Is ISO 9001:2015 Certification right for your medical tourism business?

Earlier this week, I spent two days in my Denver office, coaching a new medical tourism startup company's founders on business model design, infrastructure and workflows. They are planning a new medical tourism and health travel referral and logistics agency.

We examined the underwriting applications for professional liability insurance from Custom Assurance in South Carolina and one thing became very real for them: You cannot apply for insurance without formalized and documented policies, procedures, best practices, and risk-based thinking workflows. Well you can apply, but you will either be rated as very high risk or declined for coverage. These guys didn't want to spend money on higher premiums by applying before they had traffic and they didn't want traffic until they were ready for it.

One thing that became very clear for them was the need for structure to tie together all the moving parts that pose risk to their business, their profits, their shareholders, their patients and their suppliers. My recommendation was that they aim for certification - but not some "one-day wonder" certification for medical tourism sellers. I refer specifically to the "Mac Daddy" of international certifications: ISO 9001:2015.

In their case, time and money are both precious. ISO 9001:2015 for a medical tourism facilitator firm reduces risks and costs to a facilitator's business. It is also a certification that can be endeavored by employers, insurers, hospitals, clinics, and other stakeholders. ISO certificants seek out other certificants as part of their risk-based thinking in vetting potential business partners in their company's procurement and affiliation activities. Unlike all these new one-day wonder certifications in medical tourism that underwriters either don't recognize or flat out reject, ISO 9001:2015 is globally recognized by manufacturers, insurers, and underwriters. It needs no introduction to those form whom it matters.

I often recommend that small businesses utilize of one of the numerous solutions available online. There are “ready-to-use” documentation templates. By doing this, you can spare some time on technicalities to develop their Quality Management System (QMS).

Developing the Project Plan

In order to developing a project plan for the creation and documentation of the QMS, in a small medical tourism firm, the CEO is usually the leader of the project and the Quality Assurance Manager (QAM) often a physician or nurse is designated the Project Manager.

Step 1

The first step for the Project Manager is to determine how much work the project will entail. Our work in Denver to refine business model and brainstorm on workflows, strategies, etc, was part of their gap analysis to determine to what level the company was already compliant with the standard, and what needed to be done to achieve full compliance. They would have to do more when they returned to their office, but I got them started on the pathway to success.

As a part of this analysis, we made an estimate of how many people would be needed on the project. The CEO brought technical writing skills from a previous position and role, so the expense of the technical writing and familiarity with ISO terminology and protocols would be easier than for someone who has no such experience. This would also reduce costs because an external technical writer's skills would not necessary.

When you are implementing a Quality Management System (QMS) according to the requirements of ISO 9001:2015, no doubt you will be concerned about how long this will take. There is no simple answer to this question because ISO 9001 implementation differs so much from company to company, but there are a number of things you can do to get a good idea of what needs to be done and how long it will take. The gap analysis is the first step. Typically, Small organizations up to 50 employees could implement ISO 9001:2015 in 6-8 months. Medium-sized organizations up to 500 employees could implement in 8-12 months. Larger organizations can take 12-15 months to implement. These estimates do not include any required time to operate your QMS before your certification audit as dictated by your certification body. The time that you need to operate your QMS and perform these tasks will be set by your certification body; i.e., all certification bodies have a pre-determined timeframe that they want the Quality Management System to operate and accumulate records for them to be able to satisfactorily audit and determine it is in compliance with the ISO 9001:2015 standard requirements. Most require at least 6 months.

A good gap analysis is critical when deciding how much needs to be done during your implementation. Most medical tourism startups don't know what they don't know - hence the multi-day coaching I offer either at my office in Denver or at their location. With a gap analysis tool, you compare what you already have in place in your company with the requirements of the ISO 9001:2015 standard and identify what processes and procedures you already have in place that meet the requirements and what you are missing. An excellent gap analysis tool that is free to use is available from Advisera.

Use this free tool to identify what you need to close the gap. If your company is already very process based, rather than using ad-hoc activities, you will find it easier to implement an ISO 9001:2015 QMS. Medical tourism facilitator work is very process based if you are doing more than sourcing leads and making appointments and booking hotel rooms and collecting a commission fee for your efforts. If you are really going to add value through your services, medical tourism facilitation and case management is 100% process based.

