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- 1. © Bittium 2021 | Public 004QW4554
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SupplierManual
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Version 3.0.0 © Bittium 2021
Published by
Bittium Wireless Ltd.
Ritaharjuntie 1
90590 Oulu
Finland
Phone: +358 40 344 2000
www.bittium.com
Legal Notice
Copyright 2021 Bittium. All rights reserved. The information contained herein is subject to change without
notice. Bittium retains ownership of and all other rights to the material expressed in this document. Any
reproduction of the content of this document without prior written permission from Bittium is prohibited.
Notice
Bittium reserves the right to change its products and the information in this document without notice due
to continuous improvement and development. Bittium makes no warranty of any kind with regard to this
material, including, but not limited to, the implied warranties of merchantability or fitness for a particular
purpose. Bittium shall not be liable for errors contained herein or for damages in connection with the fur-
nishing, performance, or use of this material.
Summary of Changes
Version Date Changes Between Releases Status
1.0.0 2019.10.24 Approved
2.0.0 2020.03.12 Links updated, figures 1-3 updated. Approved
3.0.0 2021.04.23 Duplicate removed from chapter 1 and updates in chapter 10. Approved
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Version 3.0.0 © Bittium 2021
Table of Contents
1 INTRODUCTION TO BITTIUM SUPPLIER MANUAL....................................................................................... 7
2 BITTIUM POLICIES........................................................................................................................................ 8
2.1 Bittium Quality Policy ........................................................................................................................ 8
2.2 Bittium Medical Quality Policy .......................................................................................................... 8
2.3 Bittium Defense Quality Policy.......................................................................................................... 8
2.3.1 Allied Quality Assurance Publication (AQAP) ................................................................................ 8
2.4 Bittium counterfeit material avoidance ............................................................................................ 9
2.5 Environmental and Energy Efficiency Policy...................................................................................... 9
2.6 Bittium halogen-free statement........................................................................................................ 9
2.7 Bittium anti-corruption statement.................................................................................................. 10
2.8 Bittium Security Management Policy.............................................................................................. 10
2.9 Bittium statement of conflict minerals............................................................................................ 10
3 BITTIUM SUPPLIER SELECTION AND APPROVAL ....................................................................................... 11
3.1 Bittium supplier selection, qualification and approval.................................................................... 11
3.2 About Bittium supplier quality management system requirements............................................... 13
3.3 Fulfillment of requirements in Bittium supplier assessment .......................................................... 13
4 SUPPLIER QUALITY MANAGEMENT SYSTEM REQUIREMENTS.................................................................. 14
4.1 Common requirements ................................................................................................................... 14
4.1.1 Business vision and strategy........................................................................................................ 14
4.1.2 Key performance indicators ........................................................................................................ 14
4.1.3 Customer satisfaction program................................................................................................... 14
4.1.4 Personnel competence and training ........................................................................................... 14
4.1.5 Continuous improvement............................................................................................................ 14
4.1.6 Facilities and utilities ................................................................................................................... 14
4.1.7 Ethical considerations.................................................................................................................. 14
4.2 Quality requirements ...................................................................................................................... 15
4.2.1 Quality management system....................................................................................................... 15
4.2.2 Supplier manual........................................................................................................................... 15
4.2.3 Document information................................................................................................................ 15
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4.2.4 Quality records ............................................................................................................................ 15
4.2.5 Quality plan.................................................................................................................................. 15
4.2.6 Internal quality audits.................................................................................................................. 15
4.2.7 Corrective and preventive actions............................................................................................... 15
4.2.8 Metrics......................................................................................................................................... 16
4.3 Risk management requirements ..................................................................................................... 16
4.3.1 Risk management system............................................................................................................ 16
4.3.2 Occupational safety..................................................................................................................... 16
4.3.3 Security procedure(s) .................................................................................................................. 16
4.3.4 Access control.............................................................................................................................. 17
4.3.5 Confidentiality agreement........................................................................................................... 17
4.3.6 Document and data safety .......................................................................................................... 17
4.3.7 Information and communication infrastructure and security..................................................... 17
4.3.8 Product liability............................................................................................................................ 17
4.3.9 Business continuity plan.............................................................................................................. 17
5 ENVIRONMENTAL REQUIREMENTS........................................................................................................... 18
5.1 Environmental policy....................................................................................................................... 18
5.2 Environmental management system............................................................................................... 18
5.3 Design for Environment, DfE ........................................................................................................... 18
5.4 Raw material content...................................................................................................................... 18
5.5 Legal compliance ............................................................................................................................. 18
5.6 Programs for improving environmental performance.................................................................... 19
5.6.1 Competence, training and awareness......................................................................................... 19
5.7 Emergency preparedness and response ......................................................................................... 19
5.8 Suppliers' environmental performance........................................................................................... 19
6 CONTRACT REVIEW REQUIREMENTS ........................................................................................................ 20
6.1 Contract review system................................................................................................................... 20
6.2 Business contacts............................................................................................................................. 20
6.3 Third party IPR policy....................................................................................................................... 20
6.4 Software and tools licensing............................................................................................................ 20
6.5 Design requirements ....................................................................................................................... 20
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6.6 Configuration management ............................................................................................................ 20
6.7 Change management and traceability ............................................................................................ 20
6.8 Development tools and software.................................................................................................... 21
6.9 Design reviews................................................................................................................................. 21
7 PROCESS REQUIREMENTS ......................................................................................................................... 22
