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ISO 13485 - MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS ISO 13485 is a standard that represents the requirements of a comprehensive quality management system (QMS) for the design and development, production, storage, distribution, installation and servicing of medical devices. It specifies requirements for organizations involved in one or more stages of the medical device life cycle. ​ ISO 13485 can also be used by importers or the appointed agency who import and distribute medical devices who maybe mandatory to set up medical devices QMS as to comply with their local regulation. ​ Those companies who are certified to ISO 13485 are explicitly expect to comply with all the applicable regulatory requirements and established a risk based approach risk managements QMS for its processes including the outsourced activities. ​ ISO 13485 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, storage, distribution of medical devices activities and other aspects of the QMS. ​ ISO 13485 vs ISO 9001: Both ISO 9001:2015 and ISO 13485:2016 specified QMS requirements by which an organization must demonstrate that it can consistently provide products and services that meet customer and statutory/regulatory requirements. ​ ISO 9001, however, adds enhancing customer satisfaction and continual improvement as goals while ISO 13485 moved way beyond ISO 9001. For the 2016 version, one objective developed was to ensure ISO 13485 would better support the global alignment of regulatory requirements for medical devices. ​ Why Prinsip Mahir? Prinsip Mahir can help your organization: To establish QMS that is oriented towards the design, development, production, and installation of medical devices and related services. To demonstrate your ability to manufacture, supply medical devices and related services that meet customer expectations and comply with regulatory requirements. To evaluate how well your organization is able to meet ISO 13485, customer expectations and comply with regulatory requirements. To achieve ISO 13485 world class certification for compliance. < All Standards Consulting and Auditing Training Course

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AUDITING Achieve Your Goals System Auditing Meeting the needs of customers is the main objective of a Quality Management System such as ISO 9000. Success with such a program is usually attained with a systematic approach to Quality Assurances, including the elements of planning, organization, performance, and evaluation. Evaluation is often considered the most beneficial element for ISO organizations because it reveals ways to further improve quality and incrementally increase customer satisfaction. Evaluation is facilitated by audits. ​ Types Of System Auditing: Internal Audit - To provide audit as part of Internal Audit to comply with ISO requirement. Vendor Audit - To carry out independent audit on company's suppliers for quality related issues. Second Party Audit - To provide independent and unbiased audit on behalf of company on its system performances. ​ ​ Prinsip Mahir is prepared to assist you with the following first party and second party Management System audit services: Quality System Documentation Review; including contributions to the Extent of System Documentation, Documentation levels, Document Format, Operational Procedures/Work instruction, and documentation Review. Audit Planning; include input on Audit Schedule, Auditor's Activities, and Breakdown of the Audit Process. Preparation and Use of Audit Checklist; including assistance with Subject Selection, Checklist Preparation, and Use of Checklist. Conducting the audit; including the contributions to the Audit Strategy, Opening Meeting, Management Interview, Observation Of Operation, Record Review, Assessment of nonconformity, and Evaluation Of Corrective Actions. Audit Reporting; Including inputs on Nonconformity Categories, Preparation of Nonconformity Reports, Corrective Action Determination, the Audit Summary Report, and the Audit Exit Meeting. Audit follow-up; including assistance with Establishing Audit Follow-up Time Scale, Conducting Audit Follow-up, and Concluding the Management System Audit process. < All Services Get in Touch

EXPLORE PRINSIP MAHIR Helping You Become Great PRINSIP MAHIR SERVICES Backed by a team of experienced ISO specialists, our strategic services meet the needs of all types and sizes of clients - from small startups to large firms - and deliver lasting changes with measurable growth. We are a HRDF Approved Training Centre and ePerolehan registered with the Ministry of Finance (MOF). We offer a full range of services geared towards helping organizations achieve competitiveness, and developing market opportunities in the domestic and overseas. These services include: ​ Operational and process improvement consulting focused on improving an organization's effectiveness, efficiency and profitability. Services for organizations to penetrate or develop specific market or sales opportunities. Compliance and/or certification of ISO standards. Explore our site to learn how we can help your future success. CONSULTING Read More > AUDITING Read More > TRAINING Read More > CONTACT US Service Consulting Auditing Training Other Submit Thanks for submitting! This form no longer accepts submissions.

