In the beginning, Mr. John James explained the new edition aimed to keep it up to date and relevant to working practices, including requirements appropriate to genetic testing laboratories. ISO 15189 is a sector-specific variant of ISO/IEC 17025, approved as such by ISO CASCO. It is voluntary to use nationally and regionally. John said the content compared of old and new editions was 90% the same but more "user-friendly" elements added.
In the standard, Annex B - Table B.1 showed the Comparison of ISO 15189:2007 to ISO 15189:2012 and found that more elaborated in the sub-sections.
Then John briefed the relationship of ISO 15189 with ISO/IEC 17025 and ISO 9001. ISO/IEC 17025:2005 is a NORMATIVE REFERENCE in ISO 15189. ISO 9001 is listed in the Bibliography. The management system requirements in ISO 15189 are written in a language relevant to a medical laboratory's operations and meet the principles of ISO 9001:2008 Quality Management Systems - Requirements, and are aligned with its pertinent requirement. Details are in ISO 15189:2012 Annex A.
After that John told us the history of creating ISO 15189. This vision became a Reality in 1994 with ISO Technical Committee for the Medical Laboratory Standards (ISO TC 212) and its first meeting was in May/June 1995. There were experts from 20 countries included Australia, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Italy, Japan, Netherlands, New Zealand, Singapore, Sweden, Switzerland, United Kingdom and United States.
The following were summary of Changes to note in the new edition.
i) Normative references (Deleted References to ISO 9001 & ISO 31 and Added ISO/IEC 17000 - Conformity assessment - Vocabulary and general principles)
ii) Some definitions are specific to medical laboratories and had to be defined for the Standard (e.g. Examination, Alert interval, Biological reference interval, etc.)
iii) Section 4 Management Requirements has been substantially re-drafted, importing, for example, “Ethics” as a section rather than being an Annex (now Section 4.1.1.3 “Ethical conduct”)
iv) New sections in 4.1.2.1 to 4.1.2.6, 4.4.1, 4.14.2 to 4.14.8, 5.4.2, 5.4.6,
v) Major addition section was 5.10 - Laboratory Information System
Finally, John summarized that text had been moved to fit contextually, where logic determines in the new edition. Section sub headings helped "user-friendliness" and ISO TC 212 had produced a revised Standard that would contribute to continual improvement in medical laboratory quality and performance.
In the standard, Annex B - Table B.1 showed the Comparison of ISO 15189:2007 to ISO 15189:2012 and found that more elaborated in the sub-sections.
Then John briefed the relationship of ISO 15189 with ISO/IEC 17025 and ISO 9001. ISO/IEC 17025:2005 is a NORMATIVE REFERENCE in ISO 15189. ISO 9001 is listed in the Bibliography. The management system requirements in ISO 15189 are written in a language relevant to a medical laboratory's operations and meet the principles of ISO 9001:2008 Quality Management Systems - Requirements, and are aligned with its pertinent requirement. Details are in ISO 15189:2012 Annex A.
After that John told us the history of creating ISO 15189. This vision became a Reality in 1994 with ISO Technical Committee for the Medical Laboratory Standards (ISO TC 212) and its first meeting was in May/June 1995. There were experts from 20 countries included Australia, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Italy, Japan, Netherlands, New Zealand, Singapore, Sweden, Switzerland, United Kingdom and United States.
The following were summary of Changes to note in the new edition.
i) Normative references (Deleted References to ISO 9001 & ISO 31 and Added ISO/IEC 17000 - Conformity assessment - Vocabulary and general principles)
ii) Some definitions are specific to medical laboratories and had to be defined for the Standard (e.g. Examination, Alert interval, Biological reference interval, etc.)
iii) Section 4 Management Requirements has been substantially re-drafted, importing, for example, “Ethics” as a section rather than being an Annex (now Section 4.1.1.3 “Ethical conduct”)
iv) New sections in 4.1.2.1 to 4.1.2.6, 4.4.1, 4.14.2 to 4.14.8, 5.4.2, 5.4.6,
v) Major addition section was 5.10 - Laboratory Information System
Finally, John summarized that text had been moved to fit contextually, where logic determines in the new edition. Section sub headings helped "user-friendliness" and ISO TC 212 had produced a revised Standard that would contribute to continual improvement in medical laboratory quality and performance.
John mentioned the Internal Auditing and raised several questions for our thinking below.
Why do we need to demonstrate all processes meet the needs & requirements of users?
How do we demonstrate all processes meet the needs & requirements of users?
How do we quantify the observations?
Why do we need to ensure conformity of the QC management system?
How do we ensure conformity of the QC management system?
How do we quantify or codify the observations?
Why do we need to continually improve the effectiveness of the QC system?
How do we continually improve the effectiveness of the QC system?
How do we quantify the observations?
How do we demonstrate all processes meet the needs & requirements of users?
How do we quantify the observations?
Why do we need to ensure conformity of the QC management system?
How do we ensure conformity of the QC management system?
How do we quantify or codify the observations?
Why do we need to continually improve the effectiveness of the QC system?
How do we continually improve the effectiveness of the QC system?
How do we quantify the observations?
At the end of seminar, John discussed the certification and accreditation. He said this standard was not intended to be used for the purposes of certification but indicated technical competence and consistent delivery of technically valid results. During Accreditation, grading of non-conformities were classified "Very serious indeed", "Quite significant" and "Minor or isolated".
Reference:
HKAS - http://www.itc.gov.hk/en/quality/hkas/about.htm
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