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Presents an:



Presented by:

Your Company
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Today you will learn about
Changes to the Standard (ISO 9001:2008)

Impact of the Changes

Next Steps
Develop a transition plan with your Registrar
Implement the Changes
Schedule a Transition Audit

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Changes to the Standard
CHANGES (highlighted in BOLD RED italics type) show
the revised wording of the requirement.

Remember that NOTES in the Standard DO NOT
constitute requirements, but are meant to clarify them.

Our COMMENTS (highlighted in BOLD BLUE type) are
intended to further help you determine if changes to your
system are warranted by the INTENT of the new/revised
requirement or Note in the Standard.
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Changes to the Standard
4.1 General Requirements

NOTE 2: An outsourced process is identified as one being needed for the
organization's quality management system but chosen to be performed by a party
external to the organization.

Comment: This new Note provides an explanation of what is considered an outsourced process.

NOTE 3: The type and nature of control to be applied to the outsourced
process may be influenced by factors such as:

a) the potential impact of the outsourced process on the organization's capability to provide
product that conforms to requirements;

b) the extent to which the control for the process is shared;

c) the capability of achieving the necessary control through the application of clause 7.4.

Ensuring control over outsourced processes does not absolve the organization of the
responsibility of conformity to all customer, statutory, and regulatory requirements.

Comment: This new Note identifies the factors influencing the control of an outsourced process.
Outsourcing a process to another organization typically involves the purchase of those services. As a
result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply to the supplier
selected to perform the outsourced process.
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Changes to the Standard
4.2 Documentation Requirements

4.2.1 General

c) documented procedures and records required by this International Standard, and

d) documents, including records, determined by the organization to be necessary to
ensure the effective planning, operation and control of its processes.

Comment: No real change to the requirement; you can see that adding "records" to sub-
clauses c) and d) allowed sub-clause e) to be dropped.

NOTE 1: A single document may include the requirements for one or more
procedures. A requirement for a documented procedure may be covered by
more than one document.

Comment: An example for the first sentence would be satisfying the requirements for
documented procedures in 8.5.2, Corrective Action, and 8.5.3, Preventive Action, by one
combined Corrective and Preventive Action procedure. An example for the second
sentence would be splitting the required procedure for the Control of Documents into two
separate documented procedures, one for internal document control and one for external
document control.
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Changes to the Standard
4.2 Documentation Requirements

4.2.3 Control of Documents

f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are identified
and their distribution controlled, and

Comment: This change simply clarifies that not all external documents have to be
identified and controlled; only those necessary for the planning and operation of the
quality management system.


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Changes to the Standard
4.2 Documentation Requirements

4.2.4 Control of Records

Records established to provide evidence of conformity to requirements and of
the effective operation of the quality management system shall be controlled.

The organization shall establish a documented procedure to define the controls
needed for the identification, storage, protection, retrieval, retention, and
disposition of records.

Records shall remain legible, readily identifiable, and retrievable.

Comment: The opening sentence was rewritten to emphasize that records should be
"controlled (versus just maintained). Maintaining the records would be to simply keep
them in good condition; controlling the records means to regulate their use.
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Changes to the Standard
5.5 Responsibility, Authority and Communication

5.5.2 Management Representative

Top management shall appoint a member of the organization's management
who, irrespective of other responsibilities, shall have responsibility and authority
that includes:

Comment: Most organizations already appoint a Management Representative
that is a member of their own management team; this change simply clarifies that
requirement. It also appears to prohibit outsourcing of the Management
Representative role (since the intent is to establish/maintain internal oversight
and responsibility for establishing, maintaining and improving an organizations
quality management system).
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Changes to the Standard
6.2 Human Resources

6.2.1 General

Personnel performing work affecting conformity to product requirements shall
be competent on the basis of appropriate education, training, skills and
experience.

NOTE: Conformity to product requirements may be affected directly or
indirectly by personnel performing any task within the quality management
system.

Comment: Wording was changed from work affecting "product quality" to work
affecting "conformity to product requirements". Quality is the degree to which a
set of inherent characteristics fulfils requirements; conformity is the fulfillment of
a requirement. The change to the requirement (and addition of the new Note)
will not likely result in new interpretations of the requirement since anyone
performing, verifying, or managing work within the scope of the quality
management system, including supporting services, can affect conformity to
product requirements.
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Changes to the Standard
6.2 Human Resources

6.2.2 Competence, Training and Awareness

a) determine the necessary competence for personnel performing work affecting
conformity to product requirements,

b) where applicable, provide training or take other actions to achieve the
necessary competence,

c) ensure that the necessary competence has been achieved,

Comment: Use of the phrase "where applicable" seems to recognize that training
or other actions may not always be necessary, since individuals may already have
the necessary competence. Likewise, since satisfy these needs" was sometimes
taken out of context to infer action was always required, the requirement was
revised to focus on determining competence. Finally, since people have
struggled with how to evaluate the effectiveness of the actions taken, the clause
was modified to focus more on determining competence. For example, a
students evaluation of the effectiveness of training they attend, is not as useful as
an (independent) evaluation of their knowledge, skills and abilities (regardless of
how/when this competency was acquired).
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Changes to the Standard
6.3 Infrastructure

c) supporting services (such as transport, communication or information systems).

