Presentation

on

ISO 9001:2015
by
Mr. Prathamesh Dinde
Mr. Yogesh Bhujbal
Mr. S.M. Pathan
 Comparison of Clauses of
ISO 9001:2008 & 9001:2015
Claus Clause Clause Clause
e No No
4 Quality Management 4 Context of the
System organization
5 Management 5 Leadership
Responsibility
5.4.2 QMS Planning 6 Planning
6 Resource 7 Support
Management
7 Product realization 8 Operation
8 Measurement, 9 Performance
analysis & evaluation
improvement
10 Improvement
Major differences in terminology of ISO
9001:2008 & 9001:2015
ISO 9001:2008 ISO 9001:2015
Products Products & services
Exclusions Not used
Management Not used
representative
Documentation, quality Documented information
manual, documented
procedure, records
Work environment Environment for the
operation of processes
Monitoring & Monitoring & measuring
measurement resources
equipments
Purchased products Externally provided
products & services
Supplier External Provider
 Need of ISO
It is decision of management taken to improve its overall performance &
provide sound basis for sustainable development initiatives.
Benefits of implementing ISO
1) Ability to provide products & services that meet customer requirement.
2) Enhance customer satisfaction
3) Ability to demonstrate conformity of QMS
4) Address risk & opportunities associated with context & objectives.

This standard employs the process approach which incorporate PDCA cycle
& risk based thinking
process approach involves systematic definition of processes & their
interaction to achieve desired result in accordance with organization quality
policy & strategic direction. This can be achieved by PDCA cycle.
To meet requirements & address future needs & expectation poses challenge
for an organization to adopt continual improvements like breakthrough
change, innovation & re-organization.

Verbal forms for this std

-) ‘Shall’ indicates requirement
-) ‘Should’ indicates recommendation
-) ‘May’ indicates permission
-) ‘Can’ indicates possibility
 Clauses in PDCA cycle
Click to edit Master text styles
Second level
● Third level

● Fourth level

● Fifth level
 What is risk based thinking?

Risk based thinking is something we all do automatically & often sub-

consciously to get the best result.
Concept of risk in this ISO more explicit & builds it into the whole QMS
Risk based thinking ensures risk is considered from the beginning &
throughout the process approach.
Risk based thinking : enables organization to determine factors that
cause processes & QMS to deviate from planned results to put in place
preventive controls to minimize negative effect & to make maximum use
of opportunities.

What should we do?

We have to identify risks & opportunities in our organization.
 Where is risk addressed in ISO 9001:2015

Clause 4 (context 4.4) the organization is required to determine the risk in

accordance with clause 6.1
Clause 6 (Planning 6.1) the organization is required to take actions to identify
risks & opportunities.
Clause 8 (Operation 8.1) the organization is required to implement processes
to addresses risks & opportunities.
Clause 9 (performance evaluation 9.3) the organization is required to
monitor, measure, analyze, evaluate & review the effectiveness of actions
taken to address risks & opportunities.
Clause 10 (Improvement) the organization is required to improve by
responding to changes in risk.
 Key changes, the organization do not need to make

Remove their MR as there is no requirement of MR in ISO

9001:2015.
Refresh existing documentation to use the new terms &
terminologies contained within ISO 9001:2015 (e.g “ Records”
instead of “documented information”, or “supplier” instead of
“external provider”)
Throw out their documented procedure & quality manual.
Re-number existing QMS documentation to correspond to the
new clause references.
 QMS Principles

1) Customer Focus
2) Leadership
3) Engagement of people
4) Process approach
5) Improvement
6) Evidence based decision making
7) Relationship management
“Systems approach” to management principle has been deleted.
 1. Scope

This std Specifies requirement for QMS when an organization

Needs to demonstrate its ability to consistently provide products & services
that meets customer requirement
To increase customer satisfaction by implementing system, process
improvement, confirming customer requirements.

