strategy for iso 15189.2012.pdf

8/10/2019 Strategy for ISO 15189.2012.pdf

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I I 15189:2012

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What isWhat isWhat isWhat isQualityQualityQualityQualityManagement?Management?Management?Management?

Quality Management is a systematic

approach to organizationalimprovement.

Todays Quality Management Systemsare the end product over 100 years ofknowledge and experience

Quality Management Systems provide a composite approachto address and protect :

Organization Management StaffSuppliers Customers PartnershipsInstitutions Community Environment

from the hazards and risks associated with faulty andinconsistent practices which result in dissatisfaction,unacceptable outcomes.


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WhyWhyWhyWhyQualityQualityQualityQualityManagement?Management?Management?Management?

The benefits of an active Quality

Management System are toopowerful to disregard.

A structured approach toorganization and management

More knowledgeable and effectivemanagement

More knowledgeable andcohesive staff

Organizational harmony andculture More effective and efficient

delivery of product and service

Fewer errors (especially repeaterrors!)

Reduced cost and Increasedsavings

Greater management and staffsatisfaction

Greater customer satisfaction Greater community satisfaction Reduced risk Reduced liability


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I 9004:2009

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9001

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What isWhat isWhat isWhat isISOISOISOISO

15189:2012?15189:2012?15189:2012?15189:2012?

I 1994

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What isWhat isWhat isWhat isISOISOISOISO15189:2012?15189:2012?15189:2012?15189:2012?

I (I)

15189:2003 :

.


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Why AdoptWhy AdoptWhy AdoptWhy AdoptISOISOISOISO15189:2012?15189:2012?15189:2012?15189:2012?

ISO 15189 has many positive

features:

It was developed by representative from33 different countries representing regions

across all continents (except Antarctica).

It has been embraced in total or in part by medical laboratories in morethat 55 countries.

It is written consistent with internationally accepted precepts of QualityManagement.

It is consistent with the common practices accepted by medicallaboratories.

It is consistent with accreditation body requirements for Qualityeverywhere in the world.

ISO requires regular review and if appropriate, refreshment, every 5

years


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How toHow toHow toHow to

AdoptAdoptAdoptAdoptISOISOISOISO

15189:2012?15189:2012?15189:2012?15189:2012?

The following principles applyto adopted any voluntaryQuality Management standard:

1. Read the document.2. Does it meet your needs?

3. Perform a Gap Analysis4. Prepare the Laboratory5. Develop an implementation plan

6. Repeat the Gap Analysis?7. Determine your state of readiness8. Make the Accreditation decision9. Commit to the standard


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A1. Read the document.

2. Does it meet your needs?3. Perform a Gap Analysis4. Prepare the Laboratory

5. Develop an implementation plan6. Repeat the Gap Analysis?7. Determine your state of readiness

8. Make the Accreditation decision9. Commit to the standard


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A

1.Read the document.


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1. Read the document.

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A

2. Does it meet your needs?


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2. Does it meet your needs? A :

IE: Count on 2-5 person-years of time

EFF

EEG Many decisions and changes will be made

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A C.


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2. Does it meet your needs? A

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A

3. Perform a Gap Analysis


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3. Perform a Gap Analysis . E D C

PLAN

DO

STUDY

ACT


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3. Perform a Gap Analysis . E D C

PLAN

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STUDY

ACT

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A?

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EstablishEstablishEstablishEstablishNextNextNextNextStepsStepsStepsSteps


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A?

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FORMAL TRUE REVIEW

MEASURE PERFORMANCE

PROVIDE REPORT

PROVIDE RECOMMENDATIONS


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A?

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REQUIREMENTS

ASSESSED

REQUIREMENTS

MET

120 11092%


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A

4. Prepare the Laboratory


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80

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Information

Education

Guidance

Culture


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Information

Education

Guidance

CultureChange

Progress Reports

Timetable

Continuing

Education and

DialogueLeading through

Shared

Responsibilities

Developing a

Culture of Quality


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Lunch and Learn Seminars

Discussion ProgramsInternal Speakers

Invited Speakers

Workshops and Conferences

Educational Postings

NewslettersBlogs

Twitter


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1. A measurable pattern of such collective behaviors andassumptions that people share within an organization.

2. The meanings that the people attach to their actions

3. Organization values, visions, norms, working language,

systems, symbols, beliefs and habits.

