List of Mandatory Records required by ISO 9001:2008

D

Daksh

#1
Can anyone post the list of mandatory records required by ISO 9001:2008 standard ?

Thanks in advance
 
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howste

Thaumaturge
Super Moderator
#2
Re: Mandatory Records As per ISO 9001:2008

How's this?

4.2.1 Records determined by the organization to be necessary to ensure effective planning, operation and control of processes
5.6.1 Records of management review
6.2.2 Records of education, training, skills, and experience
7.1 Records of evidence that realization processes and product meet requirements
7.2.2 Records of review of customer requirements and follow-up actions
7.3.2 Records of design and development input
7.3.4 Records of design and development review
7.3.5 Records of design verification actions
7.3.6 Records of design validation actions
7.3.7 Records of design changes and results
7.4.1 Records of the evaluation of suppliers
7.5.2 Records of special process validations
7.5.3 Records of the unique identification of product (traceability)
7.5.4 Records of lost, damaged or unsuitable customer property
7.6 Records of the basis of calibration used when no traceable standards exist
7.6 Records of the results of calibration
7.6 Records of assessment of product when calibration is out of tolerance
8.2.2 Records of internal audits
8.2.4 Records of person(s) authorizing release of product to the customer
8.3 Records of the nature of nonconformities and subsequent actions
8.5.2 Records of the results of corrective action taken
8.5.3 Records of the results of preventive action taken
 
D

Daksh

#3
Re: Mandatory Records As per ISO 9001:2008

Thanks a lot....
I think record requirements for 4.2.1 , 7.6 (Records of assessment of product when calibration is out of tolerance) and 8.2.4 are added new to 2008 version
 

howste

Thaumaturge
Super Moderator
#4
Re: Mandatory Records As per ISO 9001:2008

Both were included in the previous version, but 4.2.1 just mentioned "documents" (a record is a kind of document) instead of explicitly stating records.
 

Colin

Quite Involved in Discussions
#5
Re: Mandatory Records As per ISO 9001:2008

Daksh, please don't forget, these are the records required by ISO 9001 and do not necessarily include the records your organisation may choose to keep. e.g. delivery notes and copies of purchase orders are not mentioned in that list but most organisations would want to keep them.
 
D

Daksh

#6
Re: Mandatory Records As per ISO 9001:2008

Both were included in the previous version, but 4.2.1 just mentioned "documents" (a record is a kind of document) instead of explicitly stating records.
Daksh, please don't forget, these are the records required by ISO 9001 and do not necessarily include the records your organisation may choose to keep. e.g. delivery notes and copies of purchase orders are not mentioned in that list but most organisations would want to keep them.
thanks a lot for your inputs :)
 
Last edited by a moderator:
Z

zulu warrior

#7
Re: List of Mandatory Records As per ISO 9001:2008

ISO has a guidance document titled "Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008", wherein Annex B is a list of records required by ISO 9001:2008. This is their own list of required records.
Clause Record required
5.6.1 Management reviews
6.2.2 Education, training, skills and experience
7.1 d Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3. Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 Results of corrective action
8.5.3 Results of preventive action
 
Last edited by a moderator:
W

w_grunfeld

#8
Re: List of Mandatory Records As per ISO 9001:2008

This is exactly the same list as in : ISO/TC 176/SC 2/N525,October 2000
Not a word changed
FYI
 
J

JoeOB

#9
Re: Mandatory Records As per ISO 9001:2008

7.6 Records of assessment of product when calibration is out of tolerance
Greetings:

How does this compare to AS9100? This statement focuses on keeping a record of product assessment, but my reading of the AS9100 standard is that it focuses on keeping a record of the calibration/verification of calibration. No requirement is made for keeping a record of out-of-calibration product decision and action, only that the organization take appropriate action.

What do you think?

Thanks,

J.
 
Last edited by a moderator:

howste

Thaumaturge
Super Moderator
#10
Re: Mandatory Records As per ISO 9001:2008

Greetings:

How does this compare to AS9100? This statement focuses on keeping a record of product assessment, but my reading of the AS9100 standard is that it focuses on keeping a record of the calibration/verification of calibration. No requirement is made for keeping a record of out-of-calibration product decision and action, only that the organization take appropriate action.

What do you think?

Thanks,

J.
Let's read what the standard says. AS9100 is word-for-word identical to ISO 9001 for this requirement:
AS9100 said:
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.
 
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