AS9100D

WHAT IS AS9100? 

SAE Aerospace Standard AS9100D, Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations, is a quality management system standard for the aerospace industry. It is derived from ISO 9001. AS9100D contains ISO 9001:2015 in its entirety, along with additional aerospace and defense specific requirements.

ISO 9000:2015, Quality Management Systems – Fundamentals and Vocabulary

This document, which replaced the 2005 revision, provides all sanctioned interpretations for the numerous terms used throughout the various standards. ISO 9000:2015 also provides an examination of the Seven Quality Management Principles, including a statement of rationale. Finally, ISO 9000:2015 provides a number of helpful concept diagrams showing the intended interrelationships between ideas. ISO 9000:2015 is not a certifiable standard, but it can be of great benefit to a company newly starting out in pursuit of AS9100D:2016 certification. 

The Seven Quality Management Principles:

ISO 9000:2015, Section 2.3 set forth seven quality management principles, which have been identified for leading an organization toward improved performance. Beyond simply listing the Principles, ISO 9000 also provides rationale, benefits, and information on possible approaches to each Principle. These Principles are the basis of AS9100D:2016. They are: 

a. Customer Focus. Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. 

b. Leadership. Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives. 

c. Engagement of People. Competent, empowered, and engaged people at all levels are the essence of an organization and drive the organization’s ability to create and deliver value. 

d. Process Approach. Desired results are achieved more efficiently when activities and related resources are managed as processes within a coherent system. 

e. Improvement. Improvement of the organization’s overall performance should be an ongoing focus of the organization. 

f. Evidence Based Decision Making. Decisions based on the analysis of data and information is more likely to deliver desired results. 

g. Relationship Management. An organization and its external interested parties are interdependent and share a role in each other’s success. 

AS9100D:2016 Process-Based Structure and Clauses:

The revised continues to be consistent with the plan-do-check-improvement cycle, and continues to use the process management structure widely used in business today. It introduces several new clauses intended to drive Risk Based Thinking. 

Non-Auditable clauses of AS9100D:2016 are: 

1. Scope – which provides a general statement about to whom AS9100D:2016 is intended to apply. 

2. Normative Reference – which provides an explanation of the linkage between AS9100D:2016 and ISO 9000:2015. 

3. Terms and Definitions – which establishes the use of ISO 9000:2015 for all official definitions. 

Auditable clauses of AS9100D:2016 are: 

4. Context of the Organization (4 clauses), which mandate an organization to determine the scope of its system, ascertain interested parties, and in general determine the breadth of their quality management system, which defines and manages processes in order to produce a consistent product or service and allow for continual improvement. 

5. Leadership (3 clauses), under which management defines policy, organizational roles, and assures focus on the customer. It is emphasized that Leadership means a shared responsibility for the management of the quality system. 

6. Planning (3 clauses), under which the primary requirements related to risk management, as well as objectives (planning, reporting, etc.) are found. A set of requirements pertaining to management of changes is also found here. 

7. Support (5 clauses), which provide requirements pertaining to all of the various resources an organization needs to effectively operate their quality system, including people (competency) measurement devices (calibration/verification), and documented information (maintained and retained.) 

8. Operation (7 clauses), which provides requirements pertaining to the crucial and central activities of a quality management system. All of the “day-to-day” activities are found here, including interaction with customers, design of products/services, and interface with external providers, and control of production/service provision. 

9. Performance Evaluation (3 clauses), which provide requirements pertaining to three of the most crucial methods used by Organizations to self-regulate their quality management system and ensure its effectiveness. These are Management Review, Internal Audit, and Customer Satisfaction. 

10. Improvement (3 clauses), which provides requirements pertaining to the actions that should be taken as a result of evaluations and other output monitoring actions discussed in earlier parts of the standard. Ideas covered here include Corrective Action and Continual Improvement. 

Taken together these seven auditable sections can be thought of as a three part approach to the functioning of a quality management system, as follows: 

Foundation/Basic Building Blocks (Sections 4-7) 

The first four sections of auditable content taken together represent the basic pieces that an organization needs to establish to enable a successful quality management system. Without these pieces, the later requirements will likely not be successful. 

Day to Day Activities (Section 8) 

Taken together, the requirements provided in Section 8 are almost a process flow in and of themselves. Beginning with Operational Planning in 8.1 and Customer Requirements Determination in 8.2 the organization is supposed to figure out what is needed, later taking steps such as designing the product (8.3), purchasing materials (8.4) and ensuring that production/service is carried out consistently (8.5.1.) Auditors typically spend at least 60% of available audit time in Section 8. The processes it attempts to control are inevitably the most important in any organization. 

Analysis and Improvement (Sections 9 and 10) 

The standard concludes with a pair of Sections that attempt to collect all of the best methods that a company should use to ensure that its processes are effective, its customers are satisfied, and that continual improvement is being achieved. Many auditors review these sections early in an audit to develop audit trails. 

