Implementing a Quality Management System in an Environmental Laboratory

By Ilona Taunton, TNI and Paul Junio, Northern Lake Services

July 20, 2018

A Quality Management System (QMS), Quality System, Management System, or Quality

also called a Quality System or Management System
Management System, describes the The 1990 version of ISO/IEC 17025 used the term
manner in which you, as a laboratory, Quality System to describe the process by which a
manage your operations to assure the laboratory manages its operations to “assure the quality
quality of the test results you generate. of the test results it generates.” By the time the second
edition was published in 2005, this term was changed to
This QMS is organized, defined, and Management System, although the phrase quality
documented through your Quality Manual management system also appeared in this version. The
and various policies and procedures. The NELAC Institute started using Quality System in 1994,
QMS must describe your objectives and and to date has not made the transition to
principles relative to quality and must Management System. As a transitional step, this
address: document uses the term Quality Management System.

● How your objectives and principles will be achieved through written policies and
procedures;
● How your laboratory is organized including work processes;
● How each individual is accountable for their assigned activities and responsibilities
as it relates to generating quality data;
● How you expect policies and procedures to be implemented; and
● How you will evaluate the effectiveness of your system.

The QMS is the framework under which you will plan, implement, and assess work performed
by your laboratory and the Quality Assurance (QA) and Quality Control (QC) activities that are
necessary to meet your stated objectives.

A QMS is important for two reasons:

1. The QMS (which is outlined in the Quality Manual) serves as a guide to the
laboratory in implementing the processes and procedures intended to provide data
of known and documented quality.

2. A well thought out QMS provides clients with an understanding of how your
laboratory intends to produce and document the data from samples that are
submitted for analysis and adds a significant level of confidence in your laboratory’s
reported results.
A Quality Management System (QMS) does not ensure nothing goes wrong. It tells you what to
do when it does, and it helps to prevent it from happening in the future.

Terminology and a Lesson in Hierarchy

To develop your QMS, you must understand the difference between a Quality System, Quality
Assurance, and Quality Control. These terms are intimately related, but represent very different
processes. Definitions for each of these terms are found in the TNI Environmental Laboratory
Standard (EL-V1M2, Section 3), but the relationship is often unclear as many use these terms
interchangeably.

Quality System: A structured and documented management system describing

the policies, objectives, principles, organizational authority, responsibilities,
accountability, and implementation plan of an organization for ensuring quality
in its work processes, products (items), and services. The quality system provides
the framework for planning, implementing, and assessing work performed by the
organization and for carrying out required quality assurance (QA) and quality
control (QC) activities.

Quality Assurance: An integrated system of management activities involving

planning, implementation, assessment, reporting, and quality improvement to
ensure that a process, item, or service is of the type and quality needed and
expected by the client.

Quality Control: The overall system of technical activities that measures the
attributes and performance of a process, item, or service against defined
standards to verify that they meet the stated requirements established by the
customer; operational techniques and activities that are used to fulfill
requirements for quality; also the system of activities and checks used to ensure
that measurement systems are maintained within prescribed limits, providing
protection against “out of control” conditions and ensuring that the results are of
acceptable quality.

As a summary, these three terms form a hierarchical system in which the Quality System or
QMS is the umbrella under which all activities are performed. It is a management system that is
designed to ensure data of known and documented quality and describes all activities related
to providing a quality work product:

● Policies, Procedures
● Organizational Responsibilities & Accountability
● Assessment

The description of these activities and policies is found in the Quality Manual (QA Manual,
Quality Assurance Plan, however named).
Quality Assurance are those management activities that implement the policies and oversee
the implementation of the Plan:

● Planning, including developing policies and procedures;

● Implementing policies by writing procedures to be used to accomplish the goals
outlined in the policies;
● Insuring that all procedures are being followed as written;
● Assessing how well the procedures and policies are followed;
● Assessing how well the implemented processes work;
● Establishing a mechanism for addressing failures in processes, procedures or
technical work; and
● Looking for and implementing procedures that will enhance the laboratory’s ability
to produce data of known and documented quality.

Quality Control are usually technical activities that monitor how well the processes are working
but is not limited to the testing. Quality controls:

● Measure performance of a process, and

● Verify that performance measures meet specified limits.

In this sense, a Quality Control measure could be related to accuracy of data transcription,
ordering and/or receiving supplies, etc.

Note: As a cautionary note, you may use other sources (laboratories, consultants, workshops,
etc.) to develop your quality system, but make sure that it becomes your management system.
Since the QMS is described in detail in your quality manual, you must be sure that you are
performing what is written, regardless of whether it is “extra” or “not required” for
accreditation. When you write it into your Manual, it becomes your requirement.