Quality Management · ISO 9001:2015
ISO 9001 Consultant, Belgium and the Benelux.
MEDCOR builds, audits and guides ISO 9001:2015 quality management systems through to certification. You work directly with an industrial pharmacist who has set these systems up from the ground up, particularly for medical device distributors, and defended them through certification and recertification audits.
When you need this
You need ISO 9001 when a customer, a tender or a regulator expects a certified quality management system, when you are preparing for your first certification, or when a certificate has lapsed and has to be regained. Companies also engage MEDCOR when a system exists on paper but is not holding up in practice, or when a merger or acquisition has left two ways of working that need to become one.
Regaining a certificate that has been withdrawn usually follows the route of an initial certification, with a Stage 1 and Stage 2 audit by an accredited certification body. The documents and records you already hold remain a valuable starting point, and the real question is how much of the system still stands. That is what the work begins by establishing.
Gap analysis first, then a route to certification
The effort needed depends entirely on what is already in place. Rather than quote blind, MEDCOR starts with a gap analysis and prices the implementation from its findings, so you commit to the build with the scope in front of you.
Gap analysis
A review of your quality documentation and records against every requirement of ISO 9001:2015, clauses 4 to 10, with an on-site look at your processes and interviews with key staff. The result is a written report with the findings set out clause by clause.
Prioritised action plan
A plan that puts the gaps in order of what matters, with an estimate of the effort each one takes and an indicative timeline towards certification. You see the size of the job before you take it on.
Implementation and certification
Building and updating the documentation, embedding the system, running the internal audits and management review, and supporting you through the Stage 1 and Stage 2 certification audits with the certification body.
What this covers
- —A gap analysis against ISO 9001:2015, clauses 4 to 10, with a written report and a prioritised action plan.
- —Building quality management systems from the ground up, or bringing an existing one back into shape.
- —Drafting and updating the quality manual, procedures, work instructions, forms and records.
- —Internal audits, management review and the groundwork a certification audit expects to see.
- —Support through Stage 1 and Stage 2 certification and recertification audits with an accredited certification body.
- —Aligning quality systems after a merger or acquisition, a particular strength for medical device distributors.
MEDCOR's other services
Certifying, recertifying or regaining ISO 9001?
Start with a gap analysis and see the size of the job before you commit. Tell me where your system stands today.
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