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.

IATF 16949

Since its inception, automobile industry has won many hearts and minds. It has offered passionate people endless opportunities to explore more and more by driving faster than they would have ever thought it would be possible. The increasing craze for speedy automobiles has significantly raised the standards of safety and quality.

Without your customer’s confidence in two crucial aspects, you are likely to lose their interest in the vehicles or automobiles you offer. Here’s the automotive standard IATF 16949 plays a vital role. The globally accepted quality standards for automotive industry ISO/TS 16949 was formed in 1999. It is now evolved to IATF 16949 by the International Automotive Task Force (IATF).

These standards are a necessity for those who want to get into automotive industry.

What is IATF 16949 Certification?

IATF 16949:2016 (formerly known as ISO/TS 16949:2009) is a standard to define the quality management requirements specifically for the automotive sector. The ISO/TS 16949 was fundamentally created to harmonize the different schemes for assessment and certification worldwide in the automotive supply chain.
The main objectives of the IATF 16949 standard includes:

  • The development of a QMS that fosters a culture of continual improvement.
  • Increased emphasis on the defect prevention while reducing the variations and waste in the supply chain.

Combining the standard with Customer-Specific Requirements (CSR’s) will help you have the QMS requirements for automotive functions including service, production, and/or accessory parts. You cannot implement the IATF 16949 as standalone, it must be implemented along with ISO 9001:2015 for leveraging complete benefits.

What are the benefits of having IATF 16949 Certified QMS Software?

Some of the benefits of having IATF 16949 Certified QMS Software:

Qualityze Solution Information Matrix for IATF 16949

Qualityze quality management software for medical devices is designed to help an organization to comply with IATF 16949 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help:

Requirements Section(IATF 16949) Description Qualityze Modules
Section 4: Context of the organisation

Understanding the organisation & its context

Understanding the needs & expectations of interested parties

Determining the scope of the QMS

Customer specific requirements

Quality Management System and its Processes

Conformance of products and processes

Product safety

Document Management

Change Management

Audit Management

NC Management

CAPA Management

Training Management

Complaint Management

Section 5: Leadership

Leadership & commitment

Corporate responsibility

Process effectiveness & efficiency

Process owners

Customer focus

Quality policy

Organisational roles, responsibilities & authorities

Responsibility and authority for product requirements and corrective actions

Document Management

Change Management

Audit Management

NC Management

CAPA Management

Training Management

Section 6: Planning

Actions to address risks & opportunities

Risk Analysis

Preventive action

Contingency plans

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

Plant, facility & equipment planning

Environment for the operation of processes

Monitoring and measuring resources

Measurement system analysis

Measurement traceability

Calibration/Verification records

Laboratory requirements

Organisational knowledge

Competence

Awareness

Communication

Documented information

Document Management

Change Management

Audit Management

NC Management

CAPA Management

Training Management

Complaint Management

Section 8: Operation

Operational planning & control

Requirements for product and services

Design and development of products and services

Control of externally provisioned product & services

Production and service provision

Release of products and services

Control of Nonconforming outputs

Document Management

Change Management

Audit Management

NC Management

CAPA Management

Training Management

Complaint 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

Continual Improvement

Document Management

Change Management

Audit Management

NC Management

CAPA Management

Training Management

Complaint Management