MACB cordially invites you to attend a workshop on "ISO 15189:2012 and Practical Application in the Chemical Pathology Laboratory” 24 & 25 November 2014 (Monday & Tuesday) 8.30 am to 5.00 pm The Zon All Suites & Residences 161, Jalan Ampang, 50450 Kuala Lumpur (Tel: 603-2164 8000) Objective: The ISO 15189:2012 standard (MS ISO15189:2014) will be implemented from July 2014 so it is crucial for staff of medical laboratories already accredited and those undergoing the accreditation exercise to understand this new standard. This 2 day workshop will introduce participants to ISO 15189:2012 and highlight important aspects to ensure participants understand and are able to contribute to their laboratory’s efforts in this matter. At the end of the programme, participants will be able to understand the difference between the old and new versions and apply what they learnt to help bring their laboratory up to the standard required for accreditation. The technical requirements will cover aspects in Chemical Pathology. Participants: Its main target participants are biochemists working in Chemical Pathology laboratories who are involved in quality and accreditation. Workshop Structure includes: Lectures and discussions on the requirements, practical application in the laboratory, vital documents and records. Frequently raised NCR will also be discussed. PRESENTERS Sharifah Nor'Ashikin Syed Hussein BSc Biochemistry (UM), Diploma in Medical Microbiology (SEAMEOTROPMED) A biochemist with the Ministry of Health from 1985 - 2013. Had various working experience in the field of Biochemistry including drugs of abuse, clinical biochemistry, therapeutic drugs monitoring and quality management in hospitals throughout Malaysia and the National Blood Bank. Had been involved in setting up quality control programme for the health laboratories in 2005 under the Family Health Division, MoH. Received training for the ISO 15189 standards from APLAC and Standards Malaysia. Last position held before retirement was as the Quality Manager for the National Blood Bank. Currently, is very active in assessment activities as the lead assessor and technical assessor with Standards Malaysia. THE VENUE TIME PROGRAMME 24 NOV 2014 08:30 – 09:00 Registration 09:00 – 09:15 09:15 – 09:45 Welcome remarks Introduction to ISO 15189:2012 09:45 – 10:45 Organisation and management (I) 4.1 : Organisation and Management Responsibility 4.2 : Quality Management System 4.3 : Document Control 4.4 : Service Agreements 10:45 – 11:00 Tea Break 11:00 – 13:00 Organisation and management (II) 4.5 : Examination by Referral Laboratories 4.6 : External Services & Supplies 4.7 : Advisory Services 13:00 – 14:00 14:00 – 15:00 Lunch Quality Improvement in the laboratory 4.8 : Resolution of Complaints 4.9 : Identification and Control of Non-Conformities 4.10 : Corrective Action 4.11 : Preventive Action 4.12 : Continual Improvement 15:00 – 16:00 Records and Audits 4.13 : Control of Records 4.14 : Evaluation and Audits 4.15 : Management Review 16:00 – 17:00 17:00 Assessment and Discussion Break and adjourn for the day 25 NOV 2014 09:00 – 10:00 Personnel, Training and Competency 5.1 : Personnel 10:00 – 10:30 10:30 – 11:30 Tea Break Managing your space, reagents and lab equipment 5.2 : Accommodation & Environmental Conditions 5.3 : Laboratory Equipment, Reagents and Consumables 11:30 – 13:00 Pre Analytical, Examination and Quality Issues 5.4 : Pre- Examination Processes 5.5 : Examination processes 5.6 : Ensuring Quality of Examination Procedures 13:00 – 14:00 14:00 – 15:30 Lunch Post Analytical Issues 5.7 : Post Examination Procedures 5.8 : Reporting of Results 5.9 : Release of Results 5.10 : Laboratory Information Management 15:30 – 16:00 16:00 – 17:00 17:00 Common non-conformities Assessment and Discussion Closing and tea REGISTRATION FORM ISO 15189:2012 WORKSHOP, 24-25 NOVEMBER 2014 A PAYMENT DETAILS I hereby enclose the payment of (please tick): Category MACB Member Non Member Per Person RM350 RM450 Group Registration (5 pax) NA RM400/pax being the full payment for my participation in the MACB ISO 15189:2012 Workshop Cash of RM : …………………………………… Cheque No: ……………………………............................. Bank Draft No.: ……………………………….. LPO : ……………………………………………………… Payment should be made to: Malaysian Association of Clinical Biochemists Please address LPO to: Malaysian Association of Biochemists, Biochemistry Division, Institute for Medical Research, Jalan Pahang, 50588 Kuala Lumpur Bank: Standard Chartered, Jln Ipoh, Kuala Lumpur Account No: 873-1-4640067-2 Name: ……………………………………………………………………………………………………………… Date : ………………………………………… Signature : ………………………………………………. * Payment made is not refundable. * Please fax the completed registration form and a copy of slip of payment by Thursday, 15th November 2014 to Pantai Premier Pathology at 03-4297 4911. * For accommodation, kindly contact: The Zon All Suites & Residence at 03-2164 8000. * For further enquiries, please contact: Mr. Adam Hathsey Bronson: 03- 4280 9115 | 012-215 3712 or email [email protected] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------PARTICIPANT’S DETAILS Participant’s Name: ……………………………………………………………………………………………….. IC. No : …………………………………….………. Mobile Phone No: ……………………………………….. Email Address: ………………………………......... Designation : …………………………………………….. Organization Name: ………………………………………………………………………………………………. Organization Address: ……………………………………………………………………………………………. ……………………………………………………………………………………………. Office Phone No: …………………………………. □ Vegetarian Fax No: …………………………………............................ □ Non-vegetarian Contact person, company name and phone no. of sponsor (if sponsored): …………........................................ ………………………………………...................................................................................................................... _____________________________________________________________________________________________ FOR OFFICIAL USE ONLY: We accept the above application to participate in the MACB Advanced Quality Workshop Date received: …………………………. Name: ……………………………………….. Authorised signature: …………………………………