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Utama
Tentang Kami
Latihan
Konsultasi
Berita Industri
Soalan Lazim
Hubungi Kami
Inspiring Training & Consultancy Plt
Utama
Tentang Kami
Latihan
Konsultasi
Berita Industri
Soalan Lazim
Hubungi Kami
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Soalan Lazim (FAQ)

General Enquiry

Yes, we provide on-site training at your facility to accommodate your organization’s needs, group size, and location.
We do not offer online or hybrid training.
We offer training and consultancy for a wide range of standards, including:
- ISO 9001:2015 (Quality Management System)
- ISO 14001:2015 (Environmental Management System)
- ISO 13485:2016 (Medical Devices)
- ISO 14971 (Risk Management for Medical Devices)
- GDPMD (Good Distribution Practice for Medical Devices)
- Process Improvement Related
We provide professional ISO standards related training, consultancy, documentation development, auditing support, and certification readiness (2nd party audit) services for various ISO management system standards. Our services help organizations achieve compliance, improve performance, and prepare for certification audits (3rd party audit).
Yes. All training can be fully customized to match your company’s processes, industry requirements, and certification goals — as long as the customization remains within our area of expertise and competency.
The timeline depends on the size and complexity of your organization.
On average:
6-9 months (except for IATF 16949)
13-18 months (for IATF 16949)
We also tailor the roadmap based on your readiness and resources.
Yes, we provide support in preparing all required ISO documentation—including manuals, SOPs, forms, templates, risk assessments, process maps, and internal audit checklists.
This documentation support is available, but it must be bundled together with our training services.
We provide full support to help your organization prepare for certification, including gap assessment, implementation guidance, internal audit, management review, and pre-audit checks.
However, we do not deal directly with the certification body; your organization is responsible for liaising with them throughout the certification process.
While no consultant can legally guarantee certification, our structured approach and proven methodology significantly increase the likelihood of success.
Cooperation and commitment from your organization are key factors in achieving certification.
Pricing depends on:
- Number of employees
- Scope of processes
- ISO standard(s) required
- Company location
- Timeline and support level
Contact us to receive a free quotation based on your needs.
You can contact us via our website form, email, or WhatsApp. Our team will discuss your training needs, group size, and schedule to propose a suitable on-site training program.
To begin consultancy services, contact us via our website, email, or WhatsApp. We will request a list of relevant information from your organization to prepare a customized quotation based on your scope and requirements.
All training and consultancy services are delivered by experienced and full-time ISO professionals with practical industry experience. This ensures that training is practical, relevant, and audit-ready.
Yes, participants will receive a Certificate of Attendance for our ISO training programs, which can support internal auditor qualification and professional development.
- ISO Training:
Focused on educating your staff about ISO requirements, processes, and audit readiness.

- ISO Consultancy:
Focused on helping your organization implement ISO standards, develop documentation, and prepare for certification.
Consultancy services are provided in conjunction with training to ensure your team has the required knowledge to implement and maintain the system effectively.
Yes, we can provide integrated training and consultancy for multiple standards (e.g., ISO 9001 + ISO 14001) where appropriate, but the scope must remain within our area of expertise.
Most on-site training sessions range from 1 to 2 days, depending on the topic and customization. We provide a detailed agenda in advance.

ISO 9001 Quality Management System (QMS)

