Iso 9001, 17025, 27001 And 15189 Setting Up Services Philippines

ASTRON QUALITY MANAGEMENT CONSULTING SERVICES

Mission Statement

To provide the highest quality consultancy services to companies who wish to align their existing system to the international standard.

The Company

Astron Quality Management Consulting Services was established in the year 2002, It's primary function was to cater to the various companies that would like to upgrade their systems to the International Standard ISO 9001. 

Astron Quality Management Consulting Services is a trusted company in the market after sole proprietor Ms. Annie Opeda, a freelance consultant and former Bureau of Product Standard ISO Auditor, with careful planning, research and development, brought this organization to new heights and levels. 

Our Current thrust is geared in consulting and training individuals and companies to reach their full potential in achieving it's goals for the future. 

We focus on quality system's upgrade and set up that will be compliant with the ISO 9001, ISO/IEC 17025, 2701 or ISO 15189. 

Some of our successful and satisfied clients are 8 different companies that availed of the ISO 9001, 15 companies for ISO/ISEC 17025 and 2 Medical Laboratory for ISO 15189. 

We have assisted in obtaining the ISO 15189, The American Bio-clinical Laboratories, Int'l, the first free standing non-industrial tertiary medical laboratory nationwide accredited by PAO for ISO 15189:2010. This medical laboratory was awarded with certificate of ISO 15189:2010 accreditation  last October 2010 by the Philippine Accreditation Office with Certificate No. MLA-2010-003A.  

We have assisted also in obtraining ISO 15189, the LCM Diagnostics Laboratory, the first secondary medical laboratory nationwide accredited by PAO to ISO 15189.  This laboratory passed the first compliance audit by PAO last June 2012 and was also given the Certificate of Accreditation last September 2012 with Certificate No.  MLA-2012-05A.

(Refer to http://www.abclab.com.ph/ and PAO List of Accredited Laboratories  http://www.dti.gov.ph/uploads/DownloadableForms/PAO_Accredited%20Medical%20Labs_19Jan2012.pdf,  http://www.abclab.com.ph/?page_id=293.

Currently, Astron QMCS is assisting the following companies in setting-up an ISO system:

1.  San Lazaro Hospital National Reference Laboratory for STD-AIDS Cooperative    

     Central Laboratory (SACCL) - for ISO 15189:2012 Accreditation

2.  Lifeline Diagnostics Supplies, Inc. - for ISO 9001:2008 Certification

Our Team

Our team composes of  former BPS Auditor and private ISO Auditor,and Pathologist who have undergone rigid training in ISO 15189:2010 under TRTA.  Certificate of training is traceable to Asia Pacific Laboratory Accreditation Cooperation and International Laboratory Accreditation Cooperation APLAC/ILAC a body that is recognized by the Multilateral Recognition Arrangements (MRA) in the Pacific Accreditation Cooperation, with growing qualified and trusted leaders and trainers in our industry. 

Each consultant specializes in a particular discipline, including finance, sales and marketing, technology, management, operations, and human resources, sourcing and motivational well being of the individual , uncertainty of measurement, statistics, and pre-analytical, analytical and post analytical systems in the medical laboratories.

General Approach 

The set up package contains quality system documentation, implementation, and conducts internal quality audit, management review, pre-assessment audit, gap analysis, formulation of corrective and preventive action until the company is successfully accredited to ISO 15189 or ISO/IEC 17025 by Philippine Accreditation Office and/or certified to ISO 9001 by Certifying body.

