Sistem Manajemen Mutu pdf

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Sistem Manajemen Mutu (ISO 9001:2015)

Halaman Sistem Manajemen Mutu pdf ini berisi materi tentang

• Sistem Manajemen Mutu (ISO 9001:2015)
• Manajemen Risiko (ISO 31000)
• (M)SDS 1 halaman pdf
• Lean Manufacturing, TPM, SPC
• Pengujian dan Kalibrasi (ISO 17025)
• Manajemen Keamanan Pangan (ISO 22000:2018)
• Manajemen Energi (ISO 50001)
• GMP (Good Manufacturing Practice)

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Sistem Manajemen Mutu pdf: ISO 9001:2015

Kami berikan materi manajemen modern yang paling populer, tentang ISO 9001 2015 , termasuk materi yang berhubungan praktik Manajemen Modern lainnya.

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SIstem Manajemen Mutu pdf:

Ensiklopedia Manajemen Bisnis Indonesia

MENGAPA banyak perusahaan gagal berkembang dan bertahan di zaman sekarang?

Karena karyawan anda dan (maaf) mungkin anda sendiri kurang memahami wawasan manajemen dan wawasan dunia bisnis yang penting yang mempengaruhi kelangsungan hidup perusahaan.

eBook ini memberi WAWASAN MANAJEMEN dan WAWASAN DUNIA BISNIS bagi semua karyawan baru di jajaran manajemen perusahaan s/d manajer dan pemilik perusahaan.

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SIstem Manajemen Mutu pdf:

Ensiklopedia Manajemen Bisnis Indonesia: Pengantar dan Teknis

lihat penjelasan dan download di:

• Ensiklopedia Manajemen Bisnis Indonesia – seri: Pengantar (e-book)
• Ensiklopedia Manajemen Bisnis Indonesia – seri: Teknis (e-book)
• ==> seri Teknis (ISO 9001:2015 +bisnis +akunting +SDM): merupakan “BUKU PINTAR” untuk PRAKTISI MANAJEMEN MUTU/ MANAJEMEN OPERASIONAL/ MANAJEMEN BISNIS.
• eBook seri Teknis ini berisi panduan teknis mendalam untuk menguasai ilmu dapur sistem manajemen modern.

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SIstem Manajemen Mutu pdf:

Ensiklopedia Manajemen Bisnis Indonesia – Praktika

Prosedur Bisnis yang terintegrasi dengan ISO 9001:2015 dan Akuntansi, beserta dokumen utama.

Merupakan bundel SOP (ISO 9001:2015 +bisnis +akuntansi +SDM) siap pakai (versi eBook atau versi editable) untuk operasional bisnis.

Lihat penjelasan dan download di:

• Ensiklopedia Manajemen Bisnis Indonesia – seri: Praktika (e-book)
• Ensiklopedia Manajemen Bisnis Indonesia – seri: Praktika – bisa diedit

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Manajemen Risiko (ISO 31000)

Sistem Manajemen Mutu pdf untuk Manajemen Risiko:

• Manajemen Risiko Berbasis SNI ISO 31000 – BSN – 2018
• ISO 31010:2009 Manajemen risiko – Teknik penilaian risiko
• New Models for Addressing Supply Chain and Transport Risk – WEF
• Supply Chain Risk Management Practices for Federal Information Systems and Organizations – 2nd draft – NIST
• The ISO 31000 standard on risk management – Eric Marsden – risk engineering org

link:

• Center for Risk Management Studies – Indonesia
• Institute of Risk Management (IRM)
• Insurance and Risk Management Terms – IRMI

• (M) SDS – (Material) Safety Data Sheet

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(Material) Safety Data Sheet

Sistem Manajemen Mutu pdf untuk penanganan bahan kimia,dengan format baru (GHS) 1 lembar pdf – untuk ditempel di titik lokasi penggunaan atau penempatan nya

• Material Safety Data Sheet (MSDS) – apakah itu?
• (M)SDS Caustic Soda (NaOH), (M)SDS Asam Klorida (HCl), (M)SDS asam sulfat (H2SO4), (M)SDS Natrium Klorida (NaCl), (M)SDS Asam Cuka (CH3COOH), (M)SDS Etanol (C2H5OH), (M)SDS Amonia (NH4OH), (M)SDS H2O2, … (lebih dari 80 item)

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Materi Manajemen Mutu lain

yang berhubungan dengan Sistem Manajemen Mutu pdf:

Badan Standarisasi Nasional Indonesia

• elearning bsn go id
• Buku Saku (FAQ) Badan Standarisasi Nasional – 2018
• SNI VALUASI – Flipbook dari BSN

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Artikel Sistem Manajemen Mutu pdf

• Perencanaan dan Pengendalian Sumber Daya – Vincent Gaspersz

link:

• the most popular ISO Standards – iso org
• How ISO standards help meet the SDGs

• Materi bagus dari ISO 9001 Auditing Practices Group (ISO and IAF copyright)
• Badan Standarisasi ISO dunia
• Masyarakat Standarisasi Indonesia (MASTAN)

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Six Sigma

• Introduction to Six Sigma – MAS Solutions
• Process Map to a Successful DMAIC Project – che utah edu
• Application of DMAIC to integrate Lean Manufacturing and Six Sigma – Philip Stephen

