By definition, ‘to consult’ means to get information from ‘a person or book with special knowledge on a particular subject’, which is highly beneficial when dealing with complex quality management systems.

There are many reasons why your organisation may be in the market for quality management consultancy.

It could be that you need support implementing a quality management system for the first time or that you need to adjust your existing system to meet new regulatory requirements. It could be that you are simply looking to reduce the cost of nonconformance and drive change throughout the business.

Regardless, finding a partner that is the right fit for your organisation and your organisation’s goals is essential.

In this blog, we’ve laid out some of the most important things to consider before committing to any consultancy company.

Let’s take a look…

1 – Their experience and track record

The very purpose of a quality management system (QMS) is to ensure that your organisation consistently supplies a product or service in line with customer expectations and/or relevant regulatory requirements.

When it comes to choosing a consultancy company, it’s imperative that you find one with the relevant industry experience and qualifications to ensure that these expectations are met.

Due to the multi-disciplinary nature of many highly regulated industries (such as pharma, medical device, and life sciences), be sure to ask the consultant for their specific industry experience and for any successful client engagements that closely resemble your organisation’s own project.

Whether you’re looking for a company to help you build regulatory QMS for your new facility or to adjust a non-compliant QMS to meet regulatory requirements, finding a company with a high success rate doing exactly that will likely yield you the best results.

2 – Their ability to work within set parameters

However, a company’s successful track record shouldn’t be based entirely on their relevant experience and previous successes. It should also take into account their ability to work within the parameters of a project.

It’s rare that, within a QMS project, you aren’t bound by at least one or two limitations.

If you’re looking to achieve compliance by a target date, or you need to complete all relevant work within a budget, you want to be sure that the consultancy company you choose can work to these restrictions.

When assessing their track record therefore, be sure to ask them what they can do to ensure that any deadlines are met and any work is conducted within the set limitations.

3 – Their staff

Developing, changing, or upgrading your quality management system can be a big undertaking.

For that reason, you want to partner with a company capable of addressing each and every challenge that you may come up against in the process.

When shortlisting potential consultancy companies, look beyond the consultant that you’re most likely to be working with on a day-to-day basis. Instead, be sure to look at every single member of the team and see what experience they have across the entire quality management spectrum.

These people will ultimately be responsible for the future success of your company. By partnering with a company made up of qualified and engaged personnel that cover an extensive range of skills, you’re more likely to find the best solution to any problems that may arise.

4 – Their geographical limitations

In today’s current ever-changing environment, it has been proven that remote consultancy works well utilising technology such as Microsoft Teams, WebEx, and Zoom.

With multiple locations and time zones now able to contribute simultaneously in shared virtual rooms, individual break out rooms, and with virtual whiteboards and mapping software, geographical limitations are no longer the stumbling block they once were.

Whilst face-to-face meetings can be useful as milestone gates to review progress if required, they should be minimal and should typically be strategically planned to allow you to utilise the necessity wisely and cost-effectively.

When assessing a company’s capabilities in relation to geographical limitations, be sure to ask them what they can do to ensure that they are adaptable and can work in this hybrid fashion.

5 – Their commitment to your project

The period of time in which you may need a QMS consultant could range from several weeks to several years. It all depends on the size and complexity of the project you’re undertaking.

Regardless of whether your project is short-term or long-term, you’ll want to feel confident in the consultant’s ability to provide continual support over the project’s entire lifetime and for future support. This means finding a consultancy company that is both well-established and maintains communication with your organisation even after the solution has been implemented.

When investing so much of your time, resources, and revenue into quality management, it’s best to partner with a company that is keen to build solid, long-term relationships with their clients.

How can Tower Mains support you?

Located in Edinburgh, Scotland, with Associates in six countries, the team here at Tower Mains have over 200 years of global regulatory experience, providing international audit, consultancy, and training services to the clinical, health services, life sciences, biotechnology, and scientific industries.

We believe that an organisation’s quality management system should be simple, meaningful, and consistent with the relevant standards. It must also be flexible enough to allow growth within your organisation.

We can support your organisation by designing a bespoke QMS or a QMS development plan which is consistent with the principles of GCP, GLP or GMP or for non-regulatory research. We are also experienced in developing quality management systems for medical device companies and non-commercial organisations based on various ISO standards, for example ISO 13485 and ISO 9001.

To find out more about our range of consultancy services, click here.