ISO 15189:2012

Report
ISO 15189:2012
Medical laboratoriesRequirements for
Quality and competence
นางสุขใจ ผลอาไพสถิตย ์
30 กรกฎาคม 2557
•เตรียมความพร้อมในการขอร ับรอง
ISO 15189:2012
ปี 2558
Reference: Gap analysis of ISO 15189:2012 &
ver. 2007 (NATA); issued 2013
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 the
requirements
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: 2003, 2007, 2012
• ISO 15189:2007
• ข้อกาหนด 4.1-4.15
• ข้อกาหนด 5.1-5.8
• ISO 15189:2012
• ข้อกาหนด 4.1-4.15
• ข้อกาหนด 5.1-5.10
4.1 Organization and management
Organization and
management responsibility
4.1
4.1.1.2 amend
4.1.1.3
Editorial
4.1.1.4 amend
4.1.2.2 new
4.1.2.4 new
Org. and management
responsibility
Legal entity
can be held legally responsible for its
activities
(เรียบเรียงใหม)่
-Specific responsibilities of lab
director/delegates and management
responsibilities (ensure the implement of
quality policy)
-Meet the needs of lab patients and
users
-Measurable quality objective
4.1
4.1.2.5new
4.1.2.6 new
4.1.2.7 amend
Org and management
responsibility
Responsibility ,authorities,
interrelationships defined,
documented, communicated
Effective communication both within lab
and with lab stakeholders
Responsibilities of QM include the
promotion of awareness of users’ needs and
requirements throughout the lab
4.2 Quality Management System
4.2
4.2
sig.editorial
4.2.1
4.2.2.1
QMS
4.2.1 General requirements
4.2.2 Document requirements
4.2.2.1 General
4.2.2.2 Quality manual
-Lab establish, document, implement and
maintain QMS and continually improve its
effectiveness
- Integrate all processes to fulfil its quality
policy and objective
QMS documentation: Quality policy &
objective/QM/Procedure/record
Copies of regulation, Stds, normative
docs
4.2
QMS
4.2.2.2
QM
-Quality policy/ make ref to it
-Description of scope of QMS
-Org and management structure of lab and its
place in parent org
-Role and responsibility of lab management/lab
director/ quality manager
-Structure of doc & relationships of doc in QMS
-Documented policy and reference to the both
activities
- All staff access to the use and be instructed on
the use of QM and referenced docs
4.3 Document control
4.3
4.2.2.2
amended
Doc con
a. all documents/computerized sys.
reviewed & approved before issue
b. Page 1 of 5
c. Master index/ master list: current
editions
d. Amendment by hand; marked,
initialed, dated and revised issued
within specified time
4.4 Review of contracts
Service
agreement
4.4
Service agreements
4.4.1
c. Lab personnel have the skills
and expertise for the
examination
sig
editorial
4.5 Examination by referral
laboratories
4.5
4.5.1 amended
4.5.2
amended
Examination by referral
laboratories
Selecting and evaluating referral lab and
consultants for complex testing in any
discipline
not just histopathology, cytology and
related disciplines
The report indicate which examinations
were performed by a referral lab or
consultant
4.6 External services and
supplies
4.6
4.6 Sig
editorial
External services and
supplies
-Procedure for selecting and purchasing of
external service, equipment, reagents, and
consumable supplies
-Select and approve suppliers, criteria for
Selection
-List of selected and approved suppliers
maintained
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of
nonconformities
4.9
4.9 amended
Identification and control of
nonconformities
-The procedure ensure that the
immediate actions to be taken are
defined
-when NC recur in pre-exam, exam, post
–Exam, corrective action determined
4.10 Corrective action
4.10
4.10 amended
Corrective action
-Immediate action
-Corrective action to remove the root
cause of the problem
4.11 preventive action
4.11
4.11 editorial
Preventive action
-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
4.12
new/amended
Continual Improvement
-Improvement activities are to be
directed at areas of highest priority
based on risk Assessment/NC
-lab management communicate to
staff improvement plan and goal
4.13 Control of records
4.13
4.13
Control of records
-Record created concurrently with
new/amended
performance of each activity affecting the
/ editorial
quality of examination
-Date and time of amendments capture along
with identity of personnel making the
amendment
-The length of time that records are retain
may vary, reported results as long as
medically relevant or by regulation
-The records : minute of meetings, staff
qualification
Evaluation and audits
4.14
4.14.1
Evaluation and audits
General
-Plan and implement the evaluation and IA
processes
(demonstrate examinations &supporting
processes are being conducted, to conformity to
QMS, continually improve the effectiveness of
QMS)
-Result of evaluation and improvement to MR
4.14.2
(5.4.9)
Periodic review of requests, suitability of
procedures, sample requirements
-ทบทวนวิธีวิเคราะห์เป็นระยะๆตามกาหนดเวลา
-ทบทวนปริมาณ, preservative, collect device
4.14 IA
4.14.3
4.14.4
4.14.5
Evaluation and audits
Assessment of user feedback
Staff suggestion
-สง่ เสริมให ้ staff เสนอการปรับปรุงในการให ้บริการ (lab
service) ประเมินข ้อเสนอและนาไปปฏิบต
ั อ
ิ ย่างเหมาะสม
และตอบกลับผู ้เสนอ
Internal audit
-pre- exam, exam, post-exam, all activities in the
QMS
-ต ้องแก ้ไขทันที (correction) และcorrective action
้ นไป เพือ
ต ้องแก ้ไขในระยะเวลาทีไ่ ม่ลา่ ชาเกิ
่ รีบจัดการ
แก ้ไขทีส
่ าเหตุ
4.14 IA
4.14.6
Evaluation and audits
Risk management
-ประเมินผลกระทบของขัน
้ ตอนการวิเคราะห์และ
ความผิดพลาดทีอ
่ าจเกิดขึน
้ ต่อผลการวิเคราะห์
ี่ งทีพ
-ปรับขัน
้ ตอนการวิเคราะห์เพือ
่ ลดความเสย
่ บ
และจัดการแก ้ไขและบันทึกเก็บไว ้
4.14
4.14.7
(5.8.2)
Evaluation and audits
Quality indicator
-มีตวั ชวี้ ด
ั ในการตรวจสอบ (monitor)และประเมินการ
่ จานวนตยทีไ่ ม่
ปฏิบต
ั งิ าน กระบวนการวิเคราะห์เชน
เหมาะสม จานวนรายงานผลทีต
่ ้องแก ้ไข
-การจัดเก็บตัวชวี้ ด
ั จัดทาเป็ นแผน/โครงการ (Plan):
objective, methodology, Interpretation, limits,
action plan, duration of measurement
-ทบทวนตัวชวี้ ด
ั ตามระยะเวลาทีก
่ าหนด
-ตัวชวี้ ด
ั ด ้าน non- exam procedure ; completeness
of equipment and personal record , effective of
doc control system
- ตัวชวี้ ด
ั ด ้าน Exam: TAT
4.14 IA
Evaluation and audits
4.14.8
Reviews by external organizations
เมือ
่ พบ NC
-Immediate action
-Corrective action, preventive action
4.15 Management review
4.15
4.15.2
Management review
-Review input : results of evaluations
User feedback
Staff suggestion
Risk assessment
Use of quality indicator
Recommendation for improvement
etc
-Review activities
Analyse the input for causes of NC, trend and
pattern that indicate process problems
assessing the opportunities for improvement
and changes ; quality policy and quality objectives
4 .15
4.15.2
Management review
-Review output
MR recorded with decisions made and action
taken related to improvement of the effectiveness
of QMS of its processes, services to users,
resource needs
Thank you

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