2018 Qms Maturity Assessment Tool

CAP 15189SM – QMS Maturity Assessment Tool
Laboratory/CAP#
Name, Date
Background
A laboratory’s quality management system (QMS) should continually improve and mature. CAP 15189 assessors look for
improvements during surveillance and reaccreditation visits. This tool is designed to address the following objectives:
 Provide common benchmarks for QMS maturity
 Help your laboratory identify opportunities for improvements
 Facilitate discussion about the state of your QMS – both within your laboratory and with CAP assessors
Contents
This document addresses the following topics:
Topic See Page
Instructions 2
QMS Dimensions 4
Quality Culture
Innovation 4
Speaking Up 5
Going Above and Beyond 6
Transparency 7
Process Orientation 8
Teamwork and Involvement 9
Risk Awareness 10
Document Control 11
Occurrence Management 12
Root Cause Analysis and Corrective Action 13
Evaluation and Audits
Internal Auditing 14
Risk Management 16
Continual Improvement 18
Competency and Personnel Development 19
Customer Satisfaction/Alignment with Customers 21
Management Review 22
Quality Manual 24
Summary of Maturity Ratings/Key Areas of Improvement 25
© 2018 College of American Pathologists. All rights reserved.

Instructions for using the QMS Maturity Assessment Tool for your organization:
1. Consider the dimensions of your organization’s QMS in terms of the levels described below.
2. For each dimension, rate your QMS as Level 1, 2, or 3 by checking the appropriate box. For Levels 2 and 3, note
evidence that supports your rating. (Note: A Level 3 rating incorporates the strengths of Level 2.)
3. You will have an opportunity to discuss your ratings with your assessor; after the conclusion of your CAP 15189
assessment, he or she will offer to set up a meeting to go over your report results.
Here are descriptions for the three levels of maturity:
Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice
Applicable ISO 15189 Just meets ISO 15189 requirements. Meets and in some cases exceeds Meets and consistently exceeds ISO
Requirements ISO 15189 requirements. 15189 requirements.
QMS Implementation All aspects of the QMS have been All aspects of the QMS have been Best in class – QMS exemplifies a
defined and are in the process of implemented and effectiveness is quality level that other laboratories
being implemented. being monitored. can aspire to and learn from, with
no obvious weaknesses present.
Shows clear weaknesses in Few or minor weaknesses present.
implementation. All aspects of the QMS have been
implemented, effectiveness is
monitored, and action is taken to
improve processes and reduce risk,
where appropriate.
Benefits to Laboratory Some benefits to laboratory. Substantial benefits to laboratory. Maximal benefits to laboratory.
© 2018 College of American Pathologists. All rights reserved. 2 August 21, 2018
Note on Maturity versus Accreditation:

This QMS Maturity Assessment Tool is designed to promote:
 Laboratory QMS improvement
 Discussion with your CAP 15189 assessor about your continual improvement progress
It is not a part of the formal accreditation process, which is governed by the CAP 15189 program policies and the ISO 15189
standard.
If a laboratory’s QMS is immature throughout all of these dimensions, showing all the weakness listed under Level 1, it most
likely would not be ready for accreditation by the CAP 15189 program.
Note on Relevant QMEd Courses:

For most of the QMS dimensions, the CAP has created a Quality Management Education (QMEd) Resources course that
provides guidelines and best practices.
QMEd courses are online, self-paced courses that can be shared among laboratory staff and that provide continuing
education (CE) credit. You will see references to these courses in this template.
For more information, go to cap.org and search QMEd.
Dimension Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice
Quality Culture Management shows evidence of Laboratory has a documented Laboratory has a strategy for
commitment to continual process for generating innovations or sustaining and improving a culture of
 Innovation improvement. (ISO 15189:2012 Clause a process that the laboratory can innovation, eg, through:
4.1.2.1) describe.
 Recruiting – Seeks individuals
who have a drive for
Laboratory solicits improvement Laboratory provides training on
innovating.
suggestions from staff. It evaluates continual improvement for employees
 Communication – Publicizes
and implements suggestions; it at all staff levels.
examples of successful
provides feedback. (Clause 4.14.4)
change.
Laboratory maintains a record of
 Training – Provides training in
Assessors may identify the following suggestions for innovations that were
improving processes.
weaknesses: submitted and implemented.
 Reward – Recognizes
 Staff may complain that their individuals who suggest
suggestions are not always changes.
considered.  Rituals and Programs – Initiates
 Staff may experience criticism programs (eg, ISO 15189, Lean)
for suggesting innovations. that prompt improvements.
 Number of innovations is small  Visible Leader Actions –
and scope is limited. Leader personally directs an
improvement project.
See CAP QMEd course

