#manufacturing qms

[bmqualitymaster]

The Future of Quality Management in the Pharma Industry: A Focus on QMS Software

As one of the most regulated sectors, the pharmaceutical industry plays a vital role in protecting public health. With rapid technological advancements and tightening regulations, the need for robust Quality Management Systems (QMS Software) has never been more critical.

Pharma QMS has evolved significantly, transitioning from manual methods to advanced automated systems. This evolution is driven by the increasing demand for efficiency, enhanced regulatory compliance, and superior product quality. Milestones in this journey include the adoption of Good Manufacturing Practices (GMP), ISO standards, and the integration of emerging technologies like automation and data analytics. Today’s pharmaceutical QMS incorporates elements such as electronic document management, automated quality checks, and rigorous compliance tracking to ensure the consistent delivery of safe, high-quality products.

Key Trends Shaping the Future of Pharma QMS Software:

Predictive Analytics Future QMS platforms will utilize predictive analytics to preemptively address quality issues. By identifying patterns in production data, companies can anticipate risks like contamination and take preventive actions before problems arise.

Real-Time Monitoring with IoT Integrating Internet of Things (IoT) devices with QMS will enable real-time production monitoring. Sensors can track variables like temperature and humidity in drug manufacturing, alerting teams when conditions deviate from safe thresholds, thereby preventing quality lapses.

Cloud-Based Solutions Cloud computing will revolutionize Pharma QMS by centralizing data, improving security, and enhancing team collaboration. Cloud-based QMS software can streamline quality documentation and compliance reporting across multiple global sites, ensuring data consistency and accessibility.

Mobile QMS The rise of mobile applications will allow quality professionals to manage processes remotely. With mobile QMS, quality managers can approve batch records, conduct audits, and resolve issues on-the-go, expediting response times.

Blockchain for Traceability Blockchain technology, integrated with pharmaceutical QMS, will provide transparent, tamper-proof records. This will bolster efforts to combat counterfeit drugs by ensuring traceability and authenticity throughout the drug supply chain.

Robotic Process Automation (RPA) Routine tasks like data entry and compliance tracking will be automated through RPA, freeing human resources for more strategic initiatives. RPA in QMS can streamline the generation of compliance reports, enhancing operational efficiency.

AI-Driven Decision Support Artificial Intelligence (AI) will elevate QMS for pharma industry by offering advanced decision-making tools for risk assessment, Corrective and Preventive Actions (CAPA) prioritization, and root cause analysis. AI can analyze vast datasets to quickly and accurately pinpoint the root cause of quality issues.

QMS for Personalized Therapies With the rise of personalized medicine, Pharma QMS will adapt to support customized quality controls for individual patient therapies. Tailored QMS processes will be essential for ensuring the safety and efficacy of personalized treatments, such as those for cancer care.

The future of Quality Management Systems in the pharmaceutical industry is poised to be a blend of cutting-edge technologies and innovative practices, enhancing efficiency, compliance, and product quality. Embracing these advancements will be crucial for navigating the evolving landscape and maintaining the highest standards in pharmaceutical quality. QualityMaster by TecWork stands out as a powerful pharma QMS solution that helps manufacturers build an ecosystem rooted in quality. Contact to know more about QualityMaster

[eauditor-audits]

Supplier audit utilizing eAuditor to assess and evaluate the performance, quality, and compliance of suppliers.

A supplier audit involves utilizing mobile eAuditor to assess and evaluate the performance, quality, and compliance of suppliers or vendors. The eAuditor provides features that assist in conducting audits, documenting findings, and managing supplier relationships. Here’s how it typically works:

Mobile eAuditor Installation: Begin by downloading and installing eAuditor from your smartphone’s app store.

Audit Setup: Launch the eAuditor and set up a new audit using existing or new template for the supplier you want to assess. Enter details such as the supplier’s name, location, contact information, and any specific criteria or requirements for the audit.

Audit Criteria: The eAuditor template allows customization based on your specific needs. These criteria typically cover various aspects such as quality control, compliance with standards and regulations, supply chain management, documentation, and customer satisfaction.

Data Collection: As you conduct the audit, the eAuditor guides you through the evaluation process based on the established criteria. It may prompt you to answer questions, provide ratings, take photos, or record observations to document compliance or non-compliance.

Documentation: The eAuditor allows you to document your findings, observations, or concerns regarding each criterion on the audit checklist. You can add notes, attach media files (photos, videos), and record any relevant information for future reference or reporting purposes.

Compliance Checks: The eAuditor may prompt you to assess the supplier’s compliance with specific standards, regulations, or certifications relevant to their industry or products. This could include evaluating quality management systems, production processes, safety measures, environmental practices, and ethical considerations.

Performance Evaluation: The eAuditor may include sections to assess the supplier’s performance in terms of delivery timeliness, product quality, customer service, responsiveness, and overall satisfaction. This helps ensure that the supplier meets your expectations and contributes to your business success.

Corrective Actions: If any non-compliance issues or areas for improvement are identified during the audit, the eAuditor may provide options to note the specific issues and propose corrective actions. This helps ensure that necessary steps are taken to rectify deficiencies and improve supplier performance.

Reporting: Once the audit is complete, the eAuditor generates a comprehensive report summarizing the audit findings. The report may include a breakdown of compliance ratings, identified issues, recommended actions, and any additional remarks or comments. This report can be shared with the supplier and relevant stakeholders for further analysis and action.

Supplier Management: The eAuditor along with LQATS – Lyons Quality Audit Tracking System – Manufacturers & Suppliers Quality Audit offers features to track and manage supplier relationships. This could include recording supplier contact information, managing audit schedules, setting reminders for follow-up actions, and maintaining a history of past audits and evaluations.

Using mobile eAuditor for supplier audits streamlines the auditing process, improves data accuracy, and enhances supplier management practices. It enables efficient evaluation and documentation of supplier performance, supports decision-making processes, and helps maintain a strong supply chain. By utilizing the app’s features, businesses can strengthen their supplier relationships, mitigate risks, and drive continuous improvement in their procurement processes.

[imrovementcompany]

The Power of Routine Quality Audits in Manufacturing: 6 Game-Changing Benefits

In today’s rapidly evolving manufacturing landscape, ensuring consistent product quality is more critical than ever. One effective way to maintain high standards is through routine quality audits. But what are the benefits of these regular checks? In this blog post, we explore the six game-changing advantages of routine quality audits in manufacturing, as outlined by IsoTracker, a leading…

[timesofpharma]

Quality management system in Pharmaceutical Company

Quality management system in Pharmaceutical Company

Quality management system in a pharmaceutical manufacturing company What is quality management system QMS in pharma company? Following functions all together when driven together forms, every function is more or less interlinked or impacting other, therefore systematic operating of every function is important to achieve compliance and quality aspects as defined in guidelines of regulatory…

[chinanumberonesourcing]

Guide for Importers on Manufacturing Control

Efficient Manufacturing Control in China

1. Understand the Chinese Manufacturing Environment:

Diverse Ecosystem: China offers a vast range of manufacturers, from small workshops to large factories. This variety is beneficial but also poses challenges in ensuring consistent quality.

IP Concerns: Despite improvements, IP protection in China can be inconsistent, requiring robust measures to safeguard your innovations.

Regulatory Landscape: China’s complex and changing regulations make compliance crucial to avoid fines and reputational damage.

Quality Control: While quality has improved, some sectors still prioritize quantity over quality. Rigorous quality protocols are essential.

Labor & Costs: Labor costs are rising, pushing manufacturers toward automation. Infrastructure is robust, but supply chains can be disrupted by natural disasters or policy changes.

Government Policies: China’s government heavily influences manufacturing through policies and incentives, which can affect costs and market access.