All quality management system requirements for achieving conformity of product and/or service may be placed within this process model. Leadership can be thought of as impacting all of the various activities of the quality management system. The Plan-Do-Check-Act cycle follows the various processes of the organization. Careful planning based on input from customers and other interested parties leads to effective operations, which in turn are evaluated with improvement actions taken where needed or desired. The ultimate goal of these interacting activities is a consistent effective product/service that satisfies all customers. 

AS9110C:2016 QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR AVIATION, MAINTENANCE ORGANIZATIONS

AS9110C is a sector specific standard geared towards organizations that strictly provide maintenance and repair services for the aerospace industry. In the past many of these organizations sought certification as a certified FAA Repair Station under the 14 CFR Part 145 Repair Station Standard. Realizing the necessity to incorporate these requirements into an international standard the IAQG issued the first version of AS9110 in 2003. Following an update in 2009 to incorporate the changes to the ISO 9001 standard published in 2008, the AS9110’s was revised in 2012. It was transitioned to the Annex SL format in 2016. 

The revisions in 2012 were issued in response to concerns raised by the European Aviation Safety Agency (EASA) in an effort to promote usage of the AS9110 standard by NAA (National Aviation Authorities.) Critical revisions included several additional definitions as well as clarifications of clauses necessary to promote international usage of the standard. The revisions in 2016 were made to align with ISO 9001:2015 and AS9100D:2016. 

The AS9110C standard defines the quality management system requirements and offers additional comprehensive requirements/criteria for overhaul facilities and maintenance repair for the aircraft industry at all levels of the MRO (Maintenance, Repair & Overhaul) process. 

AS9110C incorporates nearly all of the additional requirements found in AS9100D. In numerous cases, however, the requirement is modified to more appropriately reflect an MRO process. 

The primary additional clauses found in AS9110C that are not found in AS9100D primarily focus on safety. These are Safety Objectives and Safety Policy. The implication is that an MRO operation has a heighted level of responsibility for ensuring the safety and overall airworthiness of the components and aircraft that it services. Please note the product safety is addressed in several places of AS9100D. 

Additional unique requirements include the appointment of an Accountable Manager, Quality Manager, and Other Accountable Manager(s) (5.3.1-5.3.3) The implication of these requirements is to give assurance that all management resources will be made available to ensure compliance with all applicable customer and industry regulations. 

Companies whose primary business is providing maintenance, repair, and overhaul services for aviation sector products should investigate if AS9110C certification is right for them. It is also intended to be used by organizations with maintenance, repair, and overhaul operations that operate autonomously, or that are substantially different from their manufacturing operations. 

AS9120B:2016 QUALITY MANAGEMENT SYSTEM STANDARD REQUIREMENTS FOR AVIATION, SPACE, AND DEFENSE DISTRIBUTORS

AS9120B is a sector specific standard designed for organizations that provide warehousing and distribution services and do not perform any value added services. In general, value added services would include any form of repair, rework, modification, or other similar activity. 

AS9120B certified distributors are permitted to provide re-packaging (for example from a larger quantity to smaller quantities) labeling, and inspection services. 

AS9120 was originally published in 2003, later revised in 2009 to accommodate the changes made in 2008 to the ISO 9001 standard. AS9120B transitions the standard to align with Annex SL, ISO 9001:2015, and AS9100D:2016. 

The primary aim of the AS9120B standard is to promote a full line of traceability from the OEM to the customer for all aspects of the aerospace supply chain. It can be applied to any form of distributed product, including tires, fasteners, electronic systems, batteries, and numerous others. AS9120B seeks to ensure a complete chain of custody, full traceability, and availability of all related records.

One section found in the ISO 9001:2015 and AS9100D:2016 standards is addressed differently in the AS9120B standard. Design and Development of Products and Services (Clause 8.3) is reintroduced back into the standard because its applicability should be determined in accordance with section 4.3 and Annex A (see A.5). 

Numerous requirements found in AS9100D are also found in AS9120B. These include Configuration Management (8.1.2), Control of Work Transfers (per 8.4 and 8.5), and Foreign Object Controls (8.5.1l and 8.5.4b.) These additional requirements seek to emphasize the role that the distributor has in ensuring that the products it distributes are safe, free of contaminants, and airworthy. 

The only unique section found within AS9120A Evidence of Conformity (Clause 8.2.5) is now covered in 9120B, 8.6a. This clause establishes requirements for ensuring full traceability to manufacturer inspection records, including airworthiness certifications where applicable. This is particularly relevant in situations where a product’s quantity is split into two or more smaller quantities. 

https://www.pjcinc.com/Downloads/AS9100D_exov.pdf