Quality Culture
Quality Culture Laboratory establishes Laboratory maintains evidence that Laboratory has a strategy for
communication processes to support processes have been standardized sustaining and improving a culture of
 Speaking Up quality and continual improvement. and that staff have come to speaking up, eg, through:
(Clause 4.1.2.6) consensus on the right process, with
opportunity to disagree and discuss
who demonstrate willingness to
Laboratory solicits improvement (eg, list project team members).
speak up.
suggestions from staff. It evaluates
 Communication – Shares
and implements suggestions; it Laboratory creates mechanisms and
examples of the benefits of
provides feedback. (Clause 4.14.4) forums for communicating problems,
speaking up.
eg:
Assessors may identify the following
 Daily huddles. risk awareness.
weaknesses:
 Program of “management by  Reward – Recognizes those
 Instances where process and walking around,” where who speak up about
documentation do not match managers are problems.
due to workarounds (eg, staff encouraged/required to get  Rituals and Programs – Initiates
did not accept and follow the out of their offices and spend daily reporting strategies that
process, but did not speak up time with staff. encourage raising issues.
about it either).  Visible Leader Actions –
 Evidence that those who Leader takes prompt action
speak up are punished or based on suggestions and
discouraged from doing so. concerns.
 Lack of adequate.
mechanisms or forums for
communicating problems.
See CAP QMEd course

Quality Culture
Quality Culture Management shows evidence of Laboratory coordinates internal audits, Laboratory has a strategy for
commitment to continual root cause analysis, corrective action, sustaining and improving a culture of
 Going Above improvement. (Clause 4.1.2.1) and management review to find and going above and beyond, eg,
and Beyond implement opportunities for through:
Laboratory has overall strong improvement that go beyond
performance on CAP accreditation requirements.
who have ambition for going
inspection; it can show instances in
above and beyond.
which it goes beyond CLIA Laboratory uses internal audits in ways
 Communication – Provides
requirements. that go beyond standard
information about stakeholder
requirements – eg, focused audits to
priorities and needs.
Assessors may identify the following address a specific risk.
weaknesses:
topics such as mistake
Laboratory rewards and recognizes
 Few internally identified proofing.
individuals and teams for going above
occurrences.  Reward – Gives awards for
and beyond.
 Evidence that occurrences quality projects.
identified internally or  Rituals and Programs – Initiates
Laboratory communicates the
externally are viewed as programs that prompt
importance of meeting and
liabilities, or demerits. customer focus.
exceeding customer expectations.
 Internal audits are conducted  Visible Leader Actions –
inconsistently. Leader invests personal effort
 Evidence that staff have an on an improvement project.
attitude of doing the minimum
work required.
See CAP QMEd course

Quality Culture
Quality Culture Laboratory uses a communication Management demonstrates Laboratory has a strategy for
mechanism for reporting errors and awareness of the need to drive fear sustaining and improving a culture of
 Transparency near misses to management. (Clause out of the workplace and build trust transparency, eg, through:
4.1.2.6) between staff and
 Recruiting – Hires supervisors
supervisors/managers, eg, through:
with a reputation for
Laboratory analyzes reports of
 Communications. developing trust.
errors/occurrences for their potential
 Promoting the practice of  Communication – Emphasizes
to prevent future failures of work
Management by Walking the importance of driving out
processes; it uses error reports to
Around to reduce the distance fear.
improve processes. (Clauses 4.10, 4.11,
between staff and leadership.  Training – Teaches how to
4.14.6)
 Training programs (eg, Just address defects and mistakes
Culture). from a process-based and root
Assessors may identify the following
cause perspective.
weaknesses:
 Reward – Recognizes people
 Staff tell external assessors and who admit mistakes and speak
inspectors about quality issues up about problems.
that don’t appear in the  Rituals and Programs –
laboratory’s occurrence Encourages processes such as
management documents. daily status checks that create
 Staff display a “hiding errors” a supportive atmosphere for
mentality. bringing up defects and
 Staff are punished (eg, on mistakes.
annual reviews) or  Visible Leader Actions –
reprimanded for identifying Leader addresses errors and
errors. mistakes with process
 Laboratory has practices that investigation and process
put people on the spot and improvement.
make it difficult to admit
problems.
See CAP QMEd course

