ISO 13485 2016 Package

$289 Inc VAT

  • Ensure compliance with national and international regulations and guidelines that apply to the design, production, and use of medical products.
  • Complete documentation of ISO 13485 certification requirements and a practical guide to its implementation.
  • ➡️ All documents required for certification.
  • ➡️ 30-day money-back guarantee.
  • ➡️ Immediate download
  • ➡️ 24/7 Support Service
  • ➡️ Document types included: Docx, PPT, Excel, PDF

ISO 13485 is an internationally recognized quality management standard specifically designed for the medical industry and its associated suppliers. It was implemented to maintain effective quality management systems and ensure the integrity and compliance of medical products.

This standard can be applied to all organizations that develop, manufacture or distribute medical products for clinical use. ISO 13485 requires that products be designed in compliance with applicable laws and regulations and be free of significant health risks to the public.

👉 What is ISO 13485?

ISO 13485 is an internationally recognized standard that defines requirements for a specific quality management system for medical device suppliers. It aims to ensure that medical products are free from significant health risks by adhering to a specific product and process management system. ISO 13485 also requires additional procedures for internal control to ensure compliance with applicable legal and regulatory requirements.

The ISO 13485 standard not only addresses general QMS principles but also emphasizes additional procedures to ensure internal control and compliance with relevant legal and regulatory requirements. This encompasses the entire lifecycle of medical devices, from design and development to production, installation, servicing, and final decommissioning or disposal. As a result, organizations that implement ISO 13485 can effectively manage potential risks associated with their medical devices, ultimately benefiting end-users and patients.

👉 ISO 13485 requirements:

  • The implementation of a quality management system, consistent with ISO 13485;
  • The identification of specific requirements for a given product or process;
  • Documentation and control of critical processes to ensure compliance with specific product requirements and those imposed by the relevant authorities;
  • Continuous monitoring to ensure that critical chain processes evolve over time;
  • Procedures to avoid errors in all processes.
  • Identification of legal and regulatory requirements applicable to medical products developed and sold by the organization;
  • The implementation of a traceability system to track products and raw materials;
  • Continuous assessment of the quality management system’s compliance with ISO 13485 requirements;
  • Procedures to correct non-conformities and to respond to customer complaints;
  • Measures taken to ensure the safety and security of the products delivered, including the control of adverse reactions and the identification of possible risks related to the use of the products;
  • Statistical data is used to demonstrate that the quality management system is effective.

👉 This package will help you to:

  • Ensure compliance with ISO 13485.
  • Improve the quality and compliance of the products and services you provide ;
  • Reduce the risk of quality management system non-compliance; and;
  • Win customers and contracts by proving your ability to meet specifications;
  • Control the life cycle of products and related activities;
  • Develop a culture of continuous improvement for your company.

👉Who this package is for:

The ISO 13485 package is intended for organizations that manufacture, install, supply, or repair medical devices for diagnostic or therapeutic purposes. It may also be applicable to other related sectors such as:

  • Any organization that provides services to medical device manufacturers;
  • Companies that perform maintenance and repair of medical devices;
  • Companies in the research and development field;
  • Quality control organizations and testing laboratories.

👉What are the expected outcomes?

  • Increased transparency and process alignment across the organization;
  • Confirmation that you are meeting the requirements of key stakeholders and customers;
  • Increased customer satisfaction through safe and on-spec production; and
  • Increased business recognition in the marketplace;
  • Increase efficiency, and productivity and reduce operating costs.
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How many users can access this package?

This package can be used by all people working in the same company, no matter their position or department. It provides a comprehensive suite of solutions to help streamline processes and procedures, while simultaneously increasing productivity and efficiency. With this package, up to 50 users can work together in real-time, allowing them to share important data quickly and efficiently.

Is there a version of the package available in any other languages?

Yes, there are versions of the package available in several other languages. In addition to Italian, German, Portuguese, Swedish, and Japanese, Chinese is also offered. For those looking to use the package in a language other than English, this gives them a great option. If you have any queries, please contact us on the chat or send an email to

Is there a money-back guarantee if I’m unhappy with the service?

If you are not completely satisfied with the product or the service provided, we offer a 30-day money-back guarantee! We provide a secure, risk-free option so that you can feel confident in your decision to use our service. We understand that sometimes things don't work out as planned and therefore we want to give you the opportunity for a refund.

What payment options are available to me?

There are several payment options available to you. You can choose to pay by credit card, debit card, or PayPal. We also offer a convenient layaway plan for those who would like to pay for their purchase over time. If you have any questions about our payment options, please feel free to contact us.

When I order, how long will it take before I receive the entire package of documents ?

Your purchase will take you directly to the download page and a link to get your file is instantly sent to your inbox. The documents are provided in a safe, secure .zip folder that needs extracting. In case of any difficulty with downloading, kindly reach out at - our team would be more than happy to help!


