ISO 15189:2012Medical laboratories-

Requirements forQuality and competence

นางสุขใจ ผลอําไพสถิตย30 กรกฎาคม 2557

•เตรยีมความพรอ้มในการขอรบัรองISO 15189:2012

ปี 2558

Summary of changes• Improved layout & listing of subclauses• More logical ordering of subclauses• Two new normative section (5.9 and 5.10)

-5.9 Release of results ( 5.8 split into 5.8 & 5.9)-5.10 Lab Information Management (New section)

• Additional detail, no change of intent to therequirements

Reference: Gap analysis of ISO 15189:2012 &ver. 2007 (NATA); issued 2013

Summary of changes (2)• Title : Medical laboratories-Requirements

for quality and competence• Definitions

- 19 (2007) and 27 (2012) definitions- (7) removed: accuracy to measurement ,uncertainty etc.- Additional 15 definitions: alert interval,nonconformity, process etc.

• ISO 15189:2007• ขอ้กาํหนด 4.1-4.15• ขอ้กาํหนด 5.1-5.8

• ISO 15189:2012• ขอ้กาํหนด 4.1-4.15• ขอ้กาํหนด 5.1-5.10

• ISO 15189:2012• ขอ้กาํหนด 4.1-4.15• ขอ้กาํหนด 5.1-5.10

ISO 15189: 2003, 2007, 2012

4.1 Organization and management4.1 Organization and management

Organization andmanagement responsibility

Organization andmanagement responsibility

4.1 Org. and managementresponsibility

4.1.1.2 amend Legal entitycan be held legally responsible for itsactivities

4.1.1.3Editorial (เรียบเรียงใหม)4.1.1.4 amend

4.1.2.2 new4.1.2.4 new

-Specific responsibilities of labdirector/delegates and managementresponsibilities (ensure the implement ofquality policy)-Meet the needs of lab patients andusers-Measurable quality objective

4.1 Org and managementresponsibility

4.1.2.5new Responsibility ,authorities,interrelationships defined,documented, communicated

4.1.2.6 new Effective communication both within laband with lab stakeholders

4.1.2.7 amend Responsibilities of QM include thepromotion of awareness of users’ needs andrequirements throughout the lab

4.2 Quality Management System

4.2 QMS4.2sig.editorial

4.2.1 General requirements4.2.2 Document requirements

4.2.2.1 General4.2.2.2 Quality manual

4.2.1 -Lab establish, document, implement andmaintain QMS and continually improve itseffectiveness- Integrate all processes to fulfil its qualitypolicy and objective

4.2.2.1 QMS documentation: Quality policy &objective/QM/Procedure/recordCopies of regulation, Stds, normativedocs

4.2 QMS4.2.2.2 QM

-Quality policy/ make ref to it-Description of scope of QMS-Org and management structure of lab and itsplace in parent org-Role and responsibility of lab management/labdirector/ quality manager-Structure of doc & relationships of doc in QMS-Documented policy and reference to the bothactivities- All staff access to the use and be instructed onthe use of QM and referenced docs

4.3 Document control

4.3 Doc con

4.2.2.2amended

a. all documents/computerized sys.reviewed & approved before issue

b. Page 1 of 5c. Master index/ master list: current

editionsd. Amendment by hand; marked,

initialed, dated and revised issuedwithin specified time

4.4 Review of contracts

Serviceagreement

4.4 Service agreements

4.4.1 sigeditorial

c. Lab personnel have the skillsand expertise for theexamination

4.5 Examination by referrallaboratories

4.5 Examination by referrallaboratories

4.5.1 amended Selecting and evaluating referral lab andconsultants for complex testing in any

disciplinenot just histopathology, cytology and

related disciplines4.5.2amended

The report indicate which examinationswere performed by a referral lab orconsultant

4.6 External services andsupplies

4.6 External services andsupplies

4.6 Sigeditorial

-Procedure for selecting and purchasing ofexternal service, equipment, reagents, andconsumable supplies-Select and approve suppliers, criteria forSelection-List of selected and approved suppliersmaintained

4.7 Advisory services4.8 Resolution of complaints

4.9 Identification and control ofnonconformities

4.9 Identification and control ofnonconformities

4.9 amended -The procedure ensure that theimmediate actions to be taken aredefined

-when NC recur in pre-exam, exam, post–Exam, corrective action determined

4.10 Corrective action

4.10 Corrective action4.10 amended -Immediate action

-Corrective action to remove the rootcause of the problem

4.11 preventive action

4.11 Preventive action4.11 editorial -review lab data& information if

potential NC exist-determine root cause of potential NC-Involve analysis of data, trend, risk,

external quality assessment.

