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AS9100:2016 IMPLEMENTATION

That includes ISO 9001:2015

Changes and Implementation Strategies for AS9100 Revision D

Let’s explore the challenges to organizations planning their transition by first understanding the changes that AS9100

Rev. D reflects; deciding on which of the other AS standards should be implemented along with AS9100 Rev. D; and looking at other decisions and strategies, such as

using integrated management systems and related software. After that we’ll present the transition deadlines

and consider their implications.

AS9100 Rev. D changes

AS9100 Rev. D is built on a base of the recently revised quality management system standard ISO 9001:2015. The

drivers of AS9100 Rev. D are the changes found in ISO 9001:2015, along with aerospace additions and other IAQG standards. When AS9100 Rev. D is compared to AS9100 Rev. C, it’s evident that the number of additional “shalls” in

AS9100 Rev. D is 66 vs. 53 “shalls” in AS9100 Rev. C. (See figure 1 Next page.)

AS9100 Rev. D changesFigure 1: Comparison of “shalls” in AS9100 Rev. C and Rev. D

AS9100 Rev. D changes

Product safety, counterfeit parts, and human factors are the big differences between AS9100 Rev. D and Rev. C. The sub-clause 8.1.3—“Product safety” has not only been added, but also appears in five

additional areas of the standard. 8.1.4—“Counterfeit parts” likewise has been added and shows up in three additional areas of the standard.

“Human factors” has been added to 7.1.4, 8.5.1 & 10.2—“Nonconformity and corrective actions.” The other changes reflect

movement of the clauses from the process model structure in AS9100 Rev. C to the plan-do-check-act (PDCA) structure of AS9100 Rev. D

Changes and Implementation Strategies for AS9100 Revision D

Changes in ISO 9001:2015There are 18 changes in ISO 9001:2015 compared to ISO

9001:2008. Some of the significant changes include the High-Level Structure (HLS) change. Also, there is the

addition of Context, Interested-party expectations, and risk-based thinking as three of the biggest changes in the

standard.

Context, interested-party expectations, and objectives

“Context” is a term that has been hot in business circles during the last few years. Context, or “contextual

intelligence,” has been associated with setting company strategy. The argument has been that companies need to consider the context of the organization when they design

their strategy, goals, and objectives. 

Context, interested-party expectations, and objectives

The organization uses the context and the strategic direction to formulate the quality policy and objectives (sub-clause 5.1.1 b). The organization also uses the context and the interested-party expectations to determine the risks and

opportunities, and subsequently, the actions to address them (sub-clauses 6.1.1 and 6.1.2). Strategy is defined as

planned activities to achieve an objective (sub-clause 3.35), and hence, strategic direction can be thought of as the

mission and vision that define the quality policy and objectives.

Risk-based thinking

Many aerospace organizations thought that sub-clause 7.1.2—“Product realization risk” in AS9100 Rev. C would suffice for meeting the requirements of ISO 9001:2015. However, ISO 9001:2015’s risk-based thinking is more

comprehensive; clause 6.1 is about planning risk or the risk and opportunities of not meeting “intended outcomes.”

Implementing Risk Based Thinking throughout the organizations processes is required to reduce

nonconformities and increase customer satisfaction.

Leadership

Another big change found in AS9100 Rev. D is the expectations and accountability of top management. Even though responsibilities can be delegated, accountability is with top management. Top management is responsible for AS9100 performance, ensuring that senior management

perform their responsibilities and that AS9100 is functioning satisfactorily. Its no longer just the responsibility of the

Quality Manager

Transition timelines for AS9100D

There are four key dates for AS9100-registered companies. 1. The first is when the official AS 9100:2016 standard will be released in

October 2016. 2. The second key date is June 2017, which is the deadline past which no

new AS9100 Rev. C companies will be accepted, and also the deadline for when registrars will stop using AS9100 Rev. C in surveillance audits.

3. The third key date is September 2017, when all AS9100 companies must provide their transition dates and plans to their registrars.

4. The final key date for AS9100 Rev. D is September 2018, when organizations are required to be registered to AS9100D or else lose their

AS9100 certification.

Transition timelines for AS9100D

Transition timeline for ISO 9001:2015

If you wish to maintain your certification to ISO 9001, you will need to upgrade your quality management system to the new edition of the standard and seek certification to it. You have a three-year transition period from the date of publication release (September 2015) to move to the ISO 9001:2015 version. This means, after the end of September 2018, a certificate to ISO 9001:2008 will no longer be valid. Check with your Certifying Body to see what their requirements are.

AS9100 Rev D Summary

In short, ISO 9001:2015 changes affect AS9100 Rev. D significantly, and implementers must understand these

requirements as they plan their implementations

The benefits of AS9100

To do business in aerospace today, organizations must comply with AS9100. AS9100:2016 now includes the

requirements of the QMS standard, ISO 9001:2015, plus additional requirements imposed by the aerospace,

aviation, and defense industries. AS9100:2016 places additional emphasis on structured design and validation

methodologies, configuration management, risk management, counterfeit controls, human factors and

leadership.

