Areas of Practice

Audits

BespokeQS pride ourselves on our audit capabilities. We can conduct in-depth reviews of your existing processes, and compare these against your business and certification requirements.

We believe audits are your way to manage growth and can allow companies to stream line their processes.

Internal audit contracting, supplier audit contracting, and pre-certification audit reviews are our strongpoint.

Certification Services

Certification can be a daunting task for small to medium enterprises. BespokeQS will empower and help train your team to gain and maintain certification.

Our team have experience in setting up adaptive quality management systems (QMS), and have knowledge on the benefits and pitfalls of the main certification agencies (DNV, TUV, BSI, TQCS, GICG), allowing you to make an informed choice during this major step in a companies history.

Standard Implementation

BespokeQS will conduct standard specific gap analysis reports to support your business during all phases of its growth.

We will advise, edit, or help author your policies to implement any of the standards you have selected.

Our team are experts in ISO 13485:2016, ISO 9001:2016, ISO 14971:2019, MDSAP, and 21CFR.

Supplier Quality Management

With our extensive experience evaluating and managing suppliers for multinational organisations, we can conduct your supplier quality audits ensuring the quality of materials and services provided by suppliers meet your standards. .

Do you really need a QMS?

Do you want the benefits of a QMS without the certification?

Allow us help you navigate these fundamentals and set up what your company needs, at this juncture.

We believe in total honesty, and are not afraid to tell you that you might not need our services.

QMS Implementation

Medical Device Registration

We support small to medium enterprises on their journey to medical device registration with the TGA and FDA (510K).

We can facilitate your medical device needs by being the bridge between an offshore manufacturing facility, or your larger parent organisation to set up and support an Australian sales operation with all the correct certifications and registrations.