4.12 Continual Improvement

4.12 Continual Improvement4.12new/amended

-Improvement activities are to bedirected at areas of highest prioritybased on risk Assessment/NC

-lab management communicate tostaff improvement plan and goal

4.13 Control of records

4.13 Control of records4.13new/amended/ editorial

-Record created concurrently withperformance of each activity affecting thequality of examination

-Date and time of amendments capture alongwith identity of personnel making theamendment-The length of time that records are retain

may vary, reported results as long asmedically relevant or by regulation

-The records : minute of meetings, staffqualification

Evaluation and audits

4.14 Evaluation and audits4.14.1 General

-Plan and implement the evaluation and IAprocesses(demonstrate examinations &supportingprocesses are being conducted, to conformity toQMS, continually improve the effectiveness ofQMS)-Result of evaluation and improvement to MR

4.14.2(5.4.9) Periodic review of requests, suitability of

procedures, sample requirements-ทบทวนวิธีวิเคราะหเปนระยะๆตามกําหนดเวลา-ทบทวนปริมาณ, preservative, collect device

4.14 IA Evaluation and audits

4.14.3Assessment of user feedback

4.14.4Staff suggestion-สง่เสรมิให ้ staff เสนอการปรับปรงุในการใหบ้รกิาร (labservice) ประเมนิขอ้เสนอและนําไปปฏบิตัอิยา่งเหมาะสมและตอบกลับผูเ้สนอ

4.14.5Internal audit-pre- exam, exam, post-exam, all activities in theQMS-ตอ้งแกไ้ขทันที (correction) และcorrective actionตอ้งแกไ้ขในระยะเวลาทีไมล่า่ชา้เกนิไป เพือรบีจัดการแกไ้ขทีสาเหตุ

4.14 IA Evaluation and audits

4.14.6 Risk management-ประเมนิผลกระทบของขันตอนการวเิคราะหแ์ละความผดิพลาดทีอาจเกดิขึน ตอ่ผลการวเิคราะห์-ปรับขันตอนการวเิคราะหเ์พือลดความเสียงทพีบและจัดการแกไ้ขและบนัทกึเก็บไว ้

4.14Evaluation and audits

4.14.7

(5.8.2)

Quality indicator-มตีวัชีวดัในการตรวจสอบ (monitor)และประเมนิการปฏบิตังิาน กระบวนการวเิคราะหเ์ชน่จํานวนตยทีไม่เหมาะสม จํานวนรายงานผลทีตอ้งแกไ้ข-การจัดเก็บตวัชีวดั จัดทําเป็นแผน/โครงการ (Plan):objective, methodology, Interpretation, limits,action plan, duration of measurement-ทบทวนตวัชีวดัตามระยะเวลาทีกําหนด-ตวัชีวดัดา้น non- exam procedure ; completenessof equipment and personal record , effective ofdoc control system- ตวัชีวดัดา้น Exam: TAT

4.14 IA Evaluation and audits4.14.8 Reviews by external organizations

เมอืพบ NC-Immediate action-Corrective action, preventive action

4.15 Management review

4.15 Management review4.15.2 -Review input : results of evaluations

User feedbackStaff suggestionRisk assessmentUse of quality indicatorRecommendation for improvement

etc-Review activitiesAnalyse the input for causes of NC, trend andpattern that indicate process problemsassessing the opportunities for improvementand changes ; quality policy and quality objectives

4 .15 Management review4.15.2 -Review output

MR recorded with decisions made and actiontaken related to improvement of the effectivenessof QMS of its processes, services to users,resource needs

Thank you