QSD111.00 Corporate Quality Manual PDF
QSD111.00 Corporate Quality Manual PDF
QSD111.00 Corporate Quality Manual PDF
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Purpose
This procedure defines the policies and related procedures Fluke follows to comply with the
requirements of the ISO 9001:2015, ISO/IEC 17025 and ISO/IEC 80079-34 standards.
Introduction
Fluke Corporation (Fluke) is a leading manufacturer of measurement and test equipment
with corporate headquarters located in Everett, Washington, USA with global operations and
subsidiaries.
Fluke uses a process approach in our Quality Management System (QMS) where required
inputs and desired outputs are identified and monitored to ensure applicable requirements
and customer expectations are met.
Fluke is part of the Fortive Corporation and employs the Fortive Business System (FBS) as
the cornerstone of our culture and our competitive advantage. FBS drives continuous
improvement of our Quality Management System. Tools include Kaizen events, Problem
Solving Process (PSP), risk analysis using the DIVE methodology (define the problem,
investigate to drive root cause, verify and implement countermeasures, ensure sustainment)
and other tools as appropriate.
Fluke’s interaction of processes of the Quality Management system is shown in the following
diagram.
Plan Do
1 Procedure scope
This procedure applies to all personnel doing work under Fluke’s control. Facilities
may have supplementary policies, processes and local procedures to further define
their specific requirements and activities.
2 References
Internal
Fluke Corporate Scope and Context Statement
QSD111.01 Manufacturing Process Policy
QSD111.02 Corporate Training Policy
QSD111.03 External Product Quality
QSD111.04 Fluke Supplier Handbook
QSD111.07 Control of Nonconforming Material Policy
QSD111.09 Corrective Action and Risk Mitigation Policy
QSD111.10 Internal Audit Process
QSD111.11 80079-34 Ex Quality Manual
QSD111.37 Product Development Process
QSD111.39 Document Control Policy
QSD111.41 Fluke 17025 Quality Manual
QSD111.44 Measurement Management System
QSD111.50 QMS Records Retention Policy
QSD111.50.AppA QMS Records Retention Requirements
QSD111.56 Serialization Policy
QSD19.1 Electrostatic Discharge Policy
DOC_143 Management Review Template
DOC_3209 Management Review PowerPoint Template
LPD.FQM Fluke Europe Quality Manual Addendum
External
ISO 9001 Quality Management Systems – Requirements
ISO/IEC 17025 General requirements for the competence of testing and
calibration laboratories
ISO/IEC 80079-34 Explosive atmospheres – Application of quality systems for
equipment manufacture
5 Leadership
Leadership and commitment
Top management demonstrates leadership and commitment with respect to the
Quality Management System by:
taking accountability for the effectiveness of the Quality Management System
in achieving its intended results through active participation in management
review
ensuring that the quality policy and quality objectives are established and are
compatible with the strategic direction of Fluke (policy deployment, key
performance indicators (KPI’s), and employee performance objectives).
ensuring integration of the Quality Management System requirements with
Fluke’s business processes
promoting continuous improvement, the use of a process approach and risk
based thinking through use of our FBS tools
ensuring that the resources needed for the Quality Management System are
available
communicating the importance of effective quality management and
conforming to Fluke’s Quality Management System requirements
Quality policy
Top management has established Fluke’s Quality Policy which is documented in the
Fluke Corporate Scope and Context Statement and is available in Intelex. The
Quality Policy is communicated throughout the company.
Roles and responsibilities
Top management ensures that responsibilities and authorities for relevant roles are
assigned, communicated and understood throughout Fluke. This is done through
departmental organizational charts and job descriptions.
Top management has assigned the Director of Global Quality as the Management
Representative with responsibilities for:
ensuring that the Quality Management System conforms to the ISO 9001
standard requirements
ensuring that the Quality Management System conforms to the ISO/IEC 17025
standard requirements as applicable for calibration laboratories accredited to
ISO/IEC 17025.
ensuring that the Quality Management System conforms to the IEC 80079-34
standard requirements as applicable for the manufacture of products intended
for use in explosive atmospheres. See QSD111.11 Fluke 80079-34 Ex Quality
Manual.
ensuring that processes are delivering their intended outputs
reporting on the performance of the Quality Management System and on
opportunities for improvements
ensuring the promotion of customer focus throughout Fluke
ensuring that the integrity of the Quality Management System is maintained
when changes are planned and implemented.
