ISO 9001 transition guidance review

ISO 9001:2008 Amendment Review for transition guidance

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Section ISO 9001:2008 (Red font with Strikethrough are 2000
Item Bullet Para Note COMMENTS
reference deletions, blue font are 2008 changes/additions)

The design and implementation of an organization‘s quality Guidelines for the design and implementation
management system is influenced by: (a) its business added to the standard to provide flexibility.
environment, changes in that environment and risks Additional guidelines may become available in
associated with that environment;(b) its varying needs;(c)
0.1 1 ISO 9004 (yet to be released)
its particular objectives;(d) the products it provides;(e) the
processes it employs;(f) its size and organizational
structure.
This International Standard can be used by internal and This is added to be consistent with the
external parties, including certification bodies, to requirements where quot;relatedquot; is changed to
assess the organization‘s ability to meet customer,
0.1 4 quot;applicablequot;. Statutory was already part of the
statutory and regulatory requirements applicable to the requirement portion of the standard. Addition to
product, and the organization‘s own requirements. the general introduction is for consistency.
Process can be an activity or set of activities.
For an organization to function effectively, it has to identify
This is corrected to be consistent with definition in
determine and manage numerous linked activities. An
ISO 9000. The differences between quot;identifyquot; and
0.2 2 activity or set of activities using resources, and managed in
quot;determinequot; explained in 4.1
order to enable the transformation of inputs into outputs,
can be considered as a process.
The application of a system of processes within an documents for the processes determined as per
organization, together with the identification and 4.1. (a) can also include the measurability.
0.2 3 interactions of these processes, and their management to
produce the desired outcome, can be referred to as
the “process approach“.
NOTE 1 In this International Standard, the term “product” The definition of product extended to output
applies to (a) a product intended for, or required by, a resulting from product realization processes.
1.1 1 customer or the product realization processes. (b) any
intended output resulting from product realization
processes.
In some industries, some states, some countries,
NOTE 2 Statutory and regulatory requirements may be
1.1 2 the legal requirements may include statutory and
expressed as legal requirements
regulatory requirements.
identify determine the processes needed for the quality Identify: to recognize or establish as being a
management system and their application throughout the particular person or thing;Determine:to conclude
organization (see 1.2), or ascertain, as after reasoning, observation,
1 4.1 a Y N Y
etc.to cause, affect, or control; fix or decide
causally. Additional guidelines available for
quot;determinequot; in ISO 9000:2005.
monitor, measure (where applicable), and analyse these documents for the processes determined as per
2 4.1 e Y Y Y
processes, and 4.1. (a) can also include the measurability.

Govind Ramu, ASQ CQA
1 of 8 Principal Auditor IRCA (UK)


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Where an organization chooses to outsource any process Use NOTE3 as a check list to perform due
that affects product conformity with to requirements, the diligence on quot;outsourced processquot;. Create a table
organization shall ensure control over such processes. The of outsourced process and NOTE3 items to
3 4.1 4 Y N Y Y Y
type and extent of control to be applied to these outsourced create a matrix.
processes shall be defined within the quality management
system.
NOTE 1 Processes needed for the quality management To be consistent with section 8. Measurement,
system referred to above should include processes for analysis and improvement.
4 4.1 1 management activities, provision of resources, product N Y Y Y
realization, and measurement, analysis and improvement.

NOTE 2 An quot;outsourced processquot; is identified as one being There may be hundreds of outsourced processes
needed for the organization’s quality management system in an organization. However this definition helps
5 4.1 2 N Y
but chosen to be performed by a party external to the to confine to those processes needed for the
organization. organization's QMS.
NOTE 3 Ensuring control over outsourced processes does Although this is a note, quot;does not absolve the
not absolve the organization of the responsibility of organization of the responsibilityquot; is a great
conformity to all customer, statutory and regulatory addition to the standard. This clearly places the
requirements.The type and nature of control to be applied ultimate ownership on the outsourcing
to the outsourced process may be influenced by factors organization.
such as:
a) the potential impact of the outsourced process on the
6 4.1 3 N Y
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.

c) documented procedures and records required by this Rephrased for consistency. quot;Recordsquot; added
7 4.2.1 c Y Y Y
International Standard, and from earlier bullet (e)
d) documents, including records, needed determined by Rephrased for consistency. Some flexibility
the organization to be necessary to ensure the effective added with quot;to be necessaryquot;.
8 4.2.1 d Y Y Y Y
planning, operation and control of its processes.,and

e) records required by this International Standard (see Embedded in earlier bullets, no requirement
9 4.2.1 e Y Y
4.2.4) change.
NOTE 1 Where the term “documented procedure“ appears Additional clarification on requirement Vs
within this International Standard, this means that the documented procedure to accommodate smaller
procedure is established, documented, implemented and and bigger organizations.
10 4.2.1 1 maintained. A single document may include the N Y
requirements for one or more procedures. A requirement
for a documented procedure may be covered by more than
one document.



