choose your freelancers and which competencies freelancers need to have.

  You can see on the following link how our Procedure for Human resource in our ISO 13485:2016 documentation toolkit looks like: https://advisera.com/13485academy/documentation/procedure-for-human-resources-iso-13485-2016/

  2. If it is, why?

  Considering the procedure for infrastructure and working environment, if you do not have a working place, then you can exclude the working environment part. However, if you have computers, mobile phones, and/or cars for your employees, then those elements are your infrastructure. Therefore, you need to make a documented procedure for maintaining this electronic equipment. Your infrastructure is also some server where you make your back-up or cloud service so be sure that it is included as well.

  For more details on managing medical device infrastructure requirements, please read the following article:

  • 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/

  You can see on the following link how the Procedure for Infrastructure and work environment in our ISO 13485:2016 documentation toolkit looks like: https://advisera.com/13485academy/documentation/procedure-for-infrastructure-and-work-environment-iso-13485-2016/

• 6.1.3 (f) and acceptance by top management

  Please note that in the template the risks are accepted by top management on behalf of the risk owners, i.e., the acceptance is made according to what is defined by risk owners, so this approach fulfills clause 6.1.3 (f), and approval of all risk owners is not needed.

  This article will provide you a further explanation about risk owner:

  • Risk owners vs. asset owners in ISO 27001:2013 https://advisera.com/27001academy/knowledgebase/risk-owners-vs-asset-owners-in-iso-270012013/

  This material will also help you regarding risk management:

  • Book ISO 27001 Risk Management in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/

• ISO 14001 questions

  your answers are clear, concise and extremely helpful.  Thank you so much for your help!

• Sistema de gestión

  Primeramente debe contar con el apoyo de la dirección de la organización, que será clave durante el proceso de implementación de ISO 9001:2015, también para proporcionar los recursos necesarios.

  Más tarde le recomiendo llevar a cabo  un análisis GAP o de brecha, que le va a ayudar a identificar aquellos requisitos que ya cumple y los que le debe aún cumplir. Aquí puede llevar a cabo el análisis de forma gratuita: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

  Es muy importante que usted conozca cada una de las cláusulas para poder llevar a cabo el proyecto de implementación de ISO 9001, y para dar respuesta a esos requisitos con los que su organización debe cumplir . En este white paper puede encontrar información resumida sobre cada una de ellas - Clause by clause explanation of ISO 9001: https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015

  Más adelante, puede escribir un plan de proyecto en el que de signa responsabilidades, define la documentación que va a escribirse, los plazos etc. En este enlace puede descargarse una plantilla - Plan de Proyecto para la implementación de ISO 9001:https://info.advisera.com/9001academy/es/descarga-gratuita/plan-de-proyecto-para-la-implementacion-de-iso-9001-ms-word

  Luego ya podría empezar con la implementación de la norma: la definición de la política de calidad, los objetivos de calidad y planes para llevarlos a cabo, el contexto de la organización y sus partes interesadas, el alcance del SGC, etc...hasta llegar a la auditoría interna y la revisión por la dirección, que sería el paso previo para certificarse. En este enlace puede descargarse un checklist para la implementación de la norma - Projectect checklist for ISO 9001:2015: https://info.advisera.com/9001academy/free-download/project-checklist-for-iso-9001-2015-implementation

  Estos materiales pueden ayudarle con la implementación de ISO 9001:2015:
  - Libro – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
  - Formación gratuita en línea – Fundamentos de ISO 9001:2015 : https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

• Free Calculator - Duration of ISO 27001/ISO 22301 Implementation

  1. A quick question on your calculator..
  Q. Number of physical locations.. We have 5 employees who all work remotely. We don't have a physical office. So is this 5 physical locations?

  For certification purposes, you need to consider at least one of your remote places as the organizations' Head Quarters (e.g., the CEO place), and the others can be considered out of the scope and treated as remote locations. Considering that, you can inform a single location in the calculator.

  2. another question on the calculator. One of the question asks, will a project manager be assigned (or something along those lines), I ticked 'yes' as I am assigned as PM and I am a Prince2 practitioner. Does this assume a full time employee? I am part time, therefore I wonder if the calculation would be longer if it took that into account?

  The calculator considers an effort of one day per week (or 8h per week) for the person in the role of project manager

  Other people that will need to be involved:

  • Sponsor of the project (e.g. the CEO) - ca 4 hours per month - for approving main documents and resolving conflicts
  • Head of IT department - ca 2 man/days per month - for reviewing the documents and coordinating the IT side of the implementation
  • Heads of the departments - ca 5 man/days during the whole implementation - for participating in the risk assessment, reviewing the documents and coordinating the implementation in their departments