6 Planning
When planning for the Quality Management System, Fluke considers the context of
the organization, its customers and their requirements and determines the risks and
opportunities that need to be addressed in order to:
give assurance that the Quality Management System can achieve its intended
results
prevent or reduce undesirable effects and enhance desired effects
achieve improvement.
Fluke addresses these risks and opportunities by integration and implementation of
actions into the Quality Management System and evaluation of the effectiveness of
these actions through use of tools such as daily and visual management, Key
Performance Indicator (KPI) bowlers and other measurement processes. Actions
taken are proportional to the potential impact on the conformity of products and
services.
Policy Deployment and Operational KPI reviews are used to establish objectives,
measure performance and drive continuous improvement. Policy deployment is a 7
step process used by Fluke to focus on impactful, breakthrough objectives that are
critical for achieving world-class status. The crucial cornerstones to achieving this
success are the focus on the Voice of the Customer (VOC) and the planning process
that links that focus to specific support plans describing how we will satisfy the
innovation, delivery and cost objectives to meet the customer needs.
Operations KPIs are defined and flowed to the relevant functions, levels and
processes to measure the sustaining business processes. Improvement objectives
are established as part of the annual planning process and Operations Reviews are
held monthly to review results and countermeasures to misses.
7 Support
Resources
Fluke determines and provides the resources needed for the operation and
improvement of the Quality Management System to ensure the products and
processes achieve their planned results. When considering resources, Fluke
considers the capabilities and constraints on existing resources as well as needs
from external sources. Resources are determined and addressed at each facility and
functional area. These may include:
infrastructure
environment
materials and equipment
personnel
Communications
Fluke determines the communications (internal and external) relevant to the Quality
Management System and on relevant levels. Fluke uses standard processes to
determine communications including:
what will be communicated
when to communicate
with whom to communicate
how to communicate
who communicates
Documented information
Fluke’s Quality Management System includes documented information required by
the ISO 9001 standard, as well information determined necessary by Fluke to ensure
the effectiveness of the Quality Management System.
Fluke’s document structure and its control is defined in QSD111.39 Document
Control Policy. This policy ensures documents are created with the necessary
information to ensure proper control and are documented in the acceptable formats.
Documented information is made available to all necessary personnel through the
use of control systems, such as Intelex, SharePoint and Team Center. These
systems ensure only the current approved versions of documented information is
available to the users.
Retention of documented information is defined in QSD111.50 QMS Records
Retention Policy and QSD111.50.AppA QMS Records Retention Requirements or the
specific document. These procedures provide direction on how and where
documented information is retained as well as the retention period and the disposition
methods.
Organizational knowledge
Fluke has identified and documented organizational knowledge that is necessary for
the operation of its processes and to achieve conformity of products and services.
Organizational knowledge is maintained by the functional groups and made available
as necessary. As processes change, Fluke will determine whether additional
information is necessary and if so, how it will be obtained.
8 Operations
Operational planning and control
Fluke plans, implements and controls processes needed to meet the requirements for
the provision of products and services by:
determining requirements for the products and services
establishing criteria for the processes and for the acceptance of the products
and services
Calibration and repair services are provided for all our instruments that have
guaranteed performance specifications as well as for a wide range of instruments
Preservation
Fluke has implemented local processes for the handling and preservation of product
as necessary in order to prevent damage and deterioration.
Materials and stores departments are responsible for establishing processes for
purchased parts. Production departments are responsible for establishing processes
for work in process. The distribution centers are responsible for establishing
processes for shipping product to the customer.
All organizations handling printed circuit assemblies (PCAs) shall comply with
QSD.19.1 Electrostatic Discharge Policy.
Post-delivery activities
Fluke determines and meets requirements for post-delivery activities related to its
products and services. In determining post-delivery activities, Fluke considers:
statutory and regulatory requirements
potential undesired consequences associated with its products and services
the nature, use and intended lifetime of our products and services
customer requirements
customer feedback.