2. Build a Strong Foundation:

Supplier Selection: Choose reliable suppliers through thorough due diligence, including factory visits and financial checks.

Clear Communication: Provide detailed specifications and maintain open communication to avoid misunderstandings.

Quality Management: Implement a Quality Management System (QMS) and conduct regular audits to ensure consistent product quality.

Strong Relationships: Develop long-term partnerships with suppliers to build trust and collaboration.

3. Implement Effective Control Strategies:

QA & QC: Establish a robust QA/QC framework to ensure consistent product quality.

Supplier Development: Invest in your suppliers’ capabilities to improve quality and efficiency.

Risk Management: Prepare for disruptions with backup plans and diversified suppliers.

Contractual Coverage: Clearly define product specifications and include IP protections in contracts.

Third-Party Verification: Use third-party inspections to ensure compliance and quality.

4. Manage Logistics & Supply Chain:

Transportation: Choose the best transport mode and routes to minimize costs and delays.

Warehousing & Inventory: Optimize warehouse locations and use management systems to track inventory.

Customs & Documentation: Ensure compliance with customs regulations and prepare accurate documentation.

Supply Chain Visibility: Use technology to monitor shipments and collaborate with suppliers.

Risk Assessment: Develop contingency plans for disruptions like natural disasters or strikes.

5. Overcome Common Challenges:

Language & Cultural Barriers: Hire experts to bridge gaps in communication and cultural understanding.

IP Protection: Secure your IP with patents, trademarks, and NDAs; monitor for infringements.

Regulatory Compliance: Stay updated on regulations and partner with local experts for compliance.

Supply Chain Disruptions: Diversify suppliers, maintain sufficient inventory, and use smart tools for monitoring.

6. Continuous Improvement:

Use data analytics to track trends and improve processes.

Regularly evaluate supplier performance and invest in employee training.

Embrace technology to enhance communication and efficiency.

7. Build a Culture of Quality:

Encourage employees to propose improvements.

Reward contributions to quality enhancement.

Focus on exceeding customer expectations.

Conclusion: Effective manufacturing control in China requires ongoing effort, attention, and adaptation. Invest in strong practices to improve product quality, reduce costs, protect your brand, and optimize your supply chain.

[msmeregin]

A guide to enhance your business growth      

Running a business is akin to navigating a complex maze, and every entrepreneur dreams of not just surviving but thriving. In the Indian business landscape, the government has laid out a golden path for micro, small, and medium enterprises (MSMEs) through a simple yet powerful tool – MSME registration. In this guide, let's explore how this seemingly mundane registration process can be your ticket to unparalleled business growth.

Understanding the MSME Advantage

 The Heartbeat of the Economy:

Micro, Small, and Medium Enterprises collectively form the heartbeat of the Indian economy. From local grocery stores to innovative startups, these businesses contribute not only to economic development but also to job creation, fostering a robust and inclusive growth environment.

Unlocking Financial Avenues:

One of the immediate perks of MSME registration is the access to financial assistance and credit facilities. Financial institutions offer tailored loans at favorable terms, recognizing the importance of these enterprises in driving economic progress.

The MSME Registration Journey

A Simpler Path Than You Think:

Contrary to popular belief, the MSME registration process is not a bureaucratic labyrinth. It's a straightforward journey that involves providing essential details about your business, such as PAN, Aadhaar, and other relevant information. Whether you choose the online portal or opt for the traditional route at District Industries Centres, the process is designed to be accessible.

Documents: Your Passport to Opportunities:

The importance of documentation in the registration process cannot be overstated. Your Aadhaar card, PAN card, business address proof, and details of your plant and machinery are the keys that unlock the door to a myriad of government schemes and subsidies.

The MSME Advantage Unveiled

Market Access and Procurement Preferences:

Once you've acquired your MSME registration, you find yourself in a prime position in government procurement. MSMEs are often given preference in government tenders, providing a golden opportunity to secure contracts and expand your market reach.

Technology Upgradation and Subsidies:

In the rapidly evolving business landscape, technology is the differentiator. MSME registration brings with it the chance to upgrade your technology with subsidies for adopting new and advanced processes. This not only boosts efficiency but also enhances your competitiveness.

Navigating the Schemes and Subsidies Landscape

Credit Linked Capital Subsidy Scheme (CLCSS):

At the forefront of government schemes is CLCSS, a game-changer for technology upgradation. It provides capital subsidies to MSMEs, facilitating access to credit for purchasing new machinery and equipment.

Pradhan Mantri Employment Generation Programme (PMEGP):

For those looking to embark on the entrepreneurial journey, PMEGP is the beacon. This credit-linked subsidy program promotes self-employment, creating not just businesses but livelihoods.

Credit Guarantee Fund Scheme for Micro and Small Enterprises (CGMSE):

The fear of collateral is a common hurdle for many small businesses. CGMSE eliminates this barrier by offering collateral-free credit facilities, making it easier for MSMEs to access the capital needed for growth.

Tailoring Your Approach

District Industries Centres (DIC) and National Small Industries Corporation (NSIC):

Think of DIC and NSIC as your business allies. DIC, as a local agency, offers guidance and support, while NSIC provides a range of services from marketing assistance to credit facilitation. Engaging with these institutions can significantly enhance your MSME journey.

Tech and Quality Upgradation Support:

The government's emphasis on quality is evident through schemes like Lean Manufacturing Competitiveness Scheme (LMCS) and Quality Management Standards & Quality Technology Tools (QMS/QTT). These initiatives not only boost competitiveness but also position your business as a paragon of quality in the market.

Export Promotion and Market Development:

Venturing into global markets can seem daunting, but the Market Development Assistance Scheme for MSMEs is a trustworthy companion. It provides financial support for participating in international trade fairs, opening doors to new business horizons.

Overcoming Challenges for Seamless Growth

Lack of Awareness:

One of the challenges MSMEs often face is the lack of awareness about available schemes. Entrepreneurs can overcome this by actively seeking information through government portals, industry associations, and local MSME support cells.

Complex Application Processes:

Cumbersome application procedures can be discouraging, but persistence pays off. Simplifying the application process and seeking assistance from dedicated facilitation services or MSME support agencies can make the journey smoother.

Continuous Evaluation and Adaptation

Performance and Credit Rating Scheme:

Enhancing your creditworthiness is an ongoing process. The Performance and Credit Rating Scheme allows MSMEs to undergo assessments, showcasing financial stability to potential investors and lenders.

Embracing Continuous Improvement:

The business landscape is dynamic, and your approach should be too. Regularly assess the impact of government schemes on your operations, adapt to changes, and stay informed about updates to maximize benefits continually.

Conclusion: Your Journey to Unprecedented Growth

In conclusion, MSME registration in India is not just a formality; it's your gateway to a realm of opportunities. By understanding the classifications, embracing government schemes, and overcoming challenges, you position your business for sustainable growth. The government's commitment to fostering MSMEs is a testament to the integral role these enterprises play in shaping the nation's economic future. So, don't just register – embark on a journey of growth, innovation, and success. The path is laid; it's time to walk it.

Learn more at : https://msme-registration.in/

[isocertificationincanada1]

How to apply for ISO 9001 Certification in Canada

How to apply for ISO 9001 Certification in Canada

How does ISO 9001 Certification work?

There are four stages in the ISO 9001 audit process:

Pre-assessment meeting and audit preparation

Conducting the ISO 9001 Certification Audit

Meeting to discuss assessment results

Re-certification preparations

Certification Consultants in Canada

To implement ISO 9001 Certification in Canada, organizations need a process-oriented quality management system tailored to their specific requirements. ISO 9001 certification in Canada can improve communication, reduce costs, optimize processes, and more for your organization.

