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Sep 09, 2024

A US-based plastic manufacturing company got certified with ISO 9001:2015 using Effivity QMS Software

A US-based plastic manufacturing company got certified with ISO 9001:2015 using Effivity QMS Software

A US-based plastic manufacturing company was able to revamp its quality management system with the aid of Effivity. The industry had stringent compliance requirements for skilled operations, precision, and within the international standard ISO 9001:2015.

In this case study, we will explore how this company was able to transition to ISO 9001:2015 while maintaining compliance using Effivity's QMS software.

About the Organization

The organization is a family-owned corporation, renowned worldwide for its services since 1969. It provides cutting-edge technology to customers, with a commitment to continuous improvement, and a one-stop shop to handle all the prototypes, production, and value-added requirements. Through high-quality manufacturing processes, they provide customers with cost-effective, quality-driven products, making them the ultimate choice for custom plastic molding.

This corporation wanted to transition to the ISO 9001:2015 standards. During this transition, the company wanted to train its associates and make them aware of customer specifications. To meet and go beyond the required quality standards, they chose Effivity QMS Software. This smart and agile cloud-based software enables them to transition effectively and smoothly to the ISO 9001:2015 standards.

"We are driven to ensure quality requirements are met or exceeded. With Effivity QMS Software, we are now compliant with ISO 9001:2015," said the Quality Control Manager.

Challenges Faced

Switching to the new ISO 9001:2005 certification standards is not easy. It brings its difficulties, including changes in existing documentation and company processes. Employees also have to be trained according to the revised standards. The new certification focuses on integrated risk-based thinking, greater flexibility, and adapting to today's business landscape. Implementing these changes across the company proved to be complex and time-consuming.

1. Employee Training

The new QMS certification required all employees to be trained according to the latest ISO 9001:2005 requirements. Designing and executing a company-wide comprehensive training program covering all aspects of the new certification standard was challenging.

2. Resource Allocation

Switching to the new quality management system certification required careful planning and allocating personnel, time, and finances. The plastics manufacturing company needed to ensure that normal business operations were not disrupted while also meeting the ISO 9001:2015 standards.

3. Aligning with Company Operations

Plastic manufacturing companies have unique operations and processes, and a one-size-fits-all approach to implementing the new ISO 9001:2015 standards might not work. The management needed to ensure the new QMS was customized according to the company's specific strategy and internal operations.

4. Managing Documentation

Manually managing and accessing documentation as per the ISO 9001:2005 standards can be an overwhelming process. Excessive documentation was leading to time delays, difficulty locating relevant documentation, and taking focus away from maintaining quality processes.

5. Customer Service

The absence of a centralized system complicates the management of inquiries and the tracking of interactions. This caused challenges in providing high-quality customer service to a wide range of clients, impacting customer satisfaction and loyalty.

Effivity's Solution

Effivity is a comprehensive cloud-based QMS software that provides SCM tools and user-friendly and practical solutions. It helps organizations transition to and maintain different ISO certifications. Specializing in creating customized supply chain management software for small businesses, Effivity aids plastics manufacturing companies in complying with different regulations and streamlining their processes.

Effivity's Solutions for Plastics Manufacturing Companies

1. Training Management Module

Effivity's Training Management Module ensured that all staff in this company were aware of and well-versed in QMS processes. It tracks progress and manages employee training programs, providing the company with a well-structured approach to training and building high standards of compliance.

2. Non-Conformance and Corrective Actions Module

Non-conformance to standards can occur in any company's processes, services, and products. In such cases, the CAPA module ensures there are processes in place to handle non-conformance. Effivity's QMS addressed these issues by recording and acting on any dispositions, providing full records of any non-conformance activities with corrections, and maintaining easy-to-access records of these activities.

3. Risk Management Module

ISO 9001:2015 includes a new Risk and Opportunity standard. Effivity's risk management module helps assess, identify, and mitigate risks associated with manufacturing operations. It also provides tools to minimize the impact of potential hazards by regularly reviewing risks and opportunities.

4. Process Identification and Management Module

Aligning with company operations was a major concern. Effivity's process identification and management module documented processes using a standardized method, providing a central location for accessing and managing process documentation. It also ensures the most recent information is available.

5. Quality Assurance Module

Quality assurance involves inspecting products and ensuring they meet requirements. This process is critical for the effectiveness of the management system. Effivity's inspection and quality assurance module helped the company manage incoming, in-process, and final inspections effectively. It monitored inspection statuses, ensured the creation and storage of inspection records, and reviewed results for trends that called for corrective action.

6. Customer Complaint Management Module

The plastics manufacturing company struggled with managing customer service-related queries due to the lack of a centralized management system. Effivity's customer complaint management module helped track customer complaints, manage their resolution, and ensure timelines were met.

Wrapping Up

Effivity's comprehensive inventory of modules addresses the challenges and requirements of the plastics manufacturing industry. By implementing Effivity's solutions, the company benefited from supply chain planning software, streamlined communication and coordination, efficient employee training, enhanced customer experiences, and better compliance standards.

Ultimately, the audit-ready tool made it easy to achieve compliance with the ISO 9001:2015 standard.

If you want your organization to achieve the same success, visit the Effivity website today and consult with our team of experts!

Frequently Asked Questions

1. What are the benefits of QMS for a plastics manufacturing company?

A QMS, or Quality Management system, provides numerous benefits for plastics manufacturing companies. It helps improve product quality and reliability, streamline processes, increase efficiency, and enhance customer satisfaction. Regulatory compliance and enhanced safety are added benefits. A good QMS helps companies maintain high standards in the industry.

2. What are the challenges of transitioning to ISO 9001:2015?

Switching over to ISO 9001:2015 comes with many challenges, including excessive documentation, inadequate training, alignment with company operations, and poor understanding of requirements. A good QMS can help make the transition successful and easier by streamlining and customizing processes.

3. What are the new changes in ISO 9001:2015?

The new ISO 9001:2015 has several key changes, including a greater focus on risk management, greater flexibility, and a larger focus on fitting into today's business landscape.


SivaSankarVikranth B

QA Manager at Effivity
SivaSankarVikranth has extensive 7 years of experience in IT, helping clients achieve top-quality software solutions. His dedication to quality and strong technical skills drive Effivity’s success and customer satisfaction.

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Effivity is a leading QMS software for Quality Management System automation as per ISO 9001 standard, HSE software for Health – Safety - Environment Management System as per ISO 14001 & ISO 45001 standards and FSMS – HACCP software for food safety management system automation as per ISO 22000 / FSSC 22000 standards.