Post-delivery activities are documented in local process documents as required.
Control of changes
Fluke reviews and controls changes for production and service provisions, to the
extent necessary to ensure continuing conformity with applicable requirements.
Fluke retains documented information on these changes and the person(s)
authorizing the change as well as any necessary actions arising from the review.
9 Performance evaluation
Monitoring, measurement, analysis and evaluation
During new product development, or when an existing product design change is
required, the responsible engineering organization will determine the measurements
to be made, the accuracy required, the frequency of the measurement and will select
the appropriate inspection, measuring, and test equipment that is capable of the
necessary accuracy and precision.
Test systems are defined as any hardware or software used in production or service
to verify the acceptability of the product or service. Test systems will be validated
prior to their initial use and whenever a product or test system requires a change that
could affect the acceptability of the product or service. Test system use, validation,
maintenance and control will be described in local work instructions.
Where the results of processes cannot be fully verified by subsequent inspection and
testing of the product and where processing deficiencies may become apparent only
after the product is in use, the processes shall be carried out by qualified operators
and/or shall require continuous monitoring and control of process parameters to
ensure the specified requirements are met.
The requirements for qualification of process operations, including associated
equipment and personnel shall be specified.
Supervisors/process owners are responsible for in-process and final inspection,
testing, and monitoring per documented work instructions and design control
information. Equipment maintenance documentation will list all equipment in the
process owner’s area of responsibility, maintenance schedules, maintenance
instructions, and training records for all personnel performing maintenance.
Customer satisfaction
Fluke monitors customer satisfaction through surveys, data collected through the
External Product Quality Database, and the customer feedback system as defined in
local process documents.
Internal audits
QSD111.10 Internal Audit Process defines Fluke’s internal audit policy and program
for verifying the Quality Management System has been effectively implemented and
that processes conform to internal requirements and ISO standard requirements.
Frequency of audits, selection of auditors and corrective action requirements are
defined in QSD111.10 Internal Audit Process.
Management review
Fluke performs Management Review on different levels throughout the year
according to processes defined by the Fortive Business System. Over the course of
the year, a complete Management Review is performed involving the L1 and L2
managers.
Core Value Drivers (CVDs) are reviewed annually and the Strategic (Strat) Planning
meetings develop and define the strategic direction of Fluke based on current
business needs and opportunities. Policy Deployment (PD) drives breakthrough
changes and determines the capabilities needed to achieve the strategic direction.
Policy Deployment Targets to Improve (PD TTIs) are reviewed by L1 and L2
management at the PD Reviews to assess the effectiveness of actions taken to
implement the necessary changes.
Monthly Ops reviews are held for each business unit or functional group and review
KPI bowlers to determine the level to which objectives are met. KPIs and objectives
are focused on Key Stakeholders as defined by the Fortive Core Value Drivers and
including on time deliver (OTD), quality (DPPM) and revenue among others. Slide
decks are available from executive assistants for each BU/function or from
BU/function leaders.
Daily Management occurs in Obeyas throughout the Fluke facilities where details are
discussed relating to each functional area and how they contribute to the overall
KPIs.
At the monthly Ops Reviews, the Director of Global Quality is responsible for raising
key issues to the appropriate management level for consideration and actions are
determined as necessary.
The Management Review Template DOC_143 provides an outline for the discussion
and defines required inputs and outputs. The Management Review PowerPoint
Template DOC_3209 or other similar templates may also be used.
See the Management Review Matrix for information on where each aspect of the ISO
9001 standard is addressed and where records are retained
Functional areas may perform their own management review to ensure their
Business Unit management is aware of issues specific to their functions.
10 Improvement
Continuous improvement
Fluke continuously improves the suitability, adequacy and effectiveness of our Quality
Management System through the use of Fortive Business System (FBS) which
includes tools such as problem solving and Kaizen activities.
Improvement opportunities include:
improving products and processes to better address customer needs and
expectations,
correcting or preventing undesired effects,
improving the effectiveness of the Quality Management System.
The Corporate Quality Council will be notified of changes to the Corporate Quality Manual
through Intelex. Corporate Quality council members are responsible for communicating
changes to their functional groups.
QSD111.00
Corporate Quality Manual