MorganHill offers ISO 9001 Scoping & Gap Assessment services for helping organizations in the adoption and implementation of a Quality Management System (QMS) that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.  ISO 9001 is without question the world’s most well-known and accepted quality management system standard, as organizations all around the world have successfully implemented its core provisions. 

The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations, thus, for organizations new to the ISO 9001 standard, a Scoping & Gap Assessment is essential.

Steps undertaken by MorganHill for our ISO 9001 Scoping & Gap Assessment services include the following:

• Understand ISO 9001 Requirements: With MorganHill as your trusted advisor, we’ll familiarize your organization with the ISO 9001 standard and its clauses, helping you gain a clear understanding of the principles, elements, and expectations outlined in the standard. Bottom line; we’ll leave nothing open to assumptions - instead - giving you a crystal clear understanding of the intent and requirements of the ISO 9001 standard, and how it impacts and ultimately aligns with your organization’s needs.

• Define the Scope of Assessment: We’ll help you solidify and determine the scope of your Quality Management System by identifying the processes, departments, products, and services that will be evaluated within the context of your actual QMS.

• Assemble a Gap Assessment Team: Our ISO 9001 professionals have expertise in quality management, process knowledge, compliance, and auditing - the very team that will collaborate to conduct the Scoping & Gap Assessment.

• Review Current QMS Practices: We’ll gather all the necessary information about your organization's current quality management practices, including policies, procedures, documentation, records, and performance metrics.

• Identify ISO 9001 Requirements: We’ll break down the ISO 9001 standard into its individual clauses and requirements, using our proprietary methodologies of checklists and other documentation that maps each requirement to corresponding aspects of your QMS practices.

• Conduct a Gap Analysis: We’ll compare your organization's current QMS practices against the requirements of ISO 9001, identifying areas where your practices align with the standard (conformance) and where gaps exist (non-conformance).

• Document Gap Findings: We’ll document the results of your gap analysis, creating a comprehensive record of the specific clauses or requirements where your organization's QMS practices do not align with ISO 9001, and thus, require remediation.

• Prioritize Identified Gaps: We’ll prioritize the identified gaps based on factors such as their potential impact on product/service quality, customer satisfaction, regulatory compliance, and operational effectiveness.

• Develop an Action Plan: We’ll work with you to create a detailed action plan outlining the steps needed to address each identified gap. As for each gap, we’ll define the tasks, responsible individuals, deadlines, required resources, and potential challenges.

Additional services offered for ISO 9001 include remediation & implementation, performing internal audit functions, along with QMS continual improvement measures. MorganHill also offers industry leading services for ISO 27001, 22301, 27701, 14001, and 45001.

Additionally, we offer a wide range of regulatory compliance services, along with other specialty services.  Furthermore, we offer world-class ISMS security documentation and other specialty documents for today’s growing cybersecurity and data privacy reporting requirements