2. Normative references :
ISO 9000:2015 QMS – Fundamentals & vocabulary

3. Terms & definition : as per ISO 9000:2015

 4. Context of the organization
4.1 Understanding the context of the organization
- Organization shall determine external & internal issues that affect it’s
ability to achieve the intended results of it’s QMS
- Issues can be positive or negative
- External issues : customer, market, cultural, social, environment etc
- Internal issues : Culture, knowledge, performance of the organization etc

4.2 Understanding the needs & expectation of interested parties

- It directly effect on organization ability to fulfill customer requirement
- Interested parties are
1. Customer
2. Employees
3. Owner
4. Society
5. Suppliers
6. Govt. Authority
4.3 Determining the scope of the QMS
Organization shall determine the boundaries & applicability of QMS to establish scope
following things to consider while determining scope,
1) External & internal issues
2) Requirement of relevant interested parties
3) Products & services of the organization.

Scope shall be available & maintained as documented information. Scope shall cover
types & services provided. Also must include any justification for any specification
element of ISO 9001 2015 cannot be applied

4.4 QMS & it’s processes

Organization shall establish, implement, maintain & continually improve a QMS
including the processes.
- Requires the organization to establish a process based QMS.
- Organization shall
a) Determine inputs & outputs
b) Determine sequence, processes & resources needed
c) Assign responsibility & authority
d) Address risk & opportunities
e) Evaluate process & implement changes needed
f) Improve processes & QMS
 5. Leadership

5.1 Leadership & commitment Team

Top Management to be a leader Formation
“MR” The mediator has been discarded
This clause identifies aspects of QMS where top management to play an
important role by demonstrating leadership & commitment where they,
- Take Accountability for effectiveness of QMS
- Ensure that quality policy & objectives are compatible with strategic
direction & context of organization.
- Promote adoption of process approach & risk based thinking
- Ensure that Resources are available needed for QMS
- Ensure QMS achieves its intended results
- Engaging, directing, Supporting People for effectiveness of QMS
- Promoting improvement

Implementer need to update top management for new requirement & fact,
as they will be now audited as a matter of routine.
 5.1.2 Customer Focus
Core of this clause for both revisions is same but Scope has broadened
2008-Meeting Customer Requirements Customer Satisfaction & Enhancement

2015-Specifies need to comply with Statutory + Regulatory Requirements

along with Customer Requirements
Example: Nestle Product : Maggie Noodles
Know The
LAW
Need to determine RISK & OPPORTUNITIES is expressed by 2015 which
was not addressed by 2008

Both the revisions specifies need to focus on customer satisfaction &

maintaining the same What Can Go
WRONG ?
 5.2 Policy
5.2.1 Top management to Establish, review & maintain quality policy that,
a. Is appropriate to the Purpose & context to the organization & support
strategic direction.
b. Provides a framework for setting & reviewing quality objectives
c. Include a commitment to satisfy applicable requirements
d. Include a commitment for continual improvement of QMS

5.2.2 Must be available in document form, communicated, understood &

applied within the organization.
- Available to interested parties as appropriate.
- Earlier revision expects only that quality policy is communicated and
understood within the organization
 5.3 Organization Roles, Responsibility & Authorities

Clarification of requirements of clause 5.5 of ISO 9001:2008

Top management to assign, communicate the necessary responsibilities &
authorities to individuals & ensure that same are understood.
FOR WHAT PURPOSE ?

Specifically they need to assign responsibility & authority for ensuring that:
a. Ensure QMS confirms Requirement of this standard
b. Processes are delivering their intended outputs (What is Expected &
Actual Output)
c. Reporting of QMS performance & opportunities for improvement to top
management (Outcome & Improvement Plan)
d. Ensure promotion of customer focus throughout organization
e. Ensure integrity of QMS is maintained when changes to the QMS are
planned & implemented (Update the System)
 6. Planning

6.1.1 When planning QMS organization shall Determine the Risk &
Opportunities that need to be addressed for,
a) Give assurance that QMS achieve intended result
b) Enhance desirable effect
c) Reduce undesirable result System Fitness, Safety
Measures, Training,
d) Achieve improvement
Supervision, Plan to
Get Better
6.1.2 The organization shall plan
a) Actions to address these risks & opportunities
b) How to
1) Integrate & implement actions into QMS processes.
2) Evaluate effectiveness of these actions.
Actions taken to address risks & opportunities shall be proportionate to the
potential impact on the conformity of products & services
How To use Risk in Positive Way For
Improvements ?
 6.2 Quality objectives & Planning to achieve them
6.2.1 Organization shall establish quality objectives at relevant functions, levels &
process needed for QMS
Quality objective shall,
a)

b)
Be Consistent with quality policy
Be measurable
SMAR
c) Take into account applicable requirements T
d) Be relevant to conformity to products & services & enhance customer satisfaction
e) Be monitored
f) Be communicated
g) Be updated as appropriate

Organization shall maintain documented information of quality objectives.