7.1 Process flow..................................................................................................................................... 22
7.2 Project planning and management ................................................................................................. 22
7.3 Process and material quality assurance .......................................................................................... 22
7.4 Work instructions ............................................................................................................................ 22
7.5 Tool management and control........................................................................................................ 22
7.6 Statistical methods and techniques ................................................................................................ 22
7.7 Process capability ............................................................................................................................ 23
7.8 Failure analysis ................................................................................................................................ 23
7.9 Supply requirements ....................................................................................................................... 23
7.9.1 Forecasting process ..................................................................................................................... 23
7.9.2 Supply process............................................................................................................................. 23
7.9.3 Demand /supply chain performance and improvement plans ................................................... 23
7.9.4 Supplier and subcontractor selection.......................................................................................... 23
7.9.5 Supplier and subcontractor control............................................................................................. 23
7.9.6 Supply document management .................................................................................................. 23
7.9.7 Bittium supplied product control ................................................................................................ 24
7.10 Material control requirements........................................................................................................ 24
7.10.1 Incoming material verification..................................................................................................... 24
7.10.2 Material release for production .................................................................................................. 24
7.10.3 Material handling and storage .................................................................................................... 24
7.10.4 Inventory control......................................................................................................................... 24
7.10.5 Shelf life control........................................................................................................................... 24
7.11 Verification and validation requirements........................................................................................ 24
7.11.1 Inspection and test flow .............................................................................................................. 24
7.11.2 Environmental/Off-Line testing................................................................................................... 25
7.11.3 Releases for delivery.................................................................................................................... 25
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7.11.4 Inspection and test equipment ................................................................................................... 25
7.11.5 Inspection and test records......................................................................................................... 25
7.11.6 Control of non-conforming products .......................................................................................... 25
7.11.7 Product identification and traceability........................................................................................ 25
7.11.8 Product handling, storage, packing and delivery ........................................................................ 25
7.12 EOL................................................................................................................................................... 26
7.13 Physical security .............................................................................................................................. 26
7.14 Manufacturing................................................................................................................................. 26
8 SUPPLIER QUALITY ASSURANCE PLANNING.............................................................................................. 27
8.1 Generic ............................................................................................................................................ 27
8.2 Design for Manufacturing (DFM)..................................................................................................... 27
8.3 Design verification and validation................................................................................................... 27
8.4 Process verification and validation.................................................................................................. 27
8.5 Production part approval ................................................................................................................ 27
9 MATERIAL COMPLIANCE ........................................................................................................................... 28
10 TRADE COMPLIANCE ....................................................................................................................... 29
11 BITTIUM GENERAL TERMS AND CONDITIONS FOR PURCHACE OF GOODS .................................... 30
12 SUPPLIER RECLAMATIONS............................................................................................................... 31
13 DEFINITIONS, ABBREVIATIONS........................................................................................................ 32
References....................................................................................................................................................... 34
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Version 3.0.0 © Bittium 2021
1 INTRODUCTION TO BITTIUM SUPPLIER MANUAL
Bittium Supplier Quality Manual is a publicly available summary of the core requirements Bittium has for its
suppliers. These requirements will be applied to both new and existing suppliers alike.
The term Supplier is used in this document as a general term meaning all kinds of external organizations
providing products, services etc. to Bittium.
Figure 1 The origin of Bittium requirements is in Bittium QMS
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2 BITTIUM POLICIES
2.1 Bittium 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 prac-
tices to achieve, good product and service quality
• We continuously develop 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.
Latest Bittium Quality Policy can be found via: [1]
2.2 Bittium Medical Quality Policy
Bittium shall comply with Medical Device Directive (MDD) and EU 2017/745 (MDR) requirements and ISO
13485 quality management system requirements for design, development and production of medical de-
vices by:
• Following defined Bittium Management System and Principles
• Following defined Bittium processes accordingly
• Following the Medical quality systems-related standards and regulations:
o For Risk Management; apply ISO 13485 and ISO 14971 requirements for Quality Manage-
ment System described in documentation
o Applicable parts of code of Federal Regulations title 21
o For Software Lifecycle: IEC62304 SW development applicable lifecycle aspect
o For Safety; following EN/IEC/ANSI AAMI required (IEC60601 series) and applicable clauses
according to intended purpose and use.
Latest Bittium Medical Quality Policy can be found via: [2]
2.3 Bittium Defense Quality Policy
2.3.1 Allied Quality Assurance Publication (AQAP)
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 fulfillment.
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Latest Bittium AQAP Policy can be found via:[3]
2.4 Bittium counterfeit material avoidance
Counterfeit materials are any materials in relation to which the origin, age, consistency, configuration, cer-
tification status or other feature is presented falsely and with misleading markings on the material, packag-
ing or container.
Bittium is aware of the risks associated with counterfeit materials, both in the purchase of components and
the use of reported ingredients for components.
Bittium is committed to taking the necessary steps to avoid using counterfeit materials in its products. Bit-
tium has developed procedures for avoiding counterfeit materials. The procedures address different stages
of the procurement process, starting from the selection of suppliers. Suppliers are required to report im-
mediately on any known or suspected uses of counterfeit components or materials. Bittium provides train-
ing on the detection of counterfeit materials to its employees.
Latest Bittium counterfeit avoidance statement can be found via: [4]
2.5 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 protec-
tion. These include also the 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 de-
sign. These principles are supported by the development of design for environment guidelines and
practices.
• Encouraging our suppliers and partners to implement environmental management systems. These
principles are supported with the implementation of substance restriction principles.
Latest Bittium Environmental and energy efficiency policy can be found via: [5]
2.6 Bittium halogen-free statement
Bittium´s Halogen-Free Statement conforms to the IEC (International Electrochemical Commission) defini-
tion of halogen-free materials (IEC 61249-2-21).
In accordance with its environmental policy, Bittium is committed to minimizing the environmental impacts
of the production, use and disposal of products.
Halogen is typically used as a flame-retardant in plastics. However, using products that contain halogen is
problematic for the environment, because they may release dioxins and furans into the atmosphere if they
are incinerated at the end of their lifecycle.
