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Four Important Aspects of ISO 13485 Certification

by Isabel Blamey Professional writer
Medical device supply and manufacture companies need ISO 13485 certification to survive in their aggressively competitive industry. However, certification requires a company to enforce a few practices, such as meeting the ISO 13485 guidelines. These guidelines help with the implementation of the standard in the organization. The main requirement of this standard is to create and use an effective Quality Management System or QMS that will progress the quality of devices and maintain continuous improvement.
 
It is not possible to cover all the standard’s features in one article, however, listed below are four selected aspects that help to explain ISO 13485 certification:

1. Time

Transition time for the ISO 13485 standard depends on the country of the company, and if your company is currently ISO 13485 -certified or undergoing the certification process with the ISO 13485:2003 standard. Recertification will be needed if the status of certification matches one of the above situations. Additionally, there are many other timelines that need to be kept in mind. 

If quick certification is required, assign experienced employees to prepare your company for the certification audit. If your in-house resources lack ISO experience, hire a third-party ISO consultancy, who will effectively manage and help to implement all aspects of the ISO 13485 standard. 

2. Quality Management Processes 

The QMS is critical to gaining almost every ISO certification, including ISO 13485 and AS9100 certification, and there are many processes needed to comply. To effectively implement a QMS, each process must be analyzed. These processes must include:

• Nonconformance management,
• Corrective and Preventive Actions (CAPA),
• Training programs,
• Complaint resolution,
• Control of changes,
• Audits, and
• Supplier quality management.

Any changes are likely to create risk factors.  Risk should be considered whenever implementing or changing processes. Risk is not typically a standalone process, but is naturally embedded in every process.  

3. Internal Audits

Before the final certification audit, which will point out and penalize any nonconformities, it is important to guarantee the QMS is running smoothly. To ensure it does, an internal audit must be performed to evaluate the QMS, determine possible nonconformities, and resolve them. 

There are two ways to perform internal audits. First, by using in-house resources and assigning employees from separate departments to perform the audit. Second, by outsourcing with professional auditing services.
 
The first option requires employees to have experience with ISO internal auditing. If there is no budget constraint, arranging an ISO internal audit training program will ensure the employees become adequate auditors for future internal audits.
 
The second option provides an easier method to conduct an internal audit. Professional auditing services will effectively conduct the audit, reducing any chance of employee error. Additionally, it will save money and take less time. 

4. Compliance With the ISO 13485 Standard

A very important factor is compliance with the ISO 13485 standard, as the first priority must be to meet the requirements for ISO 13485 certification. Compliance is essential for certification.  

In conclusion, these four aspects heavily contribute to the ISO 13485 certification process.
 
Author Bio

Damon Anderson is a quality assurance consultant and blogger. He has worked with a leading ISO consultancy for years, and helped business gain ISO 13485 certification, ISO 9001 certification, ISO 14001 certification, AS9100 certification, among others. 

Contact Details
Business Name: Compliancehelp Consulting, LLC
Email: info@quality-assurance.com
Phone No: 877 238 5855


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About Isabel Blamey Senior   Professional writer

176 connections, 6 recommendations, 590 honor points.
Joined APSense since, June 21st, 2016, From Perth, Australia.

Created on Jan 10th 2020 02:26. Viewed 463 times.

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