ISO 15189:2012
30 กรกฎาคม 2557

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
• ข้อก าหนด 4.1-4.15
• ข้อก าหนด 5.1-5.8
ISO 15189:2012
• ข้อก าหนด 4.1-4.15
• ข้อก าหนด 5.1-5.10

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
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
Org and management responsibility
Responsibility ,authorities, interrelationships defined, documented, communicated
Effective communication both within lab and with lab stakeholders
4.1.2.7 amend Responsibilities of QM include the promotion of awareness of users’ needs and requirements throughout the lab

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
4.2.2.2
QMS
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
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
Service agreements
4.4.1 sig editorial c. Lab personnel have the skills and expertise for the examination

4.5
Examination by referral laboratories
4.5.1 amended
4.5.2 amended
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
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

4.9
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
4.10 amended
Corrective action
-
Immediate action
-Corrective action to remove the root cause of the problem

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
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
4.13 new/amended
/ editorial
Control of records
-Record created concurrently with performance of each activity affecting the 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

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
-ทบทวนวิธีวิเคราะห์เป็นระยะๆตามก าหนดเวลา
-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
ส่งเสริมให ้ staff เสนอการปรับปรุงในการให ้บริการ (lab service) ประเมินข ้อเสนอและน าไปปฏิบัติอย่างเหมาะสม
และตอบกลับผู ้เสนอ
Internal audit
-pre- exam, exam, post-exam, all activities in the
QMS
ต ้องแก ้ไขทันที (correction) และ corrective action
ต ้องแก ้ไขในระยะเวลาที่ไม่ล่าช ้าเกินไป เพื่อรีบจัดการ
แก ้ไขที่สาเหตุ

4.14 IA
4.14.6
Evaluation and audits
Risk management
ประเมินผลกระทบของขั้นตอนการวิเคราะห์และ
ความผิดพลาดที่อาจเกิดขึ้น ต่อผลการวิเคราะห์
ปรับขั้นตอนการวิเคราะห์เพื่อลดความเสี่ยงที่พบ
และจัดการแก ้ไขและบันทึกเก็บไว ้

4.14
4.14.7
(5.8.2)
Evaluation and audits
Quality indicator
มีตัวชี้วัดในการตรวจสอบ (monitor) และประเมินการ
ปฏิบัติงาน กระบวนการวิเคราะห์เช่นจ านวนตยที่ไม่
เหมาะสม จ านวนรายงานผลที่ต ้องแก ้ไข
การจัดเก็บตัวชี้วัด จัดท าเป็นแผน / โครงการ (Plan): objective, methodology, Interpretation, limits, action plan, duration of measurement
ทบทวนตัวชี้วัดตามระยะเวลาที่ก าหนด
ตัวชี้วัดด ้าน non- exam procedure ; completeness of equipment and personal record , effective of doc control system
ตัวชี้วัดด ้าน Exam: TAT

4.14 IA
4.14.8
Evaluation and audits
Reviews by external organizations
เมื่อพบ NC
-Immediate action
-Corrective action, preventive action

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