9100:2016 Gap Assessment Worksheet

Status:
9100:2016 Clause Related 9100:2009 Clause Change Summary Process Impacted Person Responsible for Gap Assessment Gap Level and Difficulty to Implement (1 Low - 5 Organization Gap Summary Gap Closure Due Date -Pending
High) -In work
-Complete
4 Context of the organization 1 Scope New...Title

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

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

1.2 Application
4.3 Determining the scope of the quality New…exclusions replaced by applicability, external and internal
management system issues, relevant interested parties
4.2.2 Quality manual

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

5 Leadership 5 Management responsibility Elevation of responsibility

5.1 Leadership and commitment 5.1 Management commitment Reworded…same intent

New…demonstrate leadership, accountability, compatible with
context and strategic direction of the organization, integration of
5.1.1 General 5.1 Management commitment business processes, achieves its intended results, supporting
persons, promoting, supporting relevant management roles, NOTE
on business.
5.1.2 Customer focus 5.2 Customer focus New…statutory and regulatory, conformity risks and opportunities
determined.

5.2 Policy 5.3 Quality policy Reworded…same intent

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

5.2.2 Communicating the Quality Policy 5.3 Quality policy New…and applied, available to relevant interested parties.

5.5.1 Responsibility and authority New…delivering their intended outputs, opportunities.

5.3 Organizational roles, responsibilities and 5.5.2 Management representative New…added management representative, assigned responsibilities
authorities

5.4.2 Quality management system planning No change

6 Planning

5.4.2 Quality management system planning New…risk and opportunities, achieve improvement, structure,
6.1 Actions to address risks and opportunities
8.5.3 Preventive action New…integrate, impact on the conformity, risk, opportunities
New…change from top management to organization, relevant to
conformity, monitored, communicated, updated, maintain
6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives documented 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 and their potential consequences,
6.3 Planning of changes 5.4.2 Quality management system planning availability of resources, allocation or reallocate of responsibilities
and authorities.

7 Support 6 Resource management

7.1 Resources 6 Resource management Reworded…same intent

New…capabilities of, and constraints on, existing internal

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

7.1.2 People 6.1 Provision of resources Reworded…same intent

7.1.3 Infrastructure 6.3 Infrastructure Reworded…same intent

New…operation of these processes, suitable environment can be a

7.1.4 Environment for the operation of processes 6.4 Work environment combination of human and physical factors.

7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment Reworded…same intent

New…resources needed to ensure valid and reliable results,

7.1.5.1 General 7.6 Control of monitoring and measuring equipment Resources (e.g. equipment)

7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring equipment New…traceability, confidence in the validity of measurement

7.1.6 Organizational knowledge New…all new requirements

6.2.1 General New…skills replaced with competence

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

New…effectiveness, benefits of improved performance,

7.3 Awareness 6.2.2 Competence, training and awareness implication of not conforming, contribution to product or service
conformity, contribution to product safety, importance of ethical
behavior.