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Although the use of halogens is not yet forbidden in electronics, Bittium tries to minimize the use of halo-
gens in its products in order to meet the growing demand in the field and reduce its own environmental
impact.
2.7 Bittium anti-corruption statement
Corruption is a key risk in the areas of social responsibility and human rights. Bittium operates in markets
and business areas where it needs to pay special attention to anti-corruption measures.
Bittium understands that bribery and corruption violate justified business benefits. All business must be
honest and ethical, and company does not accept any forms of bribery or corruption in its own operations
or the operations of its subcontractors.
Bittium is committed to meeting its statutory obligations and preventing, identifying and removing cor-
rupted practices and cooperating with others to prevent bribery and corruption. For this reason, Bittium
also expects its suppliers and other external partners to take the necessary anti-bribery and anti-corruption
measures. Bittium has both internal and external anti-corruption guidelines. The guidelines are covered by
the Bittium employee training program, and the group expects its partners to follow them.
Bittium offers an internal channel to its employees for reporting any breaches of the anti-corruption rules.
Latest Bittium anti-corruption statement can be found via: [6]
2.8 Bittium Security Management Policy
Security Management Policy is a statement by the Bittium Corporation management, which defines infor-
mation security targets, responsibilities and ways to implement it. It covers the following areas:
• Security management, organization 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
Latest Bittium Security Management Policy can be found via: [7]
2.9 Bittium statement of conflict minerals
Bittium products are composed of different electronic and mechanical components. Conflict minerals laws
and encouraged reporting practices are verified with suppliers according to Bittium Material Declaration
process. Bittium is committed to working towards ensuring that the minerals used in our products do not
originate from the conflict-affected and high-risk areas, notably DRC or neighboring countries.
Latest Bittium Statement of Conflict Minerals can be found via: [8]
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3 BITTIUM SUPPLIER SELECTION AND APPROVAL
3.1 Bittium supplier selection, qualification and approval
Bittium supplier selection targets to find the most suitable candidates for Bittium businesses in regards of
access to technologies, suitable volumes, pricing level, quality, location and support capability. Not forget-
ting the compliance to Bittium core policies and ways of working that we must ensure through the supply
chain.
First step is investigation phase where potential candidates are identified and contacted. One of the first
actions before starting any evaluations is to agree on mutual non-disclosure of confidential information
shared during the following steps. During investigation also first quotations will take place and if candidate
profile is matching for Bittium need, the actual qualification steps are planned.
Second step is supplier qualification. One of the first actions here is sharing the basic supplier requirements
and asking for supplier self-assessment against these requirements. If seen necessary, supplier audit is
planned and performed. Also during supplier qualification other necessary checks and validation steps are
taken to ensure the operational, technical and commercial suitability of the supplier for Bittium business.
Risks are also assessed based on the intelligence gathered during the qualification phase. For approved
suppliers qualification phase is typically finalized with business agreement (General Purchase Agreement),
which enables Bittium to start business with supplier under agreed terms.
Third step is all about running the daily businesses and managing the supplier base. Supplier performance
in current projects and suitability for new Bittium ventures are continuously under evaluation. Risks are
continuously monitored and managed. Bittium and suppliers will develop joint capabilities, relationship and
build the base for successful continuation of the business relationship. Bittium does not have any automatic
regular audit program for suppliers, but whenever there are significant changes in Bittium need, supplier
offer, capabilities, risks or performance, an audit can be performed. Also when due to criticality it is seen
necessary, a regular audit routine can be agreed.
Last step in Bittium supplier selection, qualification and approval process is phase out. Whenever Bittium
sees that it is not sensible to carry on business with a given supplier anymore, the supplier will be phased
out. This will be a planned procedure where supplier is duly notified, last time buys are planned and exe-
cuted, Bittium systems are updated and supplier phase out communicated.
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3.2 About Bittium supplier quality management system requirements
Bittium supplier Quality Management System (QMS) requirements are defined in sections each of which
contains a number of detailed requirement elements. Some of these requirements may not be applicable
to all suppliers and/or product areas and as such can be left out from the scope of the assessment. Bittium
will identify such re-scoping of requirements during self-assessment/audit procedure. This document gives
guidelines to suppliers and specified requirements, supplier-specific agreements may define addition-
al/more definite requirements or omissions thereof.
Applicable elements also refer to the Supplier’s main subcontractors in the area of design, manufacturing,
testing, etc. The Supplier’s conformance to these requirements is verified by means of Supplier surveys,
requested self-assessments, and audits done by Bittium or third party.
3.3 Fulfillment of requirements in Bittium supplier assessment
For a Supplier to pass Bittium Supplier Assessment the requirements given in each applicable element shall
be adequately fulfilled, in which case an “accepted” result is given; otherwise the result is “not accepted”.
In the case of “not accepted” result Bittium may request either clarification to the information shared
about fulfilment of the requirements or a plan how supplier will correct the critical findings. Supplier has to
provide, within 30 calendar days, depending on Bittium request either requested clarifications or an action
plan and, having implemented the actions, submit action report. Sometimes an action report may be a suf-
ficient proof of the implementation of the actions; otherwise, a partial on-site corrective action verification
assessment or other similar evidence may be required.
Bittium will inform the Supplier in writing about any assessment result changes (such as Bittium response
to action plan or action report and possibly resulting non-conformance removal).
After an acceptable result in Supplier Assessment, Bittium expects the Supplier to inform about significant
changes in any Requirement Section area.
Also the financial analysis is a part of Bittium supplier assessments; suppliers are expected to support these
assessments by providing consolidated and audited financial statements (profit and loss statement, balance
sheet, cash flow statement and notes) of preceding two full years when requested. For stock exchange
listed companies quarterly reports are required.
