How to Obtain the ISO 13485 Certification in 6 Steps?

ISO 13486 certification

 

In this article, you will learn what is the ISO 13485 Certification.

It is a third-party certification that demonstrates to regulators that you have met the requirements of the standard.

The ISO 13485 Certification involves the establishment and implementation successfully of the ISO 13485 Quality Management System.

It considers that the Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.

The ISO 13486 certification is designed for regulatory compliance.

Therefore, it is more prescriptive in nature and requires a more thoroughly documented quality management system.

6 steps to ISO 13485:2016 certification

Step 1 – Quality System Planning

This stage involves the preparation of the quality plans for implementing changes to your quality management system.

Selecting one partner consultant for all your locations saves time and money. The ISO standard requires that the consultant must be experienced in your sector/industry-specific business.

Step 2 – Meeting Regulatory Requirements

Understand and implement the quality plan, according to the applicable government requirements such as FDA 21 CFR 820, etc.

Step 3 – Implementing Design Controls

The establishment of the design controls is one of the most important aspects of the ISO 13485 certification, since, it describes the route to follow in the direction to start and maintain the quality management system.

Step 4 – Documents & Records Management

The Document and Record Control management is a main requirement for the ISO 13485 certification. In fact, the quality manual defines the process interactions for the quality system as described below:

  1. Support processes such as document control and training
  2. Core processes such as purchasing, production, and shipping
  3. Management processes

Each of these items shall require its associated procedures, and these procedures must be controlled. Indeed, the document control procedure is recommended to be the first procedure to guide the direction for the whole quality system.

Step 5 – Management Processes

ISO 13485 requires the implementation of risk management.  Also, it requires to consider any potential hazards in the operating environment and the quality management system.

Minimize identified risks by taking proactive steps.  ISO 13485 suggests the integration of risk management with business processes.

For example, the principal management processes are corrective and preventative actions (CAPA), internal auditing, and management review.

Step 6 – The Certification Audit

For certification audits, ISO 13485:2016 requires that an audit be conducted by sector/industry-specific personnel and ISO agent.

The certification process would begin with an audit of procedures.

During this audit, all the remaining processes in your quality system will be audited.  In order to ensure that the audit proceeds smoothly, the following documents and records should be prepared in advance:

  1. Quality manual
  2. Company organization chart
  3. Controlled list of procedures
  4. Internal auditing procedure
  5. CAPA procedure
  6. Management review procedure
  7. Internal audit schedule
  8. CAPA log
  9. Management review minutes

Benefits of the ISO 13485 Certification

How to obtain the ISO 13485 Certification?

Read more about a certification to ISO’s management system standards.

The ISO 13485 is not a public domain document available free on the internet.

It is a copyrights document which can be purchased directly from the ISO store.

Medical Device Single Audit Program (MDSAP)

Established by Regulatory Authorities (RA),  the MDSAP is an international initiative to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.

Moreover, RAs include Australian TGA, Brazilian ANVISA, Health Canada, US FDA, and Japanese MHLW.

Find out more about MDSAP and how it impacts the ISO 13485 certification.

HOW TO PURCHASE ISO 13485:2016?

ISO 13485:2016 is available from your national ISO member or the ISO Store.

Need ISO 13485  Certification Training

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about ISO 13485 certification or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

Need help & support during your ISO 13485 certification or need templates to create a quality manual and other procedures, visit us,

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For more details on specific FDA expectations and how to create quality management system documents necessary, follow us.

Quality procedures templates

Three (3) Options to Create Quality Management Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the ISO 13485 Certification?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Management Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

REFERENCES:

For more information about ISO 13485 certification, refer to:

https://www.iso.org/iso-13485-medical-devices.html

https://www.iso.org/standard/59752.html

https://en.wikipedia.org/wiki/ISO_13485

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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