Document Title: Global Quality Manual

Document Type

Manual

Process Owner

Global Quality Officer

Document Level

Level 1Document Revision

W

Document Number315001-01

Date Last Updated

April 15, 2023

NI Sites affected

All sites

Global Quality Manual

Printed copies of this document are uncontrolled and may not contain all relevant updates.

Document Number: 315001-01

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Global Quality Manual

CONTENTS1.

PURPOSE AND SCOPE ...................................................................................................................... 3

2.

QUALITY POLICY ................................................................................................................................. 3

3.

GLOBAL QUALITY MISSION ............................................................................................................... 34.

GENERAL INFORMATION ................................................................................................................... 3

5.

QUALITY ORGANIZATION STRUCTURE ........................................................................................... 46.

MANAGEMENT SYSTEMS REQUIREMENTS .................................................................................... 6

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Global Quality Manual

1. PURPOSE AND SCOPE
1.1. This is the NI Global Quality Manual. The Corporate Quality Team retains the authority to modify
this document.
1.2. This manual does not include standard operating procedures, local procedures, and processes
used to implement and manage the Quality Management System (QMS).
2. QUALITY POLICY
2.1. At NI, we establish our quality objectives using our core strategic vision and commitment toinnovation, continuous improvement, and customer satisfaction. We fulfill our customers’ needs
and meet all applicable requirements by providing high-quality products and services while
continually improving the effectiveness of our quality management system.
3. GLOBAL QUALITY MISSION
3.1. Our global quality mission is to lead and facilitate the development of a continuous improvement
mindset and skill set that accelerates productivity, innovation, and discovery inside and outside ofNI and to continuously challenge the boundaries of quality and productivity to exceed ourcustomer’s and stakeholders’ expectations.
4. GENERAL INFORMATION

4.1. NI products intended for sale and use in worldwide markets comply with applicable international
quality requirements—including, but not limited to, International Organization for Standardization(ISO), and are in accordance with their certificates and technical documentation. As a commercial
off-the-shelf supplier, NI does not conform to customer-specific quality requirements for ourproducts.
Click here to access certifications and downloadable certificates.
Click here for supplier quality program information.
Click here to learn how NI maintains information confidentiality.
Click here to learn about NI terms and conditions.

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Global Quality Manual

5. QUALITY ORGANIZATION STRUCTURE
5.1. The relationship between the Quality Group and the rest of NI is shown in Figure 1. Each NI site
has managerial and technical personnel with authority and resources to implement, maintain andcontinually improve the NI QMS.
Executive
Leadership

Regional
Quality andCI Manager

Corporate
Quality
Director

Quality andCI Managers

Corporate
Quality
Management

QualityEngineers

Quality
Auditors andTechnicians

QualityEngineers

Figure 1. NI Quality Organizational Chart
5.2. NI operates with a Global Management Team responsible for the organization’s technical andquality areas. Each key NI site is supported by quality representatives who are responsible forcoordinating all quality functions, including auditing, assessing vendors, recommending training,assessing QMS effectiveness, and assisting employees with the concepts and tools necessary for
quality improvement projects and initiatives. All NI employees are responsible for and empowered
to report nonconformances of products and services using the QMS and nonconformanceprocesses.
5.3. NI management and staff are committed to complying with applicable industry standards andregulatory requirements. The QMS covers activities performed at permanent facilities or customer
sites, as NI does not provide services in temporary or mobile facilities. Furthermore, NI
management and staff are committed to fulfilling customer needs.
5.4. NI’s QMS is a combination of policies, procedures, guidelines, manuals, locally defined
documentation, and processes to ensure the quality of work. The quality system and its
documentation are available to all NI personnel. NI provides appropriate training to ensure that
personnel understand the system and implement it effectively.

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Global Quality Manual

5.5. NI quality manager responsibilities include:•Implementing and maintaining the QMS, including the continuous improvement process•

Identifying and documenting any deviation from QMS procedures and ensuring NI
operations meet quality and business expectations•Initiating actions to prevent or minimize such deviations

5.6. NI quality management also:•

Fosters communication—via internal communication tools, email, site communication, sitemeetings, and other appropriate means—regarding QMS effectiveness and theimportance of meeting customer requirements•Maintains QMS integrity through planning, approving, and implementing QMS changes

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Global Quality Manual

6. MANAGEMENT SYSTEMS REQUIREMENTS
6.1. NI has a quality management system (QMS) and quality manual compliant with ISO 9001. Thisquality manual defines key QMS procedures and requirements.

Quality
Management
SystemContinous
Improvement

Key Process
Support andOperations R&D
Manufacturing
Supply Chain

Performace
Evaluationand Metrics

Management
revirew
Sales
Strategic
Planning

Figure 2. QMS Structure
6.2. Management System Documentation
6.2.1. NI instituted, implemented, documented, and maintains a management system adequate toits operations. The QMS documents the objective, policies, procedures, and processes NI
uses to ensure the quality of performed activities. The overall objectives set out in thequality policy statement and QMS are reviewed during management reviews. Personnel
are made aware of the relevance and importance of their activities using a system ofcascading business priorities and objectives. These business priorities are communicatedto personnel in various ways at management’s discretion.
6.2.2. NI top management is committed to developing and implementing the QMS and tocontinuous improvement through management reviews and continuous improvement
meetings.