ISO 9001 Certification in Canada Requirements

When a company achieves ISO 9001 certification in Canada, they are expected to have established quality policies, processes, responsibility assignments, roles, and responsibilities. An International Organization for Standardization quality management system procedures are covered by ISO 9001 certification in Canada. Certification bodies also conduct ISO audits to ensure that companies comply with ISO standards. ISO 45001 certification in Canada

According to ISO, an ISO-approved auditor creates, implements, and audits a quality management system (QMS) as part of ISO 9001 certification. Getting ISO 9001 certification in Canada may require a lot of paperwork, and an auditor may make suggestions. The documentation for ISO audits should be in place for organizations ready to implement ISO 9001 in Canada.

ISO 9001 Certification in Canada Audits Online

Using an online web testing platform, IAS conducts ISO 9001 certification audits. Behind the audit, IAS issued a certificate proving your company has been certified to ISO 9001 in Canada based on several criteria, including the online test scenarios for your system documentation, the testing of all policies, and other related ISO 9001 certification procedures. You can implement ISO 9001 in Canada much more quickly with remote audits from IAS. ISO Certification Bodies in Canada

ISO 9001 Certification in Canada available ?

Any organization can achieve ISO 9001 certification in Canada, regardless of its size, type, or field of operation, if they want to improve their QMS performance systematically. Several businesses in Canada can obtain ISO 9001 certification, including:

Corporate Institutions

Construction Companies

Production/Manufacturing Companies

Hospitals

Banks

Institutions of higher learning

Governmental Organizations

For more information visit: ISO certification in Canada

[isocertificationinbharain]

ISO 9001

WHAT IS QUALITY MANAGEMENT SYSTEMS ISO 9001:2015?

The international standard known as ISO 9001 is used to describe the specifications for a quality management system (QMS). The standard is used by businesses to show that they can consistently deliver goods and services that adhere to legal and customer standards. It is the most widely used standard in the ISO 9000 series and the only one to which enterprises can receive certification.

The International Organization for Standardization (ISO), a global organisation made up of the national standards organisations of more than 160 nations, initially released ISO 9001 in 1987. In September 2015, the most recent edition of ISO 9001 Certification in Kuwait was made public.

WHAT ADVANTAGES DOES ISO 9001 OFFER?

Organizations that implement ISO 9001 are able to continuously provide their consumers with high-quality goods and services, which has a number of positive effects, including happy clients, management, and staff.

Create a QMS

create contented clients, managers, and staff

constantly enhance their procedures

Save money

The Clark County School District in Nevada employed ISO 9001 Certification in Saudi arabia to reduce actual costs and cost avoidance by $174 million over a ten-year period. Three essential elements of the system's success—training, communication and respect, and efficiency—were made possible thanks to the training of more than 3,000 personnel to the required standard.

CERTIFICATION UNDER ISO 9001

Organizations can only be certified to the ISO 9001 standard out of the entire ISO 9000 series. When an organisation receives ISO 9001:2015 certification, it has proven to have:

adheres to the ISO 9001 standard's guidelines

complies with its own requirements

meets statutory and regulatory requirements as well as client expectations.

keeps documentation current

By demonstrating to clients that an organization's goods and services live up to expectations, certification to the ISO 9001 Certification in Dubai standard can increase an organization's credibility. In some situations or sectors, certification is necessary or required by law. Implementing ISO 9001:2015 requirements and successfully completing a registrar's audit to verify that the entity complies with those requirements are both required steps in the certification process.

As organisations get ready for an ISO 9001 quality management audit, they should take the following into account.

Several information regarding ISO 9001:

In spite of the fact that the ISO 9001 Certification in Bahrain family of standards contains numerous separate papers, only ISO 9001 calls for certification. Although a company will often apply for certification as a whole, the QMS's scope can be adjusted to boost productivity at a specific location or division. 

, the most recent edition, was released in September of 2015. (thus the: 2015).

Whether your organisation has one person or a million, it makes no difference. See Implementing ISO 9001 for Small Businesses.

It doesn't matter if you work in the service or manufacturing sectors; you could be a restaurant, consultant, manufacturer, government agency, etc.

Implementing ISO 9001:2015

When a business wishes to improve its QMS with the aim of improving its products or services and, ultimately, customer satisfaction, compliance with the ISO 9001 criteria is often achieved.

Although the ISO 9001 Certification in Qatar standard can be followed at any time, it is usually applied when:

Customers include this stipulation in the contract.

Trading with some nations requires certification

Businesses strive to increase client satisfaction and the quality of their products.

[bmqualitymaster]

Enhancing Efficiency with a Quality Management System in Food Manufacturing

Picture a bakery struggling with inconsistent bread quality, leading to frequent customer complaints, or a dairy processing plant grappling with a recall due to contamination, unable to trace the root cause. In both cases, the lack of a structured approach to quality and risk management severely affects product quality, customer satisfaction, and brand reputation.

In the food manufacturing industry, efficiency and quality are critical. Streamlining and automating quality processes not only enhances operational efficiency but also ensures consistency in product quality. Automating quality checks, compliance monitoring, and reporting allows tasks to be completed quickly and accurately, reducing errors and inconsistencies. This ultimately leads to better resource utilization, smoother production flows, faster delivery times, and higher product quality.

To achieve this level of efficiency, investing in Quality Management Software (QMS) is essential. Food quality management software like QualityMaster enables food manufacturers to maintain the highest standards for products, processes, and services. With features such as Change Management, Compliance Management, Complaint Management, Non-Conformance (NC) Management, Corrective and Preventive Actions (CAPA), Document Management, Inspection Management, Training Management, and SOP Management Software QualityMaster empowers food manufacturers to prevent issues, uphold quality standards, and improve efficiency.

For example, a bakery using QualityMaster could document and analyze customer complaints to quickly identify and resolve quality issues, significantly boosting operational efficiency. Similarly, a dairy manufacturer could use the system to trace the source of contamination, effectively preventing future recalls. Proper documentation and root-cause analysis would enhance both product quality and operational efficiency in these scenarios.

Let’s explore the key features of QualityMaster, a leading QMS for the food industry, that can help boost efficiency:

Change Management Tracks and assesses the impact of changes, such as ingredient substitutions or process modifications, ensuring all team members are informed and preventing workflow disruptions.

Compliance Management Automates compliance tracking and documentation, minimizing the risk of non-compliance and simplifying audits to ensure products meet safety and quality standards.

Complaint Management Systematically addresses quality inconsistencies and safety concerns, leading to faster resolution of product defects and improved customer satisfaction.

Non-Conformance (NC) Management Detects and resolves issues like spoilage or contamination early, ensuring only quality-compliant products reach the market, reducing waste, and maintaining product integrity.

Corrective and Preventive Actions (CAPA) Identifies and addresses the root causes of defects or safety issues, implementing preventive measures to improve process reliability and product quality.

Inspection Management Simplifies the setup and organization of quality control tests and inspections, digitizing the process for thorough monitoring and tracking.

Document Management Provides easy access to up-to-date documents such as formulas, verifications, batch records, and compliance certificates, reducing errors and ensuring all team members work with the latest information.

Training Management Ensures staff are properly trained in best practices for food handling, processing, and safety, improving adherence to quality standards and overall production performance.

In conclusion, adopting a comprehensive quality management software like QualityMaster is vital for food manufacturers aiming to achieve high levels of quality and efficiency. With additional features like smart tagging, cockpit view, indexing, and a dashboard for tracking complaint records, QualityMaster stands out as a best QMS software for food manufacturing. Investing in such a system is a proactive step towards ensuring that your food products are consistently safe, high-quality, and delivered efficiently, securing your brand’s reputation and long-term success.

