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Compliance & Certification

Certified to the standard your procurement team requires.

Greenwich operates to ISO 13485, the internationally recognised standard for quality management in the design, production and distribution of medical devices, backed by documentation ready for tender and procurement processes.

What ISO 13485 Covers

Four pillars of the standard.

01

Quality Management

A documented system governing every stage of how devices are designed, sourced and supplied.

02

Risk Management

Systematic identification and control of risks associated with medical device safety.

03

Traceability

Full traceability of products through the supply chain, from manufacture to delivery.

04

Continuous Improvement

Regular audits and reviews to maintain and improve quality standards over time.

Verified
Certification Active
Verified Certification

Documentation ready when you need it.

Full compliance documentation is available on request, ready to support tender submissions, procurement audits, or internal review by your quality team.

ISO 13485 Infection Control Focus SA Manufacturing
ISO 13485 CertificateOn Request
Product Spec SheetsOn Request
Quality Manual SummaryOn Request
Tender Compliance PackOn Request
Further Compliance

Beyond device certification.

P

POPIA Compliant

Greenwich handles customer and business data in line with the Protection of Personal Information Act, including how enquiries and quote requests submitted through this site are processed.

Active
B

B-BBEE Status

[[Placeholder — confirm current B-BBEE level and certificate validity with the client. This is a strong differentiator for tender-based buyers if the status is favourable.]]

[[ Level — TBC ]]
Common Questions

What procurement teams usually ask.

Can you provide certification for a specific tender submission?+

Yes. Send through the tender requirements and we'll prepare a compliance pack with the relevant certification and documentation attached.

Is your ISO 13485 certification current?+

[[Placeholder — confirm certificate expiry/renewal date with the client so this can state it precisely rather than generically.]]

Do you undergo regular compliance audits?+

[[Placeholder — confirm audit frequency and most recent audit date with the client.]]

How do I request your B-BBEE certificate?+

Request it directly through the contact form or by calling our office, and we'll send the current certificate along with any supporting documentation.

Need Documentation?

Request our compliance pack for your next tender.