9100:2016 Gap Assessment Worksheet

Gap Level and Status:

Person Gap
9100:2016 Clause Related
Clause
9100:2009 Change Summary Process
Impacted
Difficulty to
Responsible for Implement (1
Organization Gap
Summary Closure -Pending
-In work
Gap Assessment Low - 5 High) Due Date -Complete

4 Context of the 1 Scope New...Title

organization
4.1 Understanding New…external and internal
the organization and its 1.1 General issues and strategic direction
context

4.2 Understanding
the needs and 1.1 General New…interested parties, effect
expectations of or potential effect
interested parties

4.3 Determining the 1.2 Application New…exclusions replaced by

scope of the quality applicability, external and
internal issues, relevant
management system 4.2.2 Quality manual
interested parties

4 Quality New…Inputs required and the

management system outputs expected, monitoring,
measurements, performance
4.4 Quality
management system indicators, assignment of
and its processes responsibilities and authorities,
risks and opportunities,
4.1 General documented information for a
requirements quality manual or equivalent.

5 Management
5 Leadership Elevation of responsibility
responsibility
5.1 Leadership and 5.1 Management Reworded…same intent
commitment commitment

New…demonstrate leadership,
accountability, compatible with
context and strategic direction
5.1 Management of the organization, integration
5.1.1 General of business processes, achieves
commitment
its intended results, supporting
persons, promoting, supporting
relevant management roles,
NOTE on business.

New…statutory and regulatory,

5.1.2 Customer focus 5.2 Customer focus conformity risks and
opportunities determined.
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5.2 Policy 5.3 Quality policy Reworded…same intent

New…implemented and
5.2.1 Establishing the 5.3 Quality policy maintain, supports strategic
Quality Policy
direction

5.2.2 Communicating 5.3 Quality policy New…and applied, available to

the Quality Policy relevant interested parties.

5.5.1 Responsibility and New…delivering their intended

authority outputs, opportunities.

5.5.2 Management New…added management

5.3 Organizational representative, assigned
roles, responsibilities representative
responsibilities
and authorities
5.4.2 Quality
management system No change
planning
6 Planning
5.4.2 Quality New…risk and opportunities,
6.1 Actions to management system achieve improvement, structure,
address risks and planning
opportunities New…integrate, impact on the
8.5.3 Preventive action
conformity, risk, opportunities

New…change from top

management to organization,
relevant to conformity,
6.2 Quality monitored, communicated,
updated, maintain documented
objectives and planning 5.4.1 Quality objectives
to achieve them information, what will be done,
resourced required, who will be
responsible, when it will be
completed, how results will be
evaluated.

New…Purpose of the changes

5.4.2 Quality and their potential
6.3 Planning of consequences, availability of
changes management system resources, allocation or
planning
reallocate of responsibilities and
authorities.

6 Resource
7 Support management
6 Resource
7.1 Resources management Reworded…same intent
 9100:2016 Gap Assessment Worksheet

New…capabilities of, and

6.1 Provision of constraints on, existing internal
7.1.1 General resources resources, what needed to be
obtained from external
providers.

7.1.2 People 6.1 Provision of Reworded…same intent

resources
7.1.3 Infrastructure 6.3 Infrastructure Reworded…same intent

New…operation of these
7.1.4 Environment
for the operation of 6.4 Work environment processes, suitable environment
can be a combination of human
processes and physical factors.

7.1.5 Monitoring and 7.6 Control of

monitoring and Reworded…same intent
measuring resources
measuring equipment

7.6 Control of New…resources needed to

7.1.5.1 General monitoring and ensure valid and reliable results,
measuring equipment Resources (e.g. equipment)

7.1.5.2 7.6 Control of New…traceability, confidence in

Measurement monitoring and the validity of measurement
traceability measuring equipment

7.1.6 Organizational New…all new requirements

knowledge

6.2.1 General New…skills replaced with

competence
7.2 Competence New…performance,
6.2.2 Competence,
training and awareness effectiveness, new NOTE for
considering periodic reviews

New…effectiveness, benefits of
improved performance,
implication of not conforming,
7.3 Awareness 6.2.2 Competence, contribution to product or
training and awareness
service conformity, contribution
to product safety, importance of
ethical behavior.

New…external communications
5.5.3 Internal what it will communicate, when
7.4 Communication communication to communicate, whom to
communicate, how to
communicate, new NOTE
 9100:2016 Gap Assessment Worksheet

7.5 Documented 4.2 Documentation Reworded…same intent

information requirements
7.5.1 General 4.2.1 General Reworded…same intent
4.2.3 Control of
7.5.2 Creating and Reworded…same intent
documents
updating
4.2.4 Control of records Reworded…same intent
4.2.3 Control of New…Suitable for use and
documents adequately protected.
7.5.3 Control of
documented New…data protection defined to
Information 4.2.4 Control of records protect from loss, unauthorized
changes, unintended alteration,
corruption, physical damage...

