PROGRAM PEMBANGUNAN USAHAWAN

TAHUKAH ANDA TERDAPAT BEBERAPA PROGRAM KERAJAAN DAN SWASTA UNTUK MEMBANTU SYARIKAT-SYARIKAT MULA BERNIAGA?

sila klik link dibawah.

Program Kerajaan/ Berkanun

No.	Program	Agensi
1.	Skim Prosper Usahawan Muda	PUNB
2.	Dana Usahawan Muda	SMEBNK
3.	Yayasan Pembangunan Usahawan Terengganu	YPU
4.	Skim Pembiayaan Ekonomi Desa (SPED)	KKLW

5.	Skim Permulaan Usahawan Bumiputera	TERAJU
6.	Modal Usahawan 1 Malaysia	AGROBNK
7.	Program Bimbingan Usahawan	FAMA

Program Swasta

No.	Program	Syarikat
1.	Usahawan.com	Usahawan.com
2.	Klinik Usahawan	AzizanOthman
3.	Persatuan Usahawan Internet Malaysia	PUIM
4.	Akademi Perintis Usahawan Muda	ODC2U

Application for GRANT?

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GDPMD CERTIFICATION PROCESS FLOW

Gap Analysis

GDPMD Awareness Training

GDPMD RCM preparation

GDPMD Procedures preparation

GDPMD Forms preparation

Identification of related mandatory documentations

Final review of documents

Internal Audit Training

Internal Audit Workshop

Actual Internal Audit Program

Management Review Meeting

1st Stage Certification Audit - by CAB

2nd Stage Certification Audit - by CAB

Certification Issuance - by CAB

Medcast Registration

MDA review

Establishment License Issuance - by MDA

Note: Implementation of system shall be carry out concurrent with the system development and update.

Duration of each consultation and GPDMD system development processes will be varies base on :
a. Complexity of processes
b. Number for premises involved
c. Application for secondary assembly requirements
d. Type of devices involved
e. Type of GDPMD applied (LAR, Distributor, Importer and Service provider).

ETO VALIDATION AS PER ISO 11135 Requirements for the development, validation and routine control of a sterilization process for medical devices

Do you have your own ETO sterilization Chamber or Do you plan to purchase any? Have you think of the validation requirement for the ETO sterilization process?

Validation of ETO sterilizer is deem mandatory and compulsory to ensure assurance of sterilization of good being evaluated and verified in accordance to the designated manual. 

Some of the requirements for the validation are the pre validation requirements which cover the product condition, packaging specification, measuring tools and many more. 

One need to ensure the component of the validation requirements being fulfilled. 

a. Installation Qualification
b. Operational Qualification
c. Performance Qualification - Physical
d. Performance Qualification - Microbiological

During all of these stages, validation shall cover the requirements for machine (ETO) installation and operational conformance to the intended use. Evaluation of Bio Indicator to be use during the process need to be carry out to ensure accuracy, dependable, reliability and meeting the specification for ETO process. Identification of lethal cycle or Half cycle identification which will mark the final dwell time requirements for full cycle of successful sterilization process.

Need to know more information regarding the ISO 11135 (now 2014) Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Contact us now! 

Dapatkan sistem ISO 9001 dalam masa kurang 5 bulan ?

Tahukah anda bahawa sistem ISO 9001 boleh diperolehi dalam masa yang singkat jika anda tahu caranya?

ISO 9001 adalah sistem pengurusan berkualiti yang menekankan keperluan memenuhi spesifikasi dari manual ISO 9001 terbaru dan implementasi sistem yang telah dibuat. Selain itu, keperluan juga adalah untuk sistem itu di audit oleh pihak ketiga atau dinamakan badan persijilan yang terpilih.

Sistem ISO 9001 adalah sebenarnya, sistem tambahan yang membantu memperbaiki sistem syarikat sedia-ada supaya mengikut satu "acuan" perlaksanaan sistem syarikat yang menyamai standard syarikat-syarikat ber ISO yang lain dan dengan ini membuatkan pengurusan menjadi seragam dan mudah dikawal selia.

Sistem-sistem yang dibentuk akan menyebabkan secara tidak langsung:
a. Kawalan kualiti kerja
b. Pematuhan kepada keperluan pelanggan
c. Penambahbaikan berlaku dalam operasi syarikat
d. Pengenal pastian masalah-masalah dalam syarikat dan mendapatkan cara-cara penyelesaian
e. Peningkatan kualiti kerja kepada pekerja-pekerja syarikat
f. Peningkatan kesedaran kepada keperluan kepuasan pelanggan


Sistem ISO 9001 adalah sangat berguna dalam jangka masa panjang dalam menjadikan perubahan-perubahan positif dan pemantauan kepada keperluan pembaikan dalam mutu sistem sesuatu syarikat yang akhirnya akan dapat membantu peningkatan kualiti barangan dan juga perkhidmatan.