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4 SUPPLIER QUALITY MANAGEMENT SYSTEM REQUIREMENTS
4.1 Common requirements
4.1.1 Business vision and strategy
The Supplier shall have a clear business vision and strategy with regard to further development of the com-
pany, understanding its current status and vision as to where it would like to be in the future. Company
policies (quality, environmental, security, risk management) and objectives / targets (e.g. key performance
indicators) shall be existing and communicated throughout the organization.
4.1.2 Key performance indicators
The Supplier shall apply key performance indicators (KPIs) that are derived from appropriate strategic goals
covering relevant business expectations.
4.1.3 Customer satisfaction program
The Supplier shall have an active customer satisfaction program based on delivery performance, customer
ratings, customer surveys and interviews, etc. Customer feedback and identified corrective actions shall be
processed, analyzed and resolved as an important driving force for continuous improvement. The Supplier
shall also be able to provide evidence of implementation.
4.1.4 Personnel competence and training
The Supplier shall ensure that employees have the required education, training and competence for their
position and tasks. Management shall hold periodic appraisals of personnel competence and training re-
quirements and prepare training plans. During these appraisals the organization’s strategic goals and relat-
ed competence development needs shall be taken into account.
4.1.5 Continuous improvement
The Supplier shall have ongoing performance improvement programs based on strategy elements, key per-
formance indicators, quality and environmental objectives, customer satisfaction program and so on. At
suitable intervals, management shall review the status of these programs and take necessary actions.
4.1.6 Facilities and utilities
The Supplier’s incoming, design, manufacturing, testing, packing, shipping and storage facilities shall be
capable of handling production volumes required by Bittium or via EMS partners. The Supplier’s facilities,
areas and tools shall be clean and orderly and covered by regular housekeeping.
4.1.7 Ethical considerations
The Supplier shall be committed to ethical conduct, full compliance to applicable national and international
laws and respect for human rights in the spirit of internationally recognized ethical standards, e.g. SA8000.
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4.2 Quality requirements
4.2.1 Quality management system
The Supplier shall have an up-to-date, documented quality management system to ensure effective plan-
ning, management and control of quality. The quality management system shall be communicated, under-
stood and implemented at all levels within the organization. This quality management system shall satisfy
the requirements of the ISO 9001, AQAP2110, ISO13485 or other internationally recognized standard of the
business area. A description of the supplier’s quality management system documents and their hierarchy
shall be available to illustrate the structure of the system.
4.2.2 Supplier manual
The supplier shall describe quality management system preferably in a plant/site or corporate quality doc-
umentation (information or manual) giving a sufficiently detailed overview of its quality management sys-
tem. Quality responsibilities shall be clearly defined, with reference made to important higher corporate
and/or lower level documents.
4.2.3 Document information
The Supplier shall have a document management system to file, check, approve, release, distribute and
delete quality system documents and data throughout the organization.
4.2.4 Quality records
The Supplier shall define internal and external quality records. The supplier shall define responsibilities to
collect, store, maintain and dispose of such records. These records shall cover both quality management
system elements such as reviews, audits, meetings, etc., as well as material and product related tests and
inspection data. Agreed quality records shall be available to Bittium upon request. Quality records must be
kept for four years, if not separately agreed to be longer than that.
4.2.5 Quality plan
The supplier shall perform product or project-specific quality assurance activities in accordance with docu-
mented procedures and/or quality plans. Quality plans as required for Bittium-specific deliverables, com-
ponents and R&D projects are subject to mutual approval.
4.2.6 Internal quality audits
The supplier shall perform internal quality audits using qualified auditors in accordance with documented
procedures and active plans. The supplier shall review audit results, plan corrective actions and perform
follow-up verification of corrective actions effectiveness.
4.2.7 Corrective and preventive actions
The supplier shall have a documented corrective and preventive action system with input coming from
various sources such as design reviews, audits, incoming inspections, in-process monitors, product qualifi-
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cations and tests, customer complaints, field failures, etc. Output shall be in the form of corrective and
preventive actions, whose effectiveness the supplier shall verify.
4.2.8 Metrics
The supplier shall have appropriate metrics at relevant phases of the processes that facilitate performance
management and control of the processes. Metrics shall be linked to key performance indicators derived
from strategy. Agreed metrics shall be available to Bittium upon request.
4.3 Risk management requirements
4.3.1 Risk management system
The supplier shall have an up-to-date documented risk management system to ensure effective identifica-
tion, analysis, control and monitoring of associated risks, including timely preventive actions for risk mitiga-
tion. The risk management system scope shall cover business opportunity, uncertainty and hazard-based
risks. The approach shall include risk categories such as strategic, financial, operational, commercial, tech-
nical, quality and schedule as well as external categories such as location, natural hazards, export control
and product liability. The supplier shall also be able to provide evidence of implementation.
Risk management system shall be defined including risk identification, mitigation and control measures for
both company level and project level actions. Emergency procedure(s)
The supplier shall have a documented and implemented emergency procedure(s) including an evacuation
and rescue plan. Periodic evacuation and rescue drills shall be arranged and the results of such exercises
recorded. The supplier shall take necessary steps to prevent and detect emergency incidents by means of
fire and smoke alarm systems, sprinklers, etc. applicable personnel, e.g. in the form of emergency response
teams shall be trained to deal with emergencies.
4.3.2 Occupational safety
The supplier shall take occupational safety precautions throughout the organization for dealing with haz-
ardous materials, noise, powered-up equipment, etc. by means of safety instructions and appropriate safe-
ty devices; protective clothing, hearing protectors, etc. The supplier shall ensure that the organization
complies with all relevant safety regulations. Evidence of such compliance shall be available when request-
ed.
4.3.3 Security procedure(s)
The supplier shall have a documented and implemented security procedure(s) covering buildings, employ-
ees, documents and data systems. The supplier shall be able to provide evidence of the effectiveness of the
procedure(s).
