ANNEXURE

Changes in ISO 15189

Foreword New Para added at the end This second edition cancels and replaces the first edition (ISO 15189:2003) which has been technically revised in order to align it more closely with the second edition of ISO/IEC 17025. Introduction Last two paragraphs deleted and two new paragraphs added at the end. Demonstrated conformity to this International Standard does note imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This International Standard is not intended to be used for the purposes of certification. The correlation between the clauses and subclauses of this second edition of ISO 15189 and those of ISO 9001:2000 and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard. Clause 3, Terms and definitions In the introduction sentence in ISO 9000, ISO/IEC Guide 2, VIM and the following deleted. The amended sentence became For the purposes of this document, the following terms and definitions apply. Clause 3.1 New definition for accreditation added as new sub-clause 3.1. Subsequent sub-clause numbers changed accordingly. accreditation procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. Clause 3.14 between definition for quantity and referral laboratory New definition for quality management system added as new sub-clause 3.14. Subsequent sub-clause numbers changed accordingly. quality management system management system to direct and control an organization with regard to quality [ISO 9000:2005, definition 3.2.3] NOTE For the purposes of this International standard, the quality referred to in this definition relates to matters of both management and technical competence. Clause 4, title Management requirements becomes Management requirement. New Clause 4.1.6 added Laboratory management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the quality management system. Clause 4.2.4, second paragraph, last sentence [see 4.1.5 i)] moved to the end of the sentence. Clause 4.2.5, first sentence which replaced with that.
Page 1 of 3

Clause 4.3.2 g) and at the end of g) deleted. Clause 4.3.3 d) and at the end of d) deleted. Clause 4.4.4 Clients changed to Customers. Clause 4.5.2 c) and at the end of c) deleted. Clause 4.5.4 The word NOTE before National, regional and local regulations may apply. deleted. The NOTE has become a requirement. Clause 4.6.3, 3rd row should changed to shall. This system shall include the recording of lot numbers of all relevant reagents, control materials and calibrators, the date of receipt in the laboratory and the date the material is placed in service. Clause 4.9.2, last row (see 4.11) becomes (see 4.10). Clause 4.10.1 Last sentence amended. Corrective action shall be appropriate to the magnitude of the problem and commensurate with the possible risks. Clause 4.10.4, first row non-conformance changed to non-conformity. Clause 4.11.1, first sentence quality system replaced with quality management system. Clause 4.11.2 Second sentence became Note 1 under clause 4.11.2; and original NOTE became NOTE 2. NOTE 1 Apart from the review of the operational procedures, preventive action might involve analysis of data, including trend and risk-analyses and external quality assurance. NOTE 2 Preventive action is a pro-active process for identifying opportunities for improvement rather than a reaction to the identification of problems or complaints. Clause 4.13.3 The word NOTE before National, regional and local regulations may apply. deleted. The NOTE has become a requirement. Clause 4.14.2 Last sentence of paragraph 1 agreed-upon time became agreed upon time; Second paragraph quality system replaced with quality management system.

Page 2 of 3

Clause 4.15.1, first sentence Sentence restructured. In order to ensure their continuing suitability and effectiveness in support of patient care and to introduce any necessary changes or improvements, laboratory management shall review the laboratorys quality management system and all its medical services, including examination and advisory activities. The results of the review shall be incorporated into a plan that Clause 5.1.3 NOTE Sentence restructured. NOTE Here, competence is understood as the product of basic academic, postgraduate and continuing education, as well as training and experience of several years in a medical laboratory. Clause 5.2.4, second paragraph, first row permit replaced allow Laboratory facilities for examination should permit correct performance of examinations. Clause 5.3.4, last paragraph, last row law or regulation replaced by national, regional and local regulations . time period required by national, regional and local regulations Clause 5.4.3 b)2) and at the end of b)2) deleted. Clause 5.4.3 c) 8) and at the end of c) 8) deleted. Clause 5.4.3 d) 3) and at the end of d) 3) deleted. Clause 5.5.6 Sentence restructured. Upon request, the laboratory shall make its list of current examination procedures, including primary sample requirements and relevant performance specifications and requirements, available to users of laboratory services. Clause 5.8.3, second row , added after but not be limited to. Clause 5.8.3, NOTE 2 added NOTE 2 National, regional and local regulations may require the name and location of the examining (or referral) laboratory to be shown in the final report. Annex A Correlation between ISO 9001:2000 and ISO/IEC 17025:1999 amended to ISO 9001:2000 and ISO/IEC 17025:2005. Correlation between ISO 9001:2000 and ISO 15189:2002 amended to ISO 9001:2000 and ISO 15189:2007. Correlation between ISO/IEC 17025:1999 and ISO 15189:2002 amended to ISO/IEC 17025:2005 and ISO 15189:2007. ***

Page 3 of 3