QUALITY MANAGEMENT SOLUTIONs

Our mission is to Improve and Enhance the Quality

and Delivery of Healthcare Services in the World
through Effective Collaboration with Each Client
to Design and Implement
their
Customized Quality Management System
SOLUTION.
 Our vision is to become recognized as the
Healthcare Consulting firm of choice
to design and implement Medical Laboratory
Quality Management System
SOLUTIONS.
Accuracy
Respect
Collaboration: Our consulting is collaborative and our Architects SOLUTIONS are
applied upon each Clients strengths within an appreciative inquiry model.
Honesty
Innovation: Our Architects infuse innovation and creativity, through new, focused,
evidence-based, and consistent Quality Management, into each and every
SOLUTION that is created.
Teamwork
Excellence: Our consulting methods and SOLUTIONS are infused with excellence,
quality, consistency, and strict attention to detail.
Confidentiality: Our Healthcare SOLUTION Architects have lived and breathed
Quality and Confidentiality their entire careers.
Truthfulness
SPENALEX SOLUTIONS based in Ontario, Canada.
Robert D. Scheuermann:
President & Principal SOLUTION Architect
Sustainable Quality Management Systems
Healthcare Budgets and Business Cases
Laboratory Operation Management
Quality Performance Indicators
Occurrence/Defect Reporting and Management
Policy, Process, Procedure & Forms Development & Control
Quality Assurance Program Development
Manual & Automated Method Validation
Training and Development of Quality Strategies
Effective Blood Utilization Strategies
Laboratory and Blood Transfusion Safety
Laboratory Management Succession Planning
To Chair Advisory Boards and Working Groups
OUR NEWEST website holds the documents you need
available at: www.ISO15189MedLabManual.com to help
you become ISO 15189 certified.
A quality manual is just a huge book of
documents in written or electronic form.
A quality management system is the complete
network of documents in ACTION. A process-
based QMS is a network of many interrelated and
interconnected processes (elements)
Your quality management
system does not sit on your
shelf, nor does it live inside your
computer.
Any business shall operate efficiently and effectively if it meets
regulatory requirements and is managed with the interests of
stakeholders, while continually striving to improve its performance
by means of a quality management system. It is important to
identify (audit), measure, analyze, improve, and communicate those
instances where practice does not comply with the quality
management system and/or documented operational policies,
processes and procedures (problem identification). Documents
and records shall be controlled, contracts reviewed, and referral
services managed.
A process is any series of actions or
operations viewed as a whole, with a
defined start/input and a finish/output.

A procedure is a series of actions or

operations viewed as discrete steps.
Policy What to Do

Process How it Happens

Procedures How to Do It

Forms Records
Hierarchy of Documents
The International Organization for Standardization (ISO) was
established in 1947 and since then as been developing voluntary
technical standards over sectors of business, industry and
technology. The work is conducted by a worldwide federation of
national standards bodies from more than 140 countries.
With the exception of ISO 9000 and ISO 14000, the vast majority of
ISO standards are highly specific and technical in nature. The ISO
9000 series was first published in 1987, and was the first ISO
document to focus on management principles for a much wider
business community. In 2000, the series was rewritten.
It consists of three basic documents:
ISO 9000:2005. Quality management systemsFundamentals
and vocabulary
ISO 9001:2008. Quality management systemsRequirements
ISO 9004:2000. Quality management systemsGuidelines for
performance improvements
The concept of a quality management system is based on principles
described in ISO 9001:2008, Quality management systems
requirements.
It describes eight quality management principles that can be
applied to any business or service.
Five hundred thousand organizations are already registered to ISO9001.
1 basic element that must apply to each and every component
of your Quality Management System:

"SAY what you DO - then, DO what you SAY you DO

Each & Every time without exception!"

