EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001 DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL DAN KONSISTENSI MUTU PRODUK VAKSIN DI PT. BIO FARMA (PERSERO)
ISO 9001 is an international standard which commonly used for certification related to the quality management system of company or organization eventhough not all of organization that implemented ISO 9001 seems to get the benefit related to higher organizational performance or consistency of product...
Saved in:
Main Authors: | , |
---|---|
Format: | Theses and Dissertations NonPeerReviewed |
Published: |
[Yogyakarta] : Universitas Gadjah Mada
2012
|
Subjects: | |
Online Access: | https://repository.ugm.ac.id/98934/ http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=54707 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Institution: | Universitas Gadjah Mada |
id |
id-ugm-repo.98934 |
---|---|
record_format |
dspace |
spelling |
id-ugm-repo.989342016-03-04T08:48:34Z https://repository.ugm.ac.id/98934/ EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001 DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL DAN KONSISTENSI MUTU PRODUK VAKSIN DI PT. BIO FARMA (PERSERO) , Rika Murharyanti , Dr. Akhmad Kharis Nugroho, M.Si., Apt. ETD ISO 9001 is an international standard which commonly used for certification related to the quality management system of company or organization eventhough not all of organization that implemented ISO 9001 seems to get the benefit related to higher organizational performance or consistency of products quality. This research aims to evaluate the implementation of ISO 9001 in the quality management system of PT. Bio Farma (Persero), to find out the influence of the implementation of the ISO 9001 quality management system on the managerial performance and on the consistency of vaccine products quality in PT. Bio Farma (Persero). This research is a descriptive analysis retrospective research. The data collected are from the observation on the implementation of ISO 9001, the interview with the related parties, and the document review. The documents reviewed are the manual system guide, Standard Operating Procedure, Report of the Key Indicator Performance, and Report of Annual Product Review (APR). The result of the research shows that PT. Bio Farma (Persero) has already implemented the required elements of the ISO 9001 quality management system : 1) Quality management system (100%), 2) Management responsibility (99,2%), 3) Resouces management (100%), 4) Product realization (99,2%), 5) Measurement, analysis and improvement (100%). The implementation of the ISO 9001 quality management system improves the managerial performance of the company, whereas the key performance indicator in the last four years is always achieved, even there is improvement in achievement minimum standard. The consistency of the vaccine quality in the last three years is always achieved as observed from DTP-HB vaccine�s quality parameter that shows the process is capable (Cpk � 1), except for pH parameter within the year of 2007 (Cpk = 0,55) and year of 2009 (Cpk = 0,92) [Yogyakarta] : Universitas Gadjah Mada 2012 Thesis NonPeerReviewed , Rika Murharyanti and , Dr. Akhmad Kharis Nugroho, M.Si., Apt. (2012) EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001 DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL DAN KONSISTENSI MUTU PRODUK VAKSIN DI PT. BIO FARMA (PERSERO). UNSPECIFIED thesis, UNSPECIFIED. http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=54707 |
institution |
Universitas Gadjah Mada |
building |
UGM Library |
country |
Indonesia |
collection |
Repository Civitas UGM |
topic |
ETD |
spellingShingle |
ETD , Rika Murharyanti , Dr. Akhmad Kharis Nugroho, M.Si., Apt. EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001 DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL DAN KONSISTENSI MUTU PRODUK VAKSIN DI PT. BIO FARMA (PERSERO) |
description |
ISO 9001 is an international standard which commonly used for certification
related to the quality management system of company or organization eventhough
not all of organization that implemented ISO 9001 seems to get the benefit related
to higher organizational performance or consistency of products quality. This
research aims to evaluate the implementation of ISO 9001 in the quality
management system of PT. Bio Farma (Persero), to find out the influence of the
implementation of the ISO 9001 quality management system on the managerial
performance and on the consistency of vaccine products quality in PT. Bio Farma
(Persero).
This research is a descriptive analysis retrospective research. The data
collected are from the observation on the implementation of ISO 9001, the
interview with the related parties, and the document review. The documents
reviewed are the manual system guide, Standard Operating Procedure, Report of
the Key Indicator Performance, and Report of Annual Product Review (APR).
The result of the research shows that PT. Bio Farma (Persero) has already
implemented the required elements of the ISO 9001 quality management system :
1) Quality management system (100%), 2) Management responsibility (99,2%), 3)
Resouces management (100%), 4) Product realization (99,2%), 5) Measurement,
analysis and improvement (100%). The implementation of the ISO 9001 quality
management system improves the managerial performance of the company,
whereas the key performance indicator in the last four years is always achieved,
even there is improvement in achievement minimum standard. The consistency of
the vaccine quality in the last three years is always achieved as observed from
DTP-HB vaccine�s quality parameter that shows the process is capable (Cpk � 1),
except for pH parameter within the year of 2007 (Cpk = 0,55) and year of 2009
(Cpk = 0,92) |
format |
Theses and Dissertations NonPeerReviewed |
author |
, Rika Murharyanti , Dr. Akhmad Kharis Nugroho, M.Si., Apt. |
author_facet |
, Rika Murharyanti , Dr. Akhmad Kharis Nugroho, M.Si., Apt. |
author_sort |
, Rika Murharyanti |
title |
EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001
DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL
DAN KONSISTENSI MUTU PRODUK VAKSIN
DI PT. BIO FARMA (PERSERO) |
title_short |
EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001
DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL
DAN KONSISTENSI MUTU PRODUK VAKSIN
DI PT. BIO FARMA (PERSERO) |
title_full |
EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001
DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL
DAN KONSISTENSI MUTU PRODUK VAKSIN
DI PT. BIO FARMA (PERSERO) |
title_fullStr |
EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001
DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL
DAN KONSISTENSI MUTU PRODUK VAKSIN
DI PT. BIO FARMA (PERSERO) |
title_full_unstemmed |
EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001
DAN PENGARUHNYA TERHADAP KINERJA MANAJERIAL
DAN KONSISTENSI MUTU PRODUK VAKSIN
DI PT. BIO FARMA (PERSERO) |
title_sort |
evaluasi penerapan sistem manajemen mutu iso 9001
dan pengaruhnya terhadap kinerja manajerial
dan konsistensi mutu produk vaksin
di pt. bio farma (persero) |
publisher |
[Yogyakarta] : Universitas Gadjah Mada |
publishDate |
2012 |
url |
https://repository.ugm.ac.id/98934/ http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=54707 |
_version_ |
1681230450713952256 |