Qualityze Achieves ISO 9001:2015

Tampa, FL – January 30, 2020 – Qualityze, Inc. has been certified as ISO 9001:2015 – compliant after an in-depth audit of the company’s internal operations.

ISO 9001:2015

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:

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