Therefore, all personnel and other stakeholders that use the

QMS must be educated to every part of the Quality
Management System that they are responsible for.
A document specifying the quality management system of an
organization.
(However, the structure and setup of an organizations Quality manual
can diverge from the ISO QMS standard format to take into
consideration the size and complexity of an individual organization.2)
ISO 9001:2008 contains the following clause (4.2.2) regarding the
quality manual:
The organization shall establish and maintain a quality manual that
includes
a) The scope of the quality management system, including details of and
justifications for any exclusions;
b) The documented procedures or reference to them;
c) A description and interaction between the processes of the QMS.3
The following points should be considered when creating a
quality manual:
1. A Quality Manual describes an organizations quality
management system QMS) through a series of policies and
processes.
2. A Quality Manual is the basis for all operations and, therefore,
must provide a thorough description of an organizations system.
3. The expected length is from 30-70 pages although this could
vary depending on the size and scope of the facility, and the
amount of information a facility chooses to include.
4. It will usually include management processes, but does not
usually include any technical procedures. Standard Operating
Procedures are referenced where appropriate.
5. It is a road map to the rest of a laboratorys documentation,
and will refer to a myriad of supporting documentation:
procedures (work instructions), records, forms, charts, aids, etc.
6. Some of the supporting documentation may be within the
manual or included as appendices, but usually it will be kept
elsewhere. The quality manual should indicate where supporting
documentation can be found by electronic file ID (hyperlinked if
possible).
7. The medium can be either electronic or paper.
8. It must be easy for authorized personnel to update and easy
for staff to access.
9. Typically, it is maintained and reviewed by a quality manager.
10. Everyone in the organization must be encouraged and have
the ability to provide input into the development of the quality
manual.
11. It is essential for the entire staff to be educated and trained
to fully understand and use the Quality Manual and its related
documentation
Procedure Development
Identified from process mapping
Templates developed based on ISO
guidelines

Develop Standardized templates for all areas

of operations to use
Document Management System
Create
Identify
Change
Approve
File
Distribute
Archive
Customer Satisfaction
Feedback from Stakeholders
Principle 1: Customer Focus
Principle2: Leadership
Principle 3: Involvement of People
Principle 4: Process Approach
Principle 5: System Approach to Management
Principle 6: Continual Improvement
Principle 7: Factual approach to Decision Making
Principle 8: Mutually Beneficial Supplier Relationships
Principle 1: Customer Focus
Organizations depend on their customers
Key Benefits:
Increased revenue and market share obtained through
flexible and fast responses to market opportunities
Increased effectiveness in the use of the organizations
resources to enhance customer satisfaction
Improved customer loyalty leading to more interactive
and collaborative projects, working groups, etc.
Principle 2: Leadership
Leaders establish unity of purpose and direction
Key Benefits:
People will understand and be motivated towards the
organizations goals and objectives
Activities are evaluated, aligned and implemented in a
unified and collaborative way
Miscommunication between levels of the organization will be
minimized (eg. MOH-LTC, Coordinators, Field Officers,
Regions) within defined and agreeable parameters of action
Principle 3: Involvement of People
People at all levels are the essence of the organization
Key Benefits:
Empowerment and involvement of all personnel in an
organization lends itself to a more motivated and
committed team
Innovation and creativity in furthering the organizations
objectives is fostered in this type of culture
People being accountable for their own performance
People being eager to participate and contribute to
continual improvement
Principle 4: Process Approach
A desired result is achieve more efficiently when activities and
related resources are managed as a process
Key Benefits:
Lower costs and shorter cycle times through
effective use of resources
Improved, consistent and predictable results
Focused and prioritized improvement activities
Process review is more focused within RCA groups
Principle 5: System Approach to Management