The likelihood is high that there will be many documents to be created in order to be aligned with ISO 9001:2015. All your workflows, decision tools, standards, criteria for evaluation of new hospitals, hotels, doctors, cars and drivers, and patient interview processes needed to be implemented, to determine business model, how your company will make money, the unique context of the organization and how you'll mitigate risks and take advantage of business opportunities. You'll also need forms such as contracts, surveys, and other communications tools, and the processes to get them completed and analyzed and to extract data from them to inform actions and next steps.

During the gap analysis, the QAM identifies areas of the QMS that can be optimized. Each task that must be completed to prepare for the QMS must be assigned to a responsible person for each process in the company. Each is given their role in the project and assignments for different tasks; a deadline, and deliverable. The tasks include writing new documents, creating checklists and workflows, and creating standards, criteria, and processes that give life to the new or existing brand. Activities related to clauses 4, 5, 6, and 7 of ISO 9001:2015 are assigned to the QAM and the top manager, while the rest of the team deals with the clauses of the standard related to their processes. 

Section 5 of the new standard is all about leadership, and most of these requirements are very close or identical to those covered in the current version of the standard under the management responsibility requirements. The first subsection is about the ways that top management needs to demonstrate leadership and commitment with respect to the QMS, such as being accountable for the effectiveness of the QMS, ensuring resources are available, promoting continual improvement, and ensuring the Quality Policy and objectives are in place and consistent with the goals of the organization and the QMS.

The other three subsections cover the need for customer focus, requirements for the Quality Policy, and the organization’s roles, responsibilities, and authorities. These requirements all have mirror requirements in the current standard, with minor modifications. The very important role of top management to ensure that the QMS remains suitable, adequate, and effective has not been reduced, even though some requirements, such as the role of Quality Management System representative, have been removed.

Determine the context of your business

You can approach the requirement of determining the context of your business with a SWOT analysis. The CEO and QMS team should conduct the analysis independently, and the results merged into a single document afterward. 

List all interested parties

As a part of determining context of the organization, you must identify all interested parties. The ISO 9001:2015 standard talks about understanding the needs and expectations of interested parties right at the beginning of the standard (Section 4.2), just after the requirements to understand the organization. The justification for this is that interested parties will have an impact on the organization’s ability to provide products and services that consistently meet customer needs and legal requirements. This information, especially the requirements from interested parties, is used throughout the QMS, so it is important to gather all the information that is needed.  The requirements are to determine what interested parties are relevant to the QMS, and the requirements of these parties that can affect the QMS. These include, but are not limited to the following:

1. The company and its shareholders
2. The patients
3. The suppliers and provider network (hospitals doctors, dentists, drivers, accommodations, insurers, underwriters, business consultants, legal advisers, creditors, airline flight crews, travel agencies, DMCs, government authorities, software vendors, media partners, employees of your company and others).

Focus on the interested parties and group them according to your company's requirements. You'll eventually determine that some interested parties may be more important than others, so record these as separate entries in the list of interested parties.

The ISO 9001:2015 standard has several requirements that involve the knowledge you have acquired when determining the relevant interested parties and their requirements. You must elaborate on the expectations and requirements of those identified above to properly carry out these QMS processes. In brief:

• The QMS scope needs to include the requirements of relevant interested parties (Section 4.3).
• The Quality Policy is to be made available to relevant interested parties when appropriate (Section 5.2.2).
• Measurement traceability needs to be maintained when this is an expectation of relevant interested parties (Section 7.1.6). (Also a JCI accreditation exercise for healthcare organizations).
• Requirements for products and services may need to include those from relevant interested parties (Section 8.2.3).
• Design and development activities need to take into account requirements of relevant interested parties, including how much control is expected in the design and development process (Section 8.3).
• Management review needs to include issues that concern relevant interested parties (Section 9.3).

From a marketing and branding perspective you must go through the same study and analysis to KNOW YOUR CUSTOMER, so doing this exercise simultaneously will help to align your QMS with your branding and messaging efforts.

Define the scope of the QMS 

To start, there are three considerations to be included when determining the scope:

1. External and internal issues that are relevant to the purpose of the organization, the strategic direction, and the ability to achieve intended results
2. Requirements of relevant interested parties
3. The product and service of the organization

In addition, the scope is to include any requirements of the ISO 9001 standard that can be applied, and if a requirement is determined to not apply, the organization will not use this as a reason for not ensuring conformity of product and service. The scope is to state the products and services covered by the QMS, and justification for any instances where the ISO 9001 standard cannot be applied.