ISO 9001 provides a framework for an effective Quality Management System (QMS), focusing on customer satisfaction and the consistent conformance of products and services to requirements. It promotes process approach, risk-based thinking, and continual improvement.
ISO 9001 certification enhances your credibility and demonstrates your commitment to quality. It helps organizations:
- Improve operational efficiency
- Strengthen customer trust
- Reduce errors and nonconformance
- Meet regulatory and industry requirements
- Support long-term business growth
- Enhance customer satisfaction
- Promote products/services conformance
We provide on-site ISO 9001 training in Malaysia, including:
- ISO 9001 awareness training
- Internal auditor training
- Refresher and advanced ISO 9001 training
- Risk based thinking training
- Awareness training for top management
- Awareness training for shop floor employee
Customized training designed around your processes and industry needs
Online and hybrid training are not offered.
All sessions are delivered by experienced and full-time ISO consultants with strong industry backgrounds. This ensures your team receives practical, audit-ready guidance aligned with real-world practices.
Yes. Training can be tailored to suit your company’s processes, risks, and goals — as long as the customization remains within our area of expertise and competency.
Yes. We assist organizations in implementing ISO 9001, improving their processes, and preparing for certification. Consultancy services are bundled with training to ensure your team gains the required knowledge to maintain and improve the QMS effectively.
Yes, we support the development of ISO 9001 documentation such as quality manuals, SOPs, forms, templates, process maps, and audit checklists.
Documentation development is bundled together with our training services.
Yes. We provide gap assessments, implementation guidance, internal audits, management review support, and pre-audit checks.
We do not liaise directly with certification bodies; your organization will contact them for audit arrangements.
No consultant can legally guarantee certification. However, our proven approach ensures strong readiness for audits.
Cooperation and commitment from your organization are essential for successful certification.
ISO 9001 training is suitable for:
- Management representatives
- Quality managers and executives
- Internal auditors
- Process owners and supervisors
- Staff involved in quality-related activities
Yes. We can deliver integrated training and consultancy (e.g., ISO 9001 + ISO 14001) as long as it falls within our expertise.
The latest published version is ISO 9001:2015.
A revision process is currently underway, and the next edition is expected to include updates to reflect modern quality challenges. Until it is officially released, ISO 9001:2015 remains the valid and globally recognized standard.
Not yet. Organizations should continue to maintain compliance with ISO 9001:2015. Once the new revision is officially published, transition guidelines and timelines will be provided by certification bodies.
We can assist with future transition training when the new version is released.
The timeline depends on company size, complexity, and readiness.
Typically: 6 - 9 months
Your commitment and resource availability strongly influence the speed of implementation.
ISO 9001 requires organizations to establish a structured Quality Management System that includes:
- Context of the organization & interested parties
- Leadership and responsibilities
- Risk-based thinking
- Documented information (procedures, records)
- Operational control of processes
- Performance evaluation (audits, monitoring, KPIs)
- Continual improvement
Our training helps your team understand and apply these requirements effectively.
Not all employees require detailed training, but awareness training is strongly recommended so staff understand their roles within the QMS.
Key personnel (e.g., internal auditors, process owners, MR/QMR) should attend more in-depth sessions.
Costs vary depending on:
- Number of employees
- Scope of processes
- Training duration
- Consultancy depth and support level
We prepare a customized quotation based on your organization’s requirements.
Yes. ISO 9001 is suitable for businesses of all sizes, including SMEs and micro-businesses. It helps standardize processes, reduce errors, and build customer confidence.
ISO 9001 also enables small businesses to stand out in a competitive environment, and in many industries it is a requirement imposed by certain customers before awarding contracts or projects.
Yes. We offer:
- Refresher training
- Internal audit support
- Process improvement guidance
- Gap assessments before surveillance audits

These services help maintain and improve your QMS over time.
Yes. ISO 9001 can be easily integrated with other management systems such as:
- ISO 14001 (Environmental)
- ISO 13485 (Medical Device QMS)
- IATF 16949 (Automotive QMS)
We can provide integrated training and consultancy within our expertise.
ISO 9001 certification must be issued by an accredited certification body. Examples include SIRIM QAS, TĂśV SUD, TUV Nord, DQS, SGS, BSI, and others.
Your organization will liaise directly with the certification body for confirmation, scheduling, and quotation.

ISO 14001 Environmental Management System (EMS)

ISO 14001 is the international standard for Environmental Management Systems (EMS). It provides a framework to helps organizations manage environmental responsibilities, protect the environment and comply with applicable statutory & regulatory requirements.
Organizations of all sizes and industries can implement ISO 14001, including manufacturing, services, government, and non-profits.
Most organizations take 6 to 12 months to implement ISO 14001 before preparing for certification audits.
Benefits include: reduced risks and penalties, cost savings, improved brand reputation, stakeholder trust, and market opportunities.
Maintain compliance with internal audits, management reviews, continual improvement, and monitoring of regulations.
No. It is voluntary, but widely adopted to meet customer expectations, regulatory requirements, or corporate sustainability goals.
It provides a structured approach to identify legal obligations, monitor compliance, and maintain records and documentation.
The latest revision is ISO 14001: 2015.
The revised standard (likely ISO 14001:2026) is expected to be published in early 2026.
A 3‑year transition period is anticipated, giving certified organizations time to migrate.