Quality Culture
Quality Culture Laboratory has identified and Processes are standardized and Laboratory has a strategy for
documented key processes. (Clause regularly evaluated for improvement. sustaining and improving a culture of
 Process 4.2.1) process orientation, eg, through:
Orientation Laboratory staff are trained on, and
 Recruiting – Seeks people with
Laboratory has a documented root employ, root cause analysis best
problem-solving skills.
cause analysis and corrective action practices (see Root Cause Analysis
 Communication – Stresses the
process. (Clause 4.10) section of this document).
importance of asking “Why did
it happen?” instead of “Who
Assessors may identify the following Assessors notice at least some of the
did it?”
weaknesses: following best practices:
 Corrective action reports focus  Daily operations and activities root cause analysis and
blame on individuals, rather can be traced to processes. mistake proofing.
than a system or process; they  When fire-fighting occurs, it  Reward – Recognizes teams
conclude that solution is to takes place in the context of who have analyzed and
“retrain employee(s).” an improvement process. solved complex problems.
 Many “quick fixes.”  Rituals and Programs – Initiates
 Daily activities are often Assessors notice decreased frequency occurrence management
responsive to immediate of repeat problems. tools and programs.
needs or problems – there is  Visible Leader Actions –
considerable “fire-fighting.” Leader initiates and directs an
 Once the fire has been put investigation.
out, there is no awareness of
further work that needs to be
considered on the issue (eg,
root cause analysis).
See CAP QMEd course

Quality Culture
Quality Culture Laboratory management: Management regularly involves staff in Laboratory has a strategy for
decisions that affect quality. For sustaining and improving a culture of
 Solicits and uses staff
 Teamwork and example, staff chooses the metrics teamwork and involvement, eg,
suggestions (Clause 4.14.4)
Involvement that show whether their work group is through:
 Recognizes interrelationships
doing a good job.
within the organization (Clause  Recruiting – Seeks people (eg,
4.1.2.5) medical director) with
Laboratory leadership provides a
 Communicates with all staff facilitation and leadership skills.
combination of training,
(Clause 4.1.2.6)  Communication – Stresses the
communication, and management
importance of treating
such that laboratory staff work
Assessors may identify the following everyone in the organization
effectively as a team.
weaknesses: with respect and appreciation.
 Training – Provides cross
 Staff have a low sense of Laboratory staff understand the goals
training and job rotation.
ownership. that the medical staff seek to
 Reward – Recognizes
 Staff have a “cog in the achieve.
individuals who initiate team-
machine” attitude, and take based/collaborative projects.
the attitude “I just do what I’m Laboratory staff take initiative and act
 Rituals and Programs – Lets
told.” assertively to promote quality.
staff lead huddles and other
 Staff look to supervisors and meetings, giving them
managers for answers and leadership roles.
solutions.  Visible Leader Actions –
 Managers rarely involve staff in Leader explains how
decisions, such as what quality management is advancing
metrics to use. the common purpose; leader
delegates when appropriate.
See CAP QMEd course

Quality Culture
Quality Culture Laboratory management: All staff proactively look for, and Laboratory has a strategy for
report, risks in the environment. sustaining and improving a culture of
 Provides training to all
 Risk Awareness risk awareness, eg, through:
personnel on the QMS,
Staff celebrate finding errors.
including risk management.  Recruiting – Asks interview
(Clause 5.1.5) questions about scenarios
Laboratory shows strong record of
 Applies root cause analysis involving risks.
compliance with policies, processes,
and corrective action  Communication – Makes
and procedures.
concepts to nonconformities, discussions of risk and safety a
including issues such as QC part of regular meetings.
Leadership uses mistake proofing to
failures and PT anomalies.  Training – Trains individuals on
take risks into account when revising
(Clause 4.10) how to resolve QC and/or PT
processes or developing new
failures.
processes.
Assessors may identify the following  Reward – Recognizes
weaknesses: individuals who identify risk in
the environment.
 Staff attribute events to  Rituals and Programs –
“random error.” Integrates risk management
 Managers tell staff to repeat a into your core processes, eg,
QC test that failed, and validation process; use 5S
proceed with testing if it is principles.
acceptable.  Visible Leader Actions –
 Delay in addressing known Leader directs staff to stop
risks. testing when QC or PT
 Safety issues (eg, cluttered anomalies arise.
work areas, wet floor).
 Disorder (eg, work flow
interrupted by clutter).
 Lack of attention to detail (eg,
signoffs missing, data in wrong
units).
See CAP QMEd course

