ISO 15189:2007

ANNOUNCEMENT FOR MEDICAL LABORATORIES - Transition to ISO 15189:2007
The second edition of ISO 15189 “Medical laboratories – Particular requirements for quality and competence” has been published. The changes made in this edition aim at aligning with ISO/IEC 17025:2005. A new edition of IS/ISO 15189 which incorporates the changes is now being printed by Bureau of Indian Standards (BIS) and will be available shortly. However, for the benefit of the laboratories and the assessors, NABL has brought the changes in ISO 15189:2007, as annexure to this announcement. Transition Plan NABL has decided one year transition period for the laboratories to change over to the new version. With effect from 1st March, 2008, NABL will accept applications for initial accreditation in accordance with ISO 15189:2007. New applications with 2003 version will not be accepted. The applicant laboratories, who have already submitted application as per ISO 15189:2003, will be required to give a statement complying to ISO 15189:2007 version before the conduct of assessment. Accredited laboratories whose surveillance or re-assessment is due w.e.f. 1st March, 2008, the laboratories will be assessed against the requirements of ISO 15189:2007. These laboratories will be required to provide a compliance statement of 2007 version before the conduct of on-site / desktop surveillance or re-assessment visit. The accredited laboratories assessed against the new standard, if they are found to be not fully compliant with the new / amended requirements of ISO 15189:2007, continuation / renewal of accreditation will be granted based on ISO 15189:2003. However, they will be required to be compliant with the ISO 15189: 2007 version before 1st March, 2009, that means, they will have to provide sufficient evidence of conformity with the new version before the said date. Where necessary, an on-site assessment visit will be arranged to confirm conformity with the new version. The laboratories seeking extension of scope of accreditation based on the new version will only be granted such accreditation after conformity with the new version for all tests already accredited has been confirmed. The laboratories confirmed to be compliant with ISO 15189:2007 will be issued new certificates of accreditation superceding existing certificates. The accredited laboratories which do not provide sufficient evidence of conformity with the new version by 1st March, 2009 may have their accreditation suspended.
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ISO 15189:2007 Fact Sheet




Posted March 3, 2008
Preparing your laboratory to become ISO 15189:2007 accredited may require time and resources that go beyond the boundaries of the laboratory. CAP has prepared this fact sheet to outline the steps that a laboratory should take in preparation for ISO 15189 accreditation.
Gain buy-in from key stakeholders (e.g., Senior Administrators, Vice President of Risk Management, Chief Medical Officer, Executive Officers, and Senior Managers outside the laboratory) in the organization that is seeking to become accredited.
Obtain and read an official copy of ISO 15189:2007 standards. A laboratory must purchase an official copy of the standards in order to become accredited. You may purchase the official standards from www.ISO.org or from www.ANSI.org.
Assign appropriate roles for conducting an internal audit.
Updated Organizational chart with key personnel(ISO Reference # 5.1.1)
The Laboratory Director (5.1.3)
All Supervisors (5.15)
All Internal Auditors (4.14.2)
The Quality Manager (4.1.5.i)
Apply for ISO accreditation with CAP.
For those organizations that are not familiar with ISO, CAP recommends the following optional services to help you prepare for your accreditation assessment:
Gap assessment: A Gap assessment is conducted more than 90 days in advance of an accreditation assessment and will be a detailed review to the standards to determine areas of strengths and weaknesses. No corrective action response to CAP is required from a Gap assessment.
Pre-assessment: A pre-assessment will be a dry-run assessment that is a high level review for degree of conformity to the standards and will take place within 90 days of the accreditation assessment. We encourage you to send your documentation to us, prior to our visit, so we may conduct a desk assessment. This will allow our independent assessor to evaluate your written system against your working practices. No corrective action response to CAP is required from a pre-assessment.
Perform an internal audit to ISO 15189. Note that internal auditors may not audit their own work product.
Document the internal audit findings.
Perform root cause analysis and corrective actions where necessary.
Continue the auditing and corrective action process until all major non-conformances (systemic process issues) are corrected.
Document a description of participation in external quality assessment schemes/proficiency testing programs for all tests and evidence of participation over the preceding two years (5.6.4 and 5.6.5)
Update your Quality Manual, including Quality Policy and any supporting documentation for the Quality Manual (electronic is preferred) (4.2.4)
When the laboratory has corrected all non-conformances that were identified in the internal audit, then contact CAP to schedule your accreditation assessment.