Services Offered by freelance Consultant

• ISO 9001:2007; ISO/IEC 17025, ISO 15189 QUALITY SYSTEM SETTING UP SERVICES
• LABORATORY INFORMATION SYSTEM (LIS) Homegrown setting-up
• Free assessment to verify adequacy and suitability of the company's existing system.
• Training on System Documentation; ISO Orientation, Internal Quality Audit and Statistical Techniques and Analysis
• Formulation of Corrective and Preventive Action, Preparation of Continuous Improvement Plan and Gap Analysis
• Free assistance to PAO accreditation and Certification from accredited certifying body (ISO 9001)

Trainings Offered

1.    System Documentation Training/Seminar Workshop

2.    ISO Orientation Training/Seminar

3.    Internal Quality Audit Seminar/Workshop

4.   Statistical Techniques and Analysis Seminar

5.   Gap Analysis Training

6.   Uncertainty of Measurement Training/Workshop

7.   Customer Service Training

8.   Milestone and KPI preparations Training/Workshop

9.   5s  Training/Workshop

10. Quality Management Representative Training

11. Corrective and Preventive Action Training

Contact Person: Ms. Ana Sophia "Annie" Opeda
                           Contact No.  0906-4646446

Email: annie_opeda@yahoo.com/astronamcs@yahoo.com

           annie.opeda@astronqmcs.com

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Why Medical Laboratories need to align their existing system to ISO 15189:2007 Standard?

Currently the Department of Trade and Industry thru the Philippine Accreditation Office is accepting application for the accreditation of Medical Testing Laboratories, which is based on ISO 15189:2010 – Medical Laboratories Particular Requirements for Quality and Competence.  

The over all accreditation policies of Philippine Accreditation Office for medical laboratories are focused on patients'' care and quality services essential to meet the needs of both the patients and the clinical personnel providing such care. PAO also focuses on the safety and ethics in performing those medical laboratory works.

What is ISO 15189:2010?

ISO 15189:2010 is an international quality management system standard designed specifically for medical laboratories. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations and customer satisfaction.

What is Laboratory Accreditation?

Laboratory accreditation provides formal recognition to competent laboratories, providing a ready means for customers to identify and select reliable testing, measurement and calibration services. 

To maintain this recognition, laboratories are re-evaluated regularly by the accreditation body to:

–         ensure their continued compliance with their requirements; and

–         check that their standard of operation's are being maintained.

NEWS 

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DTI pushes for accreditation of medical laboratories
By Ma. Elisa P. Osorio (The Philippine Star) Updated August 27, 2010 12:00 AM Comments (0)

MANILA, Philippines - The Department of Trade and Industry (DTI) is pushing for the accreditation of medical laboratories in order to ensure the accuracy and reliability of medical test results.

The Philippine Accreditation Office (PAO) has launched its accreditation scheme for medical laboratories to improve the quality and credibility of local medical and health care services and to urge clinical laboratories to be recognized globally to further promote medical tourism in the country.

Trade Undersecretary for comsumer welfare Zenaida Maglaya said the accuracy of medical test results is crucial for it “is the basis of a medical practitioner’s diagnosis.”

A patient’s life is at risk if test results and interpretations are erroneous for it would lead to inappropriate treatment, prolonged illness and even death,” she noted.

As such, she stressed it is important to have an independent body such as PAO to assess the quality of services provided by medical laboratories.

“Medical laboratory accreditation would give patients the confidence in the medical institution administering laboratory tests as its technical competence complies with ISO 15189:2007, the international standard used for medical laboratory accreditation,” Maglaya said.

“The PAO accreditation seal guides patients in choosing competent and reliable medical laboratory that provides excellent services that is worth their time and money, and more importantly values life,” she added.

Maglaya said with the growing demand for reliable and cost-efficient medical and health care services particularly in the Asian region, laboratory accreditation would further enhance medical tourism in the country as it promotes quality and technical competence of local medical services that can compete with neighboring countries.

ISO 15189:2007 is the standard that PAO uses to accredit medical laboratories on its technical capacity. It specifies the particular requirements for quality and competence of medical laboratories, which relies on several factors which include: the qualifications, training and experience of personnel, calibrated and maintained equipment, adequate quality assurance procedures, proper sampling practices, appropriate testing procedures, traceability of measurements to national standards, accurate recording and reporting procedures and suitable testing facilities.

Accreditation of medical laboratories to ISO 15189:2007 assures clients of the capacity of the institution to provide accurate and accepted test results as these accredited laboratories have established quality management system, and qualified and competent medical practitioners that perform appropriate tests based on valid methods.