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4.3.4 Access control
The supplier shall have access control by means of controlled keys, key cards, code locks, etc. to areas
where new developments are taking place or where Bittium confidential information is stored. Personnel in
these areas should wear ID-cards.
4.3.5 Confidentiality agreement
All supplier employees are subject to the provisions of a Non-Disclosure Agreement / Confidentiality
Agreement, either separately or as a part of the work contract. Employees shall be aware of the meaning of
the agreement in practice.
4.3.6 Document and data safety
The supplier shall have a system such as fireproof cabinets for documents, computer virus scan provisions,
electronic files backup, which shall be stored in a separate building. The supplier shall take actions to pre-
vent breaches of security including the integrity of documents and data systems by providing lockable doc-
ument cabinets, computer user Id’s and passwords, “firewalls”, etc.
4.3.7 Information and communication infrastructure and security
Workstations and servers connected to Bittium infrastructure have to comply with Bittium security and
network architecture requirements. Similar requirements may apply when supplier is storing sensitive Bit-
tium material in their systems or premises. Bittium shall have the right to assess supplier’s infrastructure,
equipment and premises to verify this compliance.
4.3.8 Product liability
The supplier shall have a documented product liability procedure including the recall process. The supplier
shall take necessary steps to protect against future product liability actions. Non-hazardous and safe mate-
rials and components shall be used in products and their approval obtained from applicable authorities
(e.g. CE, UL). The supplier shall have world-wide liability insurance for finished components and products.
4.3.9 Business continuity plan
The supplier shall have a documented business continuity plan. The plan shall establish the procedures and
responsibilities to be used by the management to guarantee business operations continuity and customer
service following an interruption event.
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5 ENVIRONMENTAL REQUIREMENTS
5.1 Environmental policy
The supplier shall have an up-to-date, documented environmental policy including commitment to envi-
ronmental protection, prevention of pollution, compliance with environmental legislation and continual
improvement. The policy shall be effectively communicated to and understood at all levels within / working
for the organization. The supplier shall also be able to provide evidence of implementation.
5.2 Environmental management system
The supplier shall have a documented environmental management system to identify significant environ-
mental aspects of its activities, products and services and shall ensure that these aspects are taken into
account in establishing, implementing and maintaining its environmental management system. This envi-
ronmental management system shall satisfy the requirements of ISO 14001 or other internationally recog-
nized standard. Continuous improvement efforts shall be addressed within the environmental management
system.
5.3 Design for Environment, DfE
The supplier shall consider environmental aspects in all phases of product development, e.g. with specific
Design for Environment tools or defined checklists. Choices made during this phase shall reduce or elimi-
nate negative impacts on the environment. All reasonable attempts should be made to use pro-
environmental materials/components (use of renewable natural resources, no hazardous substances,
harmless manufacturing process, SW fortification). Supplier shall also aim to material efficiency (minimum
size, minimum variety of materials, maximized recycling/reusing/recovery), energy efficiency (low pow-
er/voltage components, automatic power down etc), remote management (self-diagnosis, upgradeability,
configurability, controlling, dynamic memory), extended product life time (modularity, upgradeability,
downward compatibility, parameterization, dynamic configuration, reliability), reduce impact on landscape,
avoid over-design, enable recovery and recycling (reuse of the materials from a used product, minimum
number of different materials, material identifications, easy to dismantle, material compatibility) and envi-
ronmental life-cycle thinking.
5.4 Raw material content
Supplier is responsible to ensure that all Bittium-related raw materials and data are compliant to relevant
environmental legislation and compliance evidence according to EU RoHS and EU REACH and relevant mar-
ket specific regulations. The data shall be delivered to Bittium upon request.
5.5 Legal compliance
The supplier shall identify national and international environmental legislation applicable to its operation
and products supplied to Bittium and ensure compliance. Evidence of compliance shall be available to Bit-
tium upon request.
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5.6 Programs for improving environmental performance
The supplier shall identify significant environmental impacts associated with its activities, products and
services and implement continuous improvement programs to address them. These programs shall cover
the efficient recycling and/or disposal of waste materials and improving treatment and control of waste
emissions affecting air, water and soil. The supplier shall be able to provide supporting evidence.
5.6.1 Competence, training and awareness
The supplier shall ensure that any persons performing tasks for it or on its behalf that have the potential to
cause significant environmental impacts are competent on the basis of appropriate education, training or
experience, and retain associated records
5.7 Emergency preparedness and response
The supplier shall respond to actual emergency situations and accidents and prevent or mitigate associated
adverse environmental impacts.
5.8 Suppliers' environmental performance
The supplier shall evaluate its subcontractors' and suppliers’ performance and set necessary environmental
improvement targets. If a subcontractor is used for waste disposal the supplier shall determine if that sub-
contractor is correctly authorized and licensed through on-site inspection or third party certification.
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6 CONTRACT REVIEW REQUIREMENTS
6.1 Contract review system
The supplier shall have a formal contract review system in place to convert customer’s requirements into
supplier internal requirements with respect to requests for quotation, purchase agreements, purchase or-
ders, internal plans and specifications etc. The supplier shall be able to provide evidence of the use of the
contract review system.
6.2 Business contacts
The supplier shall nominate contact person(s) such as contract contact person to handle business opera-
tions between Bittium and the supplier. When required, a list of nominated contacts shall be provided.
6.3 Third party IPR policy
The supplier shall have a 3rd Party Intellectual Property Rights (IPR) policy. In line with the policy the sup-
plier shall have principles and methods for ensuring that no 3rd party Intellectual Property Rights are in-
cluded in any deliverables to Bittium without the right to do so.