Comment: The only change was to add information systems" as an example of
a supporting service included within the definition of infrastructure).

6.4 Work Environment

NOTE: The term work environment relates to conditions under which work
is performed including physical, environmental and other factors (such as noise,
temperature, humidity, lighting, or weather).

Comment: The only change was to add a NOTE to explain the term Work
Environment by providing examples of work environment conditions for
achieving product conformity .
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Changes to the Standard
7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the Product

a) requirements specified by the customer, including the requirements for
delivery, and for post-delivery activities,

c) statutory and regulatory requirements applicable to the product, and

d) any additional requirements considered necessary by the organization.

NOTE: Post delivery activities include, for example, actions under warranty
provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal.

Comment: The slight change to "for delivery, and for post-delivery activities"
adds emphasis to post-delivery activities; for similar reasons a Note was added
with examples. The change from "related" to "applicable" shifts the meaning from
determining legal requirements that are merely associated with the product to
those that are relevant and can be applied to the product. The final revision to
this clause clarifies that the additional requirements aren't just determined, they
are determined to be needed by the organization.
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Changes to the Standard
7.3 Design and Development

7.3.3 Design and Development Outputs

The outputs of design and development shall be in a form suitable for
verification against the design and development input and shall be approved
prior to release.

Comment: The change switches from "a form that enables verification" to "a
form suitable for verification". To enable something is to make it possible;
however, to be suitable means it is meant for use, or in this case, for verification.

NOTE: Information for production and service provision may include details for
the preservation of product.

Comment: The new Note was added to remind the reader that clause 7,
Production and Service Provision, includes sub-clause 7.5.5, Preservation of
product, probably to indicate that the design output should consider product
preservation, especially product packaging.
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Changes to the Standard
7.5 Production and Service Provision

7.5.2 Validation of Process for Production and Service Provision

The organization shall validate any processes for production and service
provision where the resulting output cannot be verified by subsequent monitoring
or measurement and as a consequence, deficiencies become apparent only after
the product is in use or the service has been delivered.

Comment: The revised text clarifies that any process output that can't be verified
may result in deficiencies becoming known only after the product is in use or the
service has been delivered. Accordingly, validation requirements could apply to
processes such as welding, sterilization, training, heat treatment, call center
service, or emergency response.
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Changes to the Standard
7.5 Production and Service Provision

7.5.3 Identification and Traceability

The organization shall identify product status with respect to monitoring and
measurement requirements throughout product realization.

Comment: The revised text clarifies that identifying product status applies
throughout product realization, from received product, through in-process
product, to final product.

Where traceability is a requirement, the organization shall control the unique
identification of the product and maintain records (see 4.2.4).

Comment: By moving the "records" reference to the end of the sentence, the
meaning has changed from recording the product identification, to keeping any
type of record associated with product traceability.
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Changes to the Standard
7.5 Production and Service Provision

7.5.3 Identification and Traceability

The organization shall identify product status with respect to monitoring and
measurement requirements throughout product realization.

Comment: The revised text clarifies that identifying product status applies
throughout product realization, from received product, through in-process
product, to final product.

Where traceability is a requirement, the organization shall control the unique
identification of the product and maintain records (see 4.2.4).

Comment: By moving the "records" reference to the end of the sentence, the
meaning has changed from recording the product identification, to keeping any
type of record associated with product traceability.
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Changes to the Standard
7.5 Product and Service Provision

7.5.4 Customer Property

If any customer property is lost, damaged or otherwise found to be unsuitable for
use the organization shall report this to the customer and maintain records (see
4.2.4).

NOTE: Customer property can include intellectual property and personal data.

Comment: The requirement was revised to read better and the NOTE was
revised to The existing Note was modified to include "personal data" as an
example of customer property, broadening the applicability of clause 7.5.4 to
more organizations, especially service organizations.
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Changes to the Standard
7.5 Product and Service Provision

7.5.5 Preservation of Product

The organization shall preserve the conformity of product during internal
processing and delivery to the intended destination in order to maintain
conformity to requirements.

Comment: The term conformity to requirements" should be easier to
understand than conformity of product.

As applicable, preservation shall include identification, handling, packaging,
storage and protection. Preservation shall also apply to the constituent parts of a
product.

Comment: The addition of as applicable allows product preservation to be
applied (i.e. include or not include product identification, handling, packaging,
storage, and protection) as appropriate.
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Changes to the Standard
7.6 Control of Monitoring and Measuring Equipment

The organization shall determine the monitoring and measurement to be undertaken and
the monitoring and measuring equipment needed to provide evidence of conformity of
product to determined requirements.

Where necessary to ensure valid results, measuring equipment shall
c) have identification in order to determine its calibration status.

NOTE: Confirmation of the ability of computer software to satisfy the intended
application would typically include its verification and configuration management to
maintain its suitability for use.

