#qms

[kneipe]

berlin 2023

[shareyourideas]

A Comparison Of ISO 9001 And Quality Management System

[dramairime]

What is "IWTBN" ?

IWTBN or “It won’t turn back now” is an illustration project made by dramairime that is mostly uploaded on youtube, the series describes about a middle schooler suffering through multiple mental conditions such as Depression, PTSD (Post-traumatic stress disorder), and much terrible things. This illustration project is actually a way to spread more awareness and signs about certain mental conditions that are described through different styles of illustrations.

One of the most viewed and favorite style illustration is the paper project, I'll be posting more of these very soon soooo stay tuned! I'll post the information about the characters too ヾ(｡･ω･)ｼ !!

[odigodisse]

Eu recebi um novo certificado 🎓 E este tem muito valor para mim 😍🥰😘🤩 Mais uma meta alcançada com muito esforço 🙌👏👍👊🤘🙏🫵 Certifica que eu frequentei e concluí com sucesso a avaliação do curso 👨‍🏫📚✏️📖 realizado pelo @bureauveritasbr 🏫😍🥰😘🤩 o exame para o PR328: Curso de Formação de Auditor Líder QMS ISO 9001:2015 Curso nº 17929 certificado pelo CQI e IRCA 😍🥰😘🤩 Este curso satisfaz os requisitos de treinamento para o Sistema Certificação de Auditor CQI e IRCA QMS 🙌👏👍👊🤘🙏🫵

[nikunjbhoraniya]

➡️ What is an Equipment Breakdown? Types of Breakdowns | Examples

[radiophd]

qms -- t love

[blackbird-brewster]

Welcome to #Queerminal Minds Saturdays!

Each Saturday, I'm queuing up old Queerminal Minds posts for your viewing pleasure. Every week will focus on a different character of Criminal Minds.

This Week's Character: Jennifer Jareau

[edullence]

ISO 9001:2015 QMS Lead Auditor Training Course

Edullence Education Excellence offers an ISO 9001:2015 QMS Lead Auditor Training Course, designed to equip professionals with the skills to audit quality management systems effectively. This comprehensive course covers auditing principles, techniques, and ISO 9001 standards, ensuring participants gain expertise to lead successful audits and enhance organizational quality.

[rustomaapte]

Starting from 9th, 10th, 15th, 16th, 17th November 2024 Time:- 10:00 A.M. to 06:00 P.M. Indian Standard Time (IST). PLease call +91-8882213680 or training@siscertifications.com to answer your questions. SIS Certifications will be issuing certificates powered by Exemplar Global. Elevate your expertise and your organization’s performance today!

[pharmatechy]

Quality Assurance in Pharma Company

The Quality Assurance department plays a major role in the Pharmaceutical industry. The quality of the products that are manufactured in the production areas from starting to following and reviewing documents from the final release or rejection of every batch of Drug substance and Products for distribution and sale. QA department ensures every stage of manufacturing of the drug substance or drug product and also monitors each processing stage and maintains all manufacturing-related documentation as per BPR, Standard Operating Procedures (SOPs). The most important activity for in-process manufacturing and critical process and quality parameters checks up to batch release. Examples: Clean condition and proper manufacturing area, temperature probes, Pressure, steam, RT water, brine, and Personal protective equipment. IPQA persons monitor the in-process and control. After completing the manufacturing batch process record reviewed all data related to product manufacturing like line clearance, raw materials, temperature times, pressure, chemist signature, any deviations, time delays etc., and a checklist of all the calculations related to Batch Processing Records(BPR). Ex: Yield calculations Type complaint based on quality and safety QA responsible action for the decision taken by HODs as per SOPs. Change Control (CCF): Any changes based on minor or major processes and validation applied required a change control form which the department finally reviewed and approved by QA within timelines. These are two types based on product quality 1) Temporary 2) Minor deviation 3) Major deviation

Deviation: The deviation is the observation of any process-related information that deviates from the standard process or Protocol. These are two types based on product quality 1) Major deviation 2) Minor deviation In case of any out results from testing given Specification Standard testing procedure. QA department investigates to find the root cause of results Out of Specification (OOS): The results are coming out of the specification These are two types of investigations. Phase 1: Laboratory investigation (Quality Control) Phase 2: Full-scale investigation (Manufacturing, warehouse and Safety) and also additional tests required for investigation. Find out the root cause of the results and decide to take corrective and preventive action so these are not repeated in future. Out-of-trend (OOT): The results are within the specification limits but do not follow the previous batch trend results and are also near the specification limits.