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to ensure that documents of external origin determined by This addition to requirement takes into
the organization to be necessary for the consideration practicality of identifying external
planning and operation of the quality management system documents and controlling distribution. There
are identified and their distribution controlled, may be many external documents to an
11 4.2.3 f Y Y Y
and organization including photocopier manual to ISO
9001 standard. The change gives flexibility for the
organization to determine external documents
that matters.
Records shall be established and maintained to provide Rephrased for consistency.
evidence of conformity to requirements and of the effective
operation of the quality management system shall be
controlled.Records shall remain legible, readily identifiable
and retrievable. The organization shall establish a
12 4.2.4 1 documented procedure shall be established to define the Y Y Y
controls needed for the identification, storage, protection,
retrieval, retention time and disposition of records.
Records shall remain legible, readily identifiable and
retrievable.

Top management shall appoint a member of the Clarification to prevent from organizations
organization’s management who, irrespective of other appointing consultants/ external members of
13 5.5.2 1 Y Y Y Y
responsibilities, shall have responsibility and authority that management as Quality Management
includes. representative.
Personnel performing work affecting conformity to product Conformity to quot;product requirementsquot; is much
quality requirements shall be competent on the basis of broader than quot;product quality requirementsquot;. This
14 6.2.1 1 Y N Y Y Y
appropriate education, training, skills and experience. is to accommodate safety, statutory, regulatory,
legal, etc.
NOTE Conformity to product requirements may be affected quot;directly or indirectlyquot; opens up many activities in
15 6.2.1 1 directly or indirectly by personnel performing any task N Y Y product lifecycle management.
within the quality management system.
16 6.2.2 6.2.2 Competence, training and awareness N Y Y No change, rearrangement of words.
determine the necessary competence for personnel Rephrased for consistency.
17 6.2.2 a performing work affecting conformity to product quality Y Y Y Y Y
requirements,
where applicable, provide training or take other actions to quot;where applicablequot; and quot;necessary competencequot;
satisfy these needs achieve the necessary competence, provides flexibility. However quot;satisfyquot; changed to
quot;achievequot;. This may raise expectations.
18 6.2.2 b Y N Y Y

supporting services (such as transport, or communication Since many organizations use Information
or information systems). systems to manage their MES, ERP,
19 6.3 c Y Y Y Y
documentation control, records control, backup,
recovery, etc. this addition is helpful.



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NOTE The term quot;work environmentquot; relates to conditions Typically users of the standard interpret
under which work is performed including physical, temperature, humidity, ESD, MSD, etc as work
environmental and other factors (such as noise, environment considerations to achieve conformity
temperature, humidity, lighting, or weather). to product requirements. Now this notes expands
20 6.4 1 N Y Y
to physical (Ergonomics), and factors like noise,
lighting , weather etc. This is probably added to
include certain work performed outdoor, extreme
situation, etc.
the need to establish processes and documents, and to No Comments.
21 7.1 b N Y
provide resources specific to the product;
required verification, validation, monitoring, measurement, Monitor is to keep track of systematically with a
inspection and test activities specific to the product and the view to collecting information. Measurement is to
criteria for product acceptance; determine the value of a quantity. That said, one
needs to measure in order to monitor. Inspection
22 7.1 c Y Y Y Y is evaluating conformity by observation and
judgement accompanied by measurement testing
or gauging. Testing is determining one or more
characteristics according to a procedure.

statutory and regulatory requirements related applicable to quot;Applicablequot; is broader than quot;relatedquot;. quot;Relatedquot;
the product, and requirements may be quot;applicablequot;. But
23 7.2.1 c Y Y Y Y Y
quot;applicablequot; requirements may not necessarily be
quot;relatedquot;
any additional requirements determined considered Provides flexibility and also opens up broader for
necessary by the organization. the organization to identify additional
24 7.2.1 d Y Y Y Y
requirements from overall product requirements
point of view.
NOTE Post delivery activities include, for example, actions Typically users of the standard have considered
under warranty provisions, contractual obligations such as warranty and maintenance are post delivery
maintenance services, and supplementary services such activities. Now the note clarifies quot;supplementary
as recycling or final disposal. services such as recycling or final disposalquot; also
25 7.2.1 1 N Y Y
part of the post delivery activities. With the
emphasis on ROHS, WEEE in the recent years,
this notes is helpful.

