Quality Manual and Context of the Organization

The Quality Manual provides a structured framework for documenting and communicating the organization's quality management system. It outlines the scope of the QMS, including the processes, procedures, and resources needed to meet customer requirements and enhance satisfaction. Furthermore, it serves as a reference document for employees, customers, auditors, and other stakeholders, ensuring consistency and clarity in quality management practices. Additionally, the Quality Manual demonstrates the organization's commitment to quality and compliance with ISO 9001 standards.

The context of the organization provides essential insights into the internal and external factors that influence quality management practices. These factors may include the organization's industry, market trends, regulatory requirements, cultural norms, competitive landscape, stakeholder expectations, and the newly included Climate Change. Together, these elements help organizations establish robust QMSs that drive continual improvement and customer satisfaction under ISO 9001 standards.

Objective

The objective of this webinar is twofold:

1. to provide the details one may consider including in a Quality Manual; and,
2. to provide usable models when addressing the inputs and outputs of the Context of the Organization (COTO) within a quality management system.

Agenda

• Introduction
• Quality Manual (QM)
• Context of the Organization (COTO)
• Q&A

Target Audience:

• Quality Management Professionals: Professionals responsible for implementing, maintaining, or auditing quality management systems within organizations. This could include quality managers, quality assurance officers, quality engineers, and compliance officers.
• ISO 9001 Implementation Teams: Individuals involved in developing, implementing, and maintaining ISO 9001-compliant quality management systems within their organizations.
• Top Management and Executives: Decision-makers within organizations who have the authority to allocate resources, set quality objectives, and establish policies related to quality management.
• Internal Auditors: Professionals responsible for conducting internal audits to assess the effectiveness of the organization's quality management system and ensure compliance with ISO 9001 requirements.
• Consultants and Advisors: Professionals providing consultancy services or guidance to organizations seeking ISO 9001 certification or looking to improve their quality management practices.
• Students and Academics: Individuals studying quality management, ISO standards, or related disciplines interested in gaining a deeper understanding of the Quality Manual and Context of the Organization in ISO 9001.
• Stakeholders and Customers: Individuals or entities interested in the quality of products or services provided by the organization, such as customers, suppliers, regulatory bodies, and shareholders.

Language: English

Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event.

Speakers:

Sabrina Ippolito

Lead Auditor

With an avid passion for implementing efficient, effective, and lean quality systems, Sabrina believes that at the heart of any successful organization is a learning organization. She works with organizations to break down the barriers of silo mentality that plague many companies and helps surface an array of talent within organizations.

Sabrina is a classically trained biochemist and certified lead auditor who ensures organizations maintain compliance and certification across a range of industries and standards spanning pharmaceuticals, cosmetics, and general manufacturing. She has directed, overseen, and improved several quality systems to reduce deficiencies and increase product flow across the US, Canada, and Europe. She is affiliated with the Professional Order of Chemists of Quebec (l'OCQ) and the American Society for Quality (ASQ).

Cindy Haight

Inside Sales Representative, Industrial & Medical Device, SGS North America, Inc.

Cindy joined SGS North America a year ago to work in the Business Assurance Division. Her focus is to assist customers with Certification for Core ISO standards, ISO 13485, SMETA, and she also supports SGS Academy. Cindy began her career in the certification industry 20 years ago as a Global Key Account Manager for Bureau Veritas, where she helped large international companies achieve their certification objectives. In 2016, she moved to the Training Department, where she was responsible for customer support, sales, and many operational processes until joining SGS in January 2022.

Cindy is a long-time resident of Western NY, close to Lake Erie. She enjoys cooking and baking, as well as hiking and kayaking (to burn off the calories!).

 

For further information, please contact:

Dominic James
Marketing Assistant
t: +1-862-339-6737