0.1 Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It’s also clarified that these requirements are restricted to those applicable to the product.
0.4 There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
1.1 &1.2 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.
After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.
2Normative reference – the ISO 9000 is now replaced by ISO 9000:2005.
3The explanations about what is a customer and what is an organization and what is a supplier had been removed.
4.1 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.
4.2.1 Slight change of words but when you examine the change you realize the meaning is the same.
Note 2 was changed – a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.
It’s about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book – now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the requirements.
4.2.3 A clarification that external documentation is considered while it is part of the quality management system.
5.1 Clause a – the word “statutory” had been added.
5.5.2 An addition for a requirement that the management representative would be a member of the organization’s management.
That addition puts all external consultants at risk – you can no longer be the
management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative.
6.2.2Clause 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”
Clause c – you must ensure that the training is with competence rather than if it was an effective training.
It all goes back to defining .You defined what is necessary now you must provide it nothing is new.
On one hand it is an improvement. The training must be reviewed before. But I think it’s not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before.
6.3 Clause c – information systems are included.
6.4 A new note: noise, humidity, temperatures are part of a working environment.
7.1 Clause c – measurement had been added to the activities.
7.2.1
Clause a – change of words – not of the meaning.
Clause c – the word ‘applicable’ replaces ‘related’.
Clause d – change of words – not of meaning.
A note has been added to explain what is the meaning of “post delivery activities”.
7.3.1 A note had been added clarifying that design review, verification and
validation are separated processes but they might be conducted together.
7.3.3
A change of words.
A note had been added clarifying what is included in “preservation of product”.
7.5.3 A requirement added specifying that product traceability must be included throughout the product realization.
That actually means that the product must be identified not only on the shelves after or between, but also throughout the realization process. Is pacticable? Only time will tell…
7.5.4
A change of words in the requirement to inform the customer of any problem
regarding his property.
The note had been amended that also personal data is included as customer’s
property.
7.5.5
A change of words:
from “conformity of” to “in order to maintain conformity to requirements”.
7.6
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 100012-2 had been removed.
Note 3 – explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
That means that from now on a computers that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done.
8.2.1
A note had been added to suggest some means of conducting customer satisfaction evaluation.
8.2.2
Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.
8.2.3
A change of words:
“to ensure conformity of the product” had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
8.2.4
A change of word:
“maintain evidence of conformity with acceptance criteria” had been removed but it is still a requirement.
8.3
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.
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