6.2.2 When planning to achieve quality objective organization shall determine,

h) What will be done
i) What resources will be required
j) Who will be responsible
k) When it will be completed
l) How the results will be evaluated
 6.3 Planning of changes
When organization decides to change QMS, the changes shall be carried out in
planned manner & organization shall consider,
a) The Purpose of changes & their potential consequences
b) The Integrity of QMS
c) The availability of resources
d) The allocation or reallocation of responsibilities & authorities.
 7. Support
7.1 Resources
7.1.1 General (similar to clause 6.1 of ISO 9001:2008) Organization shall
determine & provide the resources needed for the establishment,
implementation, maintenance & continual improvement of QMS
Organization shall consider,
a) The capabilities of and constraints on existing internal resources
b) What need to be obtained from external providers.
7.1.2 People (similar to clause 6.1 of ISO 9001:2008)
Organization shall determine & provide the persons necessary for the effective
implementation of QMS & operation & control of processes.
7.1.3 Infrastructure (similar to clause 6.3 of ISO 9001:2008 some portion
has come in the form of ‘note’)
include
c) Building & associate activities
d) Equipment including hardware & software
e) Transportation resources
f) Information & communication technology
7.1.4 Environment for the operation of process (similar to clause 6.4 of
ISO 9001:2008)
Includes
a) Social b) Psychological c) Physical

7.1.5 Monitoring & Measuring Resources (This clause is update of clause

7.6 control of monitoring & measuring equipment of ISO 9001:2008)
-) Organization is now required to retain documented information as
evidence that the measuring & monitoring resources are fit for purpose.
-) Requirement of measurement traceability is more explicit now.

7.1.6 Organization knowledge (New requirement)

-) Organization shall determine the knowledge necessary for the operation
of its processes to achieve conformity of products.
-) Knowledge shall be maintained & made available to the extent necessary.
-) Internal source – knowledge gained from past experience, lessons learned
from failures or successful projects sharing knowledge & experience.
-) External source – standard, conferences, gathering knowledge from
customers or external providers.
 7.2 Competence

This clause is combination of clause 6.2.1. & 6.2.2 of ISO 9001:2008.

Determine necessary competence of persons doing work under it’s control that
affect the performance & effectiveness of QMS.
Example: Skill Matrix, Training records

7.3 Awareness
(Awareness part of clause 6.2.2 of ISO 9001:2008 is separated & enhance
further in this clause)
Organization shall ensure people working under organization control are aware of,
a) The quality policy
b) Relevant quality objectives
c) Their contribution to the effectiveness of QMS, including the benefits of
improved performance
d) Impact of not confirming with QMS requirements
 7.4 Communication
Expands ISO 9001:2008 clause 5.5.3 by extending scope to include external
communication as well as internal one related to QMS.
Organization to determine,
a) On what it will communicate
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who to communicate
7.5 Documented information
(This clause is similar to clause 4.2 of ISO 9001:2008 except for requirement to
have quality manual & procedure)
7.5.1 Organization QMS shall include documented information req. by this std.
7.5.2 Creating & updating documented information, organization shall ensure,
f) Identification & description (title, author or reference number)
g) Format (language, software version, graphics) & media (e.g paper, electronic)
h) Review & approval for suitability & adequacy
7.5.3 Control of documented information
Documented information retained as evidence of conformity shall be protected
from unintended alterations.
New Clause No and Title
8 Operation Summary of Changes

Clause 8, Operation, has seven sub-clauses:

7.1 8.1 Operational planning and control

7.2 Sales
8.2 Requirements of product & services
7.3 8.3 Design and development of products and services
7.4 8.4 Control of external provision of products and services
Purchase
(Purchasing and outsourcing addressed together)

