Areas of Practice
Audits
BQS has built its reputation on strong audit work. Our team have been extensively audited, so we understand both the stress and what is required.
We will conduct detailed, practical reviews of your processes and measure them against your business objectives, certification requirements, regulatory obligations, and operational risks.
Our audits are not box-ticking exercises. They are designed to show you where your system is strong, where it is exposed, and where unnecessary complexity is slowing the business down. We know the difference between the need to have and good to have.
BQS provides internal audit contracting, supplier audit support, and pre-certification audit reviews for businesses that need clear findings, sharp judgement, and confidence before the auditor arrives.
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
BQS 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 Management
BQS helps businesses assess, qualify, and manage suppliers with practical quality controls that match the level of risk.
We conduct supplier audits, review supplier performance, and help ensure purchased materials, components, and services meet your requirements before they affect your product, customer, or compliance position.
A quality management system should support your business, not bury it in paperwork.
BQS helps you put the right processes, controls, and records in place for your current stage — whether you are preparing for certification, improving operations, or simply need a more reliable way to manage quality.
We’ll tell you what you need, what you don’t, and where to start.
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.