ISO STANDARDS ISO 9001 - QUALITY MANAGEMENT SYSTEMS (QMS) ISO 13485 - MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS GOOD MANUFACTURING PRACTICES (GMP) & HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) ISO 14001 - ENVIRONMENTAL MANAGEMENT SYSTEMS (EMS) ISO & IEC 17025 - TESTING AND CALIBRATION LABORATORIES HALAL ASSURANCE SYSTEM (HAS) ISO 45001 - MANAGEMENT SYSTEMS OF OCCUPATIONAL HEALTH AND SAFETY (OH&S) IATF 16949 - AUTOMOTIVE QUALITY MANAGEMENT SYSTEM GOOD MANUFACTURING PRACTICES (GMP) FOR FACTORY CONSTRUCTION AND RENOVATION ISO & FSSC 22000 - FOOD SAFETY MANAGEMENT SYSTEMS (FSMS) GOOD DISTRIBUTION PRACTICES FOR MEDICAL DEVICES (GDPMD) ISO 37001 - ANTI-BRIBERY MANAGEMENT SYSTEM (ABMS)

GOOD MANUFACTURING PRACTICES (GMP) & HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) Good Manufacturing Practices (GMP)​ GMP is a pre-requisite programme for ensuring that products are consistently produced and controlled under good hygiene practices to achieve the expected finished goods outcome. The main objective of implementing GMP is to minimize risks for the company that could affect the food safety and quality of the finished good. ​ Key GMP element covers vendor assurance programme, quality control of ingredients, premises infrastructure and equipment maintenance, pest control, cleaning and sanitation of work environment to personal hygiene of staff. E.g. plant cleanliness and hygiene - manufacturers must maintain a clean manufacturing area, and pharmaceutical manufacturers must avoid cross-contamination between drugs to ensure the safety and effectiveness of their products. ​ Many countries have legislated on the manufacturers to follow GMP procedures that correspond with the required national legislation. In Malaysia, companies manufactured food, cosmetics, pharmaceuticals, dietary and traditional supplements are required to have GMP system to certify by Ministry of Health Malaysia for them to operate the business. Malaysia Standard GMP provides minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch and for their intended use. ​ Hazard Analysis Critical Control Point (HACCP) HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles: ​ Conduct a hazard analysis Determine the critical control points (CCPs) Establish critical limits Establish monitoring procedures Establish corrective actions Establish verification procedures Establish record-keeping and documentation procedures ​ HACCP can be applied to all processes throughout each and every stage of the food supply chain. This includes production, preparation, packaging and distribution. ​ As a food safety initiative, HACCP is a preventative system. It focuses on potential physical, chemical and biological hazards that could occur during the food manufacturing process and make the end product unsafe. A fundamental aim of the HACCP principles is to discover any potential hazards so that control measures can be designed. If necessary, these control measures would be put in place and reduce the risk of the hazards occurring. ​ Why Prinsip Mahir? Prinsip Mahir can help your organization: To provide initial assessment of client's facility to determine their needs and the requirements for GMP/HACCP. To assist in creating a work plan for developing and implementing a food safety system including development of a record keeping system. To develop a GMP programs and monitoring on the system implementation. To provide training on HACCP to provide an overview of the purpose and requirements of a HACCP certification scheme. This training also covers the Codex Alimentarius Commission Good Manufacturing Practices and preliminary steps to full HACCP systems. To assist with the preparation for auditing by carry out Internal/Adequacy Audit. To examine the contents of the HACCP Manual and supportive documents submitted and to verify that all elements of the HACCP has been addressed. To provide maintenance program of your GMP/HACCP system. < All Standards Consulting and Auditing Training Course