Quality Culture
Document Control Laboratory has developed and Laboratory has deployed a user- Assessors do not encounter any
implemented a procedure to control friendly document control system. document control problems.
documents. (Clause 4.3)
 Staff are able to locate
The document control system uses
documents quickly.
Assessors may identify the following current technology to create
 Software is user friendly, or
deployment issues/weaknesses: efficiencies and prevent errors or
paper system is well designed.
oversights. For example, the system
 Cheat sheets that are not  There are terminals near work
sends review notifications and
controlled are posted in the areas, or binders near work
escalates action items.
laboratory. areas.
 Staff are not able to locate  Work aids/job aids are
controlled documents quickly. controlled (eg, through
 Outdated documents found in secondary document log).
circulation.
 Document control system is
difficult or time consuming to
use.
See CAP QMEd course

Document Control
Occurrence Laboratory has a system for Laboratory uses occurrence Occurrence management system
Management collecting and storing information management data to identify facilitates laboratory’s ability to
about errors and incidents. trends and anticipate problems.
 Explore data.
(Clauses 4.8-4.11)
 Detect trends.
Occurrence management system
 Compare past and present.
Laboratory has deployed an enables laboratory to take
 Compare different kinds of
occurrence management system, appropriate preventive measures.
occurrences (eg, internally-
has collected data, and has taken
identified versus externally-
actions based on collected data.
identified).
Assessors may identify the
Laboratory has occurrence
following weaknesses:
management tools that enable easy
 The system is organized to comparison of trends from different
gather data, not to analyze it. sources (eg, one database that
 There are many locations for contains occurrence information on
storage of data; the locations suppliers, customer complaints,
are not integrated, making it instrument generated data, PT failures,
difficult to compare data and etc).
find trends.
 The system tends to be used
for one-off fixes, rather than
development of proactive
plans to address multiple
issues, or issue trends.
 Laboratory sometimes reacts
slowly to issues; long closure
times.
See CAP QMEd courses:

 Root Cause Analysis
 Mistake Proofing
Root Cause Analysis Laboratory has a documented Laboratory uses a structured process Laboratory can show evidence that
and Corrective Action process for corrective action, for root cause analysis. problems have been solved
including conducting root cause permanently as a result of
analyses. (Clause 4.10) The root cause analysis and corrective investigation and root cause analysis.
action process incorporates at least
Laboratory has completed and some recognized best practices, eg: Laboratory demonstrates that it
documented multiple root cause understands and uses a variety of root
 Define problem first.
analyses. cause analysis tools (eg, Five Whys)
 Use a team.
and selects those that best fit the
 Understand as is/current state
Assessors may identify the following situation.
using process mapping.
weaknesses:
 Drill down to root cause using
Laboratory consistently integrates
 No structured process is used a tool such as Five Whys, Fault
change management tools (eg,
for root cause analysis. Tree, or Flowcharting.
Stakeholder Analysis) into
 One tool, such as Five Whys, or  Choose “stronger” solutions
implementation plans.
Fishbone diagram, tends to be such as process redesign over
used repeatedly, even when “weaker” solutions such as
Corrective actions employ mistake
another tool such as process training.
proofing tactics, such as eliminating
mapping may be more  Plan out implementation
mistake-prone steps, constraining the
appropriate. (including change
process to prevent slips, Lean and
 Detail of analysis is out of sync management).
visibility principles, checks, and alerts.
with complexity of problem –  Check for effectiveness of
usually too simple. implemented corrective
 Analysis tends to blame action(s).
individual(s).  Generalize the root cause
 Analysis yields simple solutions, analysis results – use them to
such as “operator error” or find and solve similar problems,
“need for retraining.” with similar causes.
 Analysis concludes with need
to “continue monitoring.”
See CAP QMEd courses:

