Want an ISO 15189 checklist? Here are some specific ways that MasterControl allows
medical laboratories to effectively automate and streamline compliance with
ISO 15189 quality standards:
Clause 4.2.1 -
"Policies, processes, programmes, procedures and instructions shall
be documented and communicated to all relevant personnel. The management
shall ensure that the documents are understood and implemented."
Clause 4.2.4 -
"All personnel shall be instructed on the use and application of
the quality manual and all referenced documents, and of the requirements
for their implementation. The quality manual shall be kept up to
date under the authority and responsibility of an individual appointed
to be responsible for quality by the laboratory management."
MasterControl Document Control
Documentation is often the central facet of an effective quality management
system. Medical and clinical laboratories need to be able to create
documents that will be automatically tracked, routed and controlled
(as they are revised) in a secure, centralized system to ensure compliance
with ISO 15189 quality standards. MasterControl allows medical and
clinical laboratories to create any type of file and secure that
file in the MasterControl system. MasterControl's advanced meta-data
InfoCards allow any approved employee to quickly search and find
essential documentation such as an ISO 15189 quality manual, SOPs,
etc. Routing, approvals, escalations and storage procedures are also
automated for best results to comply with ISO 15189 quality standards.
Documentation is also often necessary for training purposes in medical
and clinical laboratory environments to ensure compliance with ISO
15189 quality standards. MasterControl makes it simple to combine
training and documentation management. For example, if a quality
manual or an SOP is revised within the document system it can be
set to automate the release of training tasks or full-scale training
units to employees anytime and from anywhere which will help in meeting
ISO 15189 quality standards ultimately.
MasterControl also provides integrated change control management
that connects different departments with data and processes under
a secure and centralized system. This connectivity vastly improves
efficiency through automatic task assignment, routing, scheduling,
notification, and escalation of incomplete tasks.
Remember, MasterControl is Web-based, so even suppliers and others
outside the company (off-site or traveling employees) who need
to participate in change control can do so from virtually anywhere.
Training for ISO 15189 Quality Standards Compliance
Clause 5.1.4(g) -
"...ensure that there are sufficient qualified personnel with adequate
documented training and experience to meet the needs of the laboratory;"
MasterControl Training Management
One of the main items on any ISO 15189 checklist is managing training
processes effectively. MasterControl automates the routing, tracking,
and follow-up of training tasks and even grading of online exams.
Users are automatically notified about new training tasks. Upon task
completion, the verifier is also automatically notified whether the
training for ISO 15189 quality standards is complete or not.
MasterControl integrates the training process with the rest of the quality
system to ensure ISO 15189 quality standards compliance for a holistic
approach to management. If there's any change in a document linked
to a required course because of a revised SOP, policy, ISO 15189
quality manual, etc., all affected trainees will immediately receive
new training tasks.
MasterControl's advanced analytics and reporting capability includes
customizable reports and online charting. The system automatically
performs gap analysis for all training tasks making it simple
to access real-time data and to adhere to ISO 15189 standards.
"All operational procedures shall be systematically reviewed by laboratory
management at regular intervals, as defined in the quality management
system, in order to identify any potential sources of nonconformance
or other opportunities for improvement in the quality management
system or technical practices. Action plans for improvement shall
be developed, documented and implemented, as appropriate."
MasterControl Nonconformance Management
MasterControl's best-practice form and five-step process connect all
responsible personnel for effective and timely disposition of a nonconformance.
MasterControl offers ensurity of compliant processes with ISO 15189
quality standards with the choice of maintaining a stand-alone nonconformance
process for small-scale, localized incidents, or you may connect
it to the CAPA process for automatic escalation when the situation
MasterControl automates data collection, routing, follow-up, and escalation
of nonconformance cases. The electronic "in" box tracks all active
tasks for a user and provides tools for staying on top of things.
Approvers can also review and sign electronically. All of these things
help shorten cycle time.
The system tracks all routing information and data entered into the electronic
form, allowing the nonconformance owner to identify bottlenecks and
understand the sequence of events during processing.
Audits for ISO 15189 Quality Standards Compliance
Clause 4.14.1 -
"In order to verify that operations continue to comply with the requirements
of the quality management system, internal audits of all elements
of the system, both managerial and technical, shall be conducted
at intervals defined by the system itself. The internal audit shall
progressively address these elements and emphasize areas critically
important to patient care."
