ISO 13485:201X Preparation (Medical Device Audits)

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iso13485ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.”

Every few years, ISO issues standard revisions with 13485 originally scheduled for release this year.  However, due to the high volume of comments received by the ISO Technical Committee, the 13485 revision is planned for early 2016. It is currently referred to as ISO 13485:201X, or DIS (Draft in Standard).

The proposed revisions are significant, and it is important for medical device organizations to start preparing now.

Three changes that are speculated include:

1) Due to to the increasing complexity of the international regulatory environment for medical devices, it is expected that ISO 13485:201X will incorporate EN ISO 13485:2012 elements and reflect more current requirements by the EU.

2) ISO 13485:201x will reach the entire supply chain in the medical device industry. “While the existing version is mainly tailored to device manufacturers, the DIS aims to be relevant to suppliers of components and services as well.”

3) The revisions will incorporate the entire lifecycle of a device. The current standard focuses on quality up to the point where the device is purchased by the consumer.

Beyond certification… 

The benefits of performing ISO 13485 based audits go beyond required certification.  With an effective and efficient quality system, organizations are able to identify errors early in the process, avoid costly regulatory fines and provide employees with appropriate training.

According to Quality Digest, “there is more than one way to save money by adhering to ISO 13485 standards. Having a quality management system [based on ISO 13485 standards] at an early stage provides another advantage to these companies [medical device companies]: quicker market access. Many regulatory organizations were involved in the development of this standard. Therefore, requirements in regulatory laws such as the 93/42/EEC MDD share numerous similarities with ISO 13485. Hence, after a simple update of their systems, these companies can quickly and cost-effectively seek regulatory approvals from a variety of countries.”

Sections of ISO 13485 include:

  • Sections 1-3 General purpose and use
  • Section 4 – Systemic requirements
  • Section 5 – Management requirements
  • Section 6 – Resource requirements
  • Section 7 – Product realization requirements
  • Section 8 – Remedial requirements

Versions of ISO 13485 include:

  • ISO 13485:2003 – Current international version
  • EN ISO 13485: 2012 – European harmonized version
  • ISO/TR 14969:2004 – Guidance document
  • CAN/CSA-ISO 13485:03 – Conformance to this standard is necessary in order to secure a Canadian Medical Device License for a Canadian class II, III or IV medical device.

Even in countries where adherence to the standard is not required by law, ISO 13485 is becoming increasingly required by investors, partners and customers.  Contact us for additional information regarding ISO 13485 medical device audits. We reduce quality risks and cost in over 38 countries.

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