Setiawan, Muhammad Avan (2026) RANCANGAN SISTEM MANAJEMEN MUTU PELAYANAN APOTEK MENUJU ISO 9001:2015. S1 thesis, Fakultas Teknik Universitas Sultan Ageng Tirtayasa.
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Abstract
The quality of pharmaceutical services in community pharmacies plays an essential role in ensuring patient safety and the overall quality of healthcare services. However, variations in service process implementation and limitations in quality documentation systems are still observed, leading to suboptimal quality control. This condition indicates the need for a structured evaluation of the quality management system. This study aims to identify gaps between the existing conditions of pharmaceutical services in pharmacies under PT SKA and the requirements of ISO 9001:2015, as well as to develop quality management system improvement plans for each required clause. A descriptive approach using mixed qualitative and quantitative methods was employed. Data were collected through observations, interviews with responsible pharmacists, and document reviews in five pharmacies under PT SKA located in Bandung and Cimahi. Data analysis was conducted using gap analysis based on clauses 4 to 10 of ISO 9001:2015. The results indicate that the implementation of the quality management system in pharmaceutical services has not fully met ISO 9001:2015 requirements, with gaps identified across all clauses. The most significant gaps were found in clause 5 (leadership), clause 6 (planning), and clause 10 (improvement). Improvement plans were developed for all ISO 9001:2015 clauses, with emphasis on strengthening leadership commitment, risk and opportunity-based planning, and documented corrective and continual improvement mechanisms
| Item Type: | Thesis (S1) |
|---|---|
| Additional Information: | Mutu pelayanan kefarmasian di apotek berperan penting dalam menjamin keselamatan pasien dan kualitas pelayanan kesehatan. Namun, dalam pelaksanaannya masih ditemukan variasi penerapan proses pelayanan serta keterbatasan sistem dokumentasi mutu yang berdampak pada pengendalian mutu yang belum optimal. Kondisi tersebut menunjukkan perlunya evaluasi sistem manajemen mutu secara terstruktur. Penelitian ini bertujuan untuk mengidentifikasi kesenjangan antara kondisi eksisting pelayanan kefarmasian di apotek naungan PT SKA dengan persyaratan ISO 9001:2015 serta menyusun rancangan perbaikan sistem manajemen mutu pada setiap klausul yang dipersyaratkan. Penelitian menggunakan pendekatan deskriptif dengan metode campuran kualitatif dan kuantitatif. Data dikumpulkan melalui observasi, wawancara dengan apoteker penanggung jawab, dan telaah dokumen pada lima apotek naungan PT SKA di Kota Bandung dan Kota Cimahi. Analisis data dilakukan menggunakan metode analisis gap terhadap klausul 4 hingga klausul 10 ISO 9001:2015. Hasil penelitian menunjukkan bahwa penerapan sistem manajemen mutu pelayanan kefarmasian belum sepenuhnya memenuhi persyaratan ISO 9001:2015, dengan kesenjangan yang masih ditemukan pada seluruh klausul. Gap terbesar terdapat pada klausul 5 (kepemimpinan), klausul 6 (perencanaan), dan klausul 10 (peningkatan). Rancangan perbaikan disusun untuk setiap klausul ISO 9001:2015, dengan penekanan pada penguatan kepemimpinan dalam penetapan kebijakan dan sasaran mutu, perencanaan berbasis risiko dan peluang, serta pembentukan mekanisme tindakan korektif dan perbaikan berkelanjutan yang terdokumentasi. |
| Subjects: | H Social Sciences > HD Industries. Land use. Labor H Social Sciences > HD Industries. Land use. Labor > HD28 Management. Industrial Management R Medicine > R Medicine (General) |
| Divisions: | 03-Fakultas Teknik > 26201-Jurusan Teknik Industri |
| Depositing User: | Muhammad Avan Setiawan |
| Date Deposited: | 20 Apr 2026 01:28 |
| Last Modified: | 20 Apr 2026 01:28 |
| URI: | http://eprints.untirta.ac.id/id/eprint/59809 |
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