it indicates the process is out of control or something the process not properly follow. Whenever any market complaints came for a product or any document received an official email from a customer maintained a registered as per SOP. Internal audits: QA conducts internal audits frequently as per their SOPs to check all departments follow their SOPs. External Audits: (Regulatory and Customer) To conduct an audit by QA of their contract manufacturing units or APIs to check to follow their SOPs, guidelines and policies. Monthly conducts two hours of training oral or verbal or PPT for departments in pharma guidelines and important topics of the industry. After completing training conduct a written examination for participants persons and also an evaluation. Ex: 1) cGMP (Current Good Manufacturing Practice) 2) ICH guidelines (International Council of Harmonisation for Pharmaceuticals Human Use). Annual Product Quality Review: (APQR) Prepare annual product quality review for consistency of the manufacturing process, Quality, yield, and analytical results to be represented statistically. Mainly Quality Management Systems (QMS) activities are followed by Validations (Vendor, Process, Cleaning, Method), Qualifications (IQ, OQ, PQ), Tech transfer, Market and Customer complaints RA department requirements. Conclusion: The Quality Assurance Department have the authority of each department to Audit and implement the cGMP and Pharmaopial guidelines in the Pharmaceutical companies.

[kneipe]

hamburg 2023

[weprovinginspection]

What is QMS?

Introduction

QMS (Quality Management System) plays an important role in enterprises. It helps enterprises improve product quality, reduce costs, enhance customer satisfaction, and ultimately improve their competitiveness and market position by standardizing, managing and improving all quality-related activities within the organization.

Details

QMS (Quality Management System) is a standard used to regulate the quality management behavior of an enterprise. It aims to improve the quality management level of the enterprise by establishing a quality management system, ensure that the quality of products and services meets the requirements, thereby winning customer trust and improving the competitiveness and reputation of the enterprise. The QMS system standard is designed based on the ISO/TS system management requirements. Its core value lies in the solidification of the continuous improvement mechanism of enterprise quality management.

QMS usually includes activities such as formulating quality policies, objectives, quality planning, quality control, quality assurance, and quality improvement. In order to effectively carry out various quality management activities, it is necessary to establish a corresponding management system, namely the quality management system. This includes a series of documents, procedures and processes that regulate and guide quality management activities within the organization.

Benefits of QMS to your company First, QMS can help enterprises better manage quality and ensure that the quality of products and services meets the expected level. Through standardized processes and standards, QMS can track quality indicators, record problems and improve processes, thereby identifying and solving potential quality problems and meeting customer needs.

Secondly, QMS also plays an important role in ensuring compliance. Many industries have specific quality standards and regulatory requirements, and QMS can help companies comply with these standards and requirements, ensure compliance in the market, and monitor the supply chain to ensure that suppliers and partners also meet relevant standards and requirements.

In addition, QMS can also improve efficiency and reduce costs. By identifying and eliminating quality problems, QMS can reduce the defect rate of products and services, reduce the cost of repair and recycling, and improve production efficiency and customer satisfaction. 

Last but not least, QMS has a profound impact on the sustainable development and competitiveness of enterprises. By establishing standardized quality management processes and standards, QMS helps companies achieve quality improvements, reduce defects in products and services, and improve the consistency and reliability of delivery, thereby enhancing customer trust and satisfaction with the company and enhancing the company's competitiveness.

[iso13485-blog]

The need for ISO 9001 certification is rising across a wide range of industries, helping organizations' quality management systems to meet worldwide standards. It is the most extensively used standard for quality management systems globally. It assists companies in moving forward and making sure that the standard of the products or services they offer meets the demands of their customers. But who precisely benefits from an ISO 9001 certification, and why is it so crucial for these kinds of businesses?

[amplelogicpharma]

Why Medical Device Companies Need CAPA Software to Ensure Quality & Safety

In the fast-paced world of medical device manufacturing, ensuring the highest quality and safety is not just a goal—it's a regulatory necessity. Whether it’s preventing defects, reducing risk, or meeting stringent FDA guidelines, medical device companies must maintain rigorous oversight of their processes. One essential tool that’s become a game-changer for quality management is CAPA (Corrective and Preventive Action) software.

CAPA management software helps companies address potential and existing problems in their processes, products, and even documentation. But why is it a must-have for medical device companies? Let's break it down.

