ISO9001-2008Revisions SQA SedlakConsulting

8/4/2019 ISO9001-2008Revisions SQA SedlakConsulting

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ISO 9001:2008 Revisions from ISO 9001:2000

Introduction:

ISO 9001 is now in its fourth edition. Starting with the 1987 initial edition, it changed in 1994and again in 2000. The 2000 change was pretty extensive. It introduced the concept of process

auditing and added a lot of emphasis to the importance of top management to the effectiveness of

quality management systems. In November 2008, the fourth edition was released.

Discussion:

On November 13, 2008, the fourth edition of ISO 9001 became official. It is referred to as ISO9001:2008. The good news is that it contains no substantive changes or new requirements. The

changes that were made were done for two reasons: 1) clarifications to the requirements of ISO

9001:2000; 2) to improve alignment with ISO 14001:2004.

The ANSI-ASQ National Accreditation Board (ANAB) has issued two Heads-up documents that

deal with the changes and transition process for moving from ISO 9001:2000 to ISO 9001:2008.These can be accessed from the ANAB web page www.anab.org. Refer to Heads-up numbers

129 (migration) and 135 (where/how to buy the standard.)

The transition/migration process has the following requirements:

Twelve months after the release of ISO 9001:2008, all new and re-certification auditsmust be done to the ISO 9001:2008 standard. Twenty-four months after release of ISO 9001:2008, all ISO 9001:2000 certificates will

be invalid.

Upgrading from ISO 9001:2000 to ISO 9001:2008 requires a surveillance or re-certification audit to be conducted.

If you are certified to ISO 9001:2000, you can continue with that revision level for a period of

time depending where your organization is within its current three-year certificate cycle. Eachcertification/registration body (CRB) will have its own practices/rules regarding when and underwhat conditions an existing certification can be upgraded to ISO 9001:2008. However, in all

cases, there must be either a surveillance or re-certification audit executed before an ISO

9001:2000 certificate can be upgraded to ISO 9001:2008.


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How to Use the Checklist:

First and foremost obtain at least one copy of ISO 9001:2008. (See ANAB Heads-upNo. 135 for directions on how to obtain a copy.)

Next, determine if the existing documented QMS and actual practices meet therequirements of ISO 9001:2008. The checklist has three categories:

o Meets this requiremento Needs some modificationo Clause not applicable.

(If you check this box, remember that only sub-clauses in section 7 can beclaimed to be not applicable, and your scope statement and related

documentation must contain justification for such exclusions.)

For each clause/sub-clause, use the Comments/Notation cells to annotate where therequirement is met. This may be a reference to a document, policy, procedure, work

instruction, process document, etc.

When completed, notify your CRB that you are ready to be audited in accordance withthe requirements of ISO 9001:2008. The completed checklist will provide one form of

objective evidence (at the minimum, it will be a solid audit-trail) that your organization

has completed an analysis of ISO 9001:2008 and, if applicable, made required changes to

its QMS.

About Smithers Quality Assessments

Smithers Quality Assessments was established in 1993 as an accredited third-party registrar,

providing manufacturers and service providers quality and environmental management systemcertification services to ISO 9001, ISO 14001 and other industry-specific standards. SQA is

consistently ranked as a leader in customer satisfaction by independent surveys of registered

companies. www.smithersregistrar.com

About J&S Sedlak, LLC (Sedlak Consulting)

For over fifteen years, John Sedlak led Smithers Quality Assessments, a leading

certification/registration body located in Akron, OH. Since retirement, he has established a

training/consulting practice, J&S Sedlak, LLC, specializing in the ISO standards and theiri l i Y l b i h b dl k l i


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Smithers Quality Assessments 2009: www.smithersregistrar.com Phone: 1-866-688-0134

J&S Sedlak, LLC 2009: www.sedlakconsulting.com Phone: 330-936-3436

ISO 9001:2000 vs. ISO 9001:2008 Analysis Tool* ISO 9001:2008 was released on November 13, 2008

* On or after November 13, 2009, all new certifications and re-certifications must be to ISO 9001:2008.

* On or after November 13, 2010, any existing certification to ISO 9001:2000 will no longer be valid.

Current QMS Documentation & Practice ----

Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable

Comments / Notations

4.1 a Very slight change inwording.

