What is the ISO 13485 standard? What are the advantages of this standard? And how is the ISO 13485 quality management system built? What practical benefits does it bring to businesses? Join us to explore in detail in the article below.
1. What is the ISO 13485 standard?
ISO 13485 is a management system standard applied in the manufacturing and business of medical devices and supplies, issued by the International Organization for Standardization (ISO) and used worldwide.
The previous version of this standard was released in 2003, ISO 13485:2003, with the Vietnamese version TCVN 13485:2004. In March 2016, the ISO 13485:2016 version was introduced, replacing the 2003 version and is in use today.
To better understand what the ISO 13485 standard is, refer to the specific applicable objects of ISO 13485 as follows:
- All organizations regardless of type, size, location, including medical device manufacturing facilities/plant/company;
- Distributors, healthcare equipment trade, and healthcare services in general such as supply chains, medical gloves, sterilization services, needles…
- This standard is voluntary, focusing on healthcare product safety management.
Currently, manufacturers and traders of medical equipment and supplies must establish and obtain a ISO 13485 quality management system certification to comply with all current legal requirements, enhance credibility, and satisfy customers.
2. Benefits of implementing the ISO 13485 system
As mentioned above, ISO 13485 was developed to be applicable to all medical device manufacturing and trading enterprises, regardless of their size and staff. Therefore, many businesses are interested and apply it because of its real benefits:
- Help your business maximize customer requirements, even the most demanding customers, by supplying high-quality, safe products, and complying with current regulations;
- Implementing the quality improvement system reduces operational costs to a minimum and limits defective products;
- Quickly improve relationships with interested parties;
- Thanks to the consistency of the system, it helps enhance risk management;
- Demonstrate organizational capacity through independent evaluations and certifications;
- Enhance the organization’s reputation, credibility, and increase competitive advantage, especially in bidding scenarios;
- Expand markets and increase opportunities to participate in large-scale markets with high quality and safety standards;
- Improve business image to customers, reduce complaints, and increase trust and competitiveness with rivals.
3. Building the ISO 13485 quality management system process
To successfully build and apply the ISO 13485 management system in your business, besides understanding what the ISO 13485 standard is, you also need to plan and follow a clear process according to the following steps:
- Step 1: Define the scope, review existing documents, and actual records;
- Step 2: Conduct awareness training about ISO 13485 for staff in the company;
- Step 3: Plan and assign tasks for documentation development according to standard requirements;
- Step 4: Issue and implement the documentation;
- Step 5: Conduct internal audits;
- Step 6: Request certification bodies to evaluate the system and obtain ISO 13485 certification.
-> You may also be interested in: ISO 14001:2015 Certification Service – Decree 40/2019/NĐ-CP
Hopefully, with this article, you have answered the question what is the ISO 13485 standard? and the benefits and process involved. If you still have questions or need further consultation, contact VINAQUALITY immediately for quick support from our experts.
VINAQUALITY QUALITY CERTIFICATION CORPORATION
- Address: 65 Đường D10, Phường Tây Thạnh, Quận Tân Phú, TPHCM
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