On February 23, 2022, the FDA announced plans to adopt ISO 13485:2016 as well as additional requirements. The new rule will be referred to as the Quality Management System Regulation (QMSR).

Impact

The FDA estimates that the proposed rule change will result in annualized net cost savings to medical device companies.  The new rule will be required to be implemented 1 year after going into effect. 

Here’s a list of what’s similar and different between ISO13485 and the new QMSR.

The proposed rule is similar to the following ISO clauses:

• Clauses 1-3
• Clauses 5-6
• Clauses 8-9

The proposed rule is different than the following ISO clauses:

• Clause 4, Quality Management System. Specifically Documents and Records.
• Clause 7. Product Realization. Specifically Design Controls and Servicing.

FDA Requirements

• Clause 4.2.5 will have an additional requirement to include signature and date, whether paper or electronic records.  Complaints and servicing activity records will capture information as per 21 CFR Part 803. The Unique Device Identification (UDI) for each medical device or batch of medical devices will be documented as per 21 CFR Part 830.
• ISO Clause 7.3 will apply only to manufacturers of class I devices listed in the provision, as well as all class II and class III devices.
• ISO Clause 7.5.1 will have additional requirements from 820.45 for labeling, packing and inspection of labeling.
• ISO Clause 7.5.4 will have additional requirements from 820.35(b) for servicing activities.
• ISO Clause 7.5.9.2 will have an additional requirement for devices that support or sustain life, in addition to ISO’s implantable device requirements. 

FDA Terminology Being Removed 

• Establish. Why? Because ISO’s requirement to document a requirement implies that it is first established, which is sufficient.
• Management with executive responsibility. Why? Because it’s being replaced with ISO’s top management term.
• Device Master Record (DMR). Why? Because it’s being replaced with ISO’s Medical Device File term.

Terminology Being Kept

• Act. Specifically there will be an addition of Federal Food Drug and Cosmetic Act.
• Process validation. Although FDA maps this to the ISO validation of processes term, it notes that the term is not defined by ISO and therefore will be retained as-is. 
• Customer. This is being defined as component manufacturers, contract manufacturers and end users. 
• Device. As defined by the FDA.
• Labeling. As defined by the FDA.
• Manufacturer. This is being defined as an additional type of Organization.
• Safety and Effectiveness. This is different than ISO’s safety and performance.
• Product. As defined by the FDA.

Your Plan With Origami

Assess. Take the time to review the planned rule changes, and determine the scope of impacts on your processes. 

Plan. Contact Origami or your consulting partner to plan changes to your system.  There may be entirely new processes to add to your operations, such as risk management and UDI. We’re here to help you by providing you with good practices and examples. 

Budget and Implement. You may allocate people and time to configure system changes, and to conduct training. 

Continually Improve. Change is an opportunity to improve. We have experience and can help you.  Don’t forget to set up a project in Origami to track and status your company’s transition activities and costs.  

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• There are many tasks and processes that your team members perform, which are repetitive, time consuming and which they’d prefer not to have to perform. Retain great staff by giving them interesting work and automating repeatable. tasks they perform such as filing, saving, chasing, emailing, aggregating and more
• According to IBM’s 2021 Global AI Adoption Index, 80% of companies are already using automation software or plan to use this technology in the next 12 months, with key benefits being improved employee productivity and resiliency. 
• If you haven’t invested in automation, it will become increasingly hard to catch up to automation-enabled competitor efficiencies, margins, and interesting work environment advantages.
• Where’s the automation platform in all this?  When our customers talk to their teams and find out how many people not only perform fatiguing repeatable activities, they discover the people and software duplication that exists in their businesses from so many people updating the same data in different systems. After internal discussions, executives usually call us up urgently to help them “fix our unnecessary people and software costs across our organization”.   No executive that we work with has ever said to us that their status quo will grow their organizations. None. 

There is also an automation is bad perspective

• As with the industrial revolution, it’s pointed out that automation is a threat to some people’s jobs. We don’t dispute this. The questions are: how many manual, repetitive, and duplicative costs can an organization afford as they try to scale or fulfill their mandates? Will the organization still be relevant, competitive or attract the desired caliber of people with the status quo? These are the most important questions our customers ask themselves when they discuss the impact on jobs.
• For a refreshing perspective, we’ll share how one of our customers decided they couldn’t fulfill their mandate unless they implemented platform automation.  This customer gets 1000s of records per day from a government database. Each record is associated with one of their hundreds of patient care locations, scheduled to experts to review and update with new healthcare information and sent back to the government database throughout the day. There are simultaneous activities to pre-screen, welcome, and follow up with patients.  This customer decided that they MUST help the government keep healthcare costs under control by delivering high quality patient care, minimizing administrative overhead, and optimizing time spent by healthcare experts.  When they worked out the costs of manually completing all their necessary steps, they realized that platform automation would save the healthcare system over 87 people every year, before they factored in their own growth! 

Some stakeholders claim not to care about or think that automation doesn’t affect them

• The root cause of these perspectives is often the same. Many people have team mandates and don’t even think twice about absorbing inefficiencies. If a process is frequently repeated, requires unideal manual or software steps, requires chasing, data re-entry, data matching, data cleanup or is ‘just how the team does things’, the time and costs of these inefficiencies are often distributed across team members and aren’t quantified. 
• There are some team leaders and department executives who consider team level inefficiencies the cost of doing business. 
• Organizations with people that look across all processes, often the COO, CIO and CEO roles determine their direct and indirect inefficiency costs by asking insightful questions about each team’s structure, technologies and processes. They also examine processes, data, software and reports that extend across cross teams.    
• People that think that automation isn’t relevant, or doesn’t affect their teams may not be taking an organization-wide perspective, and may not be quantifying inefficiencies or experience impacts in their scaling forecasts.
• Where’s the automation platform in all this? It’s right with the people who plan the future of the organization, by quantifying team and cross-team inefficiencies. Lack of automation impacts companies now, and as they grow. Implementing an automation platform is a scaling, growth, and mandate enabler. 

It’s never too early or too late to engage with internal stakeholders to quantify the impact of some current processes, and to investigate how your organization operates across teams. 

At Origami, we’ve worked through these important discussion with our customers and their stakeholders. 

What we love, is to bring our experience to your teams and open up opportunities that often weren’t even imagined to be possible. 

Contact us to discuss how we can help your organization take steps now, to enable your future.