4.1 e "where applicable"added to "measure"

these processes.

Provides some

leeway to

organization - not all

process need to be

"measured."

4.1 plus

Notes 1,

2 & 3

If process(es) that

affect quality of

product are

outsourced,

organization must

define controls.

More emphasis on

the need for the

organization to retain

control for

outsourced

processes, and not

rely solely on the

controls of the

organization to which

the process was

outsourced;

"processes" not

limited to product

realization processes.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


4.2.1

c&d

"Records" now

included in these

sub-clauses.

Slight shift in

emphasis to indicate

"procedures" and

"records" are related.

4.2.1,

Note 1

Slight elaboration on

meaning of

"Documented

procedure"

Can be: a stand

alone procedure; one

document containing

more than one

procedure; one

procedure may be

expressed in more

than one document.

4.2.3 f External documents

determined to be

important must be

controlled

Reduces the need to

control all external

documents.

However, places

extra responsibility

on the organization

to define thoseexternal documents

that are important.

4.2.4 Records are to be

controlled.

Added emphasis

from previous

"maintained."


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


5.5.2 Management

representative to be

a member of

organization's

management.

Emphasis on the fact

that the

management

representative needs

to be employed bythe organization and

be a member of the

organization's

management team.

6.2.1 Persons that affect

product conformity

requirements to be

competent

"Affecting product

quality

requirements"

applies to any taskwithin the QMS, not

just direct

manufacturing or

service provision

6.2.2

a ,b

Determine

competency of

personnel affecting

productrequirements;

provide training to

achieve needed

competence.

Removed the word

"quality" to indicate

that all requirements

are important, notjust "quality

requirements."

Emphasis on need to

"achieve" and not

just "satisfy"

competency

requirements.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


6.3 Added "information

systems" (IS) to

support services.

Recognized the

importance of IS in

today's environment.

6.4 Added a note to

explain "workenvironment."

Physical factors and

others, e.g., noise,temperature,

humidity, lighting,

weather.

7.1 b Restructure of

grammar.

Grammar only.

7.1 c Added

"measurement" as an

action to beconsidered.

"Measurement"

added to be sure that

this action is includedwhen considering

elements of the QMS

needed to achieve

conformity with

requirements.

7.2.1 c Added word

"applicable."

Added to clarify the

"statutory" as used

applies only toproduct

requirements.

7.2.1 d "Determined"

changed to

"considered

necessary."

Slight shift in

emphasis from

simply taking action

to taking

responsibility.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


7.2.1 New Note. Explains what is

meant by "post

delivery activities."

7.3.1 New Note. Elaborates on thedifferences and

similarities between

design "review,"

"verification" and

"validation;" may be

separate or

combined depending

upon needs ofproduct or

organization.

7.3.2

2nd

para

"These" changed to

"The."

Grammar only.

7.3.3

1st para

Changed "in a form

that enables " to "ina form suitable for"

verification.

Emphasis placed on

suitability of designbeing verified not

simply an arbitrary

acknowledgement

that it can be

verified.

7.3.3 b Eliminated "for." Grammar only.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


7.3.3 New Note Information can

include details on

preservation of

product.

7.3.7

1st &

2nd

para

No text changes -

paragraphs merged.

Grammar only.

7.5.1 d "Devices" changed to

"equipment."

Recognition that

measurements can

be taken with a wide

variety of options.

7.5.1 f Added "product"

before "release."

Clarified that the

subject was release

of product.

7.5.2 Slight change in

wording to

emphasize the needfor process controls

for "special

processes."

The word

"consequences" adds

emphasis to theresponsibility of the

organization to

establish process

controls for "special

processes."


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


7.5.3

2nd

para

Expanded

requirement for

inspection

(monitoring and

measuring) statusthroughout the

product realization

process.

Clarified that it is

important for

product to be

identified relative to

its conformancestatus throughout

the product

realization process.

7.5.3

3rd para

Regarding

"traceability:"

changed "record" to

"maintain records."

Emphasis shift from

simple recording to

maintenance of such

records.

7.5.4

1st para

Regarding damaged

or unsuitable

customer supplied

product, minor

rewording.

No substantive

change.

7.5.4

Note

Added "and personal

data."