6.4 Software and tools licensing
The supplier shall be able to provide evidence of having the right to use and/or sublicense all software and
tools needed for delivery to Bittium. Inclusion of 3rd party IPR in software deliveries to Bittium has to be
accepted by Bittium in writing. This requirement also covers all freely available (Open source, Freeware,
Public Domain etc.) software, if it has any obligations that may prohibit its intended use.
6.5 Design requirements
The following clauses define the highlighted requirements for Bittium design suppliers and partners. Bit-
tium utilizes process framework for development and design activities, which is having influences among
others methods and frameworks like APQC process framework, CMMI, Agile and Lean methods and rele-
vant requirements adapted from ISO9001, relevant AQAP (North Atlantic Treaty Organization - Allied Quali-
ty Assurance Publication ) publications and ISO13485 standards.
6.6 Configuration management
The supplier shall have version control and configuration management systems for designs, products and
product data, and version change documents shall be available as a quality record.
6.7 Change management and traceability
The supplier shall have appropriate practices to reliably manage and track changes in requirements and
project, product or solution data. These practices shall include documentation and versioning of the result-
ing changes in engineering and management plans and activities as appropriate to the nature of the work.
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The supplier shall notify Bittium of design changes and modifications made after the product has been ap-
proved. Change histories shall be available as a quality record.
6.8 Development tools and software
The supplier shall validate all development and design tools and software such as those used in Computer
Aided Design (CAD), including new versions and controls them in accordance with documented procedures.
The tools used in software development shall be jointly agreed and recorded for each project, and this in-
formation shall be part of each release/delivery to Bittium, when required.
6.9 Design reviews
The supplier shall conduct formal design reviews in order to systematically review the product develop-
ment and data at certain milestones. Minutes of the reviews and related data, such as criteria used and
action points raised in reviews shall be available as a quality record.
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7 PROCESS REQUIREMENTS
7.1 Process flow
The supplier shall have documented processes to ensure effective planning, operation and control of the
process. Any part of the process that is subcontracted or outsourced shall be indicated. The supplier shall
also have defined process metrics at appropriate stages of the process in order to keep the processes under
control. Process operators shall have access to the control data and instructions for action in out-of-control
situations. Interfacing to Bittium should be defined, organized and monitored. Also the necessary contact
personnel for project management, technical execution and testing shall be identified.
7.2 Project planning and management
The supplier shall have project planning practices ensuring fact-based estimation of work effort, competent
resourcing and scheduling. The supplier shall also have project monitoring and controlling practices ensur-
ing proper management visibility to project status and progress. The supplier shall also have a system for
notifying Bittium of potential schedule delays.
7.3 Process and material quality assurance
The supplier’s process and materials as well as their changes shall be qualified and approved internally ac-
cording to documented quality assurance procedures, and changes communicated to Bittium before im-
plementation, as mutually agreed.
7.4 Work instructions
The supplier shall have work instructions, including criteria of workmanship, illustrations and representa-
tive samples, available for all critical process steps at the place of operation.
7.5 Tool management and control
The supplier’s process equipment shall be under Preventive Maintenance (PM) in accordance with appro-
priate plans, instructions and check sheets. Equipment software versions, where applicable, shall be con-
trolled.
The supplier shall inspect, maintain and store tools, jigs, fixtures, masks etc., where applicable, according to
documented procedures in order to detect and prevent deterioration.
7.6 Statistical methods and techniques
The supplier should use applicable statistical methods and techniques such as control charts, distributions
and trend plots to analyze process data for continuous improvement of the operations.
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7.7 Process capability
The supplier shall have a system for measuring process capability such as Cpk indexes on all defined critical
process and equipment parameters. Cpk data shall be available as a quality record and used for continuous
process improvement.
7.8 Failure analysis
The supplier shall have the capability to analyze failures and defective materials and products according to
documented procedures. The analysis results shall be available as a quality record.
7.9 Supply requirements
7.9.1 Forecasting process
The supplier shall have a forecasting process including receiving of forecast, production planning and con-
firmation of forecast. Subcontractors, EMS and suppliers shall be included in this process.
7.9.2 Supply process
The supplier shall have a supply process, covering all phases from receiving and confirming orders to prod-
uct delivery or replenishment. The supplier shall also specify associated lead-times for the major steps of
the whole demand/supply chain.
7.9.3 Demand /supply chain performance and improvement plans
The supplier shall have documented procedures for measuring and monitoring internal and external de-
mand/supply chain performance and have active performance improvement plans. The supplier shall also
have a system for notifying Bittium of potential short and longer-term delivery problems, e.g. capacity
shortages or delivery delays.
7.9.4 Supplier and subcontractor selection
The supplier shall select its suppliers and subcontractors according to documented procedures for identify-
ing and evaluating potential suppliers of products as well as for selecting the suppliers. When appropriate,
a second source policy shall be applied. The supplier’s own suppliers are subject to the provisions of a Non-
Disclosure Agreement (NDA).
7.9.5 Supplier and subcontractor control
The supplier shall continuously monitor its suppliers’ performance by key indicators. The supplier shall have
a system to make complaints and claims against its suppliers and a method for requesting corrective and
preventive actions.
7.9.6 Supply document management
The supplier shall have appropriate supply document management system ensuring that all applicable re-
quirements and contractual obligations from Bittium are transferred to the suppliers.
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The supplier’s purchasing documents shall include all information necessary to define materials, products
or R&D work to be ordered. This information includes details such as item name, specification, revision
level, quantity, delivery time, price and transportation.
7.9.7 Bittium supplied product control
The supplier shall have a procedure to control materials or products supplied by Bittium, which are incor-
porated into the final product.
7.10 Material control requirements
7.10.1 Incoming material verification
The supplier shall verify incoming materials used for production for conformance to relevant specifications.
Such verification consists of incoming inspection reports, certificates of conformance, certificates of analy-
sis, etc., which shall be available as a quality record.