GOOD DISTRIBUTION PRACTICES FOR MEDICAL DEVICES (GDPMD) GDPMD refers to Good Distribution Practice for Medical Devices. It specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737). Why do you need to be certified with GDPMD? A license to trade in the logistics and shipping of medical devices Develop consistent product or service quality, efficiency and cost benefits GDPMD requires an establishment to demonstrate its ability to maintain quality, safety, and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It demonstrates that companies dealing with medical devices have an acceptable standard of quality distribution system in place. In an effort to provide such assurance, medical devices importer and distributor are required to have the documented procedures and keeping records beyond the life of the medical devices for traceability purpose. Medical devices manufacturers who have certified to ISO 13485 will not need to apply for GDPMD and will find that they have partially fulfilled the GDPMD requirements. ​ Why Prinsip Mahir? Prinsip Mahir can help your organization: To provide assistance and guidance in the development of documentation. To monitor the system implementation to detect any system defect and identify areas that requiring improvement. To carry out related training to your company personnel in creating awareness and provide them with the basic necessary knowledge and skills in the implementation of the system. To provide necessary assistance with the preparation and submission of an application to Medical Devices Authority. To carry out Internal Audit in ensuring system readiness prior to Competent Authority Body's audit. To assist in close out of non-conformance raised by the Competent Authority Body until successfully certified. < All Standards Consulting and Auditing Training Course

IATF 16949 - AUTOMOTIVE QUALITY MANAGEMENT SYSTEM IATF 16949:2016 (replaces ISO/TS 16949:2009) is a standard that establishes the requirements for a Quality Management System, specifically for the automotive sector. ​ It can be applied throughout the automotive supply chain. It is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. ​ IATF 16949:2016 is an independent QMS standard that is fully aligned with the structure and requirements of ISO 9001:2015. Therefore, the IATF 16949 cannot be implemented alone as a stand-alone document, but must be implemented as a supplement and in conjunction with ISO 9001:2015. ​ The standard is based on seven Quality Management Principles, including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. ​ These Quality Management Principles are defined as follows: Customer focus Leadership Engagement of people Process approach Improvement Evidence-based decision making Relationship management ​ ​ Why Prinsip Mahir? Prinsip Mahir can help your organization: To provide consultancy in obtaining initial IATF 16949 certification by applying our knowledge to your unique circumstances. We begin by observing the current state of your process, carry out gap analysis, propose a strategic planning and provide technical execution. To provide effective training to assist organizations develop their workforce and keep at a competitive advantage. Gain the knowledge needed to achieve your quality goals will improve the efficiency of your process and reduce wasted time and needless expenses. To assist in carry out 1st party audit i.e. internal audit in ensuring competencies of the Internal Auditor. Some organizations may not always have experienced individuals capable of leading the internal audit and lack adequate resources to support a full-time audit staff. Planning and implementation of an effective 1st Party Audit process can have a significant impact on quality, process control, and developing a culture of continuous improvement. To provide annual maintenance program in maintaining an existing system of IATF 16949 certification. This will be ensuring product safety requirements are always met and reduced number of operational process defects. < All Standards Consulting and Auditing Training Course

WHO WE ARE Prinsip Mahir Sdn Bhd was established in 2000. With more than 20 years of experience, we have expanded our services to include all aspects of management systems, such as Food Safety Management System (FSMS), Occupational Health & Safety (OH&S), Anti-Bribery Management System (ABMS), Laboratory Management System, etc. All our Consultants and Trainers are qualified and recognized by institutions such as IRCA and HRDF/PSMB. ​ Apart of the consultancy services, we also provide a wide range of public and in-house training not only related to ISO management systems but also of soft skills, quality and productivity improvement, motivational courses and soft skills trainings such as 5S, team building program, human resources, etc. Blending practical activities, group discussion and classroom learning to put recommendations into practice, to help develop workforce skills and to drive for continuous operational improvement. Our success is based on the excellence of teamwork, communication and highly motivated personnel. We believe that training must be interactive. Continually focused on your needs, our services remain the best to maintain our client's ISO systems. ​ We are a HRDF/PSMB registered training provider and it has successfully been certified with ISO 9001 Quality Management in May 2009. ​ "Working together to achieve success” - Prinsip Mahir

