1- An overview of the ISO 9001:2008 to ISO

9001:2015 transition changes

 4 5 6 7 8
Document and Org. People and
Doing Check and Fix
data control Leadership Place
 Plan Do Check Act
4 5 6 7 8 9 10
Who are we Org. Resources Operation
Planning (People-Place- Evaluation Improvement
What do we do Leadership Documentation)
(RFQ-Delivery)
8.1 APQP-orders 9.1-Monitor- 10.2-Corrective
5.2-Quality Policy 6.1-RISK and 7.4-Communication (previously
Measure Action
(previous 5.3) Opportunities (previous 5.5.3) )
7.1-7.2 (previous 8.1-8.2) (previous 8.5.2)
5.3-Roles- 7.5- 8.4-External 9.1.2-Customer 10.3-Continual
6.2-Objectives
Responsibility Document/change Providers Satisfaction Improvement
(previous 5.4.1)
(previous 5.5) (previous 4.2) (previous 7.4) (previous 7.4) (previous 8.5.1)
9.1.3-Analysis-
8.3-Design
evaluation
(previous 7.3)
(previous 8.4)
8.5.2-Traceability 9.2-Internal Audits
(previous 7.5.3) (previous 8.2.2)
8.5.3-Customer 9.3-Management
Property Review
(previous 7.5.4) (previous 5.6)
8.5.4-Preservation
of Product
(previous 7.5.5)
8.5.6-Control of
Changes
(previous 4.2)
8.6-Product
Verification
(previous 8.2.4)
8.7-Nonconforming
(previous 8.3)
 “New or Revised” transition changes to the ISO 9001:2015
standard
Legend:
BLUE font = revised with diminished requirements
ORANGE font = revised with increased requirements
RED font= new clause
BLACK font = insignificant impact
 ISO 9001-2008  9001:2015 Change Summary

Clause # Clause Name Previous New or Description of Change

Reference Revised
4.1 Understanding the Organization and its None New Identify the organization and internal-external impact
context
4.2 Understanding the Needs and Expectations None New Identify, monitor, and review interested parties and
of Interested Parties their requirements.
4.3 Determining the Scope of the Quality None New Exclusions are no longer utilized. Instead,
Management System requirements that are not applicable must have
justification identified here.
4.4 Quality Management System and your 4.1, 5.4.2, Revised Process approach is mandatory, specifically the
Processes. 7.1, 8.1, determination of INPUTS and OUTPUTS of
8.2.3 determined processes.
5.1.1 Leadership and Commitment- General None New More emphasis on Top Management responsibilities
and “engagement”. Now specific clause.
5.2 Quality Policy 5.3 Revised More explicit language is used.
5.3 Organizational Roles, Responsibilities, and 5.5 Revised Specific term “Management Representative” no
Authorities. longer exists, however, increased mandates for
specifically assigned roles and responsibility and
authority.
 ISO 9001-2008  9001:2015 Change Summary

Clause # Clause Name Previous New or Description of Change

Reference Revised
6.1 Actions to Address Risk and Opportunities. None New Must identify risks and the actions to address them.

6.2 Quality Objectives and Planning to Meet 5.4 Revised More explicit language including requirements for
Them objectives to be “monitored” and “communicated”.

6.3 Planning of Changes 4.2.3, Revised More explicit language. Purpose-resources-

5.4.2 consequences must all be considered.
7.1.1 Resources- General 6.1 Revised More explicit language regarding internal and external
resources.
7.1.2 People 6.2 N/A No significant changes
7.1.3 Infrastructure 6.3 Revised Added “information and communication technology”
7.1.4 Environment for the Operation of Processes 6.4 Revised Verbiage now states “…shall provide and maintain…”
Notes include reference to social, psychological,
physical factors.
7.1.5 Monitoring and Measurement Resources 7.6 Revised Removed specificity to “equipment”
7.1.6 Organizational Knowledge None New “…shall determine the knowledge necessary…”
 ISO 9001-2008  9001:2015 Change Summary

Clause # Clause Name Previous New or Description of Change

Reference Revised
7.2 Competence 6.2 Revised “…under its control…” implies the inclusion of
contractors. Accompanying notes confirm this.
7.3 Awareness 6.2.2 Revised “…under the organization’s control…shall be aware of
quality policy, relevant objectives, impact, etc…
7.4 Communication 5.5.3 Revised Now includes “external” communication and requires
determining Who-What-When-How.
7.5 Documented Information 4.2 Revised Now more generic, and not specifying what specific
documentation (ie. Manual, procedures).
8.1 Operational Planning and Control 7.1 Revised Added detail to include the control of outsourced
processes, changes. (previously noted in 4.1) Includes
requirement to determine the necessary resources.
8.2 Requirements for Products and Services 7.2 Revised Requires customer communication regarding handling
and controlling customer property.
8.3 Design and Development of Products and 8.3 N/A “Shall” establish…design and development process…”
Services
8.3.2 Design and Development Planning 7.3 Revised Specific considerations added.
 ISO 9001-2008  9001:2015 Change Summary

Clause # Clause Name Previous New or Description of Change

Reference Revised
8.5.4 Preservation 7.5.5 N/A No significant changes

8.5.5 Post Delivery Activities 7.5.5, Revised Added details from previous 8.2.1 regarding customer
8.2.1 (new) feedback.
8.5.6 Control of Changes None New Now a dedicated clause specific to production and
service activity. (previous references in 4.2.2, 5.4.2)
8.6 Release of Products and Services 8.2.4 N/A No significant changes
8.7 Control of nonconforming outputs 8.3 Revised Now specific inclusion of segregation (sorting).

9.1 Monitoring, Measurement, Analysis, and 8.2.1, N/A No significant changes

Evaluation 8.4
9.2 Internal Audit 8.2.2 N/A No significant changes
9.3.2 Management Review Inputs 5.6.2 Revised Changes to the input verbiage. Additional requirement
for “…adequacy of resources”, “effectiveness of
risk/opportunity actions”, “changes to internal and
external issues”..(risk sources).
 ISO 9001-2008  9001:2015 Change Summary

Clause # Clause Name Previous New or Description of Change

Referenc Revised
e
9.3.3 Management Review Outputs 5.6.3 N/A No significant changes
10.1 Improvement- General 8.3, N/A No significant changes
8.5
10.2 Nonconformity and Corrective Action 8.3, N/A No significant changes
8.5.2
------------ Preventive Action 8.5.3 Revised Eliminated a requirement for preventive action.
10.3 Continual Improvement 8.5.1 N/A No significant changes

“SHALL” RESULT- Auditable Clauses (9001:2015)

• 2008 = 136 • 7 new clauses • 7 primary
• 2015 = 127 • 18 revisions which increase requirements • 28 Secondary
• 38 Tertiary
END