7.10.2 Material release for production
The supplier shall have an operation that releases material for production and positively identifies it by
means of stickers, labels, lot number control, dispatch control, etc.
7.10.3 Material handling and storage
The supplier shall have written instructions for material handling and storage in order to prevent material
deterioration and safety hazards, and to maintain controlled storage conditions, if applicable.
7.10.4 Inventory control
The supplier’s material inventories shall only contain material of “Released for Production” status and shall
be clearly identifiable. Material usage shall follow the first-in first-out principle.
7.10.5 Shelf life control
The supplier shall define materials that have a limited shelf life and/or special storage requirements and
strictly follow their expiry dates. Concessions shall be approved by Bittium.
7.11 Verification and validation requirements
The supplier shall verify, qualify and validate all products delivered to Bittium, unless specifically otherwise
agreed in contract.
7.11.1 Inspection and test flow
The supplier shall perform all inspection and testing operations according to documented inspection and
test flow charts with reference made to relevant documented procedures and test plans. Any part of the
inspection and test that is subcontracted shall be indicated.
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7.11.2 Environmental/Off-Line testing
The supplier shall have the capability to perform periodic environmental/off-line testing to the full product
specification to ensure product conformance during its lifecycle. Such tests include vibration, shock, tem-
perature, humidity, ESD, EMC, safety, etc.
7.11.3 Releases for delivery
The supplier shall control all product releases for delivery to Bittium in accordance with documented pro-
cedures and test plans.
7.11.4 Inspection and test equipment
The supplier’s inspection and test equipment used for verification and validation of product requirements
shall be calibrated and maintained at defined intervals in accordance with appropriate plans, instructions
and check sheets. Test program versions, where applicable, shall be verified and controlled.
7.11.5 Inspection and test records
The supplier shall maintain inspection and test records as evidence that the products have been inspected
and tested in accordance with applicable procedures with acceptable results. The supplier shall review
these records regularly and take corrective and preventive actions as required. These records are part of
quality records (article 2.4).
7.11.6 Control of non-conforming products
The supplier shall have clearly documented procedures for the control, handling and disposition of non-
conforming products (scrap, use-as-is, rework). Where rework is performed the product shall be re-
inspected in accordance with applicable procedures. The supplier shall define allowable in-process rework
and appropriate procedures at all stages of the process. Actual rework performed shall be included in an
appropriate quality record. Supplier shall also ensure that appropriate traceability is enforced also for their
supply chain.
7.11.7 Product identification and traceability
The supplier shall have a system of manufacturing control such as a route card, run card, control software,
etc, used for the identification of products with regard to type, lot or serial number, and their status during
all stages of production and test. The supplier shall have a system for ensuring finished product traceability
back to factory and materials to the source. When appropriate, requirements traceability shall be imple-
mented at the request of Bittium.
7.11.8 Product handling, storage, packing and delivery
The supplier shall have adequate handling, storage, packing and delivery instructions to protect finished
products from damage and deterioration such as ESD effects, scratches, mechanical deformation, marking
losses, moisture ingress, etc.
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7.12 EOL
End of Life requirements are specified in agreements.
7.13 Physical security
Physical security requirements are specified in agreements.
Defined security requirements may be applied to facilities, storage, logistics, security clearances and other
protective measures for physical security of Bittium products.
7.14 Manufacturing
Manufacturing can be initiated only after Bittium approval. Products need to be tested, manufactured ac-
cording Bittium specifications & instructions. All materials, process and manufacturing process substance
changes must be approved by Bittium.
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8 SUPPLIER QUALITY ASSURANCE PLANNING
8.1 Generic
As part of its engineering processes Bittium uses Supplier Quality Assurance Planning (SQAP). Target of this
planning is to plan and prepare for successful supplier co-operation in design, verification and validation.
SQAP procedures will also drive Bittium part approvals.
8.2 Design for Manufacturing (DFM)
In case of Bittium designed parts supplier shall provide design and manufacturability feedback to Bittium
upon request. The aim of the feedback is to co-operate with Bittium R&D to achieve desired product re-
quirements with optimum cost and manufacturability, to achieve target yield and output capability.
8.3 Design verification and validation
Supplier shall provide required design verification and validation evidences upon request. Such evidences
consist of e.g. measurement reports (MR, FAI), capability studies (Cpk), Measurement system analysis
(Gage R&R), test reports, inspection reports etc.
8.4 Process verification and validation
Supplier shall provide required process verification and validation evidences upon request. Such evidences
consist of eg. Process Failure Mode and Effects Analysis (PFMEA), Process flow diagrams (PF), Control plans
(CP), measurement reports (MR, FAI), capability studies (Cpk), Measurement system analysis (Gage R&R),
8.5 Production part approval
For selected items, typically Bittium designed parts and assemblies, a production part approval is required.
Bittium will specify case by case what evidence items are needed to be submitted by supplier. Typically one
or more of the following are required:
• Process flowchart
• (P)FMEA
• Control plan
• Measurement reports
• Measurement system analysis (Gage R&R)
• Capability study reports (Cpk)
• Line verification report (provided by Bittium)
• Sample production parts
• Inspection reports (Sample parts production OQC)
During part approval Bittium will review all specification statuses and verify that those are mutually under-
stood.
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9 MATERIAL COMPLIANCE
Supplier shall ensure the capability to provide substance content information upon request by Bittium.
Bittium Standard Substance List for Suppliers (or Bittium Project Substance List for Suppliers when applica-
ble) describes environmental requirements for material content of Bittium products. This set of require-
ments includes EU RoHS and EU REACH requirements as well as requirements coming from Bittium's main
customers and market areas.