New…external communications what it will communicate, when to

7.4 Communication 5.5.3 Internal communication communicate, whom to communicate, how to communicate, new
NOTE

7.5 Documented information 4.2 Documentation requirements Reworded…same intent

7.5.1 General 4.2.1 General Reworded…same intent

4.2.3 Control of documents Reworded…same intent

7.5.2 Creating and updating
4.2.4 Control of records Reworded…same intent

4.2.3 Control of documents New…Suitable for use and adequately protected.

7.5.3 Control of documented Information

4.2.4 Control of records New…data protection defined to 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
8.1 Operational planning and control 7.1 Planning of product realization organization functions, determining the products to be obtained
from External 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 management
8.1.2 Configuration management
8.1.3 Product safety
8.1.4 Prevention of counterfeit products
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and 7.2.1 Determination of requirements related to the
services product
8.2.3 Review the requirements for products and
services
8.2.4 Changes to requirements for products and
services
8.3 Design and development of products and services 7.3.1 Design and development planning
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes,
products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.1.1 Control of equipment, tools and software
programs
8.5.1.2 Validation and control of special processes
8.5.1.3 Production process verification
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external
providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
9 Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
7.1.2 Risk Management
7.1.3 Configuration Management
7.2 Customer-related processes
7.2.3 Customer communication
7.2.2 Review of requirements related to the product
7.2.2 Review of requirements related to the product
7.3.1 Design and development planning
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.3 Design and development outputs
7.3.7 Control of design and development changes
7.4.1 Purchasing process
7.4.1 Purchasing process
7.4.1 Purchasing process
7.4.3 Verification of purchased product
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service
provision
7.5.1.3 Control of Production Equipment, Tools and
Software Programs
7.5.2 Validation and control of special processes
7.5.1.1 Production process verification
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.5.1 Control of production and service provision
7.5.1.4 Post-delivery support
7.3.7 Control of Design and Development Changes
7.4.3 Verification of purchased product
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8 Measurement, analysis and improvement
8 Measurement, analysis and improvement
8.1 General
8.2.3 Monitoring and Measurement Processes
8.2.1 Customer satisfaction
8.4 Analysis of data
8.2.2 Internal audit
9100:2016 Gap Assessment Worksheet
New…Addition of NOTEs
New…Control product identity and traceability, ensure
documented information is consistent with the actual attributes of
the products and services.
New
New
New…Title
New…contingency actions
New…meet the claims
New…coordinated with applicable functions and if unable to meet
customer requirements then negotiate a mutually acceptable
requirement with the customer.
Reworded…same intent
Reworded…same intent
New…plan and control the design and development of product.
New…Nature, duration and complexity of the design and
development activity, need for involvement of customer and users
in the design and development process, requirements for
subsequent provision of products and services.
New…standards or codes of practice that the organization has
committed to implement, potential consequences of failure,
potential consequences of obsolescence.
New…controls to the design and development process.
New…linkage to clause 7.1.5
Reworded…same intent
New…D&D outputs are approved by authorized person(s) prior to
rlease. New...NOTE on maintaining data to achieve conforming
product or service and technical data and repair schemes for
operating and maintaining the product.
New…process with criteria for notifying customers
New…Title and terminology
New…controls to their sub-tier suppliers, conformity and on-time
delivery performance criteria.
New…effectiveness of controls
Reworded…same intent New…effectiveness of controls, high risk
suppliers, counterfeit parts, production part approval process,
periodically monitor, periodically monitor supplier delegations,
process to evaluate test reports, raw material test report accuracy
New…requirement for qualification of competence, supplier
awareness of their contributions to product or service conformity,
contribution to product safety, and importance of ethical behavior.
Reworded…same intent
No change
New…results to be achieved, services to be provided,
infrastructure, environment, periodic revalidation, actions to
prevent human error
Reworded…same intent
Reworded…same intent
Reworded…same intent. ISO 9001:2008 text added back in.
New…Outlines how Production Process Verification is different and
not only FAI.
New…outputs, conformity, required configuration
Reworded…same intent
New…to extent necessary, change from Shall statement to NOTE,
preservation of outputs.
Reworded…same intent
New…consider…, statutory and regulatory, undesirable
circumstances, nature, use and intended lifetime, customer
requirements, customer feedback, new examples,
product/customer support.
Reworded…same intent
Reworded…same intent
Reworded…same intent
New…segregation, counterfeit or suspect counterfeit.
Requirement for nonconformity control process maintained as
documented information
Reworded…same intent
Reworded…same intent
Reworded…same intent
Reworded…same intent
New…customer perceptions
New…planning implemented effectively, effectiveness of actions
taken - risks and opportunities, performance of external providers,
new NOTE
New…New and expanded NOTEs, changes impacting the
organization, impartiality covers auditing own work.
 9100:2016 Gap Assessment Worksheet

9.3 Management review 5.6 Management review No Change

9.3.1 General 5.6.1 General New…alignment with strategic objectives

New…internal and external issues, effectiveness and trends,

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

9.3.3 Management review outputs 5.6.3 Review output New…opportunities, changes, risk identified.

10 Improvement

10.1 General 8.5.1 Continual improvement New…address future needs and expectations, undesired effects,
new NOTE.

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

8.5.1 Continual improvement New…needs or opportunities addressed.

10.3 Continual Improvement
Deleted the "how" narrative and 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?