Management Systems

Management Systems describe Bittium management principles and policies from the point of views of quality (including AQAP and Medical quality), environmental and energy efficiency and security management as well as applied company level process frameworks and methods for continuous improvement. These form altogether the baseline for certifications of the management systems according to related standards.

Overview

Our purpose, vision, culture and values enhanced with our competencies and strategy create the successful path that leads us into the future. See more about Purpose, Vision and Values.

Management and leadership includes development and communication of the mission, vision and values, policy and strategy, plans, objectives and targets to organizations and people to create a culture of Excellence. It also defines interaction with customers, partners and representatives of society and includes methods how the management systems are developed, implemented and continuously improved.

The purpose of our Management System and Processes is to give a clear and up-to-date description of management and process principles of Bittium. This section describes Bittium's management from the point of views of quality, environment, AQAP, medical, safety and security policies as well as basic process framework and methods for continuous improvement.

Bittium has ISO 9001.2015, ISO 14001.2015, EES+ (Energy Efficiency System), AQAP 2110 Revision D and ISO13485.2016 And ISO/IEC 27001:2013 certifications.

CERTIFICATES

Quality Management

Quality Management System (ISO 9001)

Bittium ISO 9001:2015

AQAP-2110 Management - Defense Business

Bittium AQAP-2110

Medical Quality Management (ISO 13485)

Bittium ISO 13485:2016

Environmental Management

Environmental Management System (ISO 14001)

Bittium ISO 14001:2015

Energy Efficiency System (ISO 50001)

Bittium ISO 50001:2011

Security Management

Security Management System (ISO/IEC 27001:2013)

Bittium ISO/IEC 27001:2013

Quality Management System


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 Directive (MDD) 93/42 requirements 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
    • Applicable parts of code of Federal Regulations title 21
    • for Software Life-cycle: IEC62304 SW development applicable lifecycle aspect
    • 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.

Environmental Management System


Environmental and Energy Efficiency Policy


Good Corporate citizenship guides us to implement the sustainable development following ISO14001 standard and includes implementation of:

  • Follow-up of and complying with changes in laws and regulations concerning environmental protection. These include also implementation of energy efficiency principles of in our development (eco-design), as well as our premises (energy efficiency systems).
  • Minimizing the environmental impact of the production, use and disposal of the products we design. These principles are supported by development of design for environment guidelines and practices.
  • Encouraging our suppliers and partners to implement environmental management systems. These principles are supported with implementation of substance restriction principles.
     
     

Implementation of Environmental Policy


Bittium applies ISO 14001 standard for Environmental Management System. On the right is a description of the applicable environmental model:

ISO 14001

ISO 14001 provides a framework for Bittium Environmental Management system and EES completes the energy efficiency target setting and performance.

Evaluation and follow up of Bittium environmental aspects and associated impacts is mainly focusing to:

  • Use of raw materials and natural resources in Bittium products, packages and manufacturing applying up-to-date global regulations 
  • Use of energy and waste management in Bittium premises and products - and personnel awareness of environmental matters
     

Energy Efficiency System

The Energy Efficiency Law (1429/2014) was entered into force on 1st of January 2015. At Bittium Energy Efficiency figures has been part of Environmental Metrics since 2015. Bittium was certified according to ETJ+/EES+ in 2017 and furthermore according to ISO 50001:2011 during 2018.

Security Management

Bittium´s security management system is based on application of ISO/IEC 27000 Information Security Management standard series, various authority requirements, and other essential requirements like set by Bittium´s customers

Security Management Policy

Security Management Policy is a statement by the Bittium Corporation management, which defines information security targets, responsibilities and ways to implement it. It covers the following areas:

  • Security management, organisation and responsibilities at Bittium
  • Information security including data processing security and preparing for exceptional conditions from the point of view of information security
  • Security of real estates and premises including personnel security

Security Policy

Customer relations built on trust - We are committed to keeping information related to customers and all interest groups confidential. These principles are implemented by the following actions:

  • Protecting and properly storing all information files, samples, etc., received from their customers
  • A confidentiality agreement is always signed by new employees. Confidentiality agreements are also made with partners, vendors and trainees.
  • Entry and visits to company and access inside our premises shall be controlled.
  • We shall comply with the laws and statutes on work safety and actively plan, promote and maintain the work safety of their personnel.
  • We encourage our suppliers and partners to implement security policies.

Bittium has adopted a holistic approach to security risk management. It consists of identifying threats and prioritizing them through likelihood and impact based risk estimation, assessing the existing controls to face those threats, and selecting the appropriate responses.