FAQs: Getting the Most from ISO 13485 Consulting with AQM

At American Quality Management, we know that ISO 13485 certification requires experienced guidance to navigate the complex requirements and avoid roadblocks. On your journey to compliance, you will likely have many questions about how partnering with AQM can facilitate your success. On this comprehensive ISO 1385 consulting FAQs page, you will find detailed answers to the most common questions medical device companies have about engaging AQM for ISO 13485 consulting. Rely on our decades of experience to provide transparency into our specialized processes, expertise, capabilities, and proven approach. After reviewing this FAQ resource, please contact us to discuss how AQM can provide tailored ISO 13485 solutions to meet the distinct needs of your organization and help you maximize the benefits of ISO 13485 certification. 

Who is American Quality Management (AQM)?

AQM is a leading management consulting firm specializing in ISO quality standards like ISO 13485. For over 20 years, AQM has assisted medical device companies to enhance processes, achieve certification, and realize continual improvements. Our passion is helping clients reap the many benefits of ISO 13485 compliance.

What makes AQM experts in ISO 13485? 

With decades of hands-on experience implementing quality systems at organizations across the medical device and diagnostic industries, AQM has the proven strategic perspective to guide your ISO 13485 journey. When you engage AQM, you get a customized approach combining domain expertise with an intimate understanding of the unique needs of your business.

What is the AQM advantage as ISO 13485 consultants?

No one knows ISO 13485 better than the qualified experts at AQM. We have successfully guided hundreds of satisfied clients through ISO 13485 certification and compliance, including risk management, auditing, implementation roadmaps, efficiency improvements, and ongoing compliance maintenance. 

What is AQM’s process for ISO 13485 success?

AQM takes a phased approach tailored to each client’s specific environment and objectives:

1. Current State Assessment 

2. Future State Definition

3. Implementation 

4. Internal Training

5. Continual Improvement

Throughout the process, you get transparent project management focused on your key milestones and budget.

What are the benefits of ISO 13485 consulting with AQM?

Partnering with AQM for your ISO 13485 needs provides measurable advantages:

• Faster implementation timelines  

• Lower costs

• Increased certification success

• Improved staff productivity and morale

• Enhanced manufacturing quality and product safety

• Reduced risk, defects, and non-conformances

How can my company get started with AQM?

Don’t leave your quality management system to chance. As leading ISO 13485 consultants, AQM has the proven process and specialized expertise to provide ideal solutions tailored to your organization. Contact us today to get started and gain the quality advantage in the global medical device marketplace.

Why should we hire an ISO 13485 consultant rather than try to do it internally?

A qualified ISO 13485 consultant brings specialized expertise from implementing these systems at numerous companies. They can guide you through the complex requirements and avoid pitfalls that could delay or derail certification. An outside expert provides an objective perspective to identify gaps and opportunities for improvement. Consultants also bring the bandwidth to focus intently on ISO 13485 implementation while your team handles day-to-day operations.

What value does a consultant add compared to our own quality team?

While your quality team understands your organization, an experienced consultant offers broad knowledge of approaches across many companies. They can advise best practices and ensure alignment with ISO 13485 beyond just what your company has done historically. Their sole focus is ISO 13485, whereas it may only be part of your internal team's responsibilities. A consultant also brings an independent voice to get buy-in across the organization.

How can a consultant help us achieve ISO 13485 more quickly? 

A qualified consultant has successfully implemented ISO 13485 systems many times. This experience creates shortcuts that avoid false starts and dead ends that could delay your project. Their familiarity with certification body expectations also streamlines approval. With tailored guidance from a consultant, certification can be achieved 30-50% more quickly.

Will an ISO 13485 consultant really save us money in the long run?

While a consultant has upfront costs, they often identify efficiency gains, risk reductions, and improved customer confidence that deliver a very high ROI. Avoiding missteps that lead to rework or facility improvements can result in major cost savings. Enhanced quality and fewer recalls also impact the bottom line. Working with a true ISO 13485 expert provides maximum financial value.

What happens if we can't get ISO 13485 certified after hiring a consultant?

Any reputable firm stands behind their work and will continue working with you until certification is achieved at no additional cost. They will critically review the assessor's findings and address any gaps until your quality management system meets ISO 13485 standards.

Can a consultant handle ISO 13485 at multiple company locations?

Yes, experienced consultants are well-versed in approaches for multi-site ISO 13485 implementation. They can provide centralized direction while still customizing elements for each facility when appropriate based on types of products, processes, regulatory jurisdictions, and more.

How does a consultant determine what to improve in our quality system? 

Through extensive assessment against ISO 13485 requirements and your business objectives, a consultant can pinpoint problem areas and roadblocks. This includes processes, documentation, infrastructure, and organizational elements. The consultant then advises solutions tailored to your situation for certification and beyond.

Will an ISO 13485 consultant integrate with our internal processes?

Absolutely. Reputable consulting firms work as an integrated extension of your team. They collaborate with your leaders and subject matter experts to mesh their ISO 13485 recommendations into existing systems. Minimal disruption is key.

Does a consultant stay involved after we achieve certification?

Many consultants offer ongoing support to assist with surveillance audits, recertification, and continual improvement of your quality management system according to the evolving standard. They become trusted partners in compliance.

How do we evaluate and select the right ISO 13485 consulting firm?

Look for experience assisting medical device companies similar to yours, proven ISO 13485 expertise, reasonable pricing, and responsiveness. Ask for client references to understand capabilities, communication, and working relationship. A chemistry check is also important - align with a consultant that meshes with your culture.

What qualifications should we look for in an ISO 13485 consultant?

Optimally your consultant will have extensive hands-on experience actually implementing ISO 13485 systems, not just abstract knowledge. They should exhibit a strong understanding of regulatory requirements in your markets. Relevant medical device industry experience is also a plus.

Approximately how much does ISO 13485 consulting cost?

Consulting fees are usually structured as a monthly retainer, plus expenses, in the $4000-$10000 range depending on level of involvement. Certification support can cost $15000-$30000. Full implementation often ranges $50000-$150000+. Value delivered typically outweighs costs.

How long does it take to implement an ISO 13485 consultant's recommendations?

With an optimized approach guided by an expert consultant, many companies can achieve ISO 13485 implementation within 6-12 months. For large multinationals, the timeline may extend to 18-24 months. Ongoing maintenance of your quality system never truly ends.