AS9100 Rev D Context of the Organization
- Determine, monitor and review external and internal issues.
- Determine, monitor and review relevant interested parties.
- Establish the quality management system (QMS) scope.
- Define, evaluate and improve QMS processes.
Section 4 Context of the Organization
AS9100 requires that you fully understand the issues, interested parties and processes that affect your QMS as well as the boundaries and applicability of your QMS. This information is referred to as the “context of the organization”. Defining these concepts will help to align your QMS with your organization’s purpose and strategic direction.
Section 4.1: Understanding the Organization and Its Context
Internal and external issues are to be determined and information around these issues is to be monitored and reviewed. “Issues” refers to any positive or negative influences such as those resulting from legal, technological, competitive, market, cultural, social or economic environments. By defining, monitoring and reviewing internal and external issues, your organization can prepare and plan for how to address these issues in order to achieve its objectives.
Section 4.2: Understanding the Needs and Expectations of Interested Parties
Relevant interested parties include any person or organization that could impact or be impacted by your QMS. Customers, suppliers, banks, and competitors are some examples of relevant interested parties. Once your interested parties are defined, you need to determine what their needs and expectations are, then have a method for monitoring and reviewing this information. You are required to document a general description of your relevant interested parties.
Section 4.3: Determining the Scope of the Quality Management System
A scope defines the limitations and applicability of your QMS. When establishing a scope you are to consider issues, interested parties and the products or services you offer. A scope is useful for any interested parties to know what markets you serve, the type of organization you are, any ISO requirements that are not applicable and other information that may define the boundaries of your QMS. The QMS scope must be documented and made available to all interested parties that may request it.
Section 4.4: Quality Management System and Its Processes
The process approach and PDCA cycle are applied in this section. The process approach is a systematic definition of processes and their interactions to achieve intended results. The PDCA (Plan-Do-Check-Act) cycle is a way of managing those processes by establishing (Plan), implementing (Do), monitoring (Check), and improving (Act) them.
The requirements of 4.4 include determination of the processes needed for your QMS and for each of those processes you must define the:
- Methods of control
- Responsibilities and authorities
- Risks and Opportunities
All defined processes, their sequence, interaction, responsibilities, and authorities need to be documented. This information may be captured within a documented procedure or quality manual. In addition, those processes are to be evaluated and continuously improved upon.
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