7.5 8.5 Production and services provision

8.2.4 8.6 Release of products and services

8.3 8.7 Control of nonconforming outputs, products and services

New Clause No and Title 8 Operation Summary of Changes
7.1 8.1 Operational planning and control
“The organization SHALL Plan, implement and control the processes needed to meet
requirements for the provision of products and services, and to implement the actions
determined in 6.1 by:
a) determining the requirements for the products and services;
b) Establish criteria for 1) processes 2) acceptance of products and services
c) Determining the resources needed
d) Implementing the control of processes NEW
e) Retaining documented information”
-NEW “Control planned changes and review the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary” ( RISK )
“Ensure that outsourced processes are controlled in accordance with 8.4

Changes:
•
Replaces 7.1 on planning for product realization
•
Extends to control of processes & planned changes
•
Adds reviewing consequences and mitigate adverse effects
•
Planning of quality objectives is covered in 6.2
New Clause No and Title Sales 8 Operation Summary of Changes
7.2 8.2 Determination of requirements for products and services
Nothing
7.2.3 8.2.1 Customer communication Really New

Establish the processes for communicating with customers to:

a) providing information relating to products and services;
b) handling enquiries, contracts or order, including changes;
c) obtaining customer views and perceptions, including customer complaints;
d) - NEW: handling or treatment of customer property, if applicable; NEW
e) - NEW: specific requirements for contingency actions, when relevant
(There could be contingency plan for any of the requirements such as product
substitution, delays in delivery of a product or service, changes in supplier processes.
)

Mandatory --
Ø

Non Mandatory -- Sales procedure

Ø

Changes:
•
Replaces 7.2.3 on customer communication Risk Based
•
Moved customer communication before determining requirements Thinking
•
Adds requirements for possible contingency actions
•
Includes handling or controlling of customer property
•
See 8.5.3 for more on customer property
New Clause No and Title 8 Operation Summary of Changes Nothing
Really New
7.2.1 8.2.2 Determination of requirements related to products and services
When determining the requirements for the products and services to be offered to
customers, the organization SHALL ensure that:
a) The requirements for the products & services are defined, including:
1) any applicable statutory & regulatory requirements;
NEW
2) those considered necessary by the organization;
b) organization can meet its claims for products & services offered.
Changes:
•
Replaces old clause 7.2.1 on determination of requirements related to the product
•
Expands that must meet “claims” for products and services offered to customers

7.2.2 8.2.3 Review of the Requirements for Products and Services

7.2.2.c 8.2.3.1 Ensure the organization has the ability to meet requirements for products and
services to be offered to customers. Before committing to supply products and services,
conduct a review to include:
a) requirements specified by the customer, including requirements for delivery and post-
Nothing
delivery activities;
Really
New b) requirements not stated by the customer, but necessary for specified or
intended use, when known;
New Clause No and Title 8 Operation Summary of Changes
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and
services;
f) contract or order requirements differing from those previously expressed
8.2.3.2 Retain documented information, as applicable:
a) on the results of the review;
b) on any new requirements for the products and services.
Mandatory -- Product/service requirements review records
Ø

Non Mandatory --
Ø

Changes:
•
Replaces old clause 7.2.2 on review of requirements related to product
•
Clause 8.2.3.1 replaces old clause 7.2.2.c on ability to meet defined requirements
•
Merges in requirements from old clause 7.2.1.a, b, and c.
7.2.2 8.2.4 Changes to Requirements for Products and Services
Ensure that relevant documented information is amended, and that relevant persons are
made aware of the changed requirements, when the requirements for products and
services are changed.
Nothing
Really New
Changes:
•
includes requirement from old clause 7.2.2 on review of product requirements
•
gives own sub-clause for focus on changes
•
same text, except for addition of term “services”
New Clause No and Title 8 Operation Summary of Changes
7.3. 8.3 Design and development of products and services

8.3.1 General NEW

This clause is new and it requires an organization to Establish, implement, and maintain a
design and development process.

where
detailed requirements of products and services are not already established,

or not defined by the customer or by other interested parties,

such that they are adequate for subsequent production or service provision

Ø
Mandatory --
Ø
Non Mandatory -- Procedure for design and development (clause 8.3)
Changes:
•New “General” clause that defines when a design and development process is
required
•Need design and development process if product or service requirements not
established or provided (explains when 8.3 is not applicable; like old clause 1.2)
•Note adds that Services organization can consider requirements of 8.3 and 8.5
New Clause No and Title 8 Operation Summary of Changes
7.3.1 8.3.2 Design & Development Planning
In determining the stages and controls for design and development, the organization
SHALL consider:

a) nature, duration, and complexity of the design and development activities;

b) the required process stages, including applicable design and development reviews;

c) required design and development verification and validation;

d) responsibilities and authorities involved in the design and development process;

e) need to control interfaces between persons involved in the design and development
process;
Ø
Mandatory -- Record about design and development outputs review
Ø
Non Mandatory --
f) need for involvement of customers and users in the design and development process;
Changes:
• g) old
Replaces necessary
clausedocumented information
7.3.1 on design to confirm that planning
and development design and development
•
Must “consider” nature, duration, and complexity of process activities; “complexity”
requirements were met.
relates to “risk”
•
Involve customer and user groups in process NEW
•
Adds documented information to confirm process requirements are met
New Clause No and Title 8 Operation Summary of Changes

7.3.2 8.3.3 Design & Development Inputs

The organization SHALL determine the requirements essential for the specific types of
products and services to be designed and developed. The organization SHALL
consider: NEW

a) functional and performance requirements;

b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
NEW
d) standards or codes of practice that the organization has committed to implement;
e) internal and external resource needs for design and development of
Ø
Mandatory -- Recordsand
products about design and development inputs
services;
Ø
Non Mandatory --
Changes: f) the potential consequences of failure due to the nature of the products
•
Replaces 7.3.2 on design and development inputs
and serviceslevel of control expected of the design and development process by
•
Includes internal and external resource needs as new inputs NEW
•
Adds potentialcustors
consequences
and other of failure;
relevant “risk” parties.
interested
New Clause No and Title 8 Operation Summary of Changes
Nothing
7.3.4 8.3.4 Design & Development Controls Really New
7.3.5
7.3.6 The organization SHALL apply controls to the design and development process to
ensure that:
a) results to be achieved by the design and development activities are clearly defined;
b) reviews are conducted to evaluate the ability of the results of design and
development to meet requirements;

c) verification is conducted to ensure that the design and development outputs have
met the design and development input requirements;

d) validation is conducted to ensure that the resulting products and services are
capable of meeting the requirements for the specified application or intended use

Ø
Mandatory (when known).
-- Records of design and development controls
Ø
Non Mandatory --
Changes:
e) any necessary actions are taken on problems determined during the reviews, or
• verification
Adds new controls andfor
clause validation
reviews,activities;
verification, and validation
•
Merges old clauses 7.3.4, 7.3.5, and 7.3.6
New Clause No and Title 8 Operation Summary of Changes
Nothing
7.3.3 8.3.5 Design & Development Outputs Really New

The organization SHALL ensure that design and development outputs:

a) meet the input requirements;

b) are adequate for the subsequent processes for the provision of products and
services;

c) ensure products to be produced, or services to be provided, are fit for intended

purpose and their safe and proper use.

d) include or reference monitoring and measuring requirements, as appropriate, and

acceptance criteria;

e) Retain the documented information resulting from the design and development
process.

Ø
Mandatory -- Records of design and development outputs
Ø
Non Mandatory --
Changes:
•
Replaces old clause 7.3.3 on design and development outputs
•
Output expanded for monitoring and measuring requirements
•
Adds to keep documented information resulting from process
New Clause No and Title 8 Operation Summary of Changes
Nothing
7.3.7 8.3.6 Design & Development Changes Really New

The organization SHALL identify, review and control changes made during, the design
and development of products and services, to the extent necessary to ensure that there
is no adverse impact on conformity to requirements

The organization SHALL retain documented information on:

a) design and development changes;

b) the results of reviews;
c) the authorization of the changes;

Ø
d) the actions taken to prevent adverse impacts.
Mandatory -- Records of Design and development changes
Ø
Non Mandatory --
Changes:
•
Replaces old clause 7.3.7 on control of design and development changes
•
Review, verify, and validate changes now covered by “control” (see 8.3.4)
•
Requirement now addressed by avoiding adverse impact on conformity
New Clause No and Title 8 Operation Summary of Changes
Purch
7.4.1 8.4 Control of externally provided products and services ase

8.4.1 General The organization SHALL ensure that externally provided processes,
products and services conform to requirements..
The organization SHALL determine the controls to be applied to externally provided
processes, products and services when:
a) products and services are provided by external providers for incorporation into the
organization’s own products and services;
b ) products and services are provided directly to the customer(s) by external
providers on behalf of the organization;
NEW
c) a process or part of a process is provided by an external provider as a result of a
decision by the organization to outsource a process or function.
Ø
Mandatory -- Criteria for evaluation and selection of suppliers
Ø
Non Mandatory --
Changes:
•Replaces most of 7.4.1 on purchasing process
•Moves control of outsourcing from old clause 4.1
•External provider is outside scope of system:
• purchasing from a supplier,
• through arrangement with an associate company,
• Through “outsourcing” of processes and functions, or by any other means.
•Adds monitoring of external provider “performance”
•Adds keeping documented information on performance
New Clause No and Title 8 Operation Summary of Changes
7.4.1 8.4.2 Type and extent of controls

The organization SHALL ensure that externally provided processes, products and
services do not adversely affect the organization’s ability to consistently deliver
conforming products and services to its customers.

Type and extent of controls to be applied depends on:

potential impact of the externally provided processes, products and services

perceived effectiveness of controls applied by external provider

NEW

Changes:
•Expands upon old clause 7.4.1 requirement on type and extent of control
•Old 4.1 NOTE 3 now auditable as requirement
•Includes verification from old clause 7.4.3 on verification of purchased product
•Consider potential impact of externally provided processes, products, and services
•Clarifies outsourced processes remain within scope
•Requires outsourcing controls on both external provider and resulting process output
New Clause No and Title 8 Operation Summary of Changes
7.4.1 8.4.3 Information for External Providers
The organization SHALL ensure the adequacy of requirements prior to their
communication to the external provider.
The organization shall Communicate to external providers its requirements for the:
a) The processes, products and services to be provided;
b) the approval of:
1) products and services
2) methods, processes and equipment;
3) the release of products and services;
c) competence of personnel, including necessary qualification;
d) The external providers interactions with the organization;
g) control and monitoring of the external provider’s performance to be applied by the
organization;
f) verification activities that the organization, or its customer, intends to perform at the
external provider’s premises.

Changes:
•Includes requirements from clauses 7.4.2 and 7.4.3
•Clarifies their requirements for interacting with our quality management system
•Adds control and monitoring of external provider’s performance
New Clause No and Title 8 Operation Summary of Changes
7.5 8.5 Production and service provision
8.5.1 Control of Production and Service
7.5.1
The organization SHALL implement production and service provision under controlled
conditions.
a) Documented information – associated with product & services
b) Provide – Suitable Monitoring and measuring resources
c) Provide - monitoring and measurement activities
d) The necessary – Infrastructure and environment
NEW
e) competence, including any required qualification of persons
f) validation, and periodic revalidation, of “special processes”;
g)  the implementation of actions to prevent human error; NEW
h) Release , Delivery , and post – delivery activities.
Ø
Mandatory -- Characteristics of product to be produced and service to be provided
Ø
Non Mandatory -- Procedure for production and service provision
Changes:
•
Replaces old clause 7.5.1 on Control of Production and Service Provision
•
Changes from “work instructions” to “documented information”
•
Adds verification that control criteria and acceptance criteria are met
•
Use of equipment expanded to use of infrastructure and process environment
•
Adds competence, and where applicable, qualification of persons
•
Moves old clause 7.5.2 on “special processes” into clause 8.5.1.f and lessens its
New Clause No and Title 8 Operation Summary of Changes
Nothing
7.5.3 8.5.2 Identification and Traceability Really New

NOTE: “Process outputs” are results of any activities which are ready for
delivery to customer or to an internal customer (e.g., receiver of inputs to next
process). “Process outputs” can include products, services, intermediate parts,
Changes:components, etc.
•
Replaces old 7.5.3 on Identification and Traceability
•
Changes from use of “product” to “process outputs”
•
Adds NOTE to define term “process outputs”
7.5.4 8.5.3 Property Belonging to Customers or External Providers
The organization SHALL exercise care with property belonging to customers or external
providers while it is under the organization’s control or being used by the organization.
NEW- Report to the customer or external provider when their property is
incorrectly used, lost, damaged, or otherwise found to be unsuitable for
NEWuse.
NOTE: Customer property can include material, components, tools and
equipment, customer premises, intellectual property, and personal data.
Ø
Mandatory -- Records about customer property
Ø
Non Mandatory --
Changes:
•
Replaces old clause 7.5.4 on Customer Property
•
Expands to include an external provider’s property
•
Adds reporting if the property is “incorrectly used”
•
Expands the NOTE on examples of property
New Clause No and Title 8 Operation Summary of Changes
Nothing
Really New
7.5.5 8.5.4 Preservation
The organization SHALL preserve the outputs during production and service provision, to
the extent necessary to ensure conformity to requirements
NOTE: Preservation can include identification, handling, packaging,
storage, transmission or transportation, and protection.
Ø
Mandatory --
Ø
Non Mandatory -- Warehousing procedure
Changes:
•
Replaces old clause 7.5.5 on Preservation of Product
•
Changes from use of “product” to “process outputs”
•
Moves the types of preservation into a new NOTE
•
NOTE adds transmission and transportation activities
NEW
7.2.1 8.5.5 Post-Delivery Activities clause
7.5.1
Meet requirements, as applicable, for post-delivery activities associated with products and
services. Consider in determining the extent of post-delivery activities that are required:
a) risks associated with products and services;
b) nature, use, and intended lifetime of products and services;
c) customer feedback;
d) legal requirements.
New Clause No and Title 8 Operation Summary of Changes
NOTE: Post-delivery activities can include:
actions under warranty provisions
contractual obligations (such as maintenance services)
supplementary services (such as recycling or final disposal)
Changes:
•
New clause on post-delivery requirement
•
Expands old clauses 7.2.1.a and 7.5.1.f on post-delivery
•
Includes NOTE from old clause 7.2.1 on determining product requirement
NEW
7.5.4 8.5.6 Control of Changes clause
Review and control unplanned changes essential for production or service (to extent
necessary to ensure continuing conformity with specified requirements).
Retain documented information describing:
a) results of review of changes,
b) personnel authorizing change, and
c) any necessary actions.
Ø
Mandatory -- Production/service provision change control records
Ø
Non Mandatory --
Changes:
•
New clause on control of unplanned changes
•
Refer to 6.3 on planning of system changes
•
See 8.1 on control of planned process changes
New Clause No and Title 8 Operation Summary of Changes
Nothing
Really
8.2.4 8.6 Release of products and services New
7.5.1
The organization SHALL implement planned arrangements, at appropriate stages, to
verify that the product and service requirements have been met

The release of products and services to the customer SHALL not proceed until the
planned arrangements have been satisfactorily completed, unless otherwise approved
by a relevant authority and, as applicable, by the customer.

The organization SHALL retain documented information on the release of products and
services. The documented information SHALL include:

a) evidence of conformity with the acceptance criteria;

b) traceability to the person(s) authorizing the release.

Ø
Mandatory -- Record of conformity of product/service with acceptance criteria
Ø
Non Mandatory --
Changes:
•
Replaces old clause 8.2.4 on Monitoring and Measurement of Product
•
Expands on old clause 7.5.1.f on product release
•
More focus on “release”, but “verifying” products and services is still a requirement
New Clause No and Title 8 Operation Summary of Changes
8.3 8.7 Control of nonconforming process outputs, products and services
8.7.1 The organization SHALL ensure that outputs that do not conform to their
requirements are identified and controlled to prevent their unintended use or delivery.
The organization SHALL take appropriate action based on the nature of the
nonconformity and its effect on the conformity of products and services. This SHALL
also apply to nonconforming products and services detected after delivery of products,
during or after the provision of services.
The organization SHALL deal with nonconforming outputs in one or more of the following
ways:
a) correction;
b) segregation, containment, return, or suspension of provision of products and
services;
c) informing customer;
d) obtaining authorization for:
– use “as-is’ or acceptance under concession

– release, continuation, or re-provision of products and services

Conformity to the requirements SHALL be verified when nonconforming outputs are

corrected.
New Clause No and Title 8 Operation Summary of Changes
8.3 8.7.2. Conformance documentation

The organization SHALL retain documented information that:

a) Describes the nonconformity

NEW
b) Describes the action taken
c) Describes any concessions obtained
d) Identifies the authority deciding the action in respect of the
nonconformity