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Global Quality Manual

6.3. Management System Document Control

Quality Policy
Quality Manual
ProceduresWork Instructions
RecordsFigure 3. Quality Documentation Hierarchy
6.3.1. NI utilizes a document control system to manage all documents used in the calibrationlaboratories. Internal and external QMS documentation is controlled, per the master list, inthe designated corporate content management system.
6.3.2. Documents are approved by senior management prior to use at NI to ensure that:••

••
•

•

The relevant approve all changes and creation or deletion of QMS documents prior
to implementation.
A process exists to ensure all NI employees work under the appropriate
documentation and that this documentation is periodically reviewed and revised asnecessary.
Documents are maintained and accessed for editing by checking them out andproviding traceable document revision control.
NI personnel can access the latest versions of the documentation; relevant versionsof applicable documents are available at points of use and wherever necessary.
The global quality officer issues QMS documents that are uniquely identified. Suchidentification shall include the date of issue and/or revision identification, page
numbering, and total number of pages.
Obsolete documents are archived once a newly revised document is approved
through approval processes.

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6.4. Records Control
6.4.1. All records are legible and stored using established processes that outline quality andtechnical record identification, collection, indexing, access, filing storage, maintenance, anddisposal.
6.5. Actions to Address Risks and Opportunities
6.5.1. The QMS considers the risks and opportunities associated with NI activities to:•Ensure the management system achieves its intended results.

•Enhance opportunities to achieve the purpose and objectives of each NI
department.

•Prevent or reduce undesired impacts and potential failures in NI activities.

•Achieve improvement.

6.5.2. NI shall have a risk and opportunity plan when a risk or opportunity has been identified. The
plan shall include the actions needed to address these risks and opportunities, how tointegrate and implement these actions into this management system and evaluate theeffectiveness of these actions.
6.5.3. Actions taken to address risks and opportunities shall be proportional to the potential
impact on the validity of NI results.
6.6. Continual Improvement
6.6.1. NI continually improves QMS effectiveness using the quality policy, quality objectives, audit
findings, and corrective and/or preventive actions. Annual management review meetings
also contribute to NI improvement.
6.6.2. NI uses established quality tools across the business. These tools include 8D, Fishbone
Diagrams, Fault Tree Analysis, D/P-FMEA, DOE, Why-Why, 5W2H, Mistake Proofing,Lean, 5S, Gemba, and data collection and analysis, among others.
6.6.3.NI seeks positive and negative feedback from its customers through many channels andanalyzes and uses this feedback to improve the QMS.
6.7. Corrective Actions and Nonconformities6.7.1. NI implements corrective actions when nonconformities are identified in NI process orproduct. The global quality officer or site quality manager approves the corrective action
documented in the designated quality database.
6.7.2. All corrective actions are determined based on the level and effect of the nonconformity
encountered.

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Global Quality Manual

6.7.3. NI retains records that evidence nonconformity nature, cause(s), subsequent action(s), andresults of such action.
6.8. Internal Audits

Do•Planning•Preparation•Conduct Audit•DiscussFindings•Write Audit
ReportPlanCheckAct•Audit Reportand Record•Follow-up•Close-out

Figure 4. Internal Audit Process Flow

6.8.1. Internal audits, scheduled by the global and site quality managers, are conducted at least
once per year. The site quality manager is responsible for planning and organizing audits
as required by the schedule or requested by management.
6.8.2. The internal audit program meets the following requirements:••••••The QMS program manager creates and maintains an audit plan. This planestablishes frequency, methods, responsibilities, planning requirements, andreporting. The plan is created considering NI activities, changes in NI, and the resultsof previous audits.
The QMS program manager reports the audit results to relevant management.
The internal auditor or designee creates an official record of audit finding(s) using anaccepted audit report approved by the global quality manager.
NI implements appropriate corrective actions without undue delay.
For major and minor non-conformances, require root cause analysis in addition tocorrective actions.
All quality records are retained as evidence of the implementation of the internal audit
program and the audit results.

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Global Quality Manual

6.9 Management Review Process

QMS Program
Manager• Requestst andOrganize Required
Inputs intoManagement
Review• Shedules
Management
ReviewQMS Program
Manager• Attends
Management
Review meeting• Assign Actions &required outputs

SeniorManagement

QMS Program
Manager• Documents meetingminutes & actions• Publish and store
Management review
slidedeck

Figure 5. Management Review Process Flow

6.9.1

6.9.2

The QMS program manager conducts annual reviews of QMS activities with each site
and top management. The review ensures continuing QMS suitability and effectivenessand introduces necessary changes and improvements to processes or documents.
Management reviews include:
•••

•
•

the status of actions from previous management reviews.
changes in external and internal issues that are relevant to the quality
management system.
information on the performance and effectiveness of the quality management
system, including trends in:o customer satisfaction and feedback from relevant interested parties.
o the extent to which quality objectives have been met.
o process performance and conformity of products and services.
o nonconformities and corrective actions.
o monitoring and measurement results.
o audit results.
o the performance of external providers.
o the adequacy of resources.
the effectiveness of actions taken to address risks and opportunities.
opportunities for improvement.

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Global Quality Manual

6.9.3 All decisions and actions resulting from the management review shall be recorded where they
relate to:•opportunities for improvement.

•any need for changes to the quality management system.

•resource needs.

END OF DOCUMENT©2020 National Instruments. All rights reserved. LabVIEW, National Instruments, NI, and ni.com aretrademarks of National Instruments. Other product and company names listed are trademarks or trade
names of their respective companies.

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