WHAT IS GDPMD?

GDPMD specifies the requirements for a quality management system to be established, implemented, and maintained by an established of medical device importer/distributor/ authorized representative to comply with the Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. The objective of GDPMD is to ensure the quality, safety, and performance of the medical device which includes but is not limited to product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration, and after-sales service; tracking, documentation, and record-keeping practices.

The aim of GDPMD is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution process. The certification to GDPMDS is a mandatory requirement in the application of an Importer's or Wholesaler's License.

Why do you need to implement and certify GDPMD?

1) A license to trade in the logistics and shipping of medical devices

2) Develop a consistent product or service quality, efficiency, and cost benefits

BENEFITS:

• Medical devices are appropriately managed and controlled throughout the supply chain thus ensuring their safety and performance at the point of use.
• Provides assurance to stakeholders through certification that the organization is able to maintain the quality, safety, and performance of medical devices while under its custody.
• Fulfillment of establishment licensing requirements.

WHAT IS ISO 55001?

ISO 55001(or ISO 55001:2014) enables organizations to implement Asset Management System necessary to manage their assets and optimize their lifetime value effectively and efficiently. With the advent of Publicly Available Specification (PAS 55), ISO 55001 standard is being widely adopted in various industries (utilities, transport, mining, process and manufacturing) over the globe and is seen as the blueprint for any organization focused on management and in maximizing their value.

The ISO 55000 family comprises of three standards:

ISO 55000
Provides an overview of the subject of asset management and the standard terms and definitions.

ISO 55001
It is the requirements specification for an integrated, effective management system for asset management.

ISO 55002
It provides guidance for the implementation of such a management system.

Scope Application:

WHAT IS ISO 39001?

BS ISO 39001 sets out the minimum requirements for a Road Traffic Safety Management System. Governments, road authorities, safety groups, and private companies were keen to develop such a standard due to the rising number of people killed or injured on the road each year.

Key Benefits

• Meet organizational safety and social responsibility targets
• Demonstrate to stakeholders that you take these targets seriously
• Identify a way to improve efficiency through better management
• Cut costs through improved efficiency
• Be recognized as one of the first companies to implement BS ISO 39001

Petroleum, Petrochemical & Natural Gas Industries

ISO 29001 (published in 2003) defines the quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. Developed as a direct result of a partnership between ISO and the international oil and gas industry (led by the American Petroleum Institute - API), ISO 29001 specifically focuses on the oil and gas supply chain.

The ISO 29001 standard is based on ISO 9001 and incorporates supplementary requirements emphasizing defect prevention and the reduction of variation and waste from service providers. They also provide global consistency and improved assurance in the supply quality of goods and services from providers. This is particularly important when the failure of goods or services has severe ramifications for the companies and industries involved.

This standard is for all organizations working within the oil and gas industry supply chain. Certification to ISO 29001 ensures standardization and improvement within the sector.

WHAT IS ISO 28000?

This standard identifies the requirements for a supply chain security management system, relating security management to many other aspects of business management. These include all activities controlled or influenced by organizations that impact supply chain security, which includes the transportation of these goods along the supply chain.

ISO 28000 uses an additional pragmatic approach where the risk levels of your supply chain operations are identified. It enables your organization to execute a risk assessment with supporting management tools (I.e., document controls, key performance indicators, internal audits, and training) and implement the controls in accordance with the risk involved.

The framework of ISO 28000 is structurally very similar to the ISO 14001 Environmental Management Systems (EMS) standard. The environmental aspects identification and evaluation process in EMS is similar to security risk assessment in security management.

WHAT IS ISO 18788?

ISO 18788 provides a framework for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving the management of security operations. It provides the principles and requirements for a security operations management system (SOMS).

ISO 18788 provides a business and risk management framework for organizations conducting or contracting security operations and related activities and functions while demonstrating:

• conduct of professional security operations to meet the requirements of clients and other stakeholders
• accountability to law and respect for human rights
• consistency with voluntary commitments to which it subscribes
• establish, implement, maintain and improve a SOMS
• assess its conformity with its stated security operations management policy
• demonstrate its ability to consistently provide services that meet client needs and are in conformance with applicable laws and human rights requirements.

WHY ISO 15189?

Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.

With 300,000 tests performed every working day of the year and around 95% of clinical pathways relying on patients having access to pathology services, it’s clear that medical laboratories sit at the heart of a fully-functional modern society. Becoming ISO 15189 accredited will verify three key components of a laboratory: your integrity, impartiality and capabilities. Here’s a little bit more about this crucial ISO standard.

What is ISO 15189?
ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, assesses their competence and ensures they are functioning in line with industry and legal standards.

As part of your ISO 15189 accreditation process, you will create a document that explains how your laboratory can work to conform to each requirement to a high standard of quality. This handy document will provide each member of your team with instructions for performing the tasks to an ISO-accredited standard.

