Quality and 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 are requested, Spencer has been obliged to rapidly create a structure and business organization 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° Q5 033230 0032 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 2859-1: Sampling 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 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 14971: Standard for risk management of medical devices
  • UNI CEI EN ISO 15223-1:2017: Medical devices - Symbols to be used on the labels of the medical device, in the labeling and in the information that must be supplied - Part 1: General requirements
  • 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

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.

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