ISO 13485 (Medical Devices QMS Standard)

ISO 13485 is the international standard for Medical Device Quality Management Systems (QMS). It provides a framework to ensure medical devices are safe, effective, and meet regulatory requirements.
ISO 13485 helps companies meet regulatory requirements, improve product quality, manage risks, and gain customer trust.
ISO 13485 training is suitable for anyone involved in the implementation and compliance of a medical device QMS. This typically includes personnel from quality, production, maintenance, facilities, purchasing, human resources, logistics, sales, customer service, and IT.
ISO 13485 certification is voluntary, but often required by regulators and customers to demonstrate compliance with medical device quality standards.
ISO 13485 is reviewed every 5 years. The current standard, ISO 13485:2016, remains valid with no major changes announced in the latest review.
Organizations should conduct a gap analysis, implement a compliant QMS, train employees, and perform internal audits before the certification audit.
Implementation typically takes 6 to 12 months, depending on company size, complexity, and readiness of existing processes.
ISO 13485 is specific to medical devices, with emphasis on regulatory compliance and medical device risk management, while ISO 9001 is general quality management for all industries.
Yes. ISO 13485 consultants provide guidance on QMS design, documentation, regulatory compliance, gap analysis, and audit preparation.
However, consultants do not liaise with external certification bodies or influence the certification decision — their role is purely advisory and supportive to help your organization prepare for a successful audit.
Challenges include maintaining documentation, meeting regulatory updates, ensuring staff competency, and integrating risk management throughout processes.
Benefits include regulatory compliance, enhanced product quality, reduced risk, market access, customer confidence, and improved operational efficiency.

IATF 16949 (Automotive QMS standard)

IATF 16949 is the international standard for automotive quality management systems (QMS). It integrates ISO 9001 requirements with additional automotive-specific requirements to ensure consistent product quality across the supply chain.
Certification helps organizations improve product quality, reduce defects, meet customer requirements, increase customer confidence, and gain access to global automotive markets.
IATF 16949 is ISO 9001-based but includes additional automotive requirements, such as product safety, traceability, supplier development, and warranty management.
IATF 16949 training is suitable for anyone involved in the implementation and compliance of a IATF 16949 QMS for Automotive. This typically includes personnel from quality, production, maintenance, facilities, purchasing, human resources, logistics, sales, customer service, IT and finance.
Implementation typically takes 12–18 months, depending on organization size, complexity, and existing QMS maturity.
The standard is periodically updated by the IATF (International Automotive Task Force). The current version, IATF 16949:2016, aligns with ISO 9001:2015 and remains current.
Consultants provide advisory services, gap analysis, documentation guidance, training, and audit preparation.
Consultant do not liaise with certification bodies or influence certification decisions.
Challenges include meeting customer-specific requirements, managing suppliers, ensuring traceability, maintaining documentation, control operational process and integrating risk management into daily operations.
IATF 16949 certification is not legally mandatory, but it is often required by automotive OEMs and Tier-1 suppliers to do business in the automotive industry.
Yes. The standard is scalable and can be adapted to small and medium-sized suppliers, though resources and training are key to successful implementation.

Good Distribution Practice for Medical Devices (GDPMD)

GDPMD (Good Distribution Practice for Medical Devices) is a set of guidelines issued by the Medical Device Authority (MDA), Ministry of Health Malaysia, to ensure that medical devices are distributed safely, securely, and in compliance with regulatory requirements.
All medical device distributors, importers, and authorized representatives in Malaysia must comply with GDPMD guidelines to maintain legal distribution of medical devices.
Key requirements include:
- Proper storage and handling of medical devices
- Inventory control and traceability
- Transportation and delivery practices
- Personnel training and qualification
- Documentation and record-keeping
- Complaint handling and recall procedures
Yes. Compliance with GDPMD is mandatory for authorized representatives (AR), importers and distributers of medical devices in Malaysia.
Companies must implement a quality management system (QMS) aligned with GDPMD requirements and undergo an audit by an authorized Conformity Assessment Body (CAB).
ISO 13485 covers the entire medical device quality management system, including manufacturing, while GDPMD focuses specifically on the distribution and supply chain of medical devices in Malaysia.
Challenges include ensuring temperature-controlled storage, maintaining traceability, staff training, and consistent documentation across all distribution points.
Yes. GDPMD requires distributors to transport devices safely, maintaining integrity and security throughout the supply chain.
Yes. Consultants can assist with gap analysis, documentation, QMS implementation, and staff training.
However, consultants cannot issue certification or liaise with the MDA on behalf of the company.
Yes. Companies that fail to comply with GDPMD may face regulatory action, fines, suspension of distribution licenses, or legal penalties under applicable statutory & regulatory requirements in Malaysia.