PLAN-DO-CHECK-ACTModel

• Phase 1 = PLAN and perform a GAP analysis of your QMS and develop a implementation plan.

• Phase 2 = DO, Implement necessary changes to close the gap between your current system and AS9100D

• Phase 3 = Check, follow up assessment to validate the changes are effectively implemented

• Phase 4 = Act, on any necessary changes needed in preparation for the certification audit.

QMS StructurePLAN

DO CHECK

ACT

and corrective

of market improveme

nt

review

of goods and

Nonconformi ng goods and services

Release of goods and services

Production of goods and provision of services

Development

servicesDocumented information

Control of external provision of goods and services

Communication

QMS

ManagementOperational planning process

AwarenessPlanning ofchanges

Roles, responsibilities andauthorities

Scope of management system

ContinualInternal audit

Determination

needs and interactions with customers

CompetenceQuality objectivesQuality

policy

Expectations of interested parties

Nonconformity

action

Monitoring, measurement, analysis and evaluation

Operations of planning and control

ResourcesActions to address risk and opportunity

Leadership and commitment

Understanding of the organization and its context

10 Improvement

9 Performance and evaluation8 Operation7 Support6 Planning5

Leadership

4 Context of the organization

Phase 1 Plan: Why a GAP Analysis?

Gap analysis is often conducted at the beginning of an organization’s journey seeking compliance to a chosen

specification or standard. However, it may also be conducted after some development of processes for

achieving compliance has taken place. We’ll provide an implementation road map to ISO

9001:2015 and/or AS9100D Certification

Phase 1 Plan: Why a GAP Analysis?

The main reason why gap analysis is conducted at the beginning of the development phase or after some

development has occurred is because the organization wants to know where it stands in regard to meeting the

standard, and it wants to know specifically what it must do to close the gaps. A gap analysis is mainly a determination of the degree of conformance of your organization to the

requirements of a specification or standard

Phase 1 Plan: Why a GAP Analysis?

A gap analysis cannot be performed by a registrar or company providing certification because they are not

allowed to provide the advice, due to an inherent conflict of interest.

What Top Gun Aerospace Provides you in Phase 1 Plan?

Statistical data related to:1. Potential major and/or minor non-conformances based

on ISO:9001:2015, AS9100D and AS9104/1, AS17021

2. Total Clauses that meet the requirements of ISO: 9001:2015 and AS9100D

3. Total Clauses that do NOT meet the requirements of ISO: 9001:2015 and AS9100D

What Top Gun Aerospace Provides you in Phase 1 Plan?

Statistical data related to: (Cont.)

1. Total potential nonconformances based on the Standards2. Opportunities for Improvement

3. Areas of Concern that are not nonconformances but could lead to nonconformances if not addressed

4. Develop a implementation plan going forward for certification as the result of the GAP analysis.

What Top Gun Aerospace Provides you? RESULTS!

Phase 2-DO: AS9100D Implementation

Top Gun Aerospace Consulting Services goal is to make the entire process of attaining AS9100D Compliance and Certification as fast,

simple and as cost-effective as possible – without sacrificing any of the benefits your current Quality Management System (QMS) was

designed to deliver.To that end, we make certain that:

1. Phase 2: Any gaps within you quality management system are clearly identified and effectively implemented.

2. Phase 2: We’ll collaborate with your process owners to understand what the AS9100D requirements are and improve your processes

What Top Gun Aerospace Provides you in Phase 1 Plan?

Phase 3-CHECK: Verification Follow Up

1. Verification follow up assessment is performed to validate all necessary changes are effectively

implemented and managed properly

Phase 4-ACT: Corrections

1. Make necessary corrections to the QMS in preparation for the Certification audit.

2. AS9100D can be fully implemented with 6 months or less (Dependent on the current status of your QMS and your dedication

to implementation)

What We Do But not not limited to the following

Conduct a “Gap Analysis” to determine needed documentation and processes

Meet with Management and develop your companies Strategic Direction (Context of the Organization and Interested Parties)

Meet with Management and establish Quality PolicyMeet with Management and establish Quality ObjectivesSynergize an ISO/AS9100D compliant Quality Manual

Synergize an ISO/AS9100D required Quality Procedures

What We Do

Synergize all required forms as needed Synergize a Corrective Action SystemDevelop a Risk Management System

Lead management through the required Management Review MeetingSynergize a Document Control system

What We Do

Coordinate activities with HR to assure employee documentation is in place

Synergize a calibration system (if required)Train an “in-house” ISO required “Management Representative”

Assist with Registrar selectionConduct and document the ISO pre-certification Internal Audit

What We Do

Act as Company’s liaison during Certification Audit (If contracted to do so)

What We Do

At the end of the day, Top Gun Aerospace Consulting will be with you throughout the implementation of AS9100D.

We do not nickel and dime our clients. One fixed price gives your company full access to our resources.

LET’S GET STARTED !

Top Gun Aerospace Consulting

Thank you for giving TOP GUN AEROSPACE CONSULTING LLC.

the opportunity to present this information.

The Best Choice in Quality Management System

Implementation!