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ISO 9001:2015 & Veeva
Quality Management System

Veeva received ISO 9001:2015 Quality Management System (QMS) certification from Schellman in September 2018.

Veeva is also certified in ISO/IEC 27001:2018 Information Security Management System.

About Veeva QualityOne 

Veeva's ISO 9001:2015 certification shows Veeva’s commitment to delivering and document control solution enables clients to unify quality processes, documents and data in a single application for employees, suppliers, contract manufacturers and auditors.

The QualityOne product supports:

  • Document Control
  • Nonconformance and Investigation
  • Complaint Management
  • CAPA Management
  • Change Control
  • Audit Management
  • Supplier Quality Management
  • Capability Training Management
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About ISO 9000

ISO 9001 7 principles

The ISO 9000 family is a standardized set of rules for Quality Management Systems to help organizations ensure they meet all statutory and regulatory requirements while also meeting the needs of their customers.

The International Organization for Standardization (ISO) does not certify organizations itself. There are many independent and accredited bodies that exist that audit organizations for compliance, and issue certifications. Certifications are not permanent and require renewal. ISO 9001 requires renewal once every three years.

Seven Quality Management Principles

1. Customer Focus- Veeva's Quality Management software helps companies meet customer requirements and to strive to exceed customer expectations.

2. Leadership - Veeva's QualityOne solution helps companies establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.

3. Engagement of People - Veeva's Quality Management and Document Control solution help foster competent, empowered and engaged people at all levels throughout the organization in order to enhance its capability to create and deliver value.

4. Process Approach - Veeva's QualityOne Solution helps to ensure consistent and predictable results are achieved more effectively and efficiently because activities are understood and managed as interrelated processes that function as a coherent system.

5. Improvement - Veeva's Quality Management solution helps customers have an ongoing focus on improvement.

6. Evidence-Based Decision Making - With Veeva's Quality Management and Document Control solution, Veeva QualityOne, customers are better equipped to make decisions based on the analysis and evaluation of data and information are therefore more likely to produce desired results.

7. Relationship Management - Veeva QualityOne helps to ensure sustained success, and helps companies better manage relationships with interested parties, such as suppliers, sub suppliers and auditors.

 

About ISO 9001

There has been global adoption of ISO 9001 due to its many benefits for all key stakeholders. ISO 9001 requirements can be adapted to meet specific contractual obligations between parties. Certified organizations achieve financial success through the procurement of new business as well as superior returns on assets.(1) 

(1)  Corbett, Charles J.; Montes-Sancho, María J.; Kirsch, David A. (2005). "The Financial Impact of ISO 9000 Certification in the United States: An Empirical Analysis"

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Global adoption of ISO 9001 has grown threefold between 2000 and 2014,
from 409,421 organizations to 1,138,1555 organizations.

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2015 Update

Increased Accountability
The updated 9001 standards removes ambiguity about the responsibility of meeting standards. Language has been changed to clearly illustrate the leadership is responsible for compliance.

Process Definition & Management
A greater emphasis has been placed on organizations to define processes and manage them through a Plan Do Check ACt (PDCA) cycle.

Documentation of Organizational Knowledge
A significant change to ISO 9001:2015 from ISO 9001:2008 is the addition of Clause 7.1.6 which requires organizations to determine knowledge required to maintain conformity with products and services. This knowledge has traditionally been obtained through experience and time, and passed through the leadership in an ad hoc manner. The new clause encourages better documentation of these processes, to improve control through times when continuity is challenged, such as staff turnover or corporate restructuring.

Read More About ISO 9001  

About Schellman & Company

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Schellman & Company is an industry leader in independent assessments or readiness based on specific standards set for different industries. They work across the most complex and heavily regulated verticals, such as Financial Services, Insurance, Manufacturing and Information Technology.

Learn more about Schellman & Company

About Veeva

Veeva

Founded in 2007, Veeva NYSE (VEEV), is a leading global provider of cloud-based software solutions for regulated industries such as consumer goods, chemical, cosmetics, and life sciences.

Our applications enable manufacturers to realize the benefits of a modern, cloud-based platform to manage the product journey and bring innovative, high-quality products to market faster without compromising industry-specific functionality, quality or regulatory compliance.

Learn more about Veeva's Solutions