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10 TRADE COMPLIANCE
Bittium and supplier shall comply with all the applicable laws and regulations related to export control and
customs. For this reason, Bittium expects the supplier to provide export control and foreign trade data of
the part in a timely manner. Such data includes information related to export control classification and
jurisdiction of the item, and any other specific trade conditions known to the item.
Components or products supplied to Bittium shall not be subjected to ITAR (International Traffic in Arms
Regulations, 22 CFR 120-130). Bittium reserves the right to cancel the purchase order without any liability
to Bittium in case component or product is subjected to ITAR.
Supplier shall take actions necessary to become informed, and inform Bittium as needed, of any change
related to ITAR subjectivity of the components or product supplied to Bittium, as they exist now or as they
may be amended in the future.
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11 BITTIUM GENERAL TERMS AND CONDITIONS FOR PURCHACE OF GOODS
Supplier shall comply with Bittium general terms and conditions in every transaction. Bittium will inform
those together with every purchase order. Those will also be made available for suppliers upon request.
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12 SUPPLIER RECLAMATIONS
Supplier reclamations will be handled according to Bittium supplier reclamation process. In case of all rec-
lamations Bittium shall use the Bittium CAR database as master repository for all documentation. Using the
CAR database data an official Bittium Corrective Actions Request (CAR) is created and sent to supplier. For
every case a case-specific reply date is defined. Upon receiving CAR from Bittium, supplier shall notify that
CAR has been received and inform the actions taken without delay. If the given deadline to CAR actions is
not sufficient, supplier shall inform Bittium of the new suggested date with reasoning for change.
Bittium assumption is that all Bittium CAR cases will be handled via supplier corrective and preventive ac-
tions process as defined in supplier internal quality management system. Bittium will accept supplier inter-
nal 8D reports as part of CAR response.
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13 DEFINITIONS, ABBREVIATIONS
Abbreviation Definition
8D
Eight disciplines problem solving method. Focused on product and process im-
provement, its purpose is to identify, correct, and eliminate recurring prob-
lems.
Assessment
A systematic evaluation process of collecting and analyzing data to determine
the current, historical or projected compliance of an organization to a standard.
Audit
The on-site verification activity, such as inspection or examination of a process
or quality management system to ensure compliance to requirements. An audit
can apply to an entire organization or might be specific to a function, process or
production step.
CAP Corrective actions plan
CAPA Corrective actions and preventive actions (process)
CAR Corrective actions request/report
Control plan (CP)
Control planning is a strategy for controlling Products and Product processes to
ensure that all process outputs remain in a state of control and that all critical
requirements are noted. The Control Plan follows the PFMEA steps, and pro-
vides more details on how the "potential issues" are checked in the incoming
quality, manufacturing- or assembly process or during inspections of finished
products.
Cpk
The process capability index or process capability ratio is a statistical measure
of process capability: the ability of a process to produce output within specifi-
cation limits.
Critical feature
Feature in the design that has been identified and marked as critical in design
specifications. Criticality may be due to end user requirement, assembly or
other requirement. When appropriate two levels of criticality can be used, one
that requires controlling only in case of any changes or the other, more strict,
that requires regular control during manufacturing.
Design for Assembly
(DFA)
Design for assembly (DFA) is a process by which products are designed with
ease of assembly in mind.
Design for Manufacturing
(DFM)
Design for manufacturing or manufacturability is the general engineering prac-
tice of designing products in such a way that they are easy and economical to
manufacture.
EMS External Manufacturing Services
EU REACH
REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Au-
thorization and Restriction of Chemicals (REACH). REACH addresses the produc-
tion and use of chemical substances, and their potential impacts on both hu-
man health and the environment.
EU RoHS
European Union’s Restriction On Use of Hazardous Substances (RoHS) Directive
2011/65/EU including amendment EU 2015/863. The restriction of the use of
certain hazardous substances in electrical and electronic equipment.
Failure Modes and Ef-
fects Analysis (FMEA,
PFMEA)
The FMEA is a design tool used to systematically analyze potential
part/assembly/process failures and identify the resultant effects on system
operations. FMEA is a study concerning design related failure modes and ef-
fects. PFMEA focuses on (manufacturing-/assembly-) process failure modes and
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effects.
Gauge/Gage Repeatabil-
ity and Reproducibility
(Gage R&R)
The evaluation of gauging an instrument’s accuracy by determining whether
the measurements taken with it are repeatable and reproducible.
Non-conformance A product or service that does not meet the requirements stated to it.
OQC Outgoing quality control.
Process flow
A description of logical steps that a process consists of. Manufacturing process
sequence that is also used in FMEA and Control plan.
QMS
A quality management system (QMS) is a collection of business processes fo-
cused on consistently meeting customer requirements and enhancing their
satisfaction. It is aligned with an organization's purpose and strategic direction
(ISO9001:2015). It is expressed as the organizational goals and aspirations, poli-
cies, processes, documented information and resources needed to implement
and maintain it.
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References
[1] Quality Policy,
https://www.bittium.com/about-bittium/management-systems/quality-management-system
[2] Medical Policy,
https://www.bittium.com/about-bittium/management-systems/quality-management-system
[3] Allied Quality Assurance Publication (AQAP),
https://www.bittium.com/about-bittium/management-systems/quality-management-system
[4] Bittium Counterfeit Material Avoidance,
https://www.bittium.com/about-bittium/sustainability/trust-based-customer-relationships-secure-
products
[5] Environmental and Energy Efficiency Policy,
https://www.bittium.com/about-bittium/management-systems/environmental-management-system
[6] Anti-Corruption Statement,
https://www.bittium.com/about-bittium/sustainability/anti-corruption-statement
[7] Security Policy,
https://www.bittium.com/about-bittium/management-systems/security-management-system
[8] Bittium Statement of Conflict Minerals,
https://www.bittium.com/about-bittium/sustainability/trust-based-customer-relationships-secure-
products