Leland R. Beaumont, Establishing Compliance since 1991.

Wrote ISO
9001 The Standard Interpretation.
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Standardization.

https://www.quora.com/What-are-the-documents-and-records-we-need-for-ISO-
9001-certification
The documents required for ISO 9001:2008 are: Quality Policy, Quality Manual, and
documented procedures for the following six activities:
· 4.2.3 Control of documents
· 4.2.4 Control of records
· 8.2.2 Internal audit
· 8.3 Control of nonconforming product
· 8.5.2 Corrective action
· 8.5.3 Preventive action

The standard requires (by use of the phrase “see 4.2.4” in each of the cited sections)
retaining the following 19 types of records:
1. Records from management reviews (5.6.1)
2. Records of education, training, skills and experience (6.2.2)
3. Records needed to provide evidence that the realization processes and resulting
product meet requirements (7.1)
4. Records of results of the product requirements review and actions arising from
the review (7.2.2)
5. Inputs relating to product requirements (7.3.2)
6. Records of results of design and development reviews and any necessary actions
taken (7.3.4)
7. Records of the results of the verification and any necessary actions taken (7.3.5)
8. Records of the results of validation and any necessary actions taken (7.3.6)
9. Records of the results of the review of design changes and any necessary actions
taken (7.3.7)
10. Records of the results of supplier evaluations and any necessary actions arising
from the evaluation (7.4.1)
11. Records required for validation of processes for production and service provision
(7.5.2)
12. Where traceability is required, records of the unique identification of the product
(7.5.3)
13. Records of the loss of any customer property (7.5.4)
14. Records of the results of calibration and verification (7.6)
15. Records of internal audits (8.2.2)
16. Records indicating the person(s) authorizing release of product (8.2.4)
17. Records of the nature of nonconformities and any subsequent actions taken,
including concessions obtained (8.3)
18. Records of the results of corrective action taken (8.5.2)
19. Records of results of preventive action taken (8.5.3)
 Records in ISO 9001:2015
Oct 20, 2015
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ISO 9001:2015 does a lot of things right, but using clear language
is not one of them. One of the most glaring examples is the
transformation of the word “records” into “retained documented
information.” That’s right, they took one word and turned it into
three. And the three words are not nearly as intuitive as the one
word they replaced. Regardless of what you call them, records are
the proof of something happening. They are historical, referring to
past events. As such, they are not revised. Records might be
“corrected” in some cases, but they are never revised. Only
documents are revised. (We’ll address documents and their status
in ISO 9001:2015 in a future article.) The primary control of
records is that of housekeeping: knowing where they are stored,
who is responsible, how long they’re kept, etc.

Here is a summary of records requirements in ISO 9001:2015:

 24 records are required in ISO 9001:2015. This is compared

to 21 records required in ISO 9001:2008. Some of the 24 records
required by ISO 9001:2015 are actually repeat requirements.
 20% of all the record requirements come from section 8.3,
Design and development of products and services. That amounts
to 5 records, which is the same number required by ISO
9001:2008.

 A completely new record that is required in 9001:2015 is

retained information on changes: review of changes, persons
authorizing the change, and necessary actions arising from
change (section 8.5.6)

 ISO 9001 continues its redundant ways. ISO 9001:2015

requires records of evidence of processes being carried out
effectively TWICE, once in section 4.4.2 and again in section
8.1.e.1.

 More redundancy: ISO 9001:2015 requires records that

demonstrate conformity of products & services processes TWICE,
once in section 8.1.e.2 and again in section 8.6.

 5 of the records in ISO 9001:2015 have qualifiers. They are

“to the extent necessary” and “as applicable.”

 One item listed as “retained documented information” (i.e.,

record) is actually a document. That is design outputs. Design
outputs are living information such as specifications, engineering
drawings, recipes, formulas, and bills of material. Since they are
living, they are subject to revision, meaning they are documents.

 A handful of requirