Standard Element

Section 2 Fire Safety Measures

2.1.1 Structural fire protection

IACS 99 2.1.1 Table 1

4.2 Understanding the needs and expectations of interested parties

ISO 9001 4.2

4.3 Determining the scope of the quality management system

ISO 9001 4.3

4.3.1 Determining the scope of the quality management system - supplemental

IATF 16949 4.3.1

4.3.2 Customer-specific requirements

IATF 16949 4.3.2

4.4 Quality management system and its processes

ISO 9001 4.4.1

4.4.1.1 Conformance of products and processes

 IATF 16949 4.4.1.1

4.4.1.2 Product safety

IATF 16949 4.4.1.2

ISO 9001 4.4.2

 IACS 99- Apr 2013 Requirements

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Minimum fire integrity of bulkheads and decks
The organization shall monitor and review information about these external and internal issues.
NOTE 1: Issues can include positive and negative factors or conditions for consideration.
NOTE 2: Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive,
market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and
performance of the organization.
s and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements, the organization
shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and
review information about these interested parties and their relevant requirements.
The organization shall monitor and review information about these interested parties and their relevant requirements.
of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider:
the external and internal issues referred to in 4.1;
the requirements of relevant interested parties referred to in 4.2;
the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its
quality management system.

The scope of the organization’s quality management system shall be available and be maintained as DOCUMENTED INFORMATION. The
scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard
that the organization determines is not applicable to the scope of its quality management system.
 Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the
organization’s ability or responsibility to ensure the conformity of its
products and services and the enhancement of customer satisfaction.

e of the quality management system - supplemental

Supporting functions, whether on-site or remote (such as design centers, corporate headquarters, and distribution centers) shall be
included in the scope of the quality management system (QMS).

The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within
ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see ISO 9001, Section 7.5).

Permitted exclusions do not include manufacturing process design.

uirements
Customer-specific requirements shall be evaluated and included in the scope of the organization's quality management system.

stem and its processes

The organization shall establish, implement, maintain and continually improve a quality management system, including the processes
needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their application throughout the
organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to
ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
ducts and processes
The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all
applicable customer, statutory requirements (see section 8.4.2.2)

The organization shall have documented processes for the management of product-safety related products and manufacturing
processes, which shall include but not limited to the following, where applicable:
a) identification by the organization of statutory and regulatory product-safety requirements;
b) customer notification of requirements in item a);
c) special approvals for design FMEA;
d) identification of product safety-related characteristics;
e) identification and controls of safety-related characteristics of product and at the point of manufacture;
f) special approval of control plans and process FMEAs;
g) reaction plans (see section 9.1.1.1);
h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer
notification;
i) training identified by the organization or customer for personnel involved in product-safety related products and associated
manufacturing processes;
j) changes of product or process shall be approved prior to implementation, including evaluation of potential effects on product safety
from process and product changes (see ISO 9001, Section 8.3.6);
k) transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources (see
Section 8.4.3.1);
l) product traceability by manufactured lot (at a minimum) throughout the supply chain ( see Section 8.5.2.1);
m) lessons learned for new product introduction.
Note: Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents
with safety-related content.
To the extent necessary, the organization shall:
a) maintain DOCUMENTED INFORMATION to support the operation of its processes;
b) retain DOCUMENTED INFORMATION to have confidence that the processes are being carried out as planned.
 Level of current Level of difficulty to
Applicable Area Commentary implementation implement
1 = Fully implemented 1 = Not difficult
5 = Nothing in place 5 = Very difficult

This was not specifically mentioned in the previous standard and is now an
explicit requirement.

The organization must now be able to demonstrate they have identified,

monitored and reviewed all external and internal issues.

No equivalent clause The intent of this requirement is to ensure that the organization considers the
requirements of relevant interested parties beyond just those of the customer.

The intention is to focus on the interested parties which are relevant to the
Quality Management System (QMS).

Sec. 1.2 The new revision to the standard now explicitly requires that before you set
the scope of the QMS, you must have previously considered and demonstrated
that the issues within 4.1 and interested parties within 4.2 are completed,
prior to setting the scope and boundaries of the QMS.

It is important to note that ISO 9001:2015 requires that all requirements within
the standard are to be met unless they do not apply. This scope must be
documented and include the products and services provided as well as any
justification for any requirements that the organization has determined do not
apply.
Sec. 1.1, 1.2 Originally included in ISO/TS 16949:2009, Sec. 1.1 and 1.2. The first
requirement relating to supporting functions was revised to not only address
the need to include them in the audit, but also to ensure that they are
included in the scope of the QMS.
Any exclusion(s) must now be documented.

Throughout This suggests the organization would need a process to evaluate each
customer-specific requirement and determine exactly how and where it
applies to their QMS.

Sec. 4.1 This further reinforces the need for risk to be considered throughout the QMS.

The requirement for ownership within the processes are now required.

Sec. 4.4.1 is a paraphrase of the entire standard. If you think about the
standard as a living organism, 4.4.1 would be the skeleton. the specifics for
4.4.1 can be found throughout the remainder of the standard.

The outputs of the activities listed may include process flow maps,
interrelationships, authority and responsibilities, quality performance data,
etc.,
Throughout This ensures 2 things: that the organization is responsible for the conformity of
outsourced processes, and that all products and processes meet all applicable
requirements and expectations of all interested parties.

Sec. 6.4.1 This is a new section with new and enhanced requirements that address
current and emerging issues the automotive industry is facing related to
product and process safety.

Organizations are specifically required to have documented processes to

manage product-safety related products and processes.

Sec. 4.2.2, 4.2.3, 4.2.4 The intent is to allow an organization to tailor the documentation around their
own value streams.
Documented information is defined as maintained = documents and
procedures & retained = records.
Level of complexity to Action / Resources Required
implement
1 = Not complex
25 = Very complex

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 Standard
Standard Requirement Area Compliance status
Ref Clause
 Deatails of Level of Current Barriers to
Resources
Compliance and how it differ from achieve
required
Required Compliance Compliance
Action Plan Action Party