Identifying, understanding and managing interrelated
processes as a system contributes to the organizations
effectiveness and efficiency in achieving its objectives.
Key Benefits:
Integration and alignment of the processes that will best
achieve the desired results
Ability to focus effort on the key processes
Providing confidence to interested parties as to the
consistency, effectiveness, and efficiency of the
organization
Principle 6: Continual Improvement
Continual Improvement of the organizations overall
performance should be a permanent objective of the
organization
Key Benefits:
Performing advantage through improved organizational
capabilities
Alignment of improvement activities at all levels to an
organizations strategic intent
High-Performance organization is confident in its actions and is
Flexible to react quickly to opportunities
Principle 7: Factual Approach to Decision Making
Effective decisions are based on the analysis of data and
information
Key Benefits:
Regular feedback from stakeholders allows Informed
decisions to be made based on data analysis
An increased ability to demonstrate the effectiveness of
past decisions through reference to factual records
Increased ability to review, challenge and change
opinions and decisions in a participative model
Principle 8: Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and
a mutually beneficial relationship enhances the ability of
both to create value
Key Benefits:
Increased ability to create value for both parties
Flexibility and speed of joint responses to changing
market or customer needs and expectations
Optimization of costs and resources
ISO 17025:2005 (General requirements for the competence of testing and
calibration laboratories) and
ISO 15189:2007 (Medical laboratories - Particular requirements for quality and
competence) are more technical documents written specifically for laboratories by
international committees.
ISO22870:2006 Point-of-care Testing (POCT) Requirements for Quality and
Competence
Example:
The OLA Program Requirements are based on ALL of the laboratory ISO
standards: ISO 17025:2005 and ISO 15189:2007, & ISO 22870:2006, which
emphasize quality management system implementation.
In addition, further requirements were added based on Ontario law. Also
included were requirements that represent generally accepted principles
of good laboratory practice, usually consensus guidelines from
professional societies and institutes.
Ontario is the first and only North American
Accreditation Authority to assess Medical Laboratories
against ISO 15189:2003. To date, Ontario Laboratories
demonstrate that they can meet this rigorous
international standard (QMP-LS.org, 2005).
Version 4 of the QMP-LS Supporting References for
Guidelines was released in December 2007 in response to
ISO 15189:2007 (Appendix 1: References for OLA
Requirements).
OLA is responsible for setting and maintaining
accreditation criteria (requirements) for Ontario's licensed
medical laboratories. Accreditation requirements are
based on the following International Organization for
Standardization (ISO) standards:
ISO15189:2007 Medical Laboratories Particular
Requirements for Quality and Competence
ISO15190:2003 Medical Laboratories Requirements for
Safety
ISO22870:2006 Point-of-care Testing (POCT)
Requirements for Quality and Competence
Caribbean, May 1, 2006:
Senator the Honourable Dr. Bernard Nottage praised Caribbean
countries for making positive and progressive steps in healthcare on
Monday, May 1, 2006.
It is intended to assure both Caribbean nationals and those from
outside the region that the same quality control and accuracy can be
obtained from our national and regional laboratories whether in
Bermuda, Belize, The Bahamas, Barbados or Anguilla and Barbuda as
from first world laboratories (Nottage, 2006).
He added that they will be adept in budgeting, laboratory design,
workplace safety, writing skills and communication and all the other
requisites from the proper functioning of a first class facility which
will be quite an achievement and long overdue (Bahamas Information
Services, 2006).
 ISO and the Ontario Laboratory Accreditation (OLA) programs
Quality Management System have based the requirements for
Organization/Personnel/Lab accreditation on twelve QSE:
Management
Physical Facilities
Path of Workflow
Equipment/Reagents/Purchasing Pre-Analytical to Analytical to Post
/Inventory
Pre-Analytical
Analytical
Analytical & Quality Assurance Quality system essentials apply to all
Post Analytical/Process Control
operations in the path of workflow
Laboratory Information System
Safety
Point of Care Testing
PURPOSE This procedure gives instructions