Slight addition to

indicate that theremay be times when

organizations come

into possession of

personal data from

folks that are not

their employees.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


7.5.5

1st para

Regarding

preservation of

product, added

words to convey that

this applies to"conformity to

requirements."

Expanded to convey

intent of

requirement.

7.6 "Devices" changed to

"equipment."

Recognition that

measurements can

be taken with a wide

variety of options.

7.6 a Added "or both" to"verified or

calibrated."

Clarified thatorganization must

decide all actions,

not just one or the

other.

7.6 c Regarding evidence

of "calibration status'

only a slight re-wording.

Grammar only.

7.6

4th para

Made a separate

paragraph of one

sentence.

Grammar only.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


7.6

Note

Completely

rewritten.

Expanded

explanation of

confirmation and

validation of

computer software;included in actions

associated with

configuration

management.

8.1 Conformity "of the

product" changed to

"to productrequirements."

Change made to

clarify that there may

be other productrequirements that go

beyond those that

simply define the

product.

8.2.1

new

Note

Customer

satisfaction.

Offers hints at

sources for

monitoring customersatisfaction.

8.2.2

2nd

para

Added the word

"The" at the

beginning of 3rd

sentence.

Grammar only.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


8.2.2

new

para

Actually, just a total

rewording dealing

with the need for a

documented

procedure.

Grammar only.

8.2.2

4th para

Simply a move of

part of "old" 3rd

paragraph to a

separate paragraph -

dealing with need to

maintain records.

Grammar only.

8.2.2

5th para

Move of some words,

and added "anynecessary corrections

and corrective."

Clarification of

required actions onthe part of persons

responsible for area

audited to take

action.

8.2.2

Note

Deleted references

to obsolete

documents (ISO

10011-1, -3) andadded reference to

ISO 19011.

Organizations should

obtain a copy of ISO

19011, review and

assess impact oninternal audit

process.

8.2.3

1st para

Deleted "to ensure

conformity of the

product."

This should be self-

evident; also actions

may be taken to

correct the system.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


8.2.3

new

Note

Deals with selection

of monitoring and

measurement

techniques for

processes.

Provides latitude to

management, but

also places onus of

proof that the

defined monitoringand measuring are

the results of a well

executed thought

process.

8.2.4

1st para

Added need to

provide evidence ofproduct conformity.

Just good record

keeping; allowsorganization to use

data for

improvement

actions.

8.2.4

2ndpara

Emphasis on

identification ofperson authorizing

release of product to

the customer.

Someone needs to

say "okay to ship."


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


8.2.4

3rd para

Slight change in

word-order dealing

with release of

product to the

customer and suchaction not being

taken until all

required actions are

taken.

No substantive

change.

8.3

1st para

Slight change in

wording of second

sentence dealing

with need for aprocedure for control

of nonconforming

product.

No substantive

change.

8.3

2nd

para

"Where applicable"

added to start of

second applicable.

Recognizes that there

are a myriad of

circumstances that

affect disposition of

nonconformingproduct.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


8.3 d

new

Addresses those

situations where

nonconforming

product may be in

the hands of thecustomer.

Actually, not a new

requirement - simply

a move of the

requirement from

paragraph status tobullet point "d."

8.3

3rd &

4th

paras

Some paragraph

positions changed.

No substantive

change.

8.4 b Deleted reference to

7.2.1; added

reference to 8.2.4.

No substantive

change.

8.4 c Added references to

8.2.3 and 8.2.4

No substantive

change.

8.4 d Added reference to

7.4.

No substantive

change.

8.5.2

1st para

Changed "cause"

(singular) to "causes"

(plural).

Recognized that

there may be one or

more causes for

problems.8.5.2 f Added "the

effectiveness"

Emphasis on the

need for corrective

actions to be

effective - e.g., not

repeat or cause other

issues/problems.


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Clause Summary of

change(s)

Comment on

Change(s)

Meets this

Requirement

Needs some

Modification

Clause is not

Applicable


8.5.3 e Added "the

effectiveness"

Emphasis on the need

for preventive actions

to be effective - e.g.,

truly prevent the

identified potentialproblem and cause

other issues/problems.

Documents

ISO9001-2008Revisions SQA SedlakConsulting