Ø
Mandatory -- Record of nonconforming outputs
Ø
Non Mandatory -- Procedure for management of nonconformities and corrective
actions
Changes:
•
Replaces old clause 8.3 on control of nonconforming product
•
Expands control to “process outputs”
•
Includes segregation, containment, return, or suspension
•
Adds notification of customer as an action
New Clause No and Title
9 Performance evaluation
Existing Clause No Summary of Changes

8.2.1 9.1 Monitoring, measurement, analysis and evaluation

( Very Similar to previous revision )

• General
• Customer satisfaction Nothing
Really New

• Analysis and evaluation of data

Nothing
8.2.2 9.2 Internal Audit Really New

5.6 9.3 Management review process

New Clause No and Title
9 Performance evaluation
Existing Clause No Summary of Changes

8.2 9.1 Monitoring, measurement, analysis and evaluation

9.1.1 Determine:
what needs to be monitored and measured
methods for monitoring, measurement, analysis and evaluation,
as applicable, to ensure valid results
when the monitoring and measuring shall be performed
when the results from monitoring and measurement shall be
analyzed and evaluated.
9.1.2 Customer satisfaction: monitor perceptions
9.1.3 Analysis and evaluation requirements:
Conformity to product & services, customer satisfaction, QMS
effectiveness, planning effectiveness, effectiveness of risks and
opportunities, performance of external providers , need for
improvements
New Clause No and Title
9 Performance evaluation
Existing Clause No Summary of Changes

8.2.2 9.2 Internal audits

Nothing Really
New
•Conduct at planned intervals
•conforms to QMS and ISO 9001:2015
•Effectively implemented
•Include frequency, methods, responsibilities, planning, and reporting
•Consider processes,
•Changes affecting the organization
•Results of previous audits
•Define audit criteria and scope
•Select auditors for objectivity and impartiality
•Report results to management
•Correction/corrective action without undue delay
New Clause No and Title
9 Performance evaluation
Existing Clause No Summary of Changes

5.6 9.3 Management Review (Now includes requirements to consider: )

•Status of actions NEW

•changes in external & internal issues that are relevant to the

QMS
•information on the performance and effectiveness of QMS
including trends in:
NEW
--Customer satisfaction & feedback from relevant interested parties
--The extent to which quality objectives have been met
--Process performance and conformity of products and services
--Nonconformities and corrective actions
--Monitoring and measuring results
--Audit results
--Performance of external providers
New Clause No and Title
9 Performance evaluation
Existing Clause No Summary of Changes

5.6 9.3 Management Review (Now includes requirements to consider: )

•The adequacy of resources NEW

•The effectiveness of action taken to address risks and opportunities

•Opportunities for improvements
Outputs: decisions and actions related to:
--Opportunities for improvement
--Changes to QMS
--Resource needs
New Clause No and Title
10 Improvement
Existing Clause No Summary of Changes

8.4.3 10.1 General

8.5.2
•Implement actions to meet customer requirements and enhance
customer satisfaction, by:

• improving processes to prevent nonconformities;

• improving products and services to meet known and predicted
requirements; NEW

• improving quality management system results.

May also include breakthrough improvements, innovation,

NEW
transformation etc.
New Clause No and Title
10 Improvement
Existing Clause No Summary of Changes

8.5.1 10.2 Nonconformity and corrective action

“When a nonconformity occurs, the organization shall:
a) react to the nonconformity, and as applicable
●
take action to control and correct it, and
●
deal with the consequences;
b) evaluate the need for action to eliminate the causes of the NEW
nonconformity, in order that it does not recur or occur elsewhere, by
• reviewing the nonconformity
• determining the causes of the nonconformity, and NEW

• determining if similar nonconformities exist, or could potentially

occur;

c) implement any action needed;

d) review the effectiveness of any corrective action taken; and
New Clause No and Title
10 Improvement
Existing Clause No Summary of Changes

10.3 Continual improvement

NEW

•Consider outputs of analysis and evaluation, and outputs from

management review, to identify areas of underperformance or
opportunities for improvement.
NEW

•Select and utilise applicable tools and methodologies for

investigation of the causes of underperformance and for supporting
continual improvement.
 Organization Task

Make people gain knowledge about changes based on ISO necessary for
up gradation of existing system.
Ensure existing internal auditors are qualified by attending transition
training.