Company

Company

Certifications

A strong inclination towards product quality and service has always been a characteristic of Spencer, leading brand in the world of emergency. Quality that originates in the professionalism of a young and dynamic work force, orientated towards satisfying the new and changing requirements of customers and to the creation of innovative added value projects in both production and promotional areas.

ISO Certified System

As a company operating in the emergency and health field, where easy to use products of high technological value, Spencer has been obliged to rapidly create a structure and business organisation with the highest levels of efficiency and quality. The roots of the company are based on two strategic factors:

  • The certication of our Quality Assurance system (since 1998) in conformity with the ISO 9001 (certificate n° 50 100 6189 issued by TÜV ITALIA ), together with the conformity to the specialist standards relative to medical devices EN ISO 13485 (certificate n° Q1N 15 05 33230 024 issued by TÜV SÜV Product Service GmbH)
  • Research and development for the design and realisation of highly advanced technological devices.

Some of the normative used as reference are briefly outlined in the following table:

  • UNI EN ISO 9001  Quality management system, requirements.
  • EN ISO 13485  Medical devices – Systems for Quality Management – Requirements for the system.
  • UNI ISO 10999 Guide for the elaboration of instruction manuals for quality systems.
  • UNI ISO 2859-1Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
  • UNI ISO 2859-2  Sampling procedures for inspection by attributes. Sampling plans indexed by limiting quality (LQ) for isolated lot inspection.
  • UNI EN ISO 19011 Guidelines for quality and/or environmental management systems auditing.
  • UNI CEI 70015  Supplier - purchaser/customer relations. Questionnaire for data and information collection for supplier's assessment.
  • UNI ISO 10015 Quality management - Guidelines for training.
  • UNI 11097  Quality management – Quality indicators and quality management synoptical tables.

Products certifications

All medical devices manufactured by Spencer are manufactured and CE marked in full conformity with the specifications of the European Directive 93/42/CE and the specific technical norms applicable.

Considering the quantity of technical norms applicable to Spencer Medical devices, the following table underlines the less specific reference norms:

  • UNI CEI EN ISO 14971Standard for risk management of medical devices.
  • UNI EN 980 SGraphical symbols for use in the labelling of medical devices
  • UNI 10893  Instruction manuals - layout and composition.
  • MEDDEV 2.12-1  Guidelines on a Medical Devices Vigilance System.
  • NB-MED/2.5.1/REC5  Technical Documentation (Medical Devices).
  • MEDDEV 2.7.1  Evaluation of clinical data.
  • EK-MED 920/03  Conformity assessment. Auditing of Subcontractors. Certification of OEM Devices.

All certificate have been issued by TÜV SÜD Product Service GmbH.

10G & 20G: Total Safety

Research, projects, prototypes, testing. For years now Spencer has constantly worked to develop new, safe and reliable products which set the standards of quality on the market. As by the specifications for emergency vehicles and their equipment and medical device by the UNI EN 1789:2007 and UNI EN 1865-1 Spencer today offers a wide range of products tested and certified 10G.

But as is our tradition – Spencer looks beyond that. Today we are the only manufacturer in the world able to offer our clients products tested and certified 20G. All components for the 20G products have been designed to offer maximum safety to both patient and rescuer thanks to the use of materials with high technological value in terms of both strength and weight (manganese and aluminium); materials that have renowned tradition in the world of aeronautics.

Safety

As requested by D.Lgs 81/08 which regulates the Health and Safety procedures in work places, Spencer guarantees that all our production centers operate following the correct procedures in order to offer the highest standards of health and safety to personnel, environment and company assets.