 Root Cause Analysis
 Mistake Proofing
Internal Auditing Laboratory has a structure in place for Laboratory has maintained Internal audits have become part of
internal auditing (schedules, training, structure of program through the culture. Laboratory can provide
methodology, documentation, and multiple audit cycles. The structure examples of small-scale audits that
mechanism for following up on audit has become institutionalized. were conducted to address a specific
findings). (Clause 4.14.1, 4.14.5) issue, even though they were not part
Laboratory has demonstrated of the process audit schedule.
Laboratory has completed and consistency in following up on
followed up on at least its first round of audit findings. Laboratory management provides
audits. auditors with training and credentials
Findings from core process audits in areas such as Lean and Six Sigma.
Assessors may identify the following consistently address support Auditors apply Lean/Six Sigma
weaknesses: processes and systemic issues, principles to their audit work to
rather than just the specific core address process flow issues.
 Lack of concrete results from
process.
internal audit program.
Auditors play the role of consultants.
 Lack of adequate follow-up.
Note: The distinction between core Bench techs see auditors as partners
 Shallow, superficial, overly-
and support processes is as follows: and ask auditors how to improve
detailed/picky audit findings.
processes and detect problems.
 Use of the same audit  Core processes bear directly
schedule, and same on the product or service that
(continued on next page)
frequency of audits, regardless the customer purchases (eg,
of previous audit findings. preanalytic, analytic,
 Audits structured based on ISO postanalytic).
standard clauses rather than  Support processes support a
the laboratory’s processes. core process (eg, document
 Audits focused on detailed control, complaint handling,
procedures rather than corrective action).
processes.
 Lack of focus on customer and (continued on next page)
patient care.
See CAP QMEd course

Internal Auditing
Internal Auditing Laboratory has identified ways to Laboratory extends internal audits into
(continued) improve efficiency of the internal hospital.
audit process since first round.
Laboratory forms partnerships with
Laboratory analyzes findings and
Nursing, Radiology, etc. to conduct
adjusts audit schedule as
joint audits for issues where there is
appropriate.
common responsibility.
Actions taken as a result of audit
Laboratory is using tracer audits and
findings have improved efficiency
laser audits to address process issues.
and/or patient care.
Risk Management Laboratory has identified and Laboratory has assigned process Process owners have training in
addressed risks for any processes that owners to core processes for risk some/all of the following disciplines:
may affect patient safety (eg, assessment purposes.
 Root cause analysis
processes or software that have
 Internal Auditing
recently been installed or revised). Assessors notice at least some of the
(Clause 4.14.6) following best practices:  FMEA
 HACCP
 Laboratory uses PT and QC
Laboratory demonstrates process
activities to identify and
mapping capability.
address risks. Processes are routinely revisited and
 Laboratory analyzes internal reassessed.
Laboratory has an ongoing program
for risk management, as audit findings for risk level.
After addressing problems and risks,
demonstrated by examples of laboratory monitors process variability
documented risk analyses and Once a risk is identified, and continues to address or reduce
mitigation strategies. investigated, and addressed, the as much as possible until 1) only
laboratory applies corrective or common cause variation remains, or
(continued on next page) preventive actions across other 2) there are economic or technology
work areas where the same risk constraints to lowering variability any
may occur. further. Laboratory uses process
variability to assess risk.
See CAP 15189