[4cconsulting]

What Are Automotive Core Tools - Importance Of Automotive Core Tools

Automotive Core Tools Overview

Today, Automobile Manufacturing organizations are working in a cut-throat market scenario where simultaneous improvement and an effective Quality Management System ensure success. Keeping this in mind, Automotive Core Tools were created.

These quality methods and tools were developed more than 30 years ago by the AIAG (Automotive Industry Action Group) and ASQ (American Society of Quality), in association with the automakers Ford, GM, and Chrysler (now FCA), to improve the efficiency of the IATF 16949-based QMS and deliver high-quality products on schedule.

According to the current standards of the automotive sector, these quality methods, which are based on IATF 16949, aid employees in optimizing processes and are essential for an efficient quality management system.

What are the Automotive Core Tools?

The five primary approaches manufacturers and supply chains use to manage quality control are called automotive core tools. They help suppliers and manufacturers adhere to IATF 16949 Automotive Quality Management System. Despite the IATF 16949 compliance obligations, organizations can still benefit from automotive quality tools. Manufacturers’ use of quality tools facilitates the detection of flaws, efficient product planning, monitoring of the development processes, and application of product quality planning. Following are the five core tools.

Advanced Product Quality Planning (APQP)

Failure Mode and Effects Analysis (FMEA)

Measurement Systems Analysis (MSA)

Statistical Process Control (SPC)

Product Part Approval Process (PPAP)

Let’s understand each tool in detail and understand how to use them.

Advanced Product Quality Planning (APQP): Advanced Product Quality Planning (APQP) and Control Plan aims to reduce the complexity of product quality plans. It is a structured method of signifying and establishing the process and steps required to ensure product quality standards and customer satisfaction. APQP allows customers to easily communicate their product quality planning requirements to their suppliers, thus reducing the complexity of product quality planning for both. With this, suppliers get a clear picture of the basic industry requirements for achieving part approval from their customers. Control Plans summarize the identified process and product parameters required to maintain product conformity. These tools are applicable throughout the supply base in all customer/supplier relationships. APQP defines the required inputs and outputs of each stage of the product development process.

Failure Mode and Effects Analysis (FMEA): Failure Mode and Effects Analysis (FMEA) identifies and addresses failure modes in products and processes. It is an analytical methodology to ensure that issues are identified and addressed throughout the product and process development process. It is an essential part of automotive core tools that encompasses risk assessment as a part of its evaluation. The analysis is conducted regarding the designs (of either the product or process), and the functions are reviewed thoroughly. Eventually, it aims at reducing the risk of potential failure. It is used before developing a control plan for a new or modified process while improving goals planned over the existing process, product or service and when the failures are analyzed about the existing process.

Measurement Systems Analysis (MSA): MSA stands for Measurement System Analysis. It is the measurement data that monitors nearly every process. It is a collection of many statistical analysis methods for evaluating variability in the measurement process. This is a significant part of automotive core tools as it helps improve data quality and decision-making. It is a guide that helps organizations assess the quality of their measurement systems by identifying improvement areas. It eventually provides knowledge based on data that can be used to improve the measurement process, improving repeatable product quality.

Statistical Process Control (SPC): Statistical Process Control (SPC) describes several basic and advanced statistical methods to ensure your process improvements are more effective. Statistical techniques such as controlling charts are utilized to analyze a process or its output. It helps take appropriate actions to achieve and maintain a state of statistical control and improve the process capability. It helps in controlling quality by closely monitoring the manufacturing process. Further, it provides solid ground for organizations to move from detection based to prevention-based quality controls.

Product Part Approval Process (PPAP): The production Part Approval Process (PPAP) is the only industry standard that ensures engineering design and product specification requirements are met without hindrance. It provides a guideline through which suppliers and customers understand the requirements to obtain part approval for supplier-manufactured parts. It applies to all parts and commodities. Further, it reduces delays and non-conformances during part approval. It addresses details pertinent to design records to ensure traceability of part design status at origin, and controls the predict a process change process, thus providing an approval outlet for all changes to ensure conformance for the next level assembly.

What data can be deduced from Automotive Core Tools?

The New Product Introduction (NPI) phases of product and process development, as well as specific situations such as experienced failures or technical changes, involve the usage of the Quality Core Tools. An analyst can deduce the following after reviewing the Quality Core Tools:

APQP provides time and advice for all actions and tools involved in product and process prevention and control, including the remaining Quality Core Tools. It includes requirements, specifications, reliability/design goals, preliminary special features, and scheduling.

The design FMEA risk assessment provides fine-tuned specific characteristics, testing inputs, and design enhancements. Process FMEA Risk Assessment considers potential process flaws, enhanced process performance, and management techniques for unique characteristics.

MSA certifies the gauge systems used for unique characteristic measurements, which is essential for correctly identifying product quality defects.

SPC illustrates process capability and stability for unique characteristics derived by DFMEA and PFMEA in the first place.

The PPAP shows that all special features have developed unique controls or reached a degree of stability and capability (Cpk) that is acceptable.

Why Automotive Core Tools are important?

The cost of poor quality (COPQ), measured in the manufacturing sector, is the expense related to processing and product failures. Compared to the industry leaders, subpar manufacturers are 5X more likely to incur expenditures related to scrap, rework, defects, retesting, and recalls.

The best manufacturers have COPQ scores of under 1%, while subpar manufacturers have scores of 5% or more. Therefore, by addressing issues, particularly fatal errors, before they become significant problems after a product has been published, the 5 Core Quality tools preventively minimize COPQ. Improved consumer and supplier communication and comprehension help achieve this.

[omcmedicalblog]

Singapore Medical Device Registration - OMC Medical Limited

Understanding HSA’s Medical Device Registration and Vigilant System

Update On: 24/01/2024

Regulatory Authority: Medical Device Branch of the Health Sciences Authority (HSA)

The Medical Device Branch of Singapore’s Health Sciences Authority (HSA) is in charge of overseeing medical device regulation. The Health Product Act was approved in 2007 by the HSA, giving them the authority to impose mandatory registration requirements, control supply distribution, manufacture, import, and advertising of all health goods.

Medical Device Definition: They are defined as health products which have a physical and mechanical effect when used on human bodies and are used to: diagnose, treat a medical condition, e.g. X-Ray Machine; Measures or monitors the function of the body e.g. Pulse oximeter;

Products which are used to maintain or support well-being, such as body toning equipment, magnetic accessories and massagers, are not medical devices and hence are not regulated by HAS. 

Link for Regulatory Authority: https://www.hsa.gov.sg/

Local Regulation: Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010

Medical Device Classification: A, B, C, D

Listing or Registration: Requirements:

Registration is not required for Class A devices. All Class A devices must be listed in the HSA’s Class A Medical Device Register by the local manufacturer or local importer.

For systems, product families or other multi-component devices, determine most favourable grouping strategy according to HSA Guidance GN-12.

Foreign medical device manufacturers must appoint a Singapore-based Registrant to submit their application and represent them to the HSA, with registrations transferable only if the current Registrant relinquishes.

For classes B, C and D, if device has been approved for sale in one or more reference markets (Australia, Canada, the Europe, Japan or the USA), it qualifies for an Immediate, Expedited, or Abridged submission process*.

Prepare Submission Dossier using ASEAN Common Submission Dossier Template (CSDT) format or IMDRF Table of Contents (ToC) format. Provide proof of compliance with reference market’s QMS requirements. Abridged/Expedited submission: Summary data can be submitted for pre-clinical and clinical data. Additional details for Classes B, C, and D may be found in HSA Guidance GN-15.

Registrant submits application electronically via the Medical Device Information and Communication System (MEDICS). Pay fee.

