Risk-based standard
New requirement in identifying risk and opportunities
Focuses on planning (who are we & competitive environment)
Change management
Organizational knowledge (what are we learning previously)
Participant of top management (leader of QMS)
Disappearance of the term:
Document to Maintaining documented information
Record to Retaining documented information
ISO 9001 : 2008 ISO 9001 : 2015
4.1 Understanding the organization and its
context
Completely new(not similar to any
clauses in 2008)
Applied by asking question using
SWOT analysis
External analysis (technologies,
competitor, environment)
Internal analysis (what people
believe, values they bring to work,
culture)
4.2 Understanding the needs and
expectations of interested parties
Completely new (not similar to any
clauses in 2008)
Interested parties are anyone that
involved in company operation
Example: customers, suppliers,
employees, owners, community,
schools & colleges, news media,
law enforcement.
Communicate with them to identify
the parties and their expectations.
4.2.2 Quality manual 4.3 Determining the scope of the QMS
The organization shall establish and Similar to subclause 4.2.2 in ISO
maintain quality manual that 9001:2008, but more CRITICAL
includes the scope of QMS, the SCOPE in previous ISO highlighted
documented procedures for the in single sentence, new ISO
QMS and a description of the SCOPE is an entire clauses.
interaction between the process of Quality manual is no longer exist in
QMS. ISO 9001:2015.
SCOPE of QMS must maintained
as documented information
(clauses 4.3 & defined the process
for QMS-clause 4.4)
4.1 QMS 4.4 Quality management system and its
Implementation of QMS based on processes
quality policy and objectives. Similar to clauses 4.1 in ISO 9001:
Management shall plan and 2008, but more rigor implied.
communicate for both internal and Inputs & outputs/ sequence &
external prospect of the interaction/ criteria & methods/
organization. resources/ authority & responsibility
/risk & opportunities/ evaluation/
improvement.
4.4.2 (No subclause)
The organizational shall maintain
documented information to support
the operation of its processes
The organizational shall retain
documented information to have
confidence that the processes are
being carried out as planned
5.1 Management Commitment 5.1 Leadership and commitment
The organization shall communicate Similar to clauses 5.1 in ISO 9001:
to meet the customer needs as well 2008, but new requirement added.
as statutory and regulatory Previous ISO highlight 4 points, but
requirements. new ISO commit to these point.
Establish the quality policy 1. Be accountable for the QMS
Ensuring that quality objectives are 2. Make sure a quality policy &
established objectives are in place &
Conducting management reviews consistent with the
Ensuring the availability of organization’s strategy
resources 3. Advocate the process
approach & how risk affect
the business
4. Make sure that resources are
available for the functioning
QMS
5. Tell everybody how
important QMS is & why it’s
critical to conform to its
requirement
6. Make sure that the QMS
produces the expected
outcome
7. Show leadership in getting
employees involved in the
QMS
8. Encourage improvement
activities
9. Assist other managers in
showing QMS leadership
8.5.4 Preservation
Similar to clause 7.5.1 & 7.2.1 in
ISO 9001: 2008
9 Performance Evaluation
9.1 Monitoring, measurement, analysis
8.1 The organization shall plan and and evaluation
implement the monitoring, analysis and 9.1.1 General
improvement processes needed Similar to clause 8.1 in ISO
a) to demonstrate conformity to 9001:2008
product requirements. The implementation steps start
b) to ensure conformity of the quality with determine what needs to be
management system, and monitored and measured.
c) to continually improve the Then, start identify the methods
effectiveness of the quality for monitoring, measurement,
management system. analysis and evaluation.
d) This shall include determination of Determined when will the
applicable methods, including monitoring and measurement be
statistical techniques. performed and when the results
can be analyzed and evaluated.
Next, performance and
effectiveness of QMS are
evaluate and retain documented
8.2.1 Customer satisfaction information.
As one of the measurements of the 9.1.2 Customer satisfaction
performance of the quality Similar to clause 8.2.1 in ISO
management system, the 9001:2008
organization shall monitor Can be observe from customer
information relating to customer surveys and feedback on
perception as to whether the delivered product and services,
organization has met. meeting with customers, market
share analysis, warranty claims
and dealer reports.
8.1 The organization shall plan and 9.1.3 Analysis and evaluation
implement the monitoring, analysis and Similar to clause 8.1 in ISO
improvement processes needed 9001:2008
a) to demonstrate conformity to It is closely related to subclauses
product requirements. 9.1.1
b) to ensure conformity of the quality Some sources need to be
management system, and analyzed including conformity of
c) to continually improve the products and services, customer
effectiveness of the quality satisfaction, effectiveness of
management system. QMS, effectiveness of planning,
d) This shall include determination of action on risk and opportunities,
applicable methods, including performance of suppliers and
statistical techniques. subcontractors and need for
improvements to the QMS.