Key: Changes in the ISO 9000-2008 standard are in this standard
block type.
Our comments are in blue
italics type.
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.
Our Comment: This has been the
intention of the ISO 9001 standard since 1987. The standard does not cover incidental
by-products.
Clause 0.2 (Process approach) - Text added to emphasize the
importance of processes being capable of achieving desired outputs.
Our Comment: This clarifies that processes must be measured to
determine if its objectives are being attained.
Clause 0.4 (Relationships) - A comment was
added that states that the new standard is made due consideration to ISO 14001:2004.
Our Comment: The world is
becoming evermore environmentally conscious, so they remind us of the ISO 14001 standard. I believe and
recommend to any organization that is in need of the ISO 14001 standard to implement the 9001, also. There is a
big correlation between these two. They actually help one another.
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.
Our Comment: After so many years of auditions the long last debate has been settled. Statutory legal
requirements and statutory requirements are obliged to the purchasing processes. Is your supplier required to
follow the law or not? Yes.
Clause 1.1 (Scope - General) - Clarification that product also
includes intermediate product. Explanation regarding statutory, regulatory and legal
requirements.
Our Comment: Product is product
at any stage of creation.
Clause 2 (Normative Reference) - Updated to read ISO
9000:2005
Clause 3 (Definitions) - Explanation about what is a customer and what is an organization
and what is a supplier had been removed.
Our
Comment: This explanation was superfluous.
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.
Our Comment: This has always
been the interpretation and understanding in the U.S.
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.
Our
Comment: There was never a restriction against this, In fact, it is not uncommon to find companies that have
combined their Corrective Action procedures and Preventive Action procedures into one procedure. Another
example is combining training and competency procedures.
Clause 4.2.3 (Control of documents) - Clarification regarding the
documents of external origin that need to be controlled.
Our Comment: If the document is
needed for the quality system, regardless of its origin, it must be controlled.
Clause 5.1 (General) - The word "statutory" has been
added.
Our Comment: An original
oversight.
Clause 5.5.2 (Management representative) - Clarifies that this
person must be a member of the organization’s own management.
Our Comment: This change takes
external consultants out of the running for this job - they can no longer be the management
representative.
Clause 6.2 (Human Resources) - Change of words from "affecting product quality" to
"affecting conformity to product requirements"
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".
Our Comment: It all goes back
to defining .You defined what is necessary now you must provide it - nothing is
new.
Clause c - you must ensure that the training is with competence
rather than if it was an effective training.
Our Comment: On one hand it is
an improvement. The training method must be reviewed before the training starts. We don't believe this is an
improvement. Instead of testing your employees, if they got anything of the training, you must now check the
training itself before. Only time will tell...
Clause 6.3, Clause c (Infrastructure) -
Information systems are included.
Our Comment:
Duh!
Clause 6.4 (Work environment) - A note has been added to clarify
the term work environment to include noise, humidity and temperature.
Our Comment: The next thing you
know they will add a note stating that work environment includes air.
Clause 7.1, Clause c (Planning of Product Realization) - measurement had been
added to the activities
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.
Our Comments: What were some
companies thinking that "post-delivery" meant? Answering the phone to take another order! The critical thing
here is that the post-delivery activity has to be a contractual obligation not a
courtesy.
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.
Our Comment: Review,
verification and validation are different and distinct. They may be performed at the same
time.
Clause 7.3.3 (Design & development outputs) - Clarifies that
information needed for production and service provision may include preservation of the
product.
Our Comment: If appropriate,
the design process must include how to preserve and maintain the product until it is in the customers'
hands.
Clause 7.5.3 (Identification and Traceability) A
requirement added specifying that product traceability must be included throughout the product
realization.
Our Comment: That actually
means that the product must be identified not only on the shelves but also throughout the realization
process.
Clause 7.5.4 (Customer property) - A note has been added to
specify that personal data should be considered customer property.
Our Comment: By adding personal
data to the definition it now requires that we inform the customer of any loss or damage to the
data.
Clause 7.5.5 (Preservation of product) - Clarification that
preservation of the product relates to the maintenance of conformity to requirements.
Our Comment: Should not have an
effect on any company that actually maintained and preserved the product
integrity.
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.
Our Comment: No significant
change here. The standard has required that software be validated if used for monitoring or measuring purposes.
We have been asked if a computer must be calibrated. If you establish that your software consistently provides
correct responses that is all that is needed. If the software does not perform correctly, you might want to
install it on another computer or two to see if that changes the output.
Clause 8.2.1 (Customer satisfaction) - Note added to provide
examples of how customer satisfaction data could be collected.
Our Comment: Expansion of the
concept that this is a pro-active method. Companies must reach out to their customers to determine the
customer's perception of how the company is doing in meeting the customer's
needs.
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.
Our Comment: This has been the
general understanding of the requirement. The question is "What is meant by the term 'management'? Can a team
leader be considered management? I assume that is upto the company to define.
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.
Our Comment: Many companies
argued that not all processes had a product or conformity requirements. This argument is the result of not
having a clear understanding of what is meant by product or internal customer and supplier
relationships.
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.
Our Comment: This could
effectively excuse you from making certain that a product in process that is sent to a subcontractor for work
meets requirements. Logically that would be foolish, but...
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.
Our Comment: The requirement
has been in the standard and no changes are needed.