POLICY

EQUIPMENT

MATERIALS

SPECIMEN

SPECIAL SAFETY

QUALITY CONTROL

PROCEDURE

LIMITATIONS

INTERPRETATION

CALCULATIONS

REFERENCE RANGE

RESULTS REPORTING

REFERENCES

RELATED DOCUMENTS

APPENDICES
Quality Control: Corrective Action
External and Internal Quality Assurance
Turn Around Time (TAT) delay
Discrepant Results
Corrected Results
Specimen Rejection Criteria
Medical laboratory services, including appropriate interpretation
and advisory services, shall be designed to meet the needs of
patients and all clinical personnel responsible for patient care. The
laboratory's organizational structure, organizational plan, and
policies shall provide the framework to meet the needs of patients
and all personnel responsible for patient care. Laboratory
management shall consist of those persons (headed by the
laboratory director)who manage activities of the laboratory and are
accountable to the parent facility. Laboratory management shall
ensure that personnel policies (including training, assessment, and
continuing education) and job descriptions define the qualifications
and duties for all personnel.
This QSE addresses managements
commitment to quality. As well as
developing a mission and vision
statement, management must
take a leadership role in
developing policies and supporting
the planning and implementation
of each QSE.
Laboratories require: clearly-defined job
qualifications; job descriptions; and processes
for selection, orientation, training, competency
assessment and performance
development plans in order to obtain
and retain the highly qualified
personnel.
The laboratory's physical facilities shall support its
activities. The laboratory space shall be allocated so
that its workload can be performed without
compromising the quality of work, safety of
personnel, and patient care services. Laboratory
design shall optimize the comfort of its occupants.
Processes for selection (purchasing), use (inventory
control), and records of purchased external services,
equipment, and consumable supplies shall be defined
as they affect the quality of the service.
The laboratory should state the quality expectations
for the equipment that is used. In addition to
manufacturers instructions for calibration,
maintenance and use, the laboratory must follow any
regulations and accreditation requirements.
Specified processes for using and
troubleshooting equipment as well as
obtaining service and retiring equipment
is required.
Critical supplies and services must be identified
and criteria for quality must be established with
vendors. These activities are conducted in
partnership with the purchasing department.
Processes for
purchasing, receiving purchased
items and for managing inventory
must be in place.
The laboratory shall identify and document pre-
analytical processes.
Each discipline must identify and define all the
processes in its operation. For each step in the process,
well-written procedures that are understood and used
by staff are key to ensuring consistent performance.
The Laboratory should use appropriate quality control
measures to detect errors and process controls where
required to prevent errors.
Analytical processes shall be defined to meet
the needs of users and shall be documented.
Quality assurance (internal quality control and
inter-laboratory comparisons such as external
quality assessment) shall provide adequate
confidence that laboratory
examinations fulfill the requirements for
quality, and records shall be maintained.
Examples are:
Quality Indicators
Internal & External QA
Internal Audits
Management Review
Reporting processes shall be defined in accordance
with patient care needs and regulations.
Process Improvement
Quality Improvement Activities
Occurrence management
Problem Solving
Process Mapping
Address the path of workflow
Describe how things happen here
Flow Charts or Tables
What Whos Procedure or Results
Happens? Responsible? Another
Process
Lean Thinking Techniques
Process Excellence is the proven way to reduce error rates, cut
costs, raise productivity, increase capacity, and improve customer
satisfaction.
It combines the tools and methodologies of:
Six Sigma measuring and reducing your error and defect rate.
Lean eliminating waste to speed your workflow and deliver
better value.
Design Excellence designing a process from the outset so that
it flows efficiently with minimal opportunities for waste or error
(Orthoclinical.com, 2008).
The laboratory information system (LIS) shall
facilitate laboratory services and its processes shall
be identified and documented.
The employer shall ensure that the safety and health
of employees, patients and visitors are protected.
Laboratory management shall assess risk and
implement a
Safe-working environment in compliance with
regulations and good practice. Laboratory
management shall be familiar with applicable safety
laws and consult
reference documents for additional guidance.
Point-of-care testing (POCT) is testing of samples
taken from a patient and performed at or near the
bedside with the result leading to possible change in
the care of that individual.
References:
1. Quality Management Program Laboratory Services. Aug 11, 2006.
Guidance for Laboratory Quality Manuals, Version 3. Retrieved from the
Internet September 8, 2008 and is available at: www.qmpls.org/ola/
2. CAN/CSA-ISO 9000-0 (ISO 9000:2000). Quality Management Systems
Fundamentals and Vocabulary. December 2000; 3.7.4:14.
3. CAN/CSA-ISO 9001-00 (ISO 9001::2000) Quality Management
SystemsRequirements. December 2000; 4.2.:2:3.
Interview & Listen
Preliminary Self-Assessment
Critical Needs/GAP analysis
Map Processes
Write procedures
Quality Manual
Communicate/Educate/Train
Audit
Possibly Accreditation
Several Quantitative ($) and Qualitative ()
R.O.I.
1. Increasing Staff Productivity ($ )
2. Reduction in Waste: Time & Energy ($ )
3. Reduction in Operational Expenses! ($ )
4. .
Sustainable Quality Management Systems are easily
within reach of any Laboratory operation.
A Quality Team consistently reviews and audits Quality
Indicators, External Quality Assurance, Occurrence
Management, etc. to maintain the right path forward.
The framework developed via the QMS captures opportunities
for additional improvements and allow you to make evidence-
based decisions. The data is extractable to reward and
recognize your staff as well.
During the peer assessment visit, assessors look for conformance to all
requirements. A non-conformance is categorized as either major or minor.
A minor non-conformance is non-fulfillment of any requirement to a minor
degree, or an isolated incident of non-conformance. Minor non
conformances are assessed when adherence to requirements and/or the
laboratory policies/processes/procedures that address them, is
inconsistent. A major non-conformance is non-fulfillment of any
requirement to a major degree or consistent/persistent incidence of non-
conformance. Major non-conformances are assessed when patient safety
is impacted, existing protocols fail to address a requirement, procedures
are consistently not followed, and/or there is repeated incidence of non-
conformance in the majority of sections of the laboratory.
What are your thoughts?
What are some challenges to Implementation?
What are some positives you can visualize?