NOTE Design and development review, verification and Verification: Did you build the product right?
validation have distinct purposes. They may be conducted Validation: Did you build the right product?
26 7.3.1 1 and recorded separately or in any combination as suitable N Y Y Design and development review: Ensuring that
for the product and the organization. the requirements for building the right product are
right.
These The inputs shall be reviewed for adequacy. No Comments.
27 7.3.2 2 Requirements shall be complete, unambiguous and not in N Y
conflict with each other.



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The outputs of design and development shall be provided Output in the form of suitability is more
in a form that enables in a form suitable for verification straightforward than enabling. An output that
28 7.3.3 1 Y Y Y
against the design and development input and shall be enables may require additional work to make it
approved prior to release. suitable.
provide appropriate information for purchasing, production No Comments.
29 7.3.3 b N Y
and for service provision,
NOTE Information for production and service provision can This is an important note, often ignored when
include details for the preservation of product. requirement for product conformity are written.
30 7.3.3 1 N Y Y
This addition of preservation on purchasing
information is a useful clarification.
the availability and use of monitoring and measuring device Measuring Equipment may include instrument,
equipment, software, (in combination), standard, reference,
auxiliary apparatus required to realize a
31 7.5.1 d Y Y Y measurement process. Measuring equipment
usually has several metrological characteristics,
device is a machine or tool used for a particular
purpose.
the implementation of product release, delivery and post- Clarification as the release refers to product.
32 7.5.1 f Y Y Y
delivery activities.
The organization shall validate any processes for Relating two sentences in way that it is not
production and service provision where the resulting output interpreted separately. (This is the special
cannot be verified by subsequent monitoring or process scenario as it used to be referred in the
33 7.5.2 1 measurement This includes any processes where and as a Y Y Y earlier versions).
consequence, deficiencies become apparent only after the
product is in use or the service has been delivered.

The organization shall identify the product status with quot;throughout product realizationquot; addition will
respect to monitoring and measurement requirements explicitly include identification of product status
34 7.5.3 2 throughout product realization. Y N Y Y Y from product early build (Alpha units).

Where traceability is a requirement, the organization shall Rephrased for consistency.
35 7.5.3 3 control and record the unique identification of the product Y Y Y
and maintain records (see 4.2.4).
If any customer property is lost, damaged or Rephrased for consistency.
otherwise found to be unsuitable for use, this shall be
36 7.5.4 1 reported to the customer and records maintained the Y Y
organization shall report this to the customer and maintain
records (see 4.2.4).
NOTE Customer property can include intellectual property Personal data may include customer quote,
37 7.5.4 1 N Y Y
and personal data. inquiry, correspondence, etc.



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The organization shall preserve the conformity of product To be consistent with earlier references.
during internal processing and delivery to the intended Flexibility added to preservation.
destination in order to maintain conformity to requirements.
38 7.5.5 1 This As applicable, preservation shall include identification, Y Y Y Y
handling, packaging, storage and protection. Preservation
shall also apply to the constituent parts of a product.

7.6 Control of monitoring and measuring devices To be consistent with earlier references. (The
39 7.6 equipment Y Y term “devices” has a broader scope and could
include non-equipment types of tools).
The organization shall determine the monitoring and To be consistent with earlier references.
measurement to be undertaken and the monitoring and
40 7.6 1 measuring devices equipment needed to provide evidence Y Y
of conformity of product to determined requirements.(see
7.2.1)
a) be calibrated or verified, or both, at specified intervals, To accommodate equipment that require both
or prior to use, against measurement calibration and verification.
standards traceable to international or national
41 7.6 a measurement standards; where no such standards exist, Y Y Y Y
the basis used for calibration or verification shall be
recorded (see 4.2.4);

c) be identified to enable the calibration status to be Rephrased for consistency.
42 7.6 c determined; have identification in order to determine its Y Y
calibration status;
NOTE See ISO 10012-1 and ISO 10012-2 for guidance Reference to obsolete standard removed. This is
Confirmation of the ability of computer software to satisfy an important note that provides guidance to
the intended application would typically include its quot;softwarequot; piece of measuring equipment. It is not
43 7.6 1 verification and configuration management to maintain its N N Y Y Y uncommon for users to take software for granted.
suitability for use. Now with this added note, software will require
version controls, CM, and verification.

to demonstrate conformity of the product to product No Comments.
44 8.1 a Y Y Y
requirements,
NOTE Monitoring customer perception may include Notes expands various avenues for soliciting and
obtaining input from sources such as customer satisfaction capturing customer perception. It is typical that
surveys, customer data on delivered product quality, user organization use customer satisfaction survey,
45 8.2.1 1 N Y Y
opinion surveys, lost business analysis, compliments, user opinion surveys, focus groups, etc. Notes
warranty claims, dealer reports. suggests to also expand to other areas.

