GDPMD - GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES




With the effective date (1 July 2013) of Act 737 and Medical Device Regulations 2012, manufacturers and distributors of medical devices are required to apply for their establishment licence to continue carrying out their manufacturing, distribution or importing activities.
Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors and Importers require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment Licence.
There is a transition period of two years and one year respectively for the industry to submit applications for medical devices product registration and establishment licensing before the law is fully enforced, as provided in Section 80, Act 737. (source: www.mdb.gov.my)
The GDPMD requirements consists of 6 parts:
  1. Preliminary
  2. Organization and GDPMD Regulatory Compliance System
  3. Establishment Responsibilities
  4. Resource Management
  5. Supply Chain and Device Specific
  6. Surveillance and Vigilance
Benefits of GDPMD Certification
  1. Savings in cost from reduction of defects and rejects
  2. Meet regulatory requirements and customer expectations
  3. Consistency to proper storage, handling, distribution and traceability
  4. Demonstrate ability to produce safer and more effective medical devices
  5. Improve operation efficiency through continual improvement processes

SQC Management PG provides management system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
  1. Identify areas requiring improvement or development within your current Management System
  2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
  3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
  4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
  5. Advise and assist, if required, with the preparation and submission of applications to your certification body
  6. Assist with the development of internal auditing procedures and training
    1. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
    2. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
Our customised in-house training services include
  1. GDPMD Awareness
  2. Understanding, Documenting and Implementing GDPMD
  3. Internal Audit of GDPMD

Timelines

Below are the key dates to remember

Highlights

  • Regulation becoming operational
    1st July 2013
  • Establishment Licence
    Before 1st July 2014 (hence need to obtain GDPMD certificate before this date)
  • Product Registration
    Before 1st July 2015

Need Advice?

Contact Mr. Eddick at 012 - 405 9003 or email to him at eddick.sqc@gmail.com
for more information pertaining to GDPMD and get a free assessment on your current situation.



CUSTOMER CONSULTED (JULY - SEPTEMBER) 2012


Company                                            Product/Service                  Certification

1)   Nores Industries S/B *O-G   Coffee Powder Manufacturer         ISO 22000
2)   O.G Textile S/B *O-G          Textile Manufacturer       ISO 9001Maintenance 
3)   Wan Pow Plastic *O-G         Medical Manufacturer            CE & ISO 13485
       Industry S/B                 
4)    CAB Food S/B             Frog Processing Manufacturer Food Handler Training
5)    NTPM S/B                               Paper Mill                  Food Handler Training
6)    Golden Chemical S/B     Food Ingredient Supplier      Food Handler Training
7)    Blendmix S/B                        Restaurant                 Food Handler Training
8)    Daily Recipe S/B *O-G   Instant Coffee Manufacturer           ISO 22000
9)    Island Lancap                       Construction                          Training
       Construction S/B
10)  Teong Jin Contractor S/B       Construction              ISO 9001 Maintenance
11)  Cocon Food Industries S/B  Food Manufacturer                     Training
12)  Saujania S/B                     Food Manufacturer                      Training  
13)  Marvellous Garden S/B *O-G   Contractor                            ISO 9001 
14)  Kim Sheng Plastic *O-G     Plastic Manufacturer                    ISO 9001
       Industries S/B                
15)  Practical Printer S/B *O-G         Printing                   ISO 9001 Maintenance
16)  G - Hotel Penang                       Hotel                      Food Handler Training
17)  NBC Food S/B                    Food Manufacturer          Food Handler Training
18)  Evergreen Laurel Hotel               Hotel                      Food Handler Training
19)  Ocean Tech Water System  Water Filter System         Food Handler Training
20)  Malayan Metal Work S/B *O-G  Metal Products        ISO 9001 Maintenance
21)  Jin Bin Corporation S/B       Honey & Glucose                        Training                   

*O-G : On-Going status

More than 2500+ companies have benefited from SQC Management consultation. At SQC Management Penang, we stand by our company policy of

S - Serve the customer and complying to requirements

Q - Quest for learning to ensure competency 

C - Continual improvement in the effectiveness of the Quality Management 
     System (QMS)

We are trustworthy and reliable. Think Business Solution, Think of us.
 

UNDERSTANDING, DOCUMENTING & IMPLEMENTING OCCUPATIONAL SAFETY & HEALTH MANAGEMENT SYSTEM *10 CEP POINT (JKKP/DOSH)

10 CEP Point will be given │ Approved by DOSH
Download OSHMS form   HERE
                 Trainer biodata HERE

Course Objective:-

• An overview OSHMS series standards.
• View on the OSHMS Regulatory Requirements within an organization’s operation.
• Relationship between organization activities and the OSHMS
• Develops the strategies to implement the OSHMS in the organization.
• Appreciate the differences and similarities of ISO 14001 and OHSAS 18001:2007.

Course Content:-

[Chapter 1: Introduction]
• What is OSHMS - MS 1722: 2005, OHSAS 18001:2007
• The goal of OSHMS
• Benefits of OSHMS Certification
• Difference between MS 1722: 2005 and OHSAS 18001:2007
• Reported Accidents to Socso

[Chapter 2: Terminology]

[Chapter 3: OSHMS Requirements]
• Scope
• Reference Publications
• Terms and Definitions
• OH & S Management System Elements
• General Requirements
• OH & S Policy
• Planning
• Implementation and Operation
• Checking and Corrective Action
• Management Review

[Chapter 4: Route to Certification]
-----------------------------------------------------------------------------------
Should you need further enquiries, kindly contact Mr Eddick Cheah
at +60-4-6593103/+60-124059003 
or email eddick.sqc@gmail.com

GET A FREE ISO CONSULTATION


In conjunction with SQC Management Penang 15th anniversary, stand a chance to get a free ISO consultation today! 

