Quality & Compliance
Direct supplier statement · To Whom It May Concern
PIK PAK Industries — Letter of Compliance for Toolsmith Ltd
Our supplier PIK PAK Industries (Sialkot, Pakistan) issues a signed letter naming Toolsmith Ltd explicitly — our registered office, Companies House number, and VAT number — confirming we are fully authorised to import, distribute, and sell their products within the UK market. The letter lists every certification PIK PAK holds:
- ISO 9001 — Quality Management System
- ISO 13485 — Quality Management System for Medical Devices
- MDR Compliance for Class I Medical Devices
- EU Authorised Representative (EU REP) — Active and Valid
- REACH Compliance Certificate
Below are the underpinning individual certificates referenced in the supplier letter.
ISO 13485:2016 — Medical Device Quality Management System
The international standard for organisations involved in any stage of the medical-device life-cycle. Our supplier's ISO 13485 certification was issued by LMS Assessments Limited (UK Companies House registered, IAF and EGAC accredited), and covers the manufacturing of non-active surgical and dental instruments including hammers, scalpels, forceps, retractors, rongeurs, drills, reamers, biopsy instruments, dental probes, mirrors, scalers, articulators, trocars and cannulas.
- Certificate number: PK250801003
- Issued: 01 August 2025
- Surveillance audit due: 31 July 2026
- Recertification due: 31 July 2028
- Issuer: LMS Assessments Limited (IAF + EGAC accredited)
Download ISO 13485 certificate (PDF)
EU MDR Authorised Representative
Under EU Medical Device Regulation 2017/745 (MDR), every non-EU manufacturer placing medical devices on the EU market must appoint an EU-based Authorised Representative. PIK PAK Industries has a current MDR Authorised Representative in place for the 2025-2026 period, confirming that products manufactured for our catalogue have a fully documented conformity-assessment route to market.
Download MDR EC Rep documentation (PDF)
ISO 9001 — Quality Management System
The world's most widely-recognised quality-management standard, ensuring consistent manufacturing across our entire range — not only the regulated medical instruments, but also our jewellery-making, watchmaking, beauty, hobby and craft tools.
Download ISO 9001 certificate (PDF)
REACH Directive — Chemical & Material Safety
EU regulation 1907/2006 (REACH) governs the registration, evaluation, authorisation and restriction of chemical substances. Our supplier's REACH declaration confirms that the steel, plating, polymer handles and surface treatments used across our catalogue meet the EU's chemical-safety requirements.
Download REACH compliance declaration (PDF)
UK market
UK Conformity Assessment under the MHRA's extended CE-recognition arrangements continues to recognise EU MDR conformity for medical devices placed on the UK market through to the next regulatory transition window. We monitor MHRA guidance and will move to full UKCA marking as that transition completes.
Questions?
For documentation, procurement, or trade-account enquiries, please contact us. We can supply original certificates, batch traceability and conformity declarations on request to qualifying trade buyers.