8 Operation 7 Product realization Reworded…same intent

New…product obsolescence,
FOD prevention, achieve
conformity and on-time delivery,
engaging representatives of
affected organization functions,
8.1 Operational 7.1 Planning of determining the products to be
obtained from External
planning and control product realization
Providers, prevent delivery of
NCM training, addition of NOTE
on time phased events
performed in a particular
sequence, and impacts and risks
to be managed.

8.1.1 Operation risk

7.1.2 Risk Management New…Addition of NOTEs
management

New…Control product identity

and traceability, ensure
8.1.2 Configuration 7.1.3 Configuration documented information is
management Management consistent with the actual
attributes of the products and
services.

8.1.3 Product safety New

8.1.4 Prevention of
counterfeit products New
 9100:2016 Gap Assessment Worksheet

8.2 Requirements for 7.2 Customer-related

products and services processes New…Title

8.2.1 Customer 7.2.3 Customer

New…contingency actions
communication communication

8.2.2 Determining 7.2.1 Determination of

the requirements for requirements related to New…meet the claims
products and services the product

New…coordinated with
8.2.3 Review the 7.2.2 Review of applicable functions and if
unable to meet customer
requirements for requirements related to
products and services the product requirements then negotiate a
mutually acceptable
requirement with the customer.

8.2.4 Changes to 7.2.2 Review of

requirements for requirements related to Reworded…same intent
products and services the product

8.3 Design and 7.3.1 Design and

development of Reworded…same intent
products and services development planning

New…plan and control the

7.3.1 Design and
8.3.1 General development planning design and development of
product.

New…Nature, duration and

complexity of the design and
development activity, need for
8.3.2 Design and 7.3.1 Design and involvement of customer and
development users in the design and
planning development planning development process,
requirements for subsequent
provision of products and
services.

New…standards or codes of
practice that the organization
8.3.3 Design and 7.3.2 Design and has committed to implement,
development inputs development inputs potential consequences of
failure, potential consequences
of obsolescence.

7.3.4 Design and New…controls to the design and

development review development process.

8.3.4 Design and

development controls
 9100:2016 Gap Assessment Worksheet

8.3.4 Design and 7.3.5 Design and

development controls development verification New…linkage to clause 7.1.5

7.3.6 Design and

Reworded…same intent
development validation

New…D&D outputs are

approved by authorized
person(s) prior to rlease.
8.3.5 Design and 7.3.3 Design and New...NOTE on maintaining data
development outputs development outputs to achieve conforming product
or service and technical data and
repair schemes for operating
and maintaining the product.

8.3.6 Design and 7.3.7 Control of design New…process with criteria for
and development
development changes changes notifying customers

8.4 Control of
externally provided 7.4.1 Purchasing process New…Title and terminology
processes, products
and services

New…controls to their sub-tier

8.4.1 General 7.4.1 Purchasing process suppliers, conformity and on-
time delivery performance
criteria.

7.4.1 Purchasing process New…effectiveness of controls

Reworded…same intent New…

effectiveness of controls, high
8.4.2 Type and extent risk suppliers, counterfeit parts,
of control production part approval
7.4.3 Verification of process, periodically monitor,
purchased product
periodically monitor supplier
delegations, process to evaluate
test reports, raw material test
report accuracy
 9100:2016 Gap Assessment Worksheet

New…requirement for
qualification of competence,
supplier awareness of their
7.4.2 Purchasing contributions to product or
8.4.3 Information for information service conformity, contribution
external providers to product safety, and
importance of ethical behavior.

7.4.3 Verification of Reworded…same intent

purchased product
8.5 Production and 7.5 Production and No change
service provision service provision

New…results to be achieved,
7.5.1 Control of services to be provided,
production and service infrastructure, environment,
provision periodic revalidation, actions to
8.5.1 Control of prevent human error
production and
service provision
7.5.2 Validation of
processes for production Reworded…same intent
and service provision

8.5.1.1 Control of 7.5.1.3 Control of

equipment, tools Production Equipment,
and software Reworded…same intent
Tools and Software
programs Programs
8.5.1.2 Validation 7.5.2 Validation and
and control of control of special Reworded…same intent. ISO
special processes processes 9001:2008 text added back in.