4. Organizational culture affects the way people and groups

interact with each other, with clients, and with stakeholders.

5. The pattern of behaviours and values that are taught to new

organization members.


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C

Practiceof Quality

Cultureof Quality


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:1. If you are running a successful laboratory, you likely only need

fine tuning rather than an overhaul.

2. The concept of Meet or Exceed standards is NONSENSE.3. When writing procedures, write down WHAT YOU ARE DOING

and not WHAT YOU WANT OTHERS TO THINK WHAT YOU

ARE DOING.4. If there is a HARD WAY and an EASY WAY, do it the EASY WAY.

5. The point of the exercise is to build a SUSTAINABLE CULTURE

that will support SUSTAINABLE PRACTICES.


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5. D I :1. Policies, Mission, Vision

2. Quality Indicators (Measurement tools)

3. Document Creation and Document Control

4. Supply Management

5. Physical Plant

6. Equipment

7. Quality Control routines (including Measurement Uncertainty)

8. Personnel training and competencies

9. Proficiency testing

10. Management Review


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A

5. Develop an implementation plan


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5. D I

,

.

.

Fine tune the

Minor Deficiencies

Keep Everyone informed about Progress

Stick to the Plan


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G C 1 2 3 4 5 6 7 8 9 10 11 12 13 14

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2 EIE I I2 I2

3 DC EIE E DC A

4 EIE IE CAC IE

5 IK COUNTERS

6 EIE EIE

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10 GAHE E EIED F AAGEE EIE WRITE MR

11 DEE AD I ABA AFE A

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A

6. Repeat the Gap Analysis?

7. Determine your state of readiness


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A?

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REQUIREMENTS

ASSESSED

REQUIREMENTS

MET

120 110

92%

85%


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7.

?

Have a Gap Analysis measure of meeting 90 % plusof requirements and NO major deficiencies.

On a process level

Going to full accreditation mode is not a major orimmediate priority.


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A

8. Make the Accreditation decision


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8. A DDo you want Quality or Accreditation or Both?Do you want Quality or Accreditation or Both?Do you want Quality or Accreditation or Both?Do you want Quality or Accreditation or Both?

.


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8. A DDo you want Quality or Accreditation or Both?Do you want Quality or Accreditation or Both?Do you want Quality or Accreditation or Both?Do you want Quality or Accreditation or Both?

External Assessment

Recommendations

Positive Support

UpdatesSupport Commitment

Validation

Confirmation

CertificateExternal Point of View

External Timetable

Cost

ACCREDITATION IS A VALUABLE PROCESS THAT CONTRIBUTES

GREATLY TO QUALITY, BUT IT IS NOT A UNIVERSAL REQUIREMENT

FOR ALL MEDICAL LABORATORIES IN ALL COUNTRIES

A


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A

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75 I9001:2000

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A

9. Commit to the standard


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9. C B

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E I

I15189:2012, :

1. What is the purpose off the clause

2. How would you implement the clause

3. How would you accomplish the clause

4. How would you document the activity.


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4.2.2.2 The laboratory shall establish and maintain a quality manual that includes:

a) the quality policy (4.1.2.3) or makes reference to it;

b) a description of the scope of the quality management system;c) a presentation of the organization and management structure of the laboratory

and its place in any parent organization;

d) a description of the roles and responsibilities of laboratory management

(including the laboratory director and quality manager) for ensuring compliancewith this International Standard;

e) a description of the structure and relationships of the documentation used in the

quality management system;f) the documented policies established for the quality management system and

reference to the managerial and technical activities that support them.

All laboratory staff shall have access to and be instructed on the use and

application of the quality manual and the referenced documents.


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CAE I ADAD

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A QUALITY MANUAL IS NOTALWAYSA BOOK

POLICIES DO NOT HAVE TO BE

WRITTEN IN PARAGRAPHS IFOTHER FORMATS ARE EASIERTO UNDERSTAND:

FLOW CHARTSPICTURES

AUDIO CLIPSVIDEO CLIPS

POLICIES NEED REGULAR

REVIEW AND DOCUMENT

CONTROL

I 15189 2012


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I 15189:2012:

4.14.5

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For a copy of theInternal Audit Master

form

visit

www.POLQM.ca

I 15189:2012


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I 15189:2012

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I 15189:2012

4.14.7

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For a copy of theQuality Indicator

Worksheet

visit

www.POLQM.ca

I 15189:2012


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I 15189:20125.1.6

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