Appoint a registered importer to bring device into Singapore.

For Classes B, C, and D devices, HSA verifies classification and performs detailed evaluation of your application.

HSA grants approval and publishes in the Singapore Medical Device Register (SMDR).

Can now begin market device in Singapore. Registrations do not expire but must pay fees annually to maintain registrations.

* Full Evaluation Route refers to the evaluation process for a medical device that has not received any prior approval from any regulatory agencies. Abridged Evaluation Route refers to a medical device that has received approval from reference regulatory agencies, such as TGA, HC, MHLW, FDA, or EC Certificates. The Immediate/Expedited Evaluation Route allows medical devices to be evaluated if they have received at least one approval, been marketed for at least three years, have no global safety issues, and have no prior rejections. The Priority Review Scheme offers faster registration and market entry for devices in five healthcare areas.

Document Requirements for registration:

The information required in submissions depends on device class and selected evaluation route.

For the most part, documentation from an EU technical file can be used to satisfy many supporting documentation requirements. One must also prepare a Declaration of Conformity to the Essential Principles. Once approved, product is listed in the Singapore Medical Device Register (SMDR) database.

Registration timeline: 1-10 Months

Registration Fee: 25,00$ – 5.700,00$

Originally Published at: https://omcmedical.com/singapore-medical-device-registration/

[medwisdom]

How To Apply Manufacturing License For Medical Device In India?

If you are manufacturer or distributor, looking for manufacturing license for your Medical Device, this guide will help you to simply understand the documents and procedure of obtaining manufacturing license for medical device in India. Manufacturing license is issued by the licensing authority of India. Classification of medical device determines which licensing authority responsible for issuing manufacturing license. State licensing authority is responsible for grant of manufacturing license for class A and B medical device. Central licensing authority is responsible for issuing manufacturing license for class C and D medical device based on the risk it possesses. This guide will help you to figure out your queries for obtaining manufacturing license for medical device in India.

Who Can Apply For Manufacturing License For Medical Device?

Below are some individual who can apply for manufacturing license for medical device in India:

Manufacturer: who is responsible for production and manufacturing of medical device can apply for manufacturing license.

Importer: Person who is looking to Import medical device in India can apply for manufacturing license.

Distributor or Authorized Person: Person who is authorized from manufacturer can apply for license.

What Is Medical Device? How Many Classes Of Medical Device Are there?

Medical device is any instrument, equipment, implant, or machine that is used in diagnosis, treatment, and mitigation of disease in humans. Medical device are classified into four types based on the risk it possesses:

Class A: Low risk medical device (stethoscope and bandages)

Class B: Intermediate risk (syringe and glucose meter)

 Class C: Moderate high risk ( catheter and implants)

Class D: Very high risk (heart valves)

Documents Required For Obtaining Manufacturing License For Medical Device In India

For the grant of manufacturing license for your medical device, following are some key documents required as per CDSCO guidelines:

Application Form: Form MD-3 is filled for class A and B medical device, form MD-7 for class C and D medical devices.

Plant Master File: Plant master file having information about the manufacturing site, layout of facility, and equipment used.

Device Master File: Detail description of medical device and risk possibilities along with the specifications and design.

Quality Management System: QMS certificate issued under ISO 13485 certification demonstrating high performance quality standard of medical device in compliance with regulatory framework.

Technical Documents: Most important documents including product specifications, clinical report and risk management plan of medical device.

Stability Data: Stability data demonstrating the shelf life of medical device.

Deceleration or Understanding: Understanding from manufacturer, ensuring compliance of medical device with regulatory standards.

Labelling and Packaging: Details of labelling for medical device is required as per Medical Device Rules, 2017.

Procedure To Obtain Manufacturing License For Medical Device

Following are the main steps for the grant of manufacturing license:

Visit Sugam Portal: Register on the CDSCO/sugam portal by creating an account.

Application Submission: Select the Form applicable as per your medical device registration. Fill the form details carefully and submit on the portal.

Fee Payment: Pay the applicable money as per the Medical Device Rules, 2017.

Audit Inspection: Specific regulatory authority will conduct the inspection of product manufacturing site, to ensure the compliance of medical device as per the regulatory standards.

License Issuance: After the successful evaluation of manufacturing site along with your application form documents, Licensing authority will grant the manufacturing license.

How Medwisdom Lifescience Can Assist You With Obtaining Manufacturing License?

Medwisdom offers expert assistance in medical device registration and license, we have secured over 2500 medical device registration so far, we take pride in our exclusive achievement for grant of 500 plus manufacturing license across all classes of medical device (A to D). Our expertise ensure timely registration and cost effective solutions for obtaining manufacturing license.

FAQS

Who Needs Manufacturing License For Medical Device In India?

Any company or individual planning to manufacture medical device for the purpose of sell or marketing, must obtain the manufacturing license for medical device under the Medical Device Rules, 2017.

Who Issue Manufacturing License For Medical Device?

State Licensing Authority is responsible for issuing manufacturing license for class A and class B medical device. Central Licensing Authority

What Is The Validity of Manufacturing License For Medical Device?

Validity of manufacturing license is five years from the date of issue.

What Is The Timeline For Obtaining Manufacturing License?

The approximate time for obtaining manufacturing license for medical device takes 5-6 months, based on the completeness of your application and the response from the regulatory authority.

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Enhancing Efficiency with Cloud-Based QMS and Asset Calibration Software

In today’s fast-paced, technology-driven world, businesses rely on cloud-based solutions to streamline their operations and improve overall efficiency. One such solution that has gained immense popularity is cloud-based Quality Management Systems (QMS). A cloud-based QMS offers businesses the flexibility to manage quality processes remotely while ensuring real-time updates and data security. Combined with specialized software for asset calibration and maintenance, companies can ensure their assets perform optimally, reduce downtime, and maintain compliance with industry standards.

A cloud-based QMS provides an integrated platform for tracking, managing, and improving various quality management processes. It enables companies to automate workflows, conduct audits, monitor performance metrics, and ensure compliance with regulatory standards without relying on physical infrastructure. This flexibility and scalability make it an ideal choice for businesses looking to enhance their quality management practices while saving on maintenance costs.

Another essential tool that complements a cloud-based QMS is asset calibration and maintenance software. Calibration is crucial for ensuring that equipment and machinery are operating at peak performance. This software helps businesses track calibration schedules, maintain records, and even automate reminders for upcoming calibration dates. In addition to calibration, maintenance software plays a vital role in keeping assets running smoothly by scheduling preventive maintenance and managing repair workflows.

By incorporating asset calibration and maintenance software into a cloud-based QMS, companies can improve their asset management processes and reduce the risk of costly failures. For instance, with regular calibration, companies can ensure that equipment produces accurate measurements, which is essential for maintaining product quality. Furthermore, a reliable asset management system can help track the lifespan of equipment, enabling businesses to schedule repairs and replacements before equipment breaks down unexpectedly.

With cloud-based solutions, businesses can access data from any location, making it easier to monitor assets and quality management systems from remote sites. This ability to manage operations from anywhere offers a significant advantage for companies with multiple locations or those with a mobile workforce. Whether employees are on-site or working remotely, they can stay up to date on calibration schedules, maintenance tasks, and quality audits, ensuring smooth and consistent operations.

Cloud-based QMS and asset calibration and maintenance software also support regulatory compliance, which is crucial for industries such as manufacturing, pharmaceuticals, and healthcare. For example, these systems can help ensure that assets are calibrated according to industry standards, such as those set by ISO, FDA, or other regulatory bodies. Compliance is made simpler with digital records and automated audit trails, reducing the risk of human error and ensuring that businesses meet required standards consistently.

