Quality Management System

Quality Management System (ISO 9001)

Bittium ISO 9001:2015

AQAP-2110 Management - Defense Business

Medical Quality Management (ISO 13485)

Bittium ISO 13485:2016

The scope of Bittium Quality management system addresses principles, methods and results related to continuous improvement. Quality Management System has been certified since year 1997. The system has been certified based on ISO 9001.2015 standard since June 2016.

Quality Policy

We are committed as individuals and as a company to follow and apply the values in all our activities:

Our target is achieve customer satisfaction by creating and implementing processes and good practices to achieve, as a result, good product and service quality.
We develop continuously our processes, system and competences to achieve our goals.
Each of us is responsible for the quality of his/her own work and continuous improvement.
We expect our partners to follow these principles as well.

Allied Quality Assurance Publication (AQAP) - Quality Management System

North Atlantic Treaty Organization (NATO) quality assurance requirements for design, development and production are published as AQAP 2110 edition D standard which is used as a base quality requirement for all Defense products and services.

AQAP 2110 emphasizes key focus areas:

Quality and Risk Management
Configuration Management and Traceability
Awareness and Competences
Enhanced evidence requirements of contractual activities and standard compliance fulfilment

AQAP Implementation

First AQAP 2110 ed.3 certificate was granted to Elektrobit Defense business 2011 and it has been maintained since. The updated AQAP 2110 Edition D (version 1) certificate was granted to Bittium Defense business 09/2017.

Bittium fulfils the North Atlantic Treaty Organization (NATO) quality assurance requirements for design, development and production described in Allied Quality Assurance Publication 2110 (AQAP 2110) publication by:

Following defined Bittium Management System and Principles.
Following defined Bittium processes accordingly.
Adding AQAP 2110 required supplements into Quality Management System.
Applying AQAP 2110 requirements in defined operations.
Applying NATO Standardisation Agreement (STANAG) 4107 which describes the “Mutual Acceptance of Government Quality Assurance (GQA) and Usage of the Allied Quality Assurance Publications (AQAPs)".

Medical Quality Management System

Medical Quality Policy

Bittium shall comply with Medical Device Regulation (MDR 2017/745) and ISO 13485 quality management system requirements for design, development and production of medical devices by:

Following defined Bittium Management System and Principles
Following defined Bittium processes accordingly
Following the Medical quality systems related standards and regulations:
- for Risk Management; apply ISO 13485 and ISO 14971 requirements for Quality Management System described in documentation
- Medical Device Single Audit Program (MDSAP)
- for Software Life-cycle: IEC62304 SW development applicable life-cycle aspects
- for Usability engineering: IEC62366 requirements for usability engineering process
- for Safety; following EN/IEC/ANSI AAMI required (IEC60601 series) and applicable clauses according to intended purpose and use

ISO 13485:2016

ISO 13485:2016 emphasizes key focus areas:

Quality and Risk Management
Awareness and Competences
Design and Development traceability
Safety and Reliability
EU Medical Device Directive MDD 93/42 requirements

ISO 13485:2016 certificate was granted to Bittium Medical Design and Development activities 09/2017

Medical Quality management system is based on standards ISO 13485:2016 and ISO 9001:2015, FDA Quality System Regulations and Japan QMS Ordinance 169. Medical quality management system covers all operations and personnel levels who are working with medical technologies related products, services or solutions.