PRINSIP MAHIR SERVICES We provide the service of system auditing, consultancy, implementing and improving Management Systems based on the ISO standards. We have experience in companies dedicated to the production of goods and services. Our consultants, auditors and trainers are highly qualified and recognized by institutions such as the IRCA and the MRCA. CONSULTING Read More > AUDITING Read More > TRAINING Read More >

GOOD MANUFACTURING PRACTICES (GMP) FOR FACTORY CONSTRUCTION AND RENOVATION Good Manufacturing Practices (GMP) focus on good processing environment to support a hygienic production to produce safe and quality products. Prinsip Mahir is specializes in construction activities subject to GMP requirements for food, pharmaceutical and medical devices industries. ​ Depending on the client's needs, our GMP Consultant will following the client through the entire project as a building owner consultant, or disciplinary specialists from designing stage until the completion of the project to ensure your factory's GMP is meeting the ISO/Halal certification standards. ​ Our GMP activities covers the following areas:​ Layout plan design to maintain factory hygiene and minimize cross contamination Analyze human flow, material and product flow, processing flow etc. Provide advice on changing room, waste disposal, cleaning and sanitation requirements. Evaluate suitable construction material for the intended used eg. exposy flooring, PVC wall paneling, lighting, ceiling etc. GMP equipment and tools Supervise factory construction works Compilation of GMP Documentation and supervise implementation: - Developing GMP Standard Operating Procedure (SOP). Implement GMP personal hygiene on personal protective garments, hairnet, face mask etc. Train the company's personnel to adhere to these GMP SOP Verify the GMP implementation effectiveness Others: - Equipment Qualification Process Validation Cleaning Validation Systems Compliance GMP Audit ​ ​ Why Prinsip Mahir? When you set out to construct complex Pharmaceutical, Food and Medical Devices Plants, it is vital to combine understanding of the technical process with GMP/HACCP/Medical Devices/Halal hygiene and process flow knowledge to achieve certification conformance. ​ With this solid process knowledge, Prinsip Mahir is in a position to cover the entire project right from the initial process of designing, if required to monitor construction until completion with the aim to make sure it meets the certification requirements. We also take on total responsibility for delivering the complete package in the project management, sometimes working with partners and subcontractors. < All Standards Consulting and Auditing Training Course

ISO 9001 - QUALITY MANAGEMENT SYSTEMS (QMS) ISO 9001 is a standard that defines the requirements for a Quality Management System (QMS). It helps businesses and organizations to manage its processes in a risk controlled manner to achieve its objectives toward excellence in operation. ​ QMS ISO 9001 provides the fundamentals in helping management at par with best-in-class practices. With the challenges that today’s organizations demand to gain through opportunities and control of risks, ISO 9001 provides a differentiator by way of; Driving efficiency and effectiveness for productivity Improve product and service performance Reduces waste and improves costs Serves as enable to fulfill legal obligations and regulations, and To meet contractual agreements ​ ​ Key emphasis of ISO 9001 Quality Management Systems: ISO 9001 requirements cover a wide range of topics, including your supplier's top management commitment to quality, risk management, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides. ​ Why Prinsip Mahir? Prinsip Mahir can help your organization: To obtain initial ISO 9001 certification with full support in guidance, coaching and supervision of the whole project until achieving ISO 9001 certification. To maintain existing ISO 9001 certification by providing annual maintenance program in verification of the status of the QMS including training of employees and close out of the Certification Body audit findings. To assist in carry out the 1st party audit i.e. internal audit for a busy organization to fulfill the mandatory requirement of ISO 9001. To represent the company to carry out second party audit on its supplier against ISO 9001 requirements for the objective of ensuring supplier continually supplying the conformance goods to the company. To provide training to maintain your staff knowledge in ISO 9001 and increase his/her awareness of producing quality product/service that lower the cost of quality for the company. < All Standards Consulting and Auditing Training Course