Incorporating these technologies not only enhances operational efficiency but also improves decision-making. With real-time data and automated reporting, businesses can identify areas for improvement and take proactive measures to address potential issues. Whether it’s optimizing asset performance, reducing maintenance costs, or improving product quality, cloud-based QMS and asset management software provide the tools companies need to stay ahead in a competitive marketplace.

In conclusion, leveraging cloud-based QMS and asset calibration and maintenance software allows businesses to streamline their operations, enhance asset performance, and maintain regulatory compliance. By integrating these technologies into their daily operations, companies can improve efficiency, reduce risks, and maintain a high level of quality across their processes. Trackmedium.com provides innovative solutions for businesses looking to embrace these technologies and enhance their operational capabilities.

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formation iso 13485

ISO 13485 Training: Enhancing Quality in Medical Device Manufacturing

ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the medical device industry. It establishes guidelines to ensure that medical devices meet stringent regulatory and customer requirements for safety, performance, and quality. Training on ISO 13485 is essential for organizations and professionals seeking to implement, maintain, or audit a compliant QMS. This article explores the importance of ISO 13485 training, its benefits, available types of courses, and its role in ensuring excellence in medical device manufacturing.

1. What is ISO 13485 Training?

ISO 13485 training provides comprehensive knowledge and practical skills to help individuals and organizations understand and apply the requirements of the ISO 13485 standard.

This training is critical for:

Quality managers and regulatory compliance officers.

Medical device designers and manufacturers.

Internal and external auditors.

Anyone involved in ensuring product quality and regulatory compliance in the medical device industry.

The goal of ISO 13485 training is to ensure that participants can:

Understand the standard’s requirements and its relevance to medical devices.

Develop and maintain an effective QMS.

Address regulatory requirements specific to the medical device industry.

Conduct internal or supplier audits to verify compliance.

With the increasing regulatory scrutiny on medical devices, ISO 13485 training is a valuable asset for organizations striving to deliver safe and effective products to the market.

2. Benefits of ISO 13485 Training

Investing in ISO 13485 training provides numerous advantages for both individuals and organizations:

Regulatory Compliance: ISO 13485 aligns with global medical device regulations, including those in the US, EU, and Canada. Training ensures organizations meet these requirements and avoid penalties or product recalls.

Improved Product Quality: Participants learn how to implement quality management processes that enhance the safety, performance, and reliability of medical devices.

Streamlined Certification: For organizations seeking ISO 13485 certification, training prepares employees to understand and fulfill the standard’s requirements, ensuring a smoother certification process.

Risk Management: The training emphasizes identifying, assessing, and mitigating risks throughout the product lifecycle, reducing the likelihood of failures or non-compliance.

Career Advancement: For professionals, ISO 13485 training and certifications boost credentials, opening doors to roles in quality management, regulatory affairs, and auditing within the medical device industry.

Organizations that prioritize ISO 13485 training can achieve operational excellence, gain a competitive edge, and build trust with customers and regulatory bodies.

3. Types of ISO 13485 Training Courses

ISO 13485 training is offered in various formats to cater to the diverse needs of participants:

Awareness Training: Introductory courses designed for employees to understand the basics of ISO 13485, its purpose, and its application in the medical device industry.

Implementation Training: These courses guide participants through the process of developing and implementing an ISO 13485-compliant QMS. Topics include documentation, process control, and risk management.

Internal Auditor Training: Focused on preparing participants to conduct internal audits, these programs cover audit planning, execution, and reporting in accordance with ISO 19011 guidelines.

Lead Auditor Training: Advanced training for individuals aiming to conduct third-party certification audits. It includes in-depth knowledge of ISO 13485 requirements, auditing techniques, and leadership skills.

Regulatory Compliance Training: These specialized courses address the integration of ISO 13485 with regulatory requirements such as the EU Medical Device Regulation (MDR) and FDA Quality System Regulation (QSR).

Training programs are delivered through various modes, including in-person workshops, online sessions, and blended learning approaches, offering flexibility for different learning preferences.

4. The Role of ISO 13485 Training in Medical Device Manufacturing

ISO 13485 training plays a critical role in enhancing the quality, safety, and regulatory compliance of medical devices:

Supporting Global Market Access: Compliance with ISO 13485 is often a prerequisite for entering international markets. Trained teams can ensure that products meet the necessary quality and regulatory standards.

Fostering a Quality-Driven Culture: Training helps organizations embed a culture of quality throughout the organization, where employees prioritize compliance and continuous improvement.

Enhancing Supply Chain Collaboration: ISO 13485 training is not limited to manufacturers; suppliers also benefit. Ensuring that all parties in the supply chain meet the standard’s requirements improves overall product quality and reliability.

Reducing Risks and Costs: Effective implementation of an ISO 13485-compliant QMS minimizes risks such as product recalls, regulatory non-compliance, and customer dissatisfaction, ultimately saving costs.

Building Customer Confidence: Customers trust organizations that demonstrate adherence to internationally recognized standards. ISO 13485 training strengthens an organization’s reputation for delivering high-quality, safe medical devices.

By integrating ISO 13485 training into their operations, organizations can ensure that their products consistently meet the highest standards of safety and quality, thereby protecting patient health and achieving business success.

Conclusion

formation iso 13485 is essential for organizations and professionals in the medical device industry who are committed to achieving excellence in quality management and regulatory compliance. From awareness programs to advanced auditor courses, these training programs equip participants with the knowledge and skills to implement and maintain an ISO 13485-compliant QMS. For individuals, it enhances career prospects in quality assurance and regulatory affairs. For organizations, it ensures the consistent delivery of safe and effective medical devices, supporting global market access and customer trust. In an industry where safety and compliance are paramount, ISO 13485 training is a critical investment for long-term success.

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Everything You Need to Know About the API Monogram Certification Process

API Standards are internationally-recognized benchmarks that establish quality, safety and environmental standards for products and equipment used in oil and gas operations. They cover an expansive list of materials, manufacturing processes and testing protocols — an API Quality Management System (QMS) should therefore be established by manufacturers to help meet them — the QMS should focus on improving production consistency while mitigating risks, thereby guaranteeing all API Monogram-bearing products fulfill stringent quality specifications.

visit us:https://www.avnprofessional.com/everything-to-know-about-api-monogram-certification-process/

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ISO 17025:2015 Certification in Nepal

ISO 17025 for Testing and Calibration Labs: Ensuring Quality and Competence

In the realm of testing and calibration laboratories, adhering to international standards is crucial to ensure accurate and reliable results. One such standard is ISO 17025. In this article, we will explore what ISO 17025 entails and why it is essential for testing and calibration labs.

What is ISO 17025 Standards?

ISO 17025 is an internationally recognized standard that sets out the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It provides guidelines and criteria for laboratories to demonstrate their technical competence and proficiency in producing accurate and reliable test results.

What is ISO 17025 and What is its Objective or Purpose?

ISO 17025 serves as a benchmark for testing and calibration labs to ensure the quality and reliability of their services. The standard’s primary objective is to establish confidence in the laboratory’s competence, impartiality, and consistent performance. Let’s delve deeper into the key objectives and purposes of ISO 17025:

1. Ensuring Technical Competence

ISO 17025 emphasizes the need for testing and calibration laboratories to possess the necessary technical competence to carry out their activities effectively. This includes having skilled personnel, adequate infrastructure, calibrated equipment, validated test methods, and reliable quality assurance procedures. By adhering to ISO 17025, labs can enhance their technical capabilities and ensure accurate and reliable testing and calibration processes.