New…Outlines how Production

8.5.1.3 Production 7.5.1.1 Production Process Verification is different
process verification process verification and not only FAI.
8.5.2 Identification 7.5.3 Identification and New…outputs, conformity,
and traceability traceability required configuration
8.5.3 Property
belonging to
customers or external 7.5.4 Customer property Reworded…same intent
providers

New…to extent necessary,

8.5.4 Preservation 7.5.5 Preservation of change from Shall statement to
product
NOTE, preservation of outputs.
7.5.1 Control of
production and service Reworded…same intent
provision

8.5.5 Post-delivery
activities
 9100:2016 Gap Assessment Worksheet

New…consider…, statutory and

8.5.5 Post-delivery regulatory, undesirable
activities circumstances, nature, use and
7.5.1.4 Post-delivery intended lifetime, customer
support
requirements, customer
feedback, new examples,
product/customer support.

8.5.6 Control of 7.3.7 Control of Design

and Development Reworded…same intent
changes
Changes
7.4.3 Verification of
Reworded…same intent
purchased product
8.6 Release of
products and services 8.2.4 Monitoring and
measurement of product Reworded…same intent

New…segregation, counterfeit or
8.7 Control of 8.3 Control of suspect counterfeit.
nonconforming outputs nonconforming product Requirement for nonconformity
control process maintained as
documented information

9 Performance 8 Measurement,
evaluation analysis and Reworded…same intent
improvement

9.1 Monitoring, 8 Measurement,

measurement, analysis analysis and Reworded…same intent
and evaluation improvement

8.1 General Reworded…same intent

9.1.1 General 8.2.3 Monitoring and
Reworded…same intent
Measurement Processes

9.1.2 Customer 8.2.1 Customer New…customer perceptions

satisfaction satisfaction

New…planning implemented
effectively, effectiveness of
9.1.3 Analysis and 8.4 Analysis of data actions taken - risks and
evaluation
opportunities, performance of
external providers, new NOTE

New…New and expanded

NOTEs, changes impacting the
9.2 Internal audit 8.2.2 Internal audit
organization, impartiality covers
auditing own work.
 9100:2016 Gap Assessment Worksheet

9.3 Management 5.6 Management No Change

review review
New…alignment with strategic
9.3.1 General 5.6.1 General
objectives

New…internal and external

issues, effectiveness and trends,
customer satisfaction and
feedback from interested
parties, extent objectives have
9.3.2 Management 5.6.2 Review input been met, nonconformities,
review inputs monitoring and measurement
results, performance of external
providers, on-time delivery,
adequacy of resources,
expanded to include risk and
opportunities.

9.3.3 Management 5.6.3 Review output New…opportunities, changes,

review outputs risk identified.
10 Improvement

8.5.1 Continual New…address future needs and

10.1 General expectations, undesired effects,
improvement new NOTE.

New…combined nonconformity
8.3 Control of and corrective actions, deal with
nonconforming product the consequences, analyzing the
nonconformity.
10.2 Nonconformity
and corrective action
New…consideration of human
8.5.2 Corrective action factors during causal analysis,
update risks and opportunities,
changes to the QMS.
8.5.1 Continual New…needs or opportunities
improvement addressed.

10.3 Continual Deleted the "how" narrative and

Improvement preventive action being at the
8.5.3 Preventive action end of the standard. Risk-based
thinking is intertwined
throughout the standard.
 Column Heading
9100:2016 Clause

Related 9100:2009
Clause

Change Summary

Process Impacted
Person Responsible for
Gap Assessment
Internal Documented
Information

Gap Level and Difficulty

to Implement (1 Low - 5
High)

Organization Gap
Summary
Gap Closure Due Date
Status:
-Pending
-In work
-Complete
 Description and Expectations
AS/EN/JISQ 9100 clause for the gap assessment workbook.
Similar requirement within 2009 version of the standard. This column provides correlation from
9100:2016 to 9100:2009 and 9100:2009 to 9100:2016. This column can be used to highlight where
the new, revised and deleted clauses are located, as well as the location of clauses that are
unchanged.

Brief description to guide the implementer in main areas of change. This is not an all inclusive listi
of the changes and organizations are expected to research potential gaps
What is the organizations process that is impacted so the process owner can get involved.
The organization point of contact to determine if gaps exists and what should be done to address
these changes.

What (if any) documented information that describes how the process will operate?

What is the Gap Level and Difficulty in making adjustments to the process or changing the
procedures. Are there aspects to the process that are not able to be changed.

What is the gap that needs to be addressed such that compliance to 9100:2016 can be achieved.
Benefit would be gained by understanding the dollar and impacted throughout.
When will these gaps be closed…estimated completion dates?

What is the current status on closing the gaps?