ISO 13485 2016 PackageHello, awesome people!
Marilyn C.
from the QSE Academy team 👋.

Marilyn C. is a leading expert in accreditation and laboratory standards set out by the International Organization for Standardization (ISO). She has extensive knowledge of ISO 17025, 17020, 17024, 17034 and 17043 accreditation, including the process of assessment and certification according to these standards. She also has experience with the implementation of Quality Management Systems (QMS) that adhere to ISO 9000 standards.

Marilyn is a highly experienced consultant who has helped numerous organizations achieve their desired ISO accreditations or certifications. She provides guidance on how to improve processes and procedures in order to meet the requirements set out by international standards bodies such as ISO and IEC. She works closely with clients to ensure that laboratory operations meet these high standards so that they can maintain their certifications for long-term success.

In addition, Marilyn offers training courses on quality management systems (QMS), risk assessments, and internal auditing for those who wish to pursue ISO accreditation. She has also published several papers on the subject and is a regular speaker at various industry conferences.

Marilyn’s expertise in accreditations and standards makes her an invaluable asset to any lab or organization looking to meet international standards of excellence. Her commitment to quality and customer service ensures that clients receive the best possible results when working with Marilyn C., making her an excellent choice for those seeking ISO certification or QMS guidance.

Marilyn is well-versed in developing and implementing quality management systems for laboratories that are compliant with ISO standards. She has the capability to review existing systems and identify areas of non-compliance or improvement. Additionally, she is capable of providing training courses to staff in order to increase their understanding of the ISO requirements and how they should be implemented within a laboratory environment.

Marilyn has worked extensively with many different organizations on accreditation projects, ensuring they could meet all the relevant criteria set out by international bodies. She also possesses experience in conducting audits of laboratory facilities to check compliance with relevant standards.

As an experienced consultant in this field, Marilyn can offer her clients advice on what changes need to be made to ensure full compliance with international standards. She can provide guidance on improving the quality of laboratory services and develop plans for future accreditation.

👉 Who’s behind QSE Academy?

QSE Academy is a small team of independent ISO consultants working from all around the world. Our team is dedicated to providing best-in-class quality and environmental standards consulting services that help businesses reach their full potential. We strive to provide personalized, cost-effective services tailored to each client’s needs. Our consultants hold numerous certifications in the fields of ISO 9001, 14001, and 45001, making them well-equipped to meet any quality or environmental challenge. At QSE Academy, we’re passionate about helping businesses grow and succeed by providing the tools they need to reach their goals. Our team is committed to offering comprehensive consulting services that are tailored to each client’s unique business needs. We strive to make sure our clients get the most out of their investments by providing top-notch service and support. With years of experience in quality, environmental, and safety standards consulting, we’re here to ensure that you reach your desired level of success. We look forward to working with you.

👉 Quick links


👉 Are you available to discuss how I can get in touch with you?

Yes, absolutely. I would love to discuss how you can get in touch with me. The best way to reach me is via email at I check my emails multiple times a day and typically respond within 24 hours so that’s the quickest way to get in touch with me. What’s more, you’ll also have 24/7 chat support around the clock.

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👉 This package provides you with the following features:

  • Full lifetime access
  • Access on a laptop, desktop, and mobile
  • Certificate of completion

👉 This Package Includes


  1. Quality Manual
  2. Document Control Procedure
  3. Record Control Procedure
  4. Management Review Procedure
  5. Internal Audit Procedure
  6. Corrective Action Procedure
  7. Preventive Action Procedure
  8. Risk Management Procedure
  9. Design and Development Procedure
  10. Purchasing Procedure
  11. Supplier Evaluation Procedure
  12. Receiving Inspection Procedure
  13. Production Control Procedure
  14. Calibration Procedure
  15. Maintenance Procedure
  16. Training Procedure
  17. Nonconforming Product Procedure
  18. Complaint Handling Procedure
  19. Advisory Notice Procedure
  20. Regulatory Reporting Procedure
  21. CAPA Procedure


  1. SOP for Quality System Maintenance
  2. SOP for Change Management
  3. SOP for Labeling and Packaging
  4. SOP for Product Storage and Distribution
  5. SOP for Traceability
  6. SOP for Validation and Verification Activities
  7. SOP for Installation and Servicing
  8. SOP for Sterilization Process Control (if applicable)
  9. SOP for Cleanroom Procedures (if applicable)
  10. SOP for Software Validation (if applicable)
  11. SOP for Post-Market Surveillance
  12. SOP for Medical Device Reporting
  13. SOP for Cybersecurity Management (if applicable)
  14. SOP for Environmental Monitoring (if applicable)
  15. SOP for Product Return and Recall
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