1. The Increasing Complexity of Regulatory Requirements

Medical device companies are under intense scrutiny from regulatory bodies like the FDA, which mandates a thorough CAPA process as part of its quality management system (QMS) requirements. Any deviation from expected outcomes must be investigated, documented, and corrected, and that’s where CAPA software steps in.

Manually tracking these actions is not only inefficient but prone to errors, potentially leading to non-compliance. CAPA software automates and streamlines the process, ensuring that every corrective and preventive action is properly documented and traceable.

By utilizing CAPA management software, you can rest assured that your company stays compliant with FDA regulations, ISO standards, and other governing bodies without the headache of constant manual oversight.

2. Improved Root Cause Analysis

One of the cornerstones of CAPA is identifying the root cause of an issue and addressing it to prevent recurrence. Without a systematic approach, identifying this root cause can feel like finding a needle in a haystack. CAPA software for pharma and medical device companies simplifies this by providing structured workflows and analytics to aid in root cause analysis.

Using this software, you can quickly spot trends, identify recurring issues, and prevent them from impacting the quality of your medical devices again. This not only helps with compliance but significantly reduces production downtime and costs associated with defects.

3. Enhanced Risk Management

Risk management is critical in the medical device industry, where any product defect can have life-threatening consequences. CAPA software provides an integrated approach to identifying, assessing, and mitigating risks across the entire lifecycle of a product.

The software enables you to connect CAPA processes with risk management practices, ensuring that any issue flagged in the CAPA system is immediately assessed for risk. This means that potential hazards are caught early, corrective actions are implemented swiftly, and patient safety is protected.

4. Real-Time Data and Reporting

In today’s data-driven world, real-time visibility into operations is essential. CAPA management software offers robust reporting and analytics features, allowing decision-makers to monitor the performance of their quality management processes in real time.

Imagine being able to pull a detailed report on the status of all open CAPAs in seconds. You’ll know exactly which areas of your production line need attention, where risks lie, and how your preventive actions are performing—all without digging through endless spreadsheets.

The ability to access real-time data not only keeps you compliant but ensures your quality control processes are always proactive, never reactive.

5. Increased Efficiency and Collaboration

Let’s face it—managing CAPAs manually is a time-consuming, cumbersome process that often involves multiple departments. From quality assurance to manufacturing, everyone needs to be on the same page.

CAPA software centralizes this process, allowing different teams to collaborate seamlessly. When an issue arises, all relevant stakeholders are automatically notified, action plans are clearly defined, and responsibilities are assigned. This collaborative approach reduces bottlenecks, speeds up problem resolution, and ensures everyone has access to the same information.

6. Scalability for Growing Companies

Whether you're a startup or an established player in the medical device industry, your company’s processes will grow in complexity over time. The beauty of CAPA management software is that it scales with your business.

As your operations expand, you’ll need to manage an increasing number of corrective and preventive actions. CAPA software can handle this growth seamlessly, ensuring that your quality management system remains robust, no matter how big your company becomes.

Conclusion: Invest in CAPA Software to Ensure Quality and Safety

In the world of medical devices, there’s little room for error. Regulatory compliance, patient safety, and product quality are all critical, and CAPA management software ensures that your company maintains the highest standards in all these areas.

By automating and optimizing your CAPA processes, this software can help you save time, reduce risk, and ensure that quality and safety remain at the heart of your operations.

If you’re looking to boost compliance, streamline workflows, and safeguard your products, investing in CAPA software is the way to go. Start today and give your company the tools it needs to succeed in this highly regulated industry!

[nikunjbhoraniya]

➡️ What is a Key Performance Indicator (KPI)? Guide and Examples

[tilausqms]

The Importance of a Quality Management System (QMS) for Businesses

A Quality Management System (QMS) is a vital framework for businesses looking to maintain and improve product and service quality. It provides a systematic approach to managing processes and ensures that customer requirements are met consistently. By implementing a QMS, companies can streamline operations, reduce waste, and enhance efficiency.

One of the core benefits of a QMS is its focus on continuous improvement. This helps businesses identify areas of inefficiency and take corrective actions to prevent future problems. Additionally, adhering to a recognized QMS standard, such as ISO 9001, can boost a company's reputation, improve customer satisfaction, and open doors to new market opportunities.

In today’s competitive landscape, having a well-structured QMS is not just an option but a necessity for ensuring long-term success. Businesses that prioritize quality management often outperform their competitors by delivering consistent value to their customers and improving their internal processes.