Based on first come, first serve basis!

So what are you waiting for?

Just call us at +60-4-6593103/+60-4-6584193
or email us at sqcpg1@gmail.com
for a reservation!
 
T & C apply
* A half-day free ISO consultation
*Offer valid until 31 Dec 2012



CUSTOMER CONSULTED (APRIL - JUNE) 2012

              Company                             Product/Service           Certification

1)   Aki Living Stars (M) S/B *O-G     Apple Extract Manufacturer      ISO 22000
2)   State Museum Board *O-G                     Museum                    ISO 9001
3)   SLM Packaging S/B                               Packaging                   ISO 22000
4)   FMM Institute, Kedah/perlis              Training Institute              ISO 14001
                                                                                               Introduction &
                                                                                         Legal Requirement
5)  Omega Sofa (M) S/B                     Furniture Manufacturer               5S
6)  Gerbang Amani S/B                              Construction               Maintenance
7)  Hong San Frozen Foods S/B          Frozen Food Manufacturer Food Handler
8)  Ming Xiang Tai Confectionery                Confectioneries         Food Handler 1
     & Drinks S/B                                      
9)  Fundamental Gains S/B *O-G   Vegetarian Food Manufacturer   Maintenance
10) Sunslab Beute S/B *O-G             Fibre Product Manufacturer        HACCP
11) Jin Bin Corporation S/B           Honey & Glucose Manufacturer   ISO 9001 
                                                                                               Introduction &
                                                                                               Internal Audit
12) Kilang Beras San Seng Lee                     Rice Mill                  Maintenance
13) TC (Malaysia) S/B                         Research & Development     ISO 9001
                                                                                               Internal Audit
14) Ming Xiang Tai Confectionery               Confectioneries         Food Handler 2
      & Drinks S/B 
15) Santomas S/B *O-G                      Plastic Injection Molding      ISO 13485
16) Engfu Feedmill *O-G                            Animal Feedmill            ISO 9001
17) Saujania S/B                                   Candies Manufacturer         Training
18) Syarikat Jaya Tugas Industri S/B            Construction                 Training
19) Kibaru Manufacturing S/B                                                         Training 
20) O-Wealth                                    Fibre Product Manufacturer      Training
21) Hung Thong Food Technology S/B        Food Manufacturer       Food Handler
22) Ming Xiang Tai Confectioneries               Confectioneries         Food Handler
      & Drinks S/B  
23) Blendmix Cafe                                             Food                  Food Handler
24) Taste & See                                               Bakery                Food Handler
25) Kwong Sang House                                      Food                  Food Handler
26) Alunan Asas S/B                                     Construction                Training

                                                                                                  

*O-G : On-Going status

More than 2500+ companies have benefited from SQC Management consultation. At SQC Management Penang, we stand by our company policy of

S - Serve the customer and complying to requirements

Q - Quest for learning to ensure competency 

C - Continual improvement in the effectiveness of the Quality Management 
     System (QMS)

We are trustworthy and reliable. Think Business Solution, Think of us.
 

CUSTOMER CONSULTED (JANUARY - MARCH) 2012

              Company                             Product/Service           Certification

1)  Sri Tanjong Bina S/B *O-G                    Construction                     ISO 9001
2)  Brazillian Food Industries S/B             Coffee Powder                Maintenance
3)  IK Panel S/B *O-G                             Soft Plywood                    ISO 9001
4)  Premier Cereal                                  Cereal Products                 Training
5)  Tean Su Food Industries               Confectionery & Snacks           Training
6)  Toujours Entrepot Enterprise             Honey Distributor               Training
7)  CHOC Artisan S/B                             Chocolate Maker                Training
8)  KoChaBi Taiwanese Delight                   Restaurant                     Training
9)  My Day Breakfast Corner                      Restaurant                     Training
10) Han Hiang                                         Hawker Stall                    Training
11) Leong Yin Pastry Sdn Bhd                       Bakery                        Training
12) Harvik Rubber Industries S/B            Manufacturers of 
                                                            Safety Footwear                 Training

13) Kibaru Manufacturing S/B                  Manufacturer of 
                                                          Rubber Component              Training
14) G Hotel                                                   Hotel                         Training
15) CAB Food S/B                                Processing of Frog                 HACCP



*O-G : On-Going status

More than 2500+ companies have benefited from SQC Management consultation. At SQC Management Penang, we stand by our company policy of

S - Serve the customer and complying to requirements

Q - Quest for learning to ensure competency 

C - Continual improvement in the effectiveness of the Quality Management 
     System (QMS)

We are trustworthy and reliable. Think Business Solution, Think of us.
 

FOOD HANDLER TRAINING


Do you feel annoyed and frustrated when the Ministry of Health (MOH) officer inspect your premise and discover that the requirements set in the Malaysian legislation is not being complied? 

Wouldn't it be good if you know what you can and should do so that everything is in place and you can have everlasting PEACE OF MIND when it comes to this matter?

At SQC Management Penang, we can solve your problem - Click HERE