2. Demonstrating Impartiality and Independence

Independence and impartiality are vital principles in testing and calibration. ISO 17025 requires labs to demonstrate freedom from commercial, financial, and other pressures that may compromise their impartiality. This ensures that test results and calibrations are objective, unbiased, and free from conflicts of interest. Clients and stakeholders can have confidence in the integrity and reliability of the lab’s services.

3. Establishing Quality Management System

ISO 17025 places great importance on implementing a robust quality management system (QMS) within the laboratory. This includes document control, record keeping, equipment maintenance, staff training, internal audits, and management review. By adopting a well-defined QMS, labs can ensure consistent adherence to quality procedures, continual improvement, and customer satisfaction.

4. Promoting International Recognition and Acceptance

ISO 17025 is an internationally recognized standard. Obtaining accreditation to ISO 17025 enhances the credibility and acceptance of a laboratory’s test results and calibrations both nationally and internationally. It facilitates the acceptance of test reports across borders and eliminates the need for retesting or recalibration, saving time and resources for clients

quality management system (QMS) within the laboratory. This includes document control, record keeping, equipment maintenance, staff training, internal audits, and management review. By adopting a well-defined QMS, labs can ensure consistent adherence to quality procedures, continual improvement, and customer satisfaction.

What are testing and calibration laboratories?

Testing and calibration laboratories are specialized facilities that conduct a wide range of activities to ensure the accuracy, reliability, and validity of measurements and testing results. These laboratories play a critical role in various industries, including manufacturing, healthcare, environmental monitoring, food and beverage, construction, and more. Here’s a closer look at testing and calibration laboratories:

Testing Laboratories: Testing laboratories are equipped with advanced instrumentation and expertise to perform tests on various materials, products, or samples. These tests can encompass a wide range of parameters, such as physical, chemical, mechanical, electrical, and biological properties. Testing labs conduct experiments and analyses to determine the characteristics, performance, quality, safety, and compliance of products, materials, or samples. The results of these tests provide essential information for decision-making, quality control, research and development, product certification, and 

Why is it important to calibrate your instruments with ISO 17025 Accredited lab?

Calibrating instruments with an ISO 17025 accredited laboratory is important for several reasons:

Accurate and Reliable Measurements: ISO 17025 accredited labs adhere to stringent quality standards and follow internationally recognized calibration procedures. They have well-defined processes and use traceable reference standards to calibrate instruments. By calibrating your instruments with such labs, you can ensure that your measurements are accurate, reliable, and traceable to national or international standards.

Compliance with Regulations and Standards: Many industries and regulatory bodies require calibration certificates from accredited labs as proof of instrument accuracy and compliance. Using an ISO 17025 accredited lab ensures that your calibration certificates are recognized and accepted by regulatory agencies, customers, and other stakeholders. It helps demonstrate your commitment to quality, regulatory compliance, and meeting industry standards.

Consistent and Comparable Results: Calibration by an accredited lab ensures consistency and comparability of measurement results. Accredited labs follow standardized procedures, control environmental factors, and employ trained personnel to minimize measurement uncertainties. This allows for consistent and repeatable measurements, enabling you to compare results over time and across different instruments or laboratories.

Confidence and Credibility: ISO 17025 accreditation signifies that a laboratory has undergone rigorous evaluation by an independent accreditation body. It demonstrates the lab’s technical competence, adherence to quality management systems, and commitment to impartiality. Calibrating your instruments with an accredited lab gives you confidence in the accuracy of your measurements and enhances your credibility with customers, regulatory agencies, and other stakeholders.

International Recognition: ISO 17025 accreditation is recognized globally, facilitating acceptance of calibration certificates across borders. If your business operates internationally or deals with customers or partners from different countries, using an accredited lab ensures that your calibration certificates are widely accepted, eliminating the need for additional calibration or verification.

 calibrating your instruments with an ISO 17025 accredited lab ensures accurate and reliable measurements, compliance with regulations and standards, consistent and comparable results, confidence and credibility, international recognition, and effective risk mitigation. It is a proactive step towards maintaining quality, meeting regulatory requirements, and demonstrating your commitment to excellence in measurement and instrumentation.

Global Recognition and Acceptance: ISO 17025 accreditation is recognized and accepted internationally. Accredited laboratories enjoy wider acceptance of their test reports and calibration certificates across borders, eliminating the need for additional testing or calibration by customers or regulatory agencies. This recognition opens doors to new markets and facilitates international collaborations.

Improved Quality Management System: ISO 17025 accreditation requires laboratories to establish and maintain a robust quality management system. Through accreditation, laboratories are encouraged to implement best practices in quality management, including document control, equipment calibration, competence assessment, proficiency testing, internal audits, and corrective actions. This focus on quality management leads to improved operational efficiency, consistency, and customer satisfaction.

Demonstrated Technical Competence: Accreditation to ISO 17025 verifies a laboratory’s technical competence in specific fields of testing and calibration. It ensures that the laboratory has the necessary infrastructure, equipment, procedures, and personnel with appropriate qualifications and expertise to perform accurate and reliable measurements. Accreditation assures stakeholders that the laboratory’s results are traceable and meet recognized standards.

Enhanced Data Accuracy and Reliability: ISO 17025 accreditation promotes the use of validated test methods, calibrated equipment, and well-documented procedures, leading to accurate and reliable test results. The accreditation process includes proficiency testing and inter-laboratory comparisons, which further validate the laboratory’s measurement capabilities and ensure consistency in results. Accurate and reliable data are essential for informed decision-making, quality control, and regulatory compliance.

Is ISO/IEC 17025 Mandatory?

ISO/IEC 17025 is not mandatory by default, but it may be required or recommended in certain situations. The applicability of ISO/IEC 17025 depends on various factors, including regulatory requirements, customer demands, industry norms, and contractual obligations. Here are a few scenarios where ISO/IEC 17025 accreditation may be mandatory or highly beneficial:

Regulatory Compliance: Some industries, such as healthcare, environmental testing, food safety, and pharmaceuticals, have specific regulations that mandate compliance with ISO/IEC 17025 or similar standards. In these cases, accreditation to ISO/IEC 17025 becomes a legal or regulatory requirement for operating in the industry.

Contractual Obligations: Customers or regulatory bodies may require suppliers or testing/calibration laboratories to have ISO/IEC 17025 accreditation as a condition for providing services or products. This is common when dealing with government contracts, large organizations, or industries that prioritize quality and accuracy.

International Recognition: ISO/IEC 17025 accreditation provides international recognition and acceptance of a laboratory’s technical competence and quality management systems. If a laboratory wants to demonstrate its capabilities to international clients or participate in global collaborations, ISO/IEC 17025 accreditation can greatly enhance its credibility and market competitiveness.

Improved Quality and Competence: Even if ISO/IEC 17025 is not mandatory, many laboratories voluntarily pursue accreditation to improve their quality management systems, enhance technical competence, and provide assurance of reliable and accurate testing/calibration results. Accreditation helps laboratories to establish standardized procedures, implement best practices, and gain customer confidence.

It’s important to consider the specific requirements of your industry, regulatory environment, and customer expectations to determine whether ISO/IEC 17025 accreditation is mandatory or highly beneficial for your laboratory. Consulting with industry associations, regulatory bodies, or accreditation bodies can provide further guidance on the applicability and advantages of ISO/IEC 17025 in your specific context.

What are the Requirements of testing and calibration laboratory for ISO 17025 ?

The ISO/IEC 17025 standard specifies the requirements for the competence and consistent operation of testing and calibration laboratories. Here are the key requirements outlined in ISO/IEC 17025 for testing and calibration laboratories:

Organization and Management:

Documented policies, procedures, and organizational structure.

Clearly defined roles, responsibilities, and authorities for personnel.

Management commitment to impartiality, confidentiality, and continual improvement.

