Greg Ventura’s Post

1.What is the lifecycle of a Quality Assurance Process? Every process in Quality Assurance involves the PDCA (Plan Do Check Act) cycle, often known as the Deming cycle. The following are the phases of this cycle: Plan: The organisation should plan and develop process-related objectives, as well as the methods necessary to provide a high-quality final product. Here, Quality Assurance ensures that the planning made takes into consideration the quality of the product. Do: This phase involves process development and testing, as well as "doing" changes to processes. Here, Quality Assurance ensures that the processes followed during development maintain the quality of the product. Check: In this phase, processes are monitored, modified, and checked to see if they achieve the intended goals. Here, Quality Assurance ensures that the processes are checked thoroughly so that no defects might be missed. Act: In this phase, a Quality Assurance tester should take the steps that are required to improve the processes.

https://lnkd.in/dkhekg5F Enhance Your Quality Management with ISONLINE: Your Path to ISO Audit Success Are you facing challenges in managing quality systems and preparing for ISO 9001, 14001, and 45001 audits? Discover ISONLINE, the advanced solution for quality management that ensures your success. Why ISONLINE? Smart Process Management: Manage all quality processes in one place, including procedures, documentation, controls, tasks, and communication. ISO Audit Preparation: Dedicated tools for ISO 9001, 14001, and 45001, including document management and tracking corrective actions. Transparency and Control: Advanced reporting provides a clear picture of your organization’s quality status, helping identify gaps and take corrective actions. User-Friendly Experience: A seamless interface tailored to user needs. Customization: Flexible system that adapts to your organization’s specific needs. How Can ISONLINE Help You Succeed? Save Time and Resources: Automate processes to focus on continuous improvement. Continuous Improvement: Monitor performance metrics and improvement plans to stay on track. Reduce Risks: Advanced risk management and non-conformity tools. Standards Compliance: Meet stringent ISO requirements and achieve certifications with ease. Thousands of organizations have already succeeded with ISONLINE. Now it’s your turn! Contact us today for more information and a free demonstration. https://lnkd.in/dkhekg5F e-mail: [email protected]

#ISO9001 #IATF #Interview #Manufacturing #QMS The differences between Clause 1.0 (Scope) and Clause 4.3 (Determining the Scope of the Quality Management System) in ISO 9001 are as - Clause 1.0: Scope General Overview: This clause provides a general overview of the standard itself. It outlines what the ISO 9001 standard covers and the intent of the standard. Purpose: It describes the purpose of ISO 9001, which is to specify requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system. Applicability: It specifies that all the requirements of the ISO 9001 standard are intended to be applicable to any organization, regardless of its type, size, or the products and services it provides. Foundation: It serves as the foundation for the entire standard, setting the context and broad requirements for a QMS. Clause 4.3: Determining the Scope of the Quality Management System Specific to the Organization: This clause is specific to the organization implementing the QMS. It requires the organization to define the boundaries and applicability of the QMS to establish its scope. Context and Requirements: The scope must be determined considering the internal and external issues, the requirements of relevant interested parties, and the products and services of the organization. Documentation: The determined scope must be documented and maintained as part of the QMS documentation. It should state the types of products and services covered, the boundaries of the QMS, and any justification for exclusions of ISO 9001 requirements. Detail: It involves detailed consideration of what the QMS will cover within the organization, including the specific sites, departments, or sections, and any applicable exclusions. Summary Clause 1.0 is a high-level, overarching clause describing the general scope and applicability of the ISO 9001 standard itself. Clause 4.3 is a specific, organization-centric clause requiring the organization to define and document the scope of its own QMS, considering its unique context, needs, and boundaries. Understanding both clauses is crucial for correctly implementing and maintaining an ISO 9001 compliant QMS within an organization.

5 ways a QMS reduces cost of poor quality

5 ways a QMS reduces Cost of Poor Quality 1.Swift Problem Resolution: A QMS automates corrective and preventive actions (CAPA), enabling faster identification and resolution of issues before they escalate, thus minimizing costs associated with defects. 2.Operational Error Reduction: By enhancing employee training and standardizing workflows, a QMS reduces human errors, which are significant contributors to poor quality costs. 3.Effective #RiskManagement: A QMS incorporates risk assessment tools, allowing organizations to prioritize high-risk areas and address potential quality failures proactively. 4.Supplier #QualityImprovements: Integrated supplier management tools help identify and communicate with top-performing suppliers, reducing costs linked to poor supplier quality. 5.Increased Visibility: A QMS provides real-time data across operations, enabling quicker identification of quality issues and facilitating informed decision-making.

Audit hint: Validation of software used within the quality management system as per ISO 13485 is not new and most of the companies did their homework. However, keep in mind that any change to such software must be assessed if revalidation is required. Just recently I audited a software which was validated two years ago and a major release was conducted in the meanwhile without any documentation.

"It was a minor change, we assumed you wouldn't care." Ever hear this from your suppliers? Even the smallest changes can have unintended consequences. An unapproved change may not only impact Form/Fit/Function but may also violate regulatory or contractual agreements. Having a good Change Management Process is important and can prevent many headaches for both the supplier and customer. What's the worst unapproved change you've seen? -------------------------- Try out our free QMS Software here: www.factoryqa.com -------------------------- #QMS #QualityManagement #ChangeRequest #ChangeManagment #QMSSoftware

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Changes are often made during the course of testing especially to your test plan due to changes in the context of testing or factors surrounding your test project. For instance, the resignation of an experience test resource, making project timeline shorter, and changes in requirements etc. During test completion, it is best practice to archive your testware so they can be revised and reused in future project if necessary. Those testware are also very useful for new testers on the team to learn from. Regardless of the scenario at hand, during the course of testing or at test completion, CONFIGURATION MANAGEMENT plays a crucial role in keeping track and managing changes of your test process and test artefacts. One of the testing principles provides a means through which test wear out situation can be mitigated; and it is to refine your test cases, changing your test technique or even employing a different test type. In each case, your refined testware must carry the latest version. Basically, CONFIGURATION MANAGEMENT in software testing is very important to track changes in your testware in reflection of changes in requirements/and test approach. #SuccessSQAMarshal

Issue Management is the key to achieving ISO 9001. And with IsoComplete it couldn't be simpler. Read about it here https://lnkd.in/e7YPXQkK