This scope is a vital part of your new quality manual. It will define how far the QMS extends within your medical tourism facilitator business operations. It will also carve out any exclusion from the ISO 9001 requirements and the justification for these. Such carve outs could be, among other things:

• the medical care itself
• treatment decisions
• the accommodation delivery
• the car and driver operations, maintenance, safety policies, etc.,
• the travel agent's responsibilities for booking and payment and GDS risk
• your software developer's updates and modifications
• your website hosts operations and safety protocols
• and more.

I could go on for pages and pages of this, but if you get this far, you'll be well on your way to professional and ethical business operations as a medical tourism business, and you'll know that you have done everything within your power to mitigate and manage risk.

Aligning with your business strategy

The reason my clients came to Denver to receive coaching was so that I could help them to narrow down their business strategy for their new medical tourism company. This is much more involved than you might realize. After the two days, they left with many more decisions to make and strategies to plan. Such is the case with all my medical tourism coaching clients. I am happy to ask their permission to connect you to talk with them directly and see if coaching might be right for you.

The new version of the standard requires a new approach to defining objectives; besides defining SMART objectives, you must also define in writing, your plans for achieving those objectives. Develop the framework for planning achievement of the objectives; for each objective, the plan must address who will be the responsible person, a set of activities that would lead to achievement of the objective, necessary resources, and deadlines. That's difficult to do when you don't know what you don't know about the business of medical tourism facilitation and case management, the operations associated iwth travel planning, anatomy, physiology, the procedures you will be requested to coordinate, the aftercare and choosing an approved provider network and destinations.

If you need help, I offer private business coaching for facilitators, hospitals, clinics, hotels, and others entering or already operating within medical tourism. The competition will only become more intense now that investors and hedge funds are entering the industry.

The medical tourism business has become more sophisticated. Those who run an appointment setting model patient brokering model for a commission payment, and those with variations on a medical tourism internet directory website like PlacidWay, MediGo and WhatClinic and others who launched and fizzled over the past 8 -10 years can already see the writing on the wall.

Small independent operators will need to rethink their strategy, USP and value proposition and sustainability to compete with startups launched with more money and staff than bootstrap startups. That's just simply evolution. It is natural, and the cottage industry of medical tourism facilitation will fade into history as new startups raise the bar.

Some who operate the patient brokering model in exchange for commission payments will be surprised to learn that they are at risk for arrest and civil fines and penalties as this business model is illegal in the USA and many other countries. It doesn't matter where the patients are sent, if you are the seller of the patient referral or the receiver, or the source of payment.

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About the Author

Maria Todd has been a strategic adviser to healthcare businesses, physicians, health systems, investors, and government leaders.

She leads a team of consultants and contractors on six continents who are knowledgeable about health policy, healthcare delivery reforms, health tourism, pharma, biotech, medical device, m-health, global health and insurance industry issues. She has mastered strategic and problem-solving consultation and performed short-term contract work and professional skills training in a variety of healthcare settings in the USA and abroad.

Her firm focuses on health policy and finance, benefits design, business startup and operations strategy, reimbursement, and healthcare organizational development. Maria helps clients solve complex problems and leverage new business opportunities in Concierge Medicine, Physician Integration, Health Tourism, Third-party Payer Negotiations, and Contracting with Hospitals for Government-paid Treatment Abroad and Healthcare Reforms.

Maria's strengths include: 

- Managed Care Contract Analysis and Negotiation Outsourcing

- Onsite Managed Care Contract Analysis, Negotiation, and Claims Appeal Training

- Troubleshooting of Complex Managed Care Claim Denials and Appeals

- End-to-end provider network design, operations, telehealth, and payer negotiations

- End-to-end Employer Health Travel Program Design

- End-to-end Worksite Health Clinic design, operations, telehealth, and clinic management

- End-to-end Concierge Medicine practice design, operations, telehealth, and social media marketing

- Concierge Medical Practice Development & Marketing Strategy

- Healthcare & Health Tourism Branding, Marketing, and Web Design

Her background includes a combination of clinical, administrative, insurance, marketing, and health law and expert witness project experience. She has led more than 2800 workshops, seminars, master classes, and short courses in the past 35 years, and trained more than 65,000 healthcare professionals, executives, and investors on a variety of the topics listed above. She is the author of 19 professional and technical books on healthcare business and health tourism.

Contact her at +1.303.823.4662 (office) or via email, to inquire about her availability to help make make your next event a success.