You must add to the list:
- 4.3 c)
- 4.4.2 a)
- 4.4.2 b)
- 5.2.2 a)
- 6.2.1
- 7.1.5.2 a)
- 8.1 e)
- 8.4.1
- 8.5.2
- 4.3 c)
- 4.4.2 a)
- 4.4.2 b)
- 5.2.2 a)
- 6.2.1
- 7.1.5.2 a)
- 8.1 e)
- 8.4.1
- 8.5.2
Informational Required Documents/Records in ISO 9001:2015
- Thread starter drgnrider
- Start date
7.1.3 doesn't ask for any record.
Auditing this clause is almost a joke, without the necessity of records...
Auditing this clause is almost a joke, without the necessity of records...
Quality-Nation
On Holiday
Why?
Because if you want, you don´t need to have any records (not required by the actual ISO 9001).
Quality-Nation
On Holiday
Why is auditing without records a joke?
There are a lot of things in the standard that don't require documents or records.
There was a time when auditors were actually trained (or seemed to be) that for every shall in the standard the auditee needed to produce a piece of paper (a document or record or sometimes even both). The standard NEVER required it.
Besides looking at documents and records, there are two more tools auditors have, and that is interviewing and observing. Even if there are documents and records to look at for a particular shall, they can still interview and observe (and often do).
An example on maintenance where an auditor could write a nonconformance even though maintenance records are not required would be if there are frequent breakdowns causing production delays and messing up delivery schedules or producing bad parts. The standard still requires that the infrastructure be determined, provided, and maintained.
By the way, if an organization chooses to keep maintenance records, they can be audited.
There was a time when auditors were actually trained (or seemed to be) that for every shall in the standard the auditee needed to produce a piece of paper (a document or record or sometimes even both). The standard NEVER required it.
Besides looking at documents and records, there are two more tools auditors have, and that is interviewing and observing. Even if there are documents and records to look at for a particular shall, they can still interview and observe (and often do).
An example on maintenance where an auditor could write a nonconformance even though maintenance records are not required would be if there are frequent breakdowns causing production delays and messing up delivery schedules or producing bad parts. The standard still requires that the infrastructure be determined, provided, and maintained.
By the way, if an organization chooses to keep maintenance records, they can be audited.
Randy
Super Moderator
Here young'uns, quit playing the silly "A" word game.
Mandatory Records ISO 9001:2015
7.1.5.1 Record of Maintenance and Calibration of Monitoring and Measuring Equipment
7 .2 Competence Records
8.2.3.2 Product/Service Requirements Review Record
8.2.3.2 Record of New Requirements for Product or Service
8.3.3 Design and Development Inputs Record
8.3.4 Record of Design and Development Controls
8.3.5 Design and Development Outputs Record
8.3.6 Record of Design and Development Changes
8.4.1 Record of Evaluation of External Provider (supplier)
8.5.1 Record of Product/Service Characteristics
8.5.3 Record of Changes on Customer’s Property
8.5.6 Record of Changes in Production/Service Provision
8.6 Evidence of Product/Service Conformity
8.7.2 Record of Nonconformity
9.1.1 Monitoring Performance Information
9.2.2 Internal Audit Program and Results
9.3 Management Review Results
10.2.2 Nonconformities and Corrective Action
Mandatory Records ISO 9001:2015
7.1.5.1 Record of Maintenance and Calibration of Monitoring and Measuring Equipment
7 .2 Competence Records
8.2.3.2 Product/Service Requirements Review Record
8.2.3.2 Record of New Requirements for Product or Service
8.3.3 Design and Development Inputs Record
8.3.4 Record of Design and Development Controls
8.3.5 Design and Development Outputs Record
8.3.6 Record of Design and Development Changes
8.4.1 Record of Evaluation of External Provider (supplier)
8.5.1 Record of Product/Service Characteristics
8.5.3 Record of Changes on Customer’s Property
8.5.6 Record of Changes in Production/Service Provision
8.6 Evidence of Product/Service Conformity
8.7.2 Record of Nonconformity
9.1.1 Monitoring Performance Information
9.2.2 Internal Audit Program and Results
9.3 Management Review Results
10.2.2 Nonconformities and Corrective Action
Not all evidence are based from documents. Audit evidence is defined as "records, statements of fact or other information, which are relevant to the audit criteria and verifiable". The ISO 9001 Auditing Practices Group Guidance on Evidence Collection of the International Accreditation Forum also provided this statement: "Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001".
You can also refer to this previous post.
Right, but QMS processes also produce by themselves documented information ( records) , that organization can decide to retain, even though not required by ISO 9001 standard ( it could also be a customer requirement in this sense)
Randy
Super Moderator
Then they are required as a customer requirement
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