MasterControl Audit Management
MasterControl connects the audit process with the rest of the quality
system for a holistic approach to quality management. A CAPA form
can be launched directly from an audit finding form, greatly streamlining
The MasterControl system also automates the scheduling of all recurring
audit-related activities so they won't be overlooked and helps sustain
compliance with ISO 15189 quality standards. It allows for the planning
and scheduling of tasks well in advance and provides powerful analytics
and reporting capabilities, including customizable reports and online
charting. Through the reports, managers get a real-time view of the
audit process and can be more proactive about improving the quality
Clause 4.10.1 -
"Procedures for corrective action shall include an investigative
process to determine the underlying cause or causes of the problem.
These shall, where appropriate, lead to preventive actions. Corrective
action shall be appropriate to the magnitude of the problem and commensurate
with possible risks."
Clause 4.10.2 -
"Laboratory management shall document and implement any changes required
to its operational procedures resulting from corrective action investigations."
Clause 4.11.1 -
"Needed improvements and potential sources of nonconformities, either
technical or concerning the quality management system, shall be identified.
If preventive action is required, action plans shall be developed,
implemented and monitored to reduce the likelihood of the occurrence
of such nonconformities and to take advantage of the opportunities
MasterControl CAPA Management
The MasterControl system automates the routing, delivery, escalation,
and approval of CAPAs and all related documents. It provides a centralized
repository for all CAPA related documentation making search and retrieval
easy during inspections and/or audits.
The MasterControl system integrates the CAPA process with the rest of
the quality system to ensure ISO 15189 quality standards compliance.
For example, the resolution of a CAPA might trigger an SOP change
and retraining of employees on a new SOP. This connectivity also
means that a CAPA form can be launched directly from another form
(i.e., customer complaint, nonconformance) to streamline the process.
The MasterControl system also tracks all routing information and data
entered into the electronic CAPA form, allowing the nonconformance
owner to identify bottlenecks and understand the sequence of events
Clause 4.15.1 -
"In order to ensure their continuing suitability and effectiveness
in support of patient care and to introduce any necessary changes
or improvements, laboratory management shall review the laboratory's
quality management system and all of its medical services, including
examination and advisory activities. The results of the review shall
be incorporated into a plan that includes goals, objectives and action
plans. A typical period for conducting a management review is once
every twelve months."
MasterControl Management Review
Management review is as essential element of a quality management system.
The MasterControl system can automate review reminders and the release
of related documentation which will help in complying with ISO 15189
Easy review of all quality documentation streamlines the College of American
Pathologists (CAP) inspections.
Clause 4.6.4 -
"The laboratory shall evaluate suppliers of critical reagents, supplies
and services that affect the quality of examinations and shall maintain
records of these evaluations and list those approved."
MasterControl Supplier Management
With MasterControl, all supplier status and quality information (such
as non-conforming material reports) is automatically contained in
a single, easy to access location. In addition to providing an easily
maintainable AVL, MasterControl Supplier features a user-friendly
interface for accessing all documentation and records related to
MasterControl automatically tracks and stores supplier information derived
from audits, non-conformance reports, supplier deviations, and CAPAs.
This electronically managed information can then be easily compiled
for supplier quality ratings according to ISO 15189 quality standards.
Furthermore, suppliers can be approved using MasterControl's robust
approval workflow technology.
With MasterControl, goods or services can be added to the "approved to
supply" list simply by linking the goods/services to a specific supplier
in MasterControl. Suppliers, conversely, can be added the same way.
If a part is linked to a supplier that is not approved, the link
will be disabled until the supplier becomes approved or reapproved.
All of this information is easily obtainable via MasterControl's
built-in reporting tool which is developed according to ISO 15189
MasterControl's web-based platform makes accessing supplier data easy
and efficient which helps in maintaining compliance with ISO 15189
quality standards. Geographically dispersed divisions have the ability
to share supplier qualification data with others in the corporation,
potentially cutting out costly duplication of effort and speeding
time to market.
To learn more about automating and streamlining compliance with ISO 15189 standards
and continuously maintaining ISO 15189 and CAP accreditation, please feel
free to contact a MasterControl representative.
MasterControl produces software solutions that enable regulated companies to
get their products to market faster, while reducing overall costs and increasing
internal efficiency. MasterControl securely manages a company's critical
information throughout the entire product lifecycle. Our software is known
for being easy to implement, easy to validate and easy to use which helps
in sustaining compliance with ISO 15189 quality standards. MasterControl
solutions include quality management, document management, product lifecycle
management, audit management, training management, document control, bill
of materials, supplier management, submissions management, and more. Supported
by a comprehensive array of services based on industry best practices, MasterControl
provides our customers with a complete information management solution, according
to ISO 15189 quality standards, across the entire enterprise.