document
Risk Assessment Guide
Risk Management Assessors may identify the following Risk management is incorporated into
(continued) weaknesses: the organization’s culture, decision
making, policies, and procedures. The
 Lack of assessment of QMS provides guidance that
probability and severity for addresses:
identified risks.
 Lack of root cause analysis for  Organizing risk assessment
identified risks. projects.
 Lack of follow-up on identified  Carrying out risk assessment
risks, such as not taking action (identification, analysis, and
to mitigate the risks or not evaluation).
tracking the effectiveness of  Taking action to mitigate risk.
mitigation strategies.  Verifying effectiveness.
 Laboratory missed obvious risks  Monitoring.
(eg, dirty areas, poor testing  Maintaining documentation.
habits, odors/fumes).
Laboratory associates risks with
costs, using Cost of Quality
concepts, and develops business
case for prevention projects
based on projected internal and
external failure costs.
Laboratory demonstrates
thorough risk analysis in Section 1
of IQCP plans for its tests.
Continual Improvement Laboratory has a process for Laboratory looks for Laboratory works in partnership with
investigating alternative methods improvements in all areas, equipment vendors to transform both
in order to improve quality including: process flow and hardware.
measures. (Clause 4.12)
 Equipment.
Laboratory uses mistake-proofing as
 Work methods that
Assessors may identify the part of continual improvement.
may impact patient
following weaknesses:
safety and/or testing
Laboratory uses methodologies like
 Many procedures are personnel.
Lean to discover more effective work
outdated, as evidenced by  Test methods.
processes.
approval dates, indicating that
the laboratory has not
Laboratory uses Cost of Quality
explored and implemented
methodology to justify improvement
alternatives.
projects (eg, by projecting internal
 Laboratory equipment is in
and external failure costs).
need of replacement.
 Laboratory makes incremental
Laboratory assigns people to keep
improvements, but nothing
aware of new/changing technologies
that transforms the way work is
to stay current with industry practices
done.
(eg, attend AACC meetings).
 Improvement records may list
Human Resources projects (eg,
In developing process documents,
new lunch room) rather than
laboratory uses structured writing
laboratory process
techniques such as outlined in CLSI
improvements.
guideline QMS02-A6: Development
and Management of Laboratory
Documents. Documents are easy to
read, navigate, and scan.
Competency and Laboratory has a documented Laboratory identifies key Laboratory initiates “shadowing”
Personnel Development procedure for personnel departments and functions programs with other key departments
management and maintains outside of the laboratory that that laboratory interacts with. For
records to ensure compliance with are critical to performance example, laboratory technologists
regulations. (Clause 5.1.5) (eg, ER specimen collection), shadow ER nurses collecting
and ensures that laboratory specimens. Floor nurses shadow
Laboratory ensures that tests are personnel understand how accessioners sorting specimens.
performed by competent they work. Laboratory provides
personnel. (Clause 5.1.2) training in “the big picture.” Laboratory ensures mutual
understanding of key processes
Continued on next page Laboratory seeks to identify among members of interacting
best practices and sources of departments.
specialized knowledge, and to
provide access to them for
everyone who can benefit.
Laboratory seeks out and

incorporates best practices
and specialized knowledge
from outside the laboratory.
Competency and Assessors may find the following

Personnel Development weaknesses:
(continued)
 Laboratory personnel have
tunnel vision; they do not have
adequate knowledge of what
happens outside the
laboratory.
 “Silos” or pockets of
knowledge and skill exist within
the laboratories that are not
shared with the rest of the
laboratory.
 The laboratory rarely goes
outside its walls to identify new
ideas and best practices that
are worth incorporating.
 Laboratory only collects
negative data (eg,
complaints). It does not use
surveys or other sources that
provide both positive and
negative feedback.
Customer Satisfaction/ Laboratory collects customer 1. Laboratory has effective Laboratory encourages customers to
Alignment with Customers satisfaction (both internal and system for organizing, provide feedback and suggestions
external) data using a survey. analyzing, and acting on that go beyond annual surveys.
Customer survey data is discussed customer satisfaction data.
in management review meetings Laboratory actively solicits and
 System incorporates
and generates action items. encourages suggestions for
complaints, comments
(Clauses 4.14.3 and 4.15.2) improvements, new products, and
received by sales
training programs.
team, and operational
Assessors may identify the
metrics.
following weaknesses: Laboratory treats customers as
 Laboratory
business partners.
 Little or no follow up on demonstrates clear
customer complaints. alignment between
Customer-centric metrics are used to
 Survey is high-level and not customer satisfaction
manage organizational performance.
specific in terms of who was surveys/metrics and
Laboratory seeks to understand
surveyed, and where they are operational metrics.
reasons for low customer
located.
satisfaction scores and makes
 Laboratory glosses over Management review meeting
appropriate adjustments.
problems because documents reflect prompt and
percentages are low, even thorough follow-through on
though absolute numbers action items.
show a potential problem.
Laboratory seeks to
understand reasons for
dissatisfaction, even if the
percentage is low; it pays
attention to absolute numbers.
Management Review Laboratory uses a structured process Management review records Laboratory management analyzes
for reviewing its QMS to ensure its demonstrate the use of information for causes of issues
continuing suitability, effectiveness, meetings to facilitate that indicate core process
and support of patient care. (Clause processes for: problems.
4.15)
 Issue identification –
Problems with core processes lead
from both internal and
Laboratory uses these meetings to the laboratory to investigate
external sources.
integrate information and “connect support processes.
 Investigation – with
the dots” regarding the core
adequate root cause
processes of its QMS. Laboratory management ties
analysis.
together trends and disparate
 Action item tracking
Laboratory has identified metrics that elements, such as:
and follow-up.
are consistent with quality policy and
 Achievement of  Customer satisfaction
objectives. Laboratory is in the process
positive results.  TAT
of gathering and monitoring data.
 Draw time
Laboratory uses these analyses to find
leading indicators of quality issues.
Management looks for unintended