Who needs ISO 15189?
Laboratory testing is incredibly important in the delivery of information-based healthcare outcomes – this is incredibly important in a world where decisions need to be driven by facts, science and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited.

Is ISO 15189 mandatory?
ISO 15189 accreditation is not mandatory in every jurisdiction, but it’s worth checking your local regulations. Nevertheless, the importance of laboratory accreditation should never be overlooked, especially when you are dealing with public health.

As part of your accreditation process, you will get your organisation up-to-date with all the complex legal requirements that a medical laboratory must adhere to. With the ISO’s culture of continuous improvement, any changes to law or regulation will be implemented as part of your ongoing commitment to best practice.

What are the benefits of ISO 15189 accreditation?
There are many reasons why ISO 15189 is important – here are some of the numerous benefits it offers to medical laboratories.

Risk reduction
When you structure your operation around best practise, your systems will be more rigorous. Planning for and identifying any potential risks will help massively reduce them – especially in laboratories that deal with sensitive information, complicated equipment and matters pertaining to people’s health.

Cost-saving
By assuring results are technically valid, your laboratory will save costs associated with retesting. There will also be other cost-saving measures implemented across the standard as your efficiency increases.

Improved team morale
The standard works to reduce staff mistakes and other preventable errors. Your staff motivation won’t only be improved by their demonstration of better performance, but also by you recognising and promoting your staff’s technical competence.

Legally compliant
By implementing legislation and industry standards into your medical laboratory, ISO 15189 assures that your clinical services are safe, reliable and of good value. This conveys trust to stakeholders and decision-makers who recognise and appreciate the commitment. Legal challenges will be less likely and, if they do occur, you can ensure the framework will support you.

Continual improvement
Best practices won’t start and end with your ISO 15189 certification: through integrating this framework into the core of what you do, you will develop additional programmes over time. The framework acts as a tool for measuring quality improvements and continually supporting consistency.

Globally recognised
Being a globally recognised standard not only has reputational benefits. For ISO 15189, global recognition is particularly pertinent. A series of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the world. This way, your work can benefit medical health not just in your country, but all over the globe.

WHAT IS HACCP?

Hazard Analysis Critical Control Points (HACCP) is defined to be the food detrimental elements major control points by the food and drug administrative agent. HACCP is composed as hazard analysis (HA) and critical control points (CCP). HA is to search for the hazard elements and analyze the hazard structure. HACCP is to decide the sanitation control points to control the major hazard control points after identifying the hazard elements from material supply, manufacture, processing, preservation and distribution to the end user consumption. In other words, HACCP is a scientific food sanitation control system to secure the safety and hygiene of food product by the effective and self-motivated hygiene control system. HACCP is the management system dealing with food safety through the following methods. Analysis and control of hazard elements from biological, chemical and physical perspectives. All food product life cycle is the object of HACCP beginning from material supply and food manufacturing to distribution and consumption.

Key Benefits

• Sanitation control
• Food production in sanitary manner
• Concentration in the sanitation effort and effective control of food
• Economic control of food products (Reduction of defective product and customer complaints)
• Safe and sanitary distribution of food product
• Choice of sanitary feted induct through public certification
• Prevention from the food hygiene problems
• Effective response to RECALL and P/L
• Advantageous inspection process
• Reliability lo the food product
• Export advantages
• HACCP mark identification

WHAT IS ISO 13485?

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation, and servicing such as added requirements on record-control, sterilization, and risk management. Organizations can register to ISO 13485 as a standalone or in conjunction with an ISO 9001 or other registration. An ISO 13485 certification from us demonstrates your organization's commitment to providing products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.

Key Benefits  Implementing ISO 13485 Really Helps Your Company In The Following Way.

• Provides a robust framework for assuring product consistency
• Creates a competitive advantage
• Engages top management involvement
• Ensures a consistent and effective approach to business
• Reduces risk factors via the use of risk management
• ISO 13485 regulatory requirements for manufacturers of medical devices co an International scale.
• A number of countries have Incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used In support of regulatory compliance.
• It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.

WHAT IS AS 9100?

AS9100 (BS EN 9100) is the single common quality management standard for the aerospace industry. It is used and supported by the world's leading aerospace companies and throughout their supply chains. AS9100 can be used by organizations across the aerospace sector, including design, manufacturing, maintenance and distributing companies. If you certify to the standard you can be confident that you have an effective quality management system in place. AS9100 may also be essential to achieving your trade license, making it essential now and in the future.

Key Benefits

• Reduce the risk of product or service mistakes and fatal failures
• Demonstrate effective quality management to achieve a license to trade
• Get a listing in the Online Supplier Information System (OASIS) database
• Become a preferred supplier and gain customer and stakeholder trust
• Continually improve and win international growth opportunities