ARE YOU REALLY READY FOR GMP LICENSING OR ISO ACCREDITATION?
Spent millions on the fit-out, the equipment, the systems — and still not sure you'd pass the audit?
Most therapeutic goods manufacturers don't perform poorly for their GMP licensing or ISO accreditation because of the equipment on the floor. They fail — or get delayed months at their own cost — because of gaps in the systems and processes within the quality management system (QMS): a validation study that's incomplete, a product specification that doesn't address critical parameters, a change control process that was never formalised, a QMS that looks fine on paper but hasn't been tested against how personnel will actually use it or the regulator reviews is.
For pharmaceutical manufacturers, medical device companies pursuing ISO 13485, testing laboratories working toward ISO 17025, and biotechs scaling from R&D into GMP manufacturing, the readiness gap usually isn't visible until an auditor finds it. By then, it's a finding, a delay, or a licence on hold — all avoidable with the right diagnostic at the right time.
The GMP & ISO Accreditation Readiness Scorecard is a free, practical self-assessment built from the same framework QSN uses when assessing new client projects for GMP licensing, ISO 13485, ISO 17025 and ISO 9001 accreditation. It takes a few minutes, and it's designed to surface the gaps that actually stop your progress — not a generic compliance checklist.
What You'll Learn
Whether your QMS meets the core regulatory expectations regulators and accreditation bodies are actually assessing against
Whether your manufacturing and laboratory workflows align with GMP, ISO 13485 or ISO 17025 requirements
How ready your documentation and validation records are for an inspection or a mock audit
Where your facility and equipment qualification sits relative to licensing requirements
What's commonly missing before companies apply for a GMP licence or ISO accreditation — the gaps we see most often in first-time and scaling applicants
A clear next step, whether that's a quick fix, a deeper gap analysis, or a full GMP/ISO readiness engagement
Who This Scorecard Is For
Pharmaceutical manufacturers preparing a first GMP licence application, or expanding an existing licence
Medical device companies working toward ISO 13485 certification
Testing laboratories pursuing ISO 17025 accreditation
Biotechs and R&D-stage companies transitioning from development into GMP-regulated manufacturing facility
Quality, regulatory and operations leads who need an honest, outside read on readiness before committing to an audit date or a licensing submission
Why This Scorecard, Why QSN?
QSN works exclusively in pharmaceutical, medical device and biotech — GMP licensing, ISO accreditation, QMS and PQS development, auditing and audit readiness, and regulatory inspection preparation. The scorecard is built from that experience, not adapted from a generic compliance template.
What Happens After You Complete It?
You'll get a clear picture of where you stand with your readiness— whether that's a small fix you can action yourself, a targeted gap analysis with QSN, or a full readiness program partnering with us ahead of your GMP licensing or ISO accreditation. If you want to engage with us, please book a consulting call with us.
