Bittium Management Systems

Management Systems describes Bittium management from the point of views of quality, environment, AQAP and medical policies as well as company process framework and methods for continuous improvement.

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Management Systems 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 certifications.

Certificates

Quality Management

Quality Management System (ISO 9001)

Bittium ISO 9001:2015 (pdf, 55.4 kb) »

AQAP-2110 Management - Defense Business

Bittium AQAP-2110 (pdf, 37 kb) »

Medical Quality Management (ISO 13485)

Bittium ISO 13485:2016 (pdf, 28 kb) »

Environmental Management

Environmental Management System (ISO 14001)

Bittium ISO 14001:2015 (pdf, 49.6 kb) »

Energy Efficiency System (EES+ / ETJ+)

Bittium 2014 (EES+) (pdf, 47.5 kb) »

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.

Certificate

Quality Management System (ISO 9001)

Bittium ISO 9001:2015 (pdf, 55.4 kb) »

 

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)".

Certificates

AQAP-2110 Management - Defense Business

Bittium AQAP-2110 (pdf, 37 kb) »

 

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.

Certificate

Medical Quality Management (ISO 13485)

Bittium ISO 13485:2016 (pdf, 28 kb) »

 

Environmental Management System

Environmental 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. Below is a description of the applicable environmental model:

 

Picture; Overview of Environmental Management System

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.

Certificates

Environmental Management System (ISO 14001)

Bittium ISO 14001 2015 (pdf, 49.6 kb) »

 

Energy Efficiency System (EES+/ETJ+)

Bittium 2014 (EES+) (pdf, 47.5 kb) »

 

Environmental metrics

Bittium's environmental performance is monitored continously. The following metrics represent environmental performance as part of Bittium's sustainability metrics.

 

Picture; Environmental metrics overview 2017

 

Picture; Environmental metrics - Waste trend 2017 (Oulu Site)

 

Picture; Environmental metrics - Electricity trend 2017 (Oulu Site)

 

Picture; Waste treatment and recycling (distribution) in Oulu 2017

Real-time Continuous Improvement

Real-Time Transparency Approach

Transparent continuous improvement is Bittium's key success factor exceeding the requirements of quality and environmental standards.

The activities and results of Continuous Improvement are followed in a real-time basis and results oriented dashboards.

Plan - Do - Check - Act -principle is applied at all levels of Bittium:

 

Picture; Plan-Do-Check-Act -principle

Metrics

Net Promoter Score

The Net Promoter Score is calculated based on responses to a single question: How likely is it that you would recommend our company, product or service to a friend or colleague? The Net Promoter Score is calculated by subtracting the percentage of customers who are detractors from the percentage of customers who are promoters.

Bittium Net Promoter Score Trend 2012-2018

 

Picture; Bittium Net Promoter Score Trend 2012 - 2018

Project Satisfaction Survey

Annual development of Customer Satisfaction is reported as part of Management Review. Customer satisfaction is one of the most important drivers on development and continuous improvement.

Bittium Customer Feedback Summary

 

Picture; Bittium Customer Feedback Summary