Quality Management System (QMS):

Establish and maintain a comprehensive quality management system.

Document control processes to ensure the availability of up-to-date documents and records.

Implement processes for managing non-conformities, corrective actions, and preventive actions.

Conduct management reviews to evaluate the effectiveness and improvement of the QMS.

Personnel Competence:

Define the competence requirements for personnel based on education, training, and experience.

Ensure that personnel are trained and competent to perform their assigned tasks.

Maintain records of personnel competence, including training, qualifications, and experience.

Testing and Calibration Processes:

Implement appropriate testing and calibration methods and procedures.

Ensure the availability and proper calibration of measurement equipment.

Validate and verify methods for their intended use.

Ensure traceability of measurements to national or international standards.

Quality Assurance:

Implement quality control procedures to monitor the validity and accuracy of test/calibration results.

Establish proficiency testing programs and participation in interlaboratory comparisons.

Maintain records of quality control activities and results.

Conduct internal audits to assess compliance with the standard and the QMS.

How to get ISO 17025 accredited?

Getting ISO/IEC 17025 accreditation involves a series of steps and processes. Here is a general overview of the typical path to achieve ISO/IEC 17025 accreditation for a testing or calibration laboratory:

Familiarize Yourself with ISO/IEC 17025: Read and understand the requirements of the ISO/IEC 17025 standard. Familiarize yourself with the specific clauses, technical competence requirements, and management system elements outlined in the standard.

Gap Analysis and Preparation: Conduct a thorough gap analysis of your laboratory’s current practices and the requirements of ISO/IEC 17025. Identify areas where your laboratory needs to improve to meet the standard’s requirements. Develop an implementation plan and establish a project team responsible for the accreditation process.

Documenting the Quality Management System: Develop and document your laboratory’s quality management system (QMS) based on the requirements of ISO/IEC 17025. This includes creating policies, procedures, and work instructions to address each clause of the standard. Document control processes and establish a system for managing records.

Implementation of the QMS: Implement the documented QMS throughout your laboratory. Ensure that personnel are trained on the new procedures and processes. Implement mechanisms for monitoring, measurement, and analysis of the QMS’s effectiveness.

Internal Audits and Corrective Actions: Conduct internal audits to assess the compliance of your laboratory’s operations with the requirements of ISO/IEC 17025. Identify any non-conformities and take corrective actions to address them. Continually monitor and improve the effectiveness of your QMS.

What does ISO 17025 accreditation mean?

ISO/IEC 17025 accreditation signifies that a testing or calibration laboratory has been assessed and found to meet the requirements of the ISO/IEC 17025 standard. It is a globally recognized accreditation that demonstrates the laboratory’s technical competence and ability to produce reliable and accurate results.

Here are the key aspects and implications of ISO/IEC 17025 accreditation:

Technical Competence: ISO/IEC 17025 accreditation confirms that the laboratory possesses the necessary technical competence to perform specific testing or calibration activities. It assures customers and stakeholders that the laboratory has the expertise, skills, and resources to conduct accurate and reliable measurements and evaluations.

Quality Management Systems: ISO/IEC 17025 requires laboratories to establish and maintain a robust quality management system (QMS). Accreditation verifies that the laboratory’s QMS conforms to the standard’s requirements, including document control, record keeping, competency management, equipment calibration, and measurement traceability.

International Recognition: ISO/IEC 17025 is globally recognized and accepted as the benchmark for testing and calibration laboratory accreditation. Accreditation provides international recognition of the laboratory’s technical competence, enhancing its credibility and facilitating acceptance of test/calibration results across national borders.

Improved Confidence and Credibility: ISO/IEC 17025 accreditation instills confidence in customers and stakeholders regarding the laboratory’s ability to deliver accurate and reliable results. It demonstrates the laboratory’s commitment to quality, accuracy, and continuous improvement, which can positively impact customer satisfaction and enhance the laboratory’s reputation.

Compliance with Regulations and Standards: ISO/IEC 17025 accreditation helps laboratories meet regulatory and industry-specific requirements. It ensures that the laboratory operates in accordance with established standards, regulations, and best practices, addressing the needs of sectors such as healthcare, environmental testing, pharmaceuticals, and more.

How many clauses are there in ISO 17025:2017?

ISO/IEC 17025:2017, the standard for testing and calibration laboratories, consists of 10 clauses. These clauses cover the various requirements that laboratories must fulfill to demonstrate technical competence and maintain a reliable quality management system. Here is a list of the 10 clauses in ISO/IEC 17025:2017:

Scope

Normative References

Terms and Definitions

General Requirements

Structural Requirements

Resource Requirements

Process Requirements

Management System Requirements

Technical Records

Management System Records

Each of these clauses outlines specific requirements that laboratories must address to achieve and maintain ISO/IEC 17025 accreditation. The standard covers various aspects of laboratory operations, including management commitment, personnel competence, equipment calibration, measurement traceability, handling of test items, and reporting of test results, among others. The requirements are designed to ensure the technical competence and consistency of laboratory operations to produce reliable and accurate test/calibration results.

How to get ISO 17025 Certification in Nepal?

Obtaining ISO/IEC 17025 certification in Nepal involves a series of steps to demonstrate compliance with the standard’s requirements. Here is a general outline of the process:

Familiarize Yourself with the Standard: Read and understand the requirements of ISO/IEC 17025:2017. Familiarize yourself with the clauses, technical competence requirements, and management system elements outlined in the standard.

Conduct a Gap Analysis: Evaluate your laboratory’s current practices against the requirements of ISO/IEC 17025. Identify areas where your laboratory needs to improve to meet the standard’s requirements.

Develop a Quality Management System (QMS): Establish and document your laboratory’s quality management system based on the requirements of ISO/IEC 17025. Develop policies, procedures, and work instructions to address each clause of the standard. Implement document control processes and establish a system for managing records.

Implement the QMS: Implement the documented QMS throughout your laboratory. Ensure that personnel are trained on the new procedures and processes.

Internal Audits and Corrective Actions: Conduct internal audits to assess the compliance of your laboratory’s operations with the requirements of ISO/IEC 17025. Identify any non-conformities and take corrective actions to address them. Continually monitor and improve the effectiveness of your QMS.

What should be the of accuracy as per ISO 17025?

ISO/IEC 17025, the standard for testing and calibration laboratories, does not prescribe specific accuracy requirements for measurements. Instead, it focuses on ensuring the competency and reliability of the laboratory’s testing and calibration processes. However, ISO/IEC 17025 emphasizes the need for laboratories to establish and maintain measurement traceability, estimate measurement uncertainty, and implement quality control measures.

To meet the requirements of ISO/IEC 17025, laboratories must:

Establish measurement traceability: Laboratories should have a documented process to demonstrate the traceability of their measurements to national or international standards. This ensures that the measurements are based on recognized reference materials and methods.

Estimate measurement uncertainty: Laboratories should estimate and report the uncertainty associated with their measurements. Measurement uncertainty quantifies the range within which the true value of the measured quantity is likely to lie. It reflects the combined effects of various sources of errors and provides an indication of the measurement’s reliability.

Implement quality control measures: Laboratories must establish procedures for quality control to monitor and control the accuracy of their measurements. This may involve using reference materials, participating in proficiency testing, conducting internal quality control checks, and maintaining suitable calibration of equipment.

Conclusion

In conclusion, ISO/IEC 17025:2017 is a vital standard for testing and calibration labs. It ensures technical competence, reliable results, and quality management. Accreditation to this standard enhances credibility and demonstrates commitment to accuracy and reliability. Adopting ISO/IEC 17025 improves processes, meets customer needs, and maintains quality improvement. It establishes a strong foundation for excellence in testing and calibration.