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Organizations need to have ISO certification that increases their ability to attain growth, cost-effectiveness, and profitability. The certification implies that you follow industry-best practices to ensure quality product and lesser amount of scrap or rework. It further allows your workforce to be more productive with established QMS standards that results in a significant improvement in customer success.

What is ISO 9001:2015 Certification?

ISO 9001:2015 is a set of standards that specify requirements for a quality management system. These requirements need an organization:

  • To show its ability to perform consistently – When it comes to providing the products and services that meet customer requirements and comply with statutory and regulatory standards, and
  • to focus on customer satisfaction through the effective implementation of the QMS, including the processes that can drive continuous improvement while assuring the conformity of products based on the customer and industry-relevant regulatory requirements.

All the requirements specified under ISO 9001:2015 are generic. They are applicable for all the businesses, regardless of their size, type, and the products & services.

What are the benefits of having ISO 9001:2015 Certified QMS Software?

Some of the benefits of having ISO 9001:2015 Certified QMS Software:

Improved Brand Recognition and Credibility

Having a certified ISO 9001 QMS software like Qualityze can help you attain better position in the market – in terms of brand recognition and credibility since ISO is an internationally accepted body of standards. Once you will start following ISO standards and best practices, you are likely to build more trust amongst your customers.

Increase in Revenue

When you will have ISO 9001 Quality Management software that can align your business processes with the business goals, you will be able to deliver improved quality products and earn more revenue. Because you will be giving your customers a reason to return and refer your products in their network.

More Consistency in the System

A compliant ISO 9001 Quality Management Systems like Qualityze can help you instill more consistency in your business processes, workflows, and systems. The more will be the consistency in the process; better will be your control on business. It will ensure that your customers are getting good quality products every time they make a purchase of your products.

Increased Customer Satisfaction

When you will adopt best practices and maintain consistency in product quality, customers will have a trust on your products that they are of superior quality and will serve the intended purpose. They will know what they can expect from you. Therefore, you will have more satisfied and happy customers, and less complaints.

Employee Empowerment

ISO 9001 certification requires your employee to be well-trained and competent for their job function. An ISO 9001 quality management system software like Qualityze ensures that they have necessary tools in place to perform their jobs as per defined work instructions, procedures, and metrics. Consequently, your employees will be more productive. A little emphasis on employee training can add to the organizational productivity.

Get Qualityze ISO 9001 EQMS Software to reap all the advantages of ISO certified processes and workflows. It will enable you to form a closed-loop system for quality management that will take care of every aspect including continuous improvement.

ISO helps Businesses Improve Efficiency and Customer Satisfaction

ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction (www.iso.org). The standard is divided in 10 sections:

  • Section 1—Scope
  • Section 2—Normative Reference
  • Section 3—Terms and Definitions
  • Section 4—Context of the organization
  • Section 5—Leadership
  • Section 6—Planning
  • Section 7—Support
  • Section 8—Operation
  • Section 9—Performance evaluation
  • Section 10—Improvement

Qualityze Solution Information Matrix for ISO 9001

Qualityze ISO 9001 EQMS software is designed to help an organization to comply with ISO 9001 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help:

Requirements Section Description Qualityze Modules
Section 4: Context of the organization

 

  • Understanding the organization & its context
  • Understanding the needs & expectations of interested parties
  • Determining the scope of the QMS
  • The QMS and its processes
  • Process approach
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
Section 5: Leadership
  • Leadership & commitment
  • Quality policy
  • Organizational roles, responsibilities & authorities
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
Section 6: Planning

 

  • Actions to address risks & opportunities
  • Quality objectives & planning to achieve them
  • Planning of changes
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
Section 7: Support
  • Resources: People, Infrastructure and Environment for Operations
  • Competence
  • Awareness
  • Communication
  • Documented information
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
Section 8: Operation
  • Operational planning & control
  • Customer communication
  • Determination and review requirements for product & services
  • Operational planning process
  • Control of externally provisioned product & services
  • Development of goods & services
  • Identification, Traceability and Preservation
  • Production of goods & services, Control of changes and
    the release of goods & services
  • Control of Nonconforming goods & services
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
  • Complaints Management
Section 9: Performance evaluation
  • Monitoring, measurement analysis & evaluation
  • Internal Audit
  • Management Review
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
Section 10: Improvement

 

  • Nonconformity & corrective action
  • Improvement
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
  • Complaints Management

Related Links

Compliance Management Software
ISO13485 Quality Management System
21 CFR 820 Quality System
FDA 21 CFR Part 11 Software
AS 9100 Quality Management Software
TS 16949 Automotive QMS Software