Comment: The term "devices" was changed to "equipment because 1) the term
equipment was already used in several places in clause 7.6, 2) the term devices has a
broader scope and could include non-equipment types of tools, and 3) the term
equipment is the better choice for this (calibration) clause. Also, wording of the clause
was changed because stating that measuring equipment must "be identified" sounded like
the organization was to add identification while most measuring equipment comes with
identification already in place . Finally, since many software development organizations
were unsure how to confirm that software used for monitoring and measurement has the
ability to satisfy the intended application (per clause 7.6), a new Note was added to explain
that it should include verification and configuration management for the software.
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Changes to the Standard
8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

NOTE: Monitoring customer perception may include obtaining input from
sources such as customer satisfaction surveys, customer data on delivered
product quality, user opinion surveys, lost business analysis, compliments,
warranty claims, dealer reports.

Comment: A new Note was added to provide examples of sources for
monitoring customer perception.
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Changes to the Standard
8.2 Monitoring and Measurement

8.2.2 Internal Audit

A documented procedure shall be established to define the responsibilities and
requirements for planning and conducting audits, establishing records and reporting
results.

Records of the audits and their results shall be maintained (see 4.2.4).

The management responsible for the area being audited shall ensure that any necessary
corrections and corrective actions are taken without undue delay to eliminate detected
nonconformities and their causes.

NOTE: See ISO 19011 for guidance.

Comment: The requirement for a documented procedure was emphasized by placing it
first in the sentence. Also, "establishing records" was moved ahead of "reporting results" in
the list of topics to be defined in the procedure because records are being captured
throughout the audit and should be listed before the reporting of results. The new text
highlights the need to maintain records of the audit and its results. Further, the change
expands management "actions" to include "any necessary corrections and corrective
actions" to emphasize that immediate correction might be needed before determining the
cause of the nonconformity and taking corrective action to prevent its recurrence. Finally,
the reference to the withdrawn ISO 10011 was replaced with a reference to ISO 19011,
Guidelines for Quality and/or Environmental Management Systems Auditing.
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Changes to the Standard
8.2 Monitoring and Measurement

8.2.3 Monitoring and Measurement of Processes

When planned results are not achieved, correction and corrective action shall be
taken, as appropriate.

Comment: Clause 8.2.3 requires applying suitable methods for monitoring and
measuring processes to demonstrate their ability to achieve planned results. For
some supporting processes, these results are only indirectly related to product
conformity. Therefore, the reference to product conformity (above) was moved
to the new Note below.

NOTE: When determining suitable methods, the organization should consider
the type and extent of monitoring or measurement appropriate to each of its
processes in relation to their impact on the conformity to product requirements
and on the effectiveness of the quality management system.

Comment: The new Note above was added to provide guidance in determining
suitable methods: it says to consider the type and extent of monitoring or
measurement based on the impact of the process on product conformity and
system effectiveness.
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Changes to the Standard
8.2 Monitoring and Measurement

8.2.4 Monitoring and Measurement of Product

The organization shall monitor and measure the characteristics of the product to
verify that product requirements have been met. This shall be carried out at
appropriate stages of the product realization process in accordance with the
planned arrangements (see 7.1). Evidence of conformity with the acceptance
criteria shall be maintained.

Comment: The requirement to maintain evidence of conformity with acceptance
criteria has been moved from the paragraph below to the paragraph above.

Records shall indicate the person(s) authorizing release of product for delivery to
the customer (see 4.2.4).

The release of product and delivery of service to the customer shall not proceed
until the planned arrangements (see 7.1) have been satisfactorily completed,
unless otherwise approved by a relevant authority and, where applicable, by the
customer.

Comment: Wording was changed to emphasize and clarify that the release of
product and delivery of service is to the customer.
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Changes to the Standard
8.3 Control of Nonconforming Product

A documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming product.

Comment: For clarity and added emphasis, the sentence above was revised to
begin with (instead of end with) the requirement for a documented procedure.

Where practicable, the organization shall deal with nonconforming product by
one or more of the following ways:

d) by taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started.

Comment: For clarity, the above requirement was added to the list of ways for
dealing with nonconforming product (from wording previously located below the
list).
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Changes Should Have Minimal Impact
on Your Quality Management System
CHANGES in ISO 9001:2008 are primarily clarifications

intended to ensure improved understanding of the existing
(ISO 9001:2000) requirements

SO

changes should be MINIMAL
IF you implemented ISO 9001:2000 as intended.


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Changes Will Impact Some (but not all)
Other Standards
AS 9100 / 9110 / 9120 - Major changes expected on the
additional aerospace requirements

TS 16949 No changes expected

TL 9000 Unclear at this time

ISO 14001 TC 176 and TC 207 are working even closer,
but (against some rumors) no integrated Q&E ISO
Standard is in the works

OHSAS 18001, revised and released in July 2007, is closer
to ISO 14001:2004.
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Develop a transition plan with your Registrar
Implement the Changes
Schedule a Transition Audit
Note: No reason for additional time during the transition audit is
expected

Contact us with questions:

IsoQual, Inc., dba ISO-Online
isoqual@bellsouth.net
(502) 299-6122