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Class IIa product

Following steps are necessary for the getting ISO certification:

1. First, you need to implement the ISO 13485:2016 in your management system and everyday work.
2. Then you need to ask for the certification according to the ISO 13485:2016 from the certification body.

It is rather hard to estimate how much time you will need for the implementation process because it depends on many things like: number of the employees, do you have any experience before with quality management systems, how complicated your processes are, and so on. On average, we can say that for the company with 10 employees it will take up to 3 months, for the company with up to 50 employees, 3-6 months. But, once again, this is just the estimation.

Considering how much money you will spend, again depends on your previous knowledge about quality management systems and the availability of your employees to dedicate to the implementation of a quality system. You can do it by yourself, which if you do not have previous experience, can be the longest way. You can hire a consultant or you can buy a documentation toolkit - pre-prepared template with all the necessary requirements from the standard and you just have to adapt them to your processes and needs.

Following articles can help you more to understand this process:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• 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/

Following same model by the health authorities or by ISO standards

What you have described here are custom made devices. Since these are defined as medical devices according to the MDR 2017/745 Article 2, all manufacturers of medical devices need to have implemented a quality management system as described in Article 10. The quality management system shall cover all parts and elements of a manufacturer’s organization dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

Also, manufacturers need to be in compliance with harmonized standards published by the Offical Journal of the European Union as described in Article 8. On that list, the only standard that covers the quality management system is ISO 13485:2016 so it is expected that all manufacturers have to implement this standard.

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

• EU MDR Article 2 Definitions - https://advisera.com/13485academy/mdr/definitions/ - see point 3)
• EU MDR Article 10 General obligations of the manufacturers - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/ - see point 9)
• EU MDR Article 8 Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• EU MDR Article 52 Conformity assessment procedures - https://advisera.com/13485academy/mdr/conformity-assessment-procedures/ - see point 8)
• EU MDR Annex XIII Procedure for custom made device - https://advisera.com/13485academy/mdr/procedure-for-custom-made-devices/

Here is the link to the List of the harmonized standard:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

To understand what harmonized standards are, please see the article on the following link:

• What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/

For more information regarding ISO 13485 please see the following links:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

• Collection of evidence

  I'm assuming you are referring to the term "Point of Contact" mentioned in section 3.1 "Receipt and classification of incidents, weaknesses, and events".

  Considering that, the term "Point of Contact" refers to the person or role to which all communication related to an issue must be directed to, and for its implementation, you only need to define a person or role in your organization to perform it.

  For example, for the information and communication technology-related events you can define the IT manager as the Point of Contact, and for other events, you can define the Operational manager.

  These articles will provide you a further explanation about the incident management:

  • How to handle incidents according to ISO 27001 A.16 https://advisera.com/27001academy/blog/2015/10/26/how-to-handle-incidents-according-to-iso-27001-a-16/
  • Using ITIL to implement ISO 27001 incident management https://advisera.com/27001academy/blog/2015/11/10/using-itil-to-implement-iso-27001-incident-management/t/

• ISO 9001 Extension for obtaining ISO certificates

  First stage certification audits and surveillance audits are being done remotely by many certification bodies.

  Second stage certification bodies are postponed because they cannot be done remotely.

  Some certification bodies are extending ISO certificates.

  Better if you contact your own certification body. Normally, they are approachable and can give you more specific information.

  You cand find more information about remote audits below:

  • Please find in this free webinar on demand - How to perform an internal audit remotely - https://advisera.com/9001academy/webinar/remote-internal-audit-free-webinar-on-demand/ 
  • Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
  • Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

• Certificate for legal entities in different countries

  Yes, you can. I already saw several examples in the automotive industry where a single certificate includes more than one legal entity in more than two countries. However, it is best to contact your certification body because they may have different requirements from accreditation bodies.

  You can find more information below:

  • How to choose a certification body? - https://advisera.com/blog/2021/01/11/how-to-choose-an-iso-certification-body/
  • 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/
     

• Life cycle and environmental aspects matrix integration

  In your environmental aspect’s matrix, you may have a column indicating where, in your organization’s activities, product or services, the environmental aspect is generated. You can also include there, activities done by suppliers or subcontractors or by interested parties downstream, like users.

  In the following example:

  

  The first activity is done by a subcontractor that electroplates metal poles for solar public lighting.

  The second activity is done by the user at the end of lifetime of the battery that stores solar energy for night use.

  Please check this information below with more detailed answer:

  • How does product life cycle influence environmental aspects according to ISO 14001:2015? - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
  • Free webinar on demand - How to use a Documentation Toolkit for the implementation of ISO 14001 - https://advisera.com/14001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-14001-free-webinar-on-demand/
  • 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/
     

• Risk management process overview

  Risk management has four elements:

  

  Risk Determination – determine risks about the system as a whole, about the processes and about the products or services delivered.

  Prioritize Risks - Risks do not all have the same importance. Some will be more serious than others. It is necessary to arrange criteria for classifying and distinguishing the most serious risks from the least serious ones.

  Mitigate Risks – Develop actions that minimize the consequences of the risks and or the likelihood of their occurrence.

  Measure Effectiveness – Evaluate if the actions were effective in handling the priority risks.

  Please check this free webinar on demand where I explain risk scope and risk management with examples. Free webinar – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar-on-demand//

  The following material will provide you more information:

  • Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
  • How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
  • How to identify risk significance in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
  • How to identify risk controls in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/21/how-to-identify-risk-controls-in-iso-90012015/
  • Methodology for ISO 9001 Risk Analysis - https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
  • ISO 9001:2015 Risk Management Toolkit - https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
  • Enroll for free course - 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 in a Public Transportation agency

  First step is to determine the scope of the quality management system. Then, determine the interested parties with whom the agency interacts to meet its purpose. Then, design a model of how the organization works based on the process approach. Please check this free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/

  Now, you can develop your quality management system based on two main vectors:

  Characterize each process
  Determine context, define policy, objectives, risks and opportunities and action plans

  Then, implement, audit and perform a management review.

  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 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/