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ISO 13485 implementation

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Guest user Created:   Jul 17, 2020 Last commented:   Jul 17, 2020

ISO 13485 implementation

1. The first thing I would do myself is to implement a general procedure to keep track of actions and agreements within the organization. I do not see it? Why? How to do it?

2. We are a very small startup for a simple small noninvasive medical device. Both my partner and myself are very experienced in MRI (***), CT (***), etc, although it is 20 years since we worked in a QMS. I want to define Research and predevelopment as a process outside the QMS, then Design transfer to a clinical trial process and to subcontractors inside the QMS We will subcontract engineering/development, manufacturing, service, logistics to ISO13485 certified high-quality partners. We will have these partners audited regularly by consultants we contract and sign the audit reports ourselves after review. Can we somewhere buy a core (just enough) QMS that complies with ISO13485? Your toolkit is much more than we need, do you have a core toolkit as well?

3. Do you have a service that adapts your toolkit to our needs? Including filling in of company name etc.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 17, 2020
The first thing I would do myself is to implement a general procedure to keep track of actions and agreements within the organization. I do not see it? Why? How to do it?

In ISO 13485:2016, there is no direct requirement to have a documented procedure to keep track of actions and agreements. In requirement 7.4.2 Purchasing information is stated there is a necessity for a written agreement that supplier. To the extent required for traceability given in 7.5.9, the organization shall maintain relevant purchasing information in the form of documents (see 4.2.4) and records (see 4.2.5). There fore, it is up to you how you will document this. You can write a procedure for managing outsourced processes where you will state methods and frequency of the control over the outsourced processes, or add this section in the Purchasing documented procedure.

Following article can provide you more information about critical suppliers:

You can see how our Quality Agreement for Critical Supplier looks like on the following link: https://advisera.com/13485academy/documentation/quality-agreement-for-critical-supplier/

We are a very small startup for a simple small noninvasive medical device. Both my partner and myself are very experienced in MRI (***), CT (***), etc, although it is 20 years since we worked in a QMS. I want to define Research and predevelopment as a process outside the QMS, then Design transfer to a clinical trial process and to subcontractors inside the QMS We will subcontract engineering/development, manufacturing, service, logistics to ISO13485 certified high-quality partners. We will have these partners audited regularly by consultants we contract and sign the audit reports ourselves after review. Can we somewhere buy a core (just enough) QMS that complies with ISO13485? Your toolkit is much more than we need, do you have a core toolkit as well?

Our ISO 13485:2016 is a basic toolkit that covers all mandatory documents required by the standard. You can buy the whole toolkit, or you can buy separately documents that you considered that you need. If you go to the end of this web page, you can see each document and purchased what is necessary for you: https://advisera.com/13485academy/iso-13485-documentation-toolkit/ 

But please be aware that no matter that you are outsourced some processes, you are still responsible for them. In the eyes of the auditor from the certification body, you need to have at least the list of the documents form the outsourced companies. All outsourced processes also need to be stated in the Quality manual together with the connection to your processes. 

For more information on controlling the outsourced processes using ISO 9001 see this article:

Do you have a service that adapts your toolkit to our needs? Including filling in of company name etc.

When buying the toolkit, depending on the type of toolkit that you buy, you can get support in the following ways:

  • 10 questions via email per month or Unlimited email support
  • 1, 5, or 15 hours of one-on-one support with an ISO 13485 expert
  • Expert review of 1, 5, or 15 completed documents
  • Pre-audit check (1-hour call where we can check the most important items that the certification auditor will be looking for)

For more details about options when buying a toolkit, please see the following link - https://advisera.com/13485academy/iso-13485-documentation-toolkit/ and go to the end of the page.

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Jul 17, 2020

Jul 17, 2020

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