Standard Operating Procedures (SOPs) for ISO 13485

The video provided below explains what is included when you purchase our standard operating procedures (SOPs) for ISO 13485:2016.

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Our turnkey quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard and 21 CFR 820, 21 CFR 803, and 21 CFR 806 for the FDA. It also includes procedures for Canadian Medical Device Licensing and European CE Marking. In total, we have 46+ procedures (listed below). The standard operating procedures (SOPs) also have associated forms, logs, and templates. We also completed updates to our procedures for Regulation (EU) 2017/745.

Turn key Quality System Standard Operating Procedures (SOPs) for ISO 13485
Turnkey Quality System - Global (1 of 4 installments)
The turnkey quality system - Global costs a total of $8,500, but we offer you the option to pay in four monthly installments of $2,125. If you want to make other payment arrangements, please contact Becca Taylor @ becca@medicaldeviceacademy.com.
Price: $2,125.00

Turnkey QMS Pricing 300x87 Standard Operating Procedures (SOPs) for ISO 13485

If your company is only interested in compliance with the US Market (i.e., 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 830 for the FDA), we offer a turnkey quality system for the US-only market at a reduced price of $6,000. The US-only turnkey quality system does not include the seven procedures identified below as “Global”. There are additional pricing options and configurations of the turnkey quality system described at the end of the work instruction that you can view when you click on the button below. However, please remember that “turnkey” does not mean “work-free“. It takes approximately 100-120 hours to implement a medical device quality system and after you implement the quality system it will take at least 4-8 hours per week to maintain the quality system for even the smallest start-up with most processes outsourced.

Turn key Quality System Standard Operating Procedures (SOPs) for ISO 13485
Turnkey Quality System - US Only (1 of 4 installments)
The turnkey quality system - US Only costs a total of $7,000, but we offer you the option to pay in four monthly installments of $1,750. If you want to make other payment arrangements, please contact Becca Taylor @ becca@medicaldeviceacademy.com. The US-only version does not include 6 of the procedures marked as "Global".
Price: $1,750.00

In addition to procedures, forms, log sheets, and templates, the quality management system includes an initial draft of your new quality. These documents require customization to fit your operations, such as the identification of your company name and logo. The Medical Device Academy logo and [Company Name] are included within the documents as placeholders. We also provide 16 pre-recorded training webinars. We also provide exams (i.e., 10-question quizzes) to verify training effectiveness. If you submit the completed exams to us by email in the native MS Word format, we will correct the exams and email you a training certificate with your corrected exams. The list of training webinars included with our turn-key quality system is provided below:

  1. Good Documentation Practices
  2. Design Controls
  3. Risk Management
  4. How to qualify your suppliers
  5. Control of Nonconforming Product
  6. How to create a risk-based CAPA process
  7. 21 CFR 820
  8. Process Validation
  9. Management Review
  10. Complaint Handling and Vigilance
  11. How to audit using the process approach webinar
  12. UDI
  13. Software Validation
  14. Create an ISO 13485 Quality Plan
  15. What is ISO 13485? – Stage 1 & 2 training webinars
  16. Design Change Webinar (Updated for 2022)

If you are thinking about purchasing standard operating procedures (SOPs), instead of writing procedures yourself, it’s essential to understand the intent of the author that wrote the procedures. Many buyers expect to “pay by the pound.” After writing hundreds of procedures, I found that it requires more work to write a short and effective procedure than a 50-page dust collector.

If a company has a sophisticated quality management system, procedures tend to be lengthy, because each time an auditor finds a problem, another section is added to “clarify” the procedure. I try to write standard operating procedures that are concise and meet the requirements for an early-stage medical device company. Larger companies do not ask me to write many procedures. They ask me to audit procedures and to edit their procedures, but they seldom want me to start from scratch.

When Medical Device Academy writes standard operating procedures, we use a standard template for the sections. Almost everyone does this, but our template contains three unique elements:

  1. monitoring and measurement requirements for the process
  2. training and retraining requirements for personnel
  3. application of risk management

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The video below is describing our new work instruction for how to implement the turnkey quality system. You can download the work instruction using the button above. The work instruction is specific to the Medical Device Academy team, but anyone may copy the content of this work instruction and adapt it to their quality system implementation needs. If you want a quote for the quality system, please contact Lindsey Walker directly at sales@medicaldeviceacademy.com.

There is a section of the work instruction that is specific to creating a project in Asana. The above video shows you how to copy the 15 steps of the quality system implementation from the work instruction into a spreadsheet. Then this is saved as a .csv file (download link). Finally, the video shows you how to import the .csv file into Asana so that you can create a project in Asana for tracking and managing the implementation of Medical Device Academy’s turnkey quality system. The video was specifically designed for the free version of Asana if you need to share the project in Asana with people outside of your organization or you do not have the budget for Asana’s paid version.

If you want to learn more about our procedure template, please read our blog about it. You can also search our blog archives for the term “SOP” or “procedure.”  Other product highlights are provided below, and the button below gives you a complete list of all our procedures, forms, templates, and logs.

Master Document List Standard Operating Procedures (SOPs) for ISO 13485

  • Written specifically for early-stage medical device companies
  • Create a ready-made off-the-shelf Quality System for your company
  • Includes free updates for the ISO 13485:2016 as they become available
  • Can be used for FDA 483 responses
  • Are audit-ready
  • Incorporates risk management into each procedure
  • Includes monitoring and measurement requirements for the process
  • Includes training and retraining requirements for personnel
  • Written by highly experienced industry subject matter experts

If you want to purchase individual procedures or review what is included in a specific procedure, you can click on any of the hyperlinks provided below. If there is not a hyperlink, we will have one soon, or we can review the content with you in a Zoom session.

Each month Alysha picks a new procedure or webinar that will be eligible for the “Alysha” 50% discount. Just type Alysha in the discount code box. April’s discounted procedure is SYS-011, Supplier Quality Management. 

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4 thoughts on “Standard Operating Procedures (SOPs) for ISO 13485”

    1. Robert Packard

      Thank you for the inquiry. We do create custom work instructions for some of our clients, but it would be for a manufacturing process that we understand like packaging, sterilization, molding, extrusion, etc. The type of SOP or clinical study you are talking about is outside of our expertise. Sorry we can be of more help.

      Reply
  2. Thermostats NZ

    Your article on standard operating procedures (SOPs) is enlightening! SOPs are the backbone of quality in the medical device industry. Your emphasis on clarity, consistency, and compliance resonates well. Implementing robust SOPs ensures operational efficiency and regulatory adherence.

    Reply
    1. Robert Packard

      The procedures certainly identify the quality system requirements for the device industry, but we still have too many people that rely on reading procedures as their only training. AAMI is working with the FDA to update the compendium that books that include best practices for each of the FDA’s quality system requirements. With the transition to ISO 13485 on the horizon, it will be fascinating to see what the FDA provides as guidance on procedures, quality plans, and training requirements.

      Reply

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