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The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know

Medical DeviceA Global Quality System Standard

As globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging.

The announcement that the FDA plans to use ISO 13485 as the basis for its quality system legislation signals an important step forward for the international standard, which is already widely used globally. United States medical device manufacturers that already address ISO 13485 will have a leg up to address FDA regulations. Those manufacturers who have yet to address ISO 13485 should start assessing their quality management system (QMS) to determine whether there are any gaps to meet the ISO 13485 guidelines. Whether you are new to 13485 or not, it is vital to use a QMS solution that enables easy adherence to quality system regulations.

What is ISO 13485?

ISO 13485 is a quality system standard specifically geared to medical device manufacturers; the latest version was published in 2016 (ISO 13485:2016). This standard provides the most common set of requirements to do business in Europe, Canada, and other countries outside the United States.

ISO 13485 is aligned with ISO 9001, which focuses on demonstrating continual improvement while ISO 13485 only requires that certified companies need to demonstrate that quality systems are implemented and maintained. The regulation also acts as the foundation of the Medical Device Single Audit Program (MDSAP), an audit program that enables companies to become compliant with regulatory bodies across several major global markets. Participating in the MDSAP allows medical device manufacturers to undergo a single audit and, for most participants, to reduce the overall number of audits or inspections, and optimizes the time and resources expended on audit activities.

5 strategic steps toward ISO 13485 certification

  1. Get Management’s Support: An initiative, like the implementation of ISO 13485, is much more likely to be successful if management supports it. If ISO 13485 adoption is not being driven from the top down, highlighting its benefits can aid in securing management support. Secure executive support for training and audit costs.
  2. Training: Identify key team members to track training in the standard. There are resources online to help your staff gain more knowledge such as 13485Store and Advisera’s ISO 13485.
  3. Gap Analysis: Given the regulatory environment surrounding the development of medical devices, businesses that have not yet accepted ISO 13485 have probably already created systems and procedures to satisfy the criteria for device approval. Align those systems and processes with the requirements of ISO 13485. The gaps that remain are the ones to address.
  4. Development and Documentation: This stage of ISO 13485 adoption is probably the most significant. The team members leading the adoption initiative will design and record each process in this step so that it complies with the standard’s requirements. The team must document every step for the QMS after those processes are created or amended.
  5. Use the QMS: When all the systems are documented and in place, the team should actively use it for at least a few months before applying for audits or
    certification. The QMS will have more gaps or deficiencies found by being actively used. When those issues come up, the team can handle them right away and change as necessary. Once the QMS is running smoothly internally, it’s time to pursue certification.

What do manufacturers need to do to comply with ISO 13485?

For FDA regulated manufacturers, the activities required to close the gap between existing QMS standards and the new ISO 13485 regulation should not be significant. For many, the majority of the labor and time will be spent ensuring new processes are well “documented” or “established,” a requirement that is fundamental to both the FDA and ISO 13485 regulations.

Like other ISO management system standards, manufacturers are not required to be certified—however, to do business in most major global markets, especially if manufacturing Class II devices are higher, manufacturers should be ISO 13485 certified. Manufacturers can reap many benefits from being ISO 13485 certified, especially by expanding the number of global markets your company can do business in, which leads to higher profitability.

To identify gaps in your current QMS and get on track with ISO 13485, consider focusing on these three areas:

  • Documentation
  • Training
  • Proactive quality feedback

Documentation: Achieving Consent Compliance and Implementation

ISO 13485 states that “documentation” extends beyond just being written down-documentary evidence must also be implemented and maintained. Just like all ISO standards, a critical element of this statement is a manufacturer’s ability to prove that you follow documented processes consistently. These requirements align with the FDA regulations set forth in 21 CFR part 820, but still present issues for many companies working with manual or document-centric QMS systems. These older approaches to QMS systems tend to focus on two key areas of compliance:

  • Document control for SOPs, specifications, work instructions, and other records
  • Process enablement and tracking for auditable processes, including CAPA and training records

Furthermore, most of the traditional document-centric QMS software solutions simply provide automation of paper-based processes and consequently fail to capture the comprehensive product record comprised of mechanical, electrical, and software components; assembly and test procedures; and other documents specified in the BOM. Arena’s product-centric QMS can manage linked relationships between DMRs, DHFs, BOMs, individual components, AML/AVL, documentation, product history, and any changes or quality issues to better facilitate process implementation and follow-through

“Without Arena being implemented within the past year we would not have passed on our first attempt for ISO certification.” – Todd Curry, ProteinSimple Biotechnology

Streamlining Training Documentation and Ensuring Compliance with Arena QMS

ISO 13485 establishes that an organization must have documented proof and processes that are used to properly train its employees, contractors, and agents. In 2017, the FDA reported 86 training related findings. Inadequate “procedures for training and identifying training needs” resulted in 46 findings. A lack of “personnel training documentation” was cited 29 times. Only 11 citations were because the employees had not been “adequately trained.”

According to these findings, many organizations have established training programs that adequately prepare employees to do their jobs well. The real struggle comes in documenting and creating a history of training processes, programs, and tools.

Arena QMS maintains training records, so managers know which employees have been trained on applicable SOPs, policies, and work instructions. As employees complete their training and tasks, Arena provides proof of competency via quizzes and creates the documented history for all impacted employees.

Proactive quality feedback

ISO 13485 specifies that product quality feedback can come from production checks and procedures, rather than from customers and other post-market communicators. This change enables devices to be released to market more quickly, and lets companies continue to make process improvements without getting extremely behind schedule or losing out on revenue.

New manufacturers may be able to get by using simple, separate systems to document quality records because they haven’t fully developed their product and have very basic recordkeeping needs early on. However, as companies grow and deliver products to market, they often run into issues keeping track of all quality and related product records due to the use of disparate systems by different teams.

Enhancing Traceability and Proactive Feedback with Arena’s Connected QMS Approach

Arena’s product-centric QMS approach ensures the entire product record (e.g., parts, BOMs, AML, drawings, packaging, specifications) and quality record (e.g., CAPAs, DHFs, DMRs, NCMRs) are connected throughout the whole product lifecycle. This connected QMS methodology allows full traceability for all key stakeholders from engineering to quality to operations and the full supply chain, enabling more proactive quality feedback and corrections before and after market release. Implementing Arena’s solution earlier in the game, before quality and product records get muddled and unwieldy, can save quality managers a lot of headaches further down the road.

Strategies for Successfully Adopting ISO 13485

The latest ISO 13485 standard is more aligned with existing FDA regulations, but that does not mean there won’t be QMS gaps to address as United States medical device manufacturers seek compliance. Companies need to become familiar with the ISO 13485 standard and begin preparing now. While ISO compliance can seem overwhelming at times, it is good to remember that at a high level, it boils down to “saying what you do and doing what you say,” and backing it up with a quality system that provides connected records between quality and products.

Strengthening Quality Compliance and Global Supply Chain Management with Arena QMS

Arena QMS allows companies to leverage a product-centric QMS solution that makes it easier to prove that you are indeed doing what you’ve stated needs to be done to ensure quality compliance. As globalization of the supply chain continues to speed up, having a solution that simplifies this process and makes it easier to avoid warning letters and citations is a vital part of any strong QMS.

Do you use manual or document-based QMS solutions today? Are you struggling to keep context between product designs, device history, and other quality records?

Let us know your thoughts for keeping up with the latest quality management challenges.