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Clause 0.1
(General) - Changes here are a statement about who and where the standard is to apply including any
statutory requirements and have the same value as any customer or regulatory requirements. It
has also clarified that these requirements are restricted to those applicable to the product
only. |
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Clause 0.2 (Process approach) - Text added to emphasize
the importance of processes being capable of achieving desired outputs. |
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Clause 0.4 (Relationships) - A comment was
added that states that the new standard is made due consideration to ISO
14001:2004. |
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Statutory requirements had been referred in connection
with purchased products and product realization. Second note explains that a statutory requirement
can be a legal requirement. |
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Clause 1.1 (Scope - General) - Clarification that
product also includes intermediate product. Explanation regarding statutory, regulatory and legal
requirements. |
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Clause 2 (Normative Reference) - Updated to read ISO
9000:2005 |
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Clause 3 (Definitions) - Explanation about what is a
customer and what is an organization and what is a supplier had been removed. |
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Clause 4.1 (General requirements) - Addition of a note
to clarify outsourced processes as well as the types of control that may be applied to such
processes.
Clause a - The word "determine" is replacing the "identify". A note had been added stating that a
purchased processes are regarded as purchasing products and another note that demand that these
processes would be controlled as far as products. |
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Clause 4.2.1 (Documentation requirements - General) -
Clarification that QMS documentation also includes records. Clarification that one document may
include the requirements of one or more procedures, and that the requirements of one procedure may
be covered by more than one document. |
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Clause 4.2.3 (Control of documents) - Clarification
regarding the documents of external origin that need to be controlled. |
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Clause 5.1 (General) - The word "statutory" has been
added. |
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Clause 5.5.2 (Management representative) - Clarifies
that this person must be a member of the organization’s own management. |
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Clause 6.2 (Human Resources) - Change of words from
"affecting product quality" to "affecting conformity to product requirements" |
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Clause 6.2.2 (Competence, training and awareness) -
Clause b -"provide training or take other actions to satisfy these needs" changed to "where
applicable training needs to be provided to achieve the necessary competence". |
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Clause c - you must ensure that the training is with
competence rather than if it was an effective training. |
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Clause 6.3, Clause c (Infrastructure) -
Information systems are included. |
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Clause 6.4 (Work environment) - A note has been added to
clarify the term work environment to include noise, humidity and temperature. |
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Clause 7.1, Clause c (Planning of Product
Realization) - measurement had been added to the activities |
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Clause 7.2.1 (Determination of requirements related
to the product) - Clarifies that post-delivery activities may include actions under warranty
provisions, contractual obligations such as maintenance services and supplementary services such as
recycling or final disposal.
Clause c- the word 'applicable' replaces 'related'.
Clause d - change of words - not of meaning.
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Clause 7.3.1 (Design & development planning) -
Clarifies that design and development review, verification, and validation have distinct purposes
but may be conducted and recorded separately or in any combination as suitable for the product and
the organization. |
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Clause 7.3.3 (Design & development outputs) -
Clarifies that information needed for production and service provision may include preservation of
the product. |
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Clause 7.5.3 (Identification and
Traceability) A requirement added specifying that product traceability must be included
throughout the product realization. |
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Clause 7.5.4 (Customer property) - A note has been added
to specify that personal data should be considered customer property. |
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Clause 7.5.5 (Preservation of product) - Clarification
that preservation of the product relates to the maintenance of conformity to
requirements. |
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Clause 7.6 (Now retitled Control of monitoring and
measuring equipment) - Addition of a note related to the confirmation of computer software used as
monitoring and measuring equipment.
A change of words: from "devices" to "equipment" The
reference to paragraph 7.2.1 had been removed. Clause c - from "be identified to enable the" to "
identification to enable their"
Changes in the notes: Note 1 - the reference to ISO
10012-2 had been removed. Note 3 - explanation about when configuration of computer must be applied
when the computer is used for monitor and measurements processes.
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Clause 8.2.1 (Customer satisfaction) - Note added to
provide examples of how customer satisfaction data could be collected. |
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Clause 8.2.2 (Internal audit) - Editorial changes to
clarify this requirement of the standard. Requirements for the audit evidence and results had been
added and also that management is responsible for ensuring preventive and corrective action to
be taken. The reference to the ISO 10011 is changed to ISO 19011. |
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Clause 8.2.3 (Monitoring and measurement of processes) -
A change of words: "to ensure conformity of the product" had been removed. A note added to clarify
that when deciding on appropriate methods, the organization should consider impact on the
conformity to product requirements and on the effectiveness of the quality management
system. |
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Clause 8.2.4 (Monitoring and measurement of product) -
Clarification that the release of the product relates to the delivery to the customer. A change of
wording: "maintain evidence of conformity with acceptance criteria" has been removed but it is
still a requirement. |
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Clause 8.3 (Control of Nonconforming Product) - An
addition - Clause d - specify how to deal with a nonconforming product that was discovered after
delivery - but actually there nothing new only that they moved it to a new clause. |