Di bawah adalah skop manual ISO 9001:2008

0.0 Foreward

0.1 Introduction

0.1.1 Quality Managment Principles

0.2 Process Approach

0.2 Types Of Business Processes

0.2 Process Characteristics

0.2 Process Plan - Do - Check - Act

0.3 Relationship With ISO 9004

0.4 Compatibility With Other Management Systems

1.1 ISO 9001 QMS Scope

1.2, - 3 QMS Application

4.1 QMS General Requirements

4.1 QMS General Requirements - Continued

4.2.1 Documentation Requirements

4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.3 Control of Documents -Continued

4.2.4 Control of Records

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4.1 Quality Objectives

5.4.2 Quality Management System Planning

5.5.1 Responsibility and Authority

5.5.2 Management Representative

5.5.3 Internal Communication

5.6 Management Review

6.1 Provision of Resources

6.2 Human Resources

6.3-4 Infrastructure and Work Environment

7.1 Planning of Product Realization

7.1 Planning of Product Realization - 2

7.2 Customer-Related Processes

7.2 Customer-Related Processes - Cont'd

7.3.1 Design and Development Planning

7.3.2 Design and Development Inputs

7.3.3 Design and Development Outputs

7.3.5-7 Verification, Validation & Changes

7.4 Purchasing Process

7.4.2-3 Purchasing Information & Verification of Purchased Product

7.5.1 Control of Production and Service Provision

7.5.2 Production Process Validation

7.5.3 Identification and Traceability

7.5.4-5 Customer Property and Preservation of Product

7.6 Control of Monitoring and Measuring Equipment

7.6 Control of Monitoring and Measuring Equipment 2

8.1 Measurement, Analysis and Improvement - General

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring and Measurement of Processes

8.2.4 Monitoring and Measurement of Product

8.3 Control of Nonconforming Product

8.4 Analysis of Data

8.5.1 Continual Improvement

8.5.2 Corrective Action

8.5.3 Preventive Action

Syarikat anda perlukan persijilan ISO 9001? Sila hubungi kami  03-7832 3502 Ummah Synergy Resource, TTDI Jaya, Shah Alam.

GDPMD AND PRODUCT REGISTRATION

GDPMD Certification, Establishment License and Product registration are two regulatory requirements for Medical Device Industry player. Started from July 2012 until closing date July 2015, all company affected required to ensure fulfillment of the said requirement or potentially face legal action base on the requirements of Medical Device Act 737.

GDPMD Certification is a design of system that designated for medical device distribution supply chain to ensure product safety and performance of devices throughout the distribution cycle.

Apart from that, the GDPMD will also ensure the company involved shall retain the necessary procedures and protocol of pre and post sales activity.

GDPMD will also help to ensure of prevention of counterfeit adulterate, unwholesome and tampered medical devices being supplied within the same supply chain. This will ensure only good products are supplied to end users.

For LAR (Local Authorised Representative), the additional requirement for the compliance of GDPMD will be the Product Registration of devices.

Product Registration will involve of the company to fulfill the Conformity Assessment such as the technical product summary by compiling technical file and producing the technical summary called the CSDT (Common Submission Dossier Template).

CSDT is a compiled of technical information, in a summary form, base on the designated CSDT documents requirement of Medical Device Authority of Malaysia and must be submitted for Product Evaluation by CAB.






For more information of the above, Kindly contact us at 03 7832 3502/4502 Ummah Synergy Resources.

GDPMD DEVELOPMENT WORKSHOP - JANUARY 2015

Ummah Synergy Resources akan mengadakan program;

 "GDPMD DEVELOPMENT WORKSHOP".


Tujuan:

•  Memberi peluang dan ruang untuk syarikat-syarikat kecil tempatan yang bermasalah untuk menyediakan    sistem GDPMD dalam masa yang singkat.

• Mengurangkan kos perbelanjaan "proses and procedure development" 
•  Menyiapkan 80%-90% keperluan sistem GDPMD dalam tempoh 2 minggu sahaja
• Memastikan semua peserta mendapat maklumat yang sama dan terbaru
• Membantu syarikat menyediakan dokumentasi secara "step by step"
• Penerangan berkenaan keperluan "Medical Device Authority"
• Membantu pendaftaran di dalam MEDCAST

 Program:

• Program ini akan berlangsung selama 5 hari
• Minimum 5 syarikat akan terlibat 
• Maximum 5 peserta setiap syarikat (Minimum 3 peserta )

 Kos Program:

• RM 6,000.00 setiap syarikat.

          - RM 5,500.00 setiap syarikat (early bird) - Pembayaran sebelum 10 Januari 2015
         Tarikh akhir pendaftaran pada 20 Januari 2015

• Tambahan RM100 setiap peserta yang melebihi jumlah maksimum.*

          - kos tidak termasuk penginapan dan perjalanan.

          - Fee inclusive: meal - breakfast, lunch and time break (2x)

Itenari Program:

1st day: Morning Session         > Training for GDPMD awareness and Q&A. Afternoon Session         > Medical Device Group and business categories 2nd day: Morning         > Gap Anaysis and Briefing of general documentation requirements         > Identification of requirement exclusion         > Company activity and depth of system Afternoon          > Preparation of level 1 documentations - Regulatory Compliance Manual          > Preparation of Level 2 documentations - General procedures 3rd day: Morning           > Preparation of Level 2 documentations - General procedures (...continue) Afternoon           > Preparation of Level 2 documentations - Specific procedures 4th day: Morning            > Preparation of Level 3 documentations - Spec, forms etc Afternoon            > Review of overall documentations            > Identification of error and conformity reference to medical device act 5th day: Morning            > Internal Quality Audit Training Afternoon            > Internal quality audit (mork up audit)            > Internal audit documentation and report  Pendaftaran: Sila berhubung dengan pihak secretariat kami di, 03-7831 3502/ 4502 @ 017-2130501 atau e mail kami di sales.ummahsynergy@gmail.com.