The selection of auditors and conduct of audits shall No Comments.
46 8.2.2 2 ensure objectivity and impartiality of the audit process. N Y
Auditors shall not audit their own work.



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The responsibilities and requirements for planning and Rephrased for consistency. Maintaining records
conducting audits, and for reporting results and of audit results called out as separate sentence
maintaining records (see 4.2.4) shall be defined in a for clarity.
documented procedure. A documented procedure shall be
47 8.2.2 3 established to define the responsibilities and requirements Y Y Y
for planning and conducting audits, establishing records
and reporting results. Records of the audit and their results
shall be maintained (see 4.2.4)

The management responsible for the area being audited Some flexibility added with quot;any necessaryquot;.
shall ensure that any necessary corrections and quot;corrections and correctivequot; is for consistency
48 8.2.2 4 Y Y Y Y Y
corrective actions are taken without undue delay to with other requirements.This statement is also
eliminate detected nonconformities and their causes. calling for broader actions.
NOTE See ISO 10011-1, ISO 10011-2 and 10011-3 ISO Add 19011 to quot;external documentquot; list.
49 8.2.2 1 N Y Y
19011 for guidance.
When planned results are not achieved, correction and 8.2.3 is about monitoring and measurement of
50 8.2.3 1 corrective action shall be taken, as appropriate. to ensure Y Y Y Y processes. This may be reason that narrowing to
conformity of the product. product is removed from the requirement.
NOTE When determining suitable methods, the Note suggests application of documents similar to
organization should consider the type and extent of Quality Plan and control plan to support the
monitoring or measurement appropriate to each of its implementation of 8.2.3
51 8.2.3 1 N Y Y
processes in relation to their impact on the conformity to
product requirements and on the effectiveness of the
quality management system.
This shall be carried out at appropriate stages of the No Change, sentence moved up from a
product realization process in accordance with the planned subsequent para.
52 8.2.4 1 arrangements (see 7.1). Evidence of conformity with the N Y
acceptance criteria shall be maintained.

Evidence of conformity with the acceptance criteria shall be Clarification as to which document require
maintained. Records shall indicate the person(s) authorization. Release of product happens at
53 8.2.4 2 Y Y Y Y Y
authorizing release of product for delivery to the customer various stages of product realization.
.(see 4.2.4)
Product release and service delivery The release of Product Service and service delivery might mean
product and delivery of service to the customer shall not something different than the intent of 8.2.4.
proceed until the planned arrangements (see 7.1) have Added specifics quot;to the customerquot;.
54 8.2.4 3 Y Y Y Y Y
been satisfactorily completed, unless otherwise approved
by a relevant authority and, where applicable, by the
customer.



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The controls and related responsibilities and authorities for Rephrased for consistency.
dealing with nonconforming product shall be defined in a
documented procedure. A documented procedure shall be
55 8.3 1 Y Y Y
established to define the controls and related
responsibilities and authorities for dealing with
nonconforming product.
Where applicable, the organization shall deal with Flexibility added to the requirement to
nonconforming product by one or more of the following accommodate situations where organization does
56 8.3 2 Y Y Y
ways: not have authority or control to deal with non
conforming product.
by taking action appropriate to the effects, or potential Moved from para to bullet and rephrased. No
57 8.3 d effects, of the nonconformity when nonconforming N Y change.
product is detected after delivery or use has started.
conformity to product requirements (see 7.2.1), (see 8.2.4) Cross reference corrected.
58 8.4 b Y Y
characteristics and trends of processes and products Cross reference added.
59 8.4 c including opportunities for preventive action, (see 8.2.3 and Y Y
8.2.4) and
60 8.4 d suppliers.(see 7.4) Y Y Cross reference added.
The organization shall take action to eliminate the cause s There may be multiple causes for
of nonconformities in order to prevent recurrence. nonconformities. There may be a single
61 8.5.2 1 Corrective actions shall be appropriate to the effects of the Y Y Y significant cause.
nonconformities encountered.

reviewing effectiveness of the corrective action taken. Effectiveness: Extent to which planned corrective
62 8.5.2 f Y N Y Y actions are realized and planned results
achieved.
reviewing effectiveness of the preventive action taken. Effectiveness: Extent to which planned preventive
63 8.5.3 f Y N Y Y actions are realized and planned results
achieved.


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