Related Links
ISO Press Release
ISO 15189:2007 Frequently Asked Questions


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WHO requirements for pharma lab

:: Themes & MeSH Subjects
· Themes > English documents > 6. Quality Assurance and Drug Safety
· MeSH > Health Care Economics and Organizations > Social Control, Formal > Legislation > Legislation, Drug
· MeSH > Health Care Quality, Access, and Evaluation > Quality Assurance, Health Care > Guidelines
· MeSH > Health Services Administration > Quality of Health Care > Quality Assurance, Health Care > Guidelines
· MeSH > Natural Sciences > Weights and Measures > Reference Standards
· MeSH > Social Sciences > Sociology > Social Control, Formal > Legislation, Drug
· MeSH > Technology, Industry, and Agriculture > Technology > Quality ControlWHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 902 - Thirty-sixth Report(WHO; 2002; 219 pages)

Annex 3 - Good practices for national pharmaceutical control laboratories

General considerations

Glossary

Part One. Management and infrastructure

Part Two. Materials and setting-up of equipment, instruments and other devices

Part Three. Working procedures

Part Four. Safety

References

Appendix 1 - Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products

Appendix 2 - Equipment for a first-stage and medium-size pharmaceutical control laboratory

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ISO 15189 in brief

ISO 15189:2003 requirements

4. Management requirements 4.1 Organization and ManagementIntroduces requirements and responsibilities of the laboratory management like compliance to legal requirements, definition of responsibilities and authorities of all personnel, definition and implementation of policies and organizational structure.4.2 Quality Management SystemIndicates the need for the implementation of a Quality System that includes Quality Assurance, Quality Control, Proficiency Testing procedures, Calibration and Maintenance, described in a Quality Manual. Policies and objectives of a Quality System should be defined. People shall be educated about Quality Management System principles. This topic also presents a summary of issues to be addressed in a Quality Manual......

for more go here http://iso-15189.blogspot.com/2006/09/whole-iso-15189-standard-summarized.html

go here also http://iso-15189.blogspot.com/2006/07/comparison-iso-15189-vs-iso-17025.html

Clinical labs list

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Clinical laboratory advisory service and ISO 15189
File Format: PDF/Adobe Acrobatin the list described in the point (f) above. The present proposal may help both clinical laboratories. seeking accreditation for compliance with ISO 15189: ...www.ingentaconnect.com/content/klu/769/2006/00000011/00000010/00000135?crawler=true - Similar pages - Note this

IngentaConnect Clinical laboratory advisory service and ISO 15189
Clinical laboratory advisory service and ISO 15189. Authors: Fuentes-Arderiu, Xavier1; Álvarez-Funes, Virtudes; Duran-Suárez, Joan; Granada-Ybern, María; ...www.ingentaconnect.com/content/klu/769/2006/00000011/00000010/00000135 - Similar pages - Note this

List of accredited bodies (DAP-Medical laboratories (ISO 15189))
List of accredited bodies (DAP-Medical laboratories (ISO 15189))www.dar.bam.de/ast/iedap89.html - 132k - Cached - Similar pages - Note this

List of accredited bodies (DACH-Medical laboratories (ISO 15189))
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Guest Essay: ISO Standards in Clinical Laboratories - the New ISO ...
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Iso 15189 quality manual - Wikipedia, the free encyclopedia
Iso 15189 quality manual ... Laboratory Background, b. Purpose of Quality Manual, c. Distribution List, d. Scope of Quality Management System, e. ...en.wikipedia.org/wiki/Iso_15189_quality_manual - 15k - Cached - Similar pages - Note this

UZ Brussel-VUB ISO-norm 15189 Certificate
On April 5th, 2005, the ISO Norm 15189 Accreditation was awarded to the laboratory for Clinical Biology and to the care programme of reproductive medicine ...www.brusselsivf.be/default.aspx?ref=ADAE&lang=EN - 86k - Cached - Similar pages - Note this

[PDF]
General Requirements for Accreditation of Medical Testing Laboratories
File Format: PDF/Adobe Acrobat - View as HTMLcorrective action to fill any documentation gaps required by ISO 15189 before ... of the laboratory, going over the findings and presenting the list of ...www.a2la.org/requirements/15189_General_Requirements.pdf - Similar pages - Note this

[PDF]
DRAFT INTERNATIONAL STANDARD ISO/DIS 15189
File Format: PDF/Adobe Acrobat - View as HTMLMedical Testing Laboratories. Assessment Standard. ISO 15189. Client: .... A list, also referred to as a document control log, identifying the ...www.ianz.govt.nz/publications2/pdfs/checklist_feb04.pdf - Similar pages - Note this

ISO 15189 : Genial Genetics
Lab Passport can support work towards multiple sets of standards, including ISO 15189, Standards for Medical laboratories. The ISO 15189 standards are ...www.genialgenetics.com/iso_15189.htm - 7k - Cached - Similar pages - Note this

Introduction

NABL must evolve protocols for standardisation
http://www.expresshealthcaremgmt.com/20050515/oped01.shtml



ISO-1: ISO Standards in Clinical Laboratories - Basics and Perspectives

Quality Management: The Gospel According to ISO
http://www.westgard.com/iso2.htm








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