consequences of individual changes
(eg, speeding up collection causes
missed orders). Management uses line
graphs to detect such patterns.
See CAP QMEd course

Management Review
Management Review Assessors may identify the following Management Review:

(continued) weaknesses:
 Focuses on QMS core
 Metrics are monitored but no processes, with high-risk
action is taken when issues or aspects discussed/
trends are identified. reviewed during every
 Action items are inadequately meeting.
addressed (eg, “Continue to  Integrates information
monitor”). from multiple sources
 Root cause analysis is (eg, audit results,
inadequate. complaints, and
 Laboratory reaches no research on new
conclusion about overall QMS technology).
effectiveness and its  Brings in the right
contribution to quality patient people to participate
care. in the meetings (eg,
staff, admins, and
vendors) to make
decisions on a specific
issue).
 Sorts and prioritizes
issues – separates out
those that require
action.
Quality Manual Manual contains necessary Manual describes the quality Manual shows link of quality policy,
elements required by standard management system in terms quality objectives, and metrics.
(eg, quality policy, scope of of processes, using process
services management structure). maps or stage tables of core In depicting processes, manual uses
(Clause 4.2.2.2) and support processes. structured writing standards such as
CLSI guideline QMS02-A6:
Assessors may identify the Manual is used for the Development and Management of
following weaknesses: following purposes: Laboratory Documents.
 Manual is either not accessible  To train and orient new
by all staff members and/or is people.
not used by anyone other than  To explain how the
the quality manager for laboratory works; to
purposes of accreditation point to key documents
visits; it sits on the shelf. and procedures.
 Manual is unnecessarily long,  To provide internal and
containing information that is external auditors with
of little or no benefit to an overview of the
defining the laboratory’s laboratory’s quality
quality management system management system
(eg, procedures that should be that is useful for
in SOPs, or that are also in planning audits.
SOPs; policy statements written
to address each clause of the
ISO 15189 standard).
See CAP QMEd course

Quality Manual
Summary of Maturity Ratings
QMS Maturity
Summary.xlsx
You can use the embedded Excel table to create a summary of your self-ratings.
Here is an example of such a summary:
Laboratory Comments on Key Areas of Improvement:

2018 Qms Maturity Assessment Tool

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2018 Qms Maturity Assessment Tool

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CAP 15189SM – QMS Maturity Assessment Tool

© 2018 College of American Pathologists. All rights reserved.

Here are descriptions for the three levels of maturity:

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Note on Maturity versus Accreditation:

Note on Relevant QMEd Courses:

For more information, go to cap.org and search QMEd.

See CAP QMEd course

See CAP QMEd course

See CAP QMEd course

See CAP QMEd course

See CAP QMEd course

See CAP QMEd course

See CAP QMEd course

See CAP QMEd course

See CAP QMEd courses:

See CAP QMEd courses:

See CAP QMEd course

(continued on next page)

See CAP 15189

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Laboratory seeks out and

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Competency and Assessors may find the following

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Management looks for unintended

See CAP QMEd course

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

Management Review Assessors may identify the following Management Review:

Level 1 – Basic Level Level 2 – Fully Functional Level 3 – Best Practice

See CAP QMEd course

Summary of Maturity Ratings

Laboratory Comments on Key Areas of Improvement:

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