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Sistem Manajemen Mutu pdf

Lean Manufacturing, TPM, dan SPC

• Introduction to Lean Concepts – MAS Solutions
• What is Lean Manufacturing? – Levantar
• Toyota Production System and Lean Manufacturing – D. Jorge Leon

• An Introduction to Total Productive Maintenance (TPM) – J. Venkatesh
• Total Productive Maintenance (TPM) – Steven Borris – McGraw-Hill
• Multivariate Statistical Process Control Charts: An Overview – mpra ub uni-muenchen de

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Pengujian dan Kalibrasi (ISO 17025)

SIstem Manajemen Mutu pdf untuk Kalibrasi

ISO/IEC 17025 Testing and calibration laboratories preview depan belakang tanpa persyaratan

Metrologi dan Kalibrasi – WMO

• TRAINING MATERIAL on METROLOGY and CALIBRATION by WMO
• Maintenance metric cheat sheet – FIIX

link:

• The World Meteorological Organization (WMO)
• Kalibrasi – Indonesia

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Manajemen Keamanan Pangan (ISO 22000)

Sistem Manajemen Mutu pdf untuk Keamanan pangan:

• ISO 22000:2018 Food safety management systems – Requirements for any organization in the food chain

• Food safety management ISO 22000:2018
• FSSC 22000 SCHEME – VERSION 5.1
• Materi Training ISO 22000-HACCP-GMP
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• Free Nutrition Label Generator – onlinelabels com

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Manajemen Energi (ISO 50001)

Sistem Manajemen Mutu pdf untuk efisiensi energi

• Beli ke BSN: Sistem manajemen energi – Persyaratan dengan pedoman penggunaan (ISO 50001:2018, IDT)
• BS EN ISO 50001:2018

.Pedoman Efisiensi Energi untuk Industri di Asia – UNEP – KLH BPPT

link ISO Standards Development – ISOTC home:

• Energy Star: www.energystar.gov
• ISO/TC 242 “Energy Management”

Contoh Energy Audit Procedure, Report, Good Practice, etc:

• Standard energy audit procedure – Schneider Electric SPA et al – European Commission
• ENERGY AUDIT REPORT – University Of Wollongong – EMET 2007
• ENERGY AUDITOR CHECKLIST – Washington State University

• Audit Energi -Danny Setiawan, ST, MT (Universitas Gunadharma)
• Total Cost of Ownership Modeling for Electronics – epa gov
• Energy Conversion Calculator – AusIndustry (download xls)
• Listrik Tenaga Surya untuk Rumah – Agus Haris

Some Material from Natural Resources Canada:

• Energy Savings Toolbox – an Energy audit Manual and Tool – Natural Resources Canada
• Energy Management Information Systems – Natural Resources Canada
• ENERGY-EFFICIENT MOTOR SYSTEMS ASSESSMENT GUIDE – Natural Resources Canada
• Pinch Analysis: For the Efficient Use OF ENERGY, WATER & HYDROGEN – Natural Resources Canada
• Energy recovery application examples from Natural Resources Canada:
  • Fluid catalytic cracking unit – (PDF, 679 KB)
  • Delayed coker unit – (PDF, 1.1 MB)
  • Integrated thermomechanical pulp plant – (PDF, 694 KB)
  • Ammonia plant – (PDF, 934 KB)

• Energy Conversion Calculator – AusIndustry (download xls)
• Energy Costs Calculator

link:

• Artikel Energi Efficiency bahasa Indonesia

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Sistem Manajemen Mutu pdf

GMP (Good Manufacturing Practice) dari Uni Eropa

GMP adalah Sistem Manajemen untuk perusahaan Farmasi dan Makanan

Introduction

• Introduction

Part I – Basic Requirements for Medicinal Products

• Chapter 1 – Pharmaceutical Quality System
• Chapter 2 – Personnel
• Chapter 3 – Premise and Equipment
• Chapter 4 – Documentation
• Chapter 5 – Production
• Chapter 6 – Quality Control
• Chapter 7 – Outsourced activities
• Chapter 8 – Complaints and Product Recall
• Chapter 9 – Self Inspection

Part II – Basic Requirements for Active Substances used as Starting Materials

• Basic requirements for active substances used as starting materials

Part III – GMP related documents

• Site Master File

• MRA Batch Certificate
• Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use
• Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
• Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
• Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

Annexes

Anx 1	Manufacture of Sterile Medicinal Products
Anx 2	Manufacture of Biological active substances and Medicinal Products for Human Use
Anx 3	Manufacture of Radiopharmaceuticals
Anx 4	Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Anx 5	Manufacture of Immunological Veterinary Medicinal Products
Anx 6	Manufacture of Medicinal Gases
Anx 7	Manufacture of Herbal Medicinal Products
Anx 8	Sampling of Starting and Packaging Materials
Anx 9	Manufacture of Liquids, Creams and Ointments
An 10	Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
An 11	Computerised Systems
An 12	Use of Ionising Radiation in the Manufacture of Medicinal Products
An 13	Manufacture of Investigational Medicinal Products Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014
An 14	Manufacture of Products derived from Human Blood or Human Plasma
An 15	Qualification and validation
An 16	Certification by a Qualified Person and Batch Release
An 17	Parametric release
An 19 ____	Reference and Retention Samples _

Glossary

• Glossary

Part IV – GMP requirements for Advanced Therapy Medicinal Products

• Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

Other documents related to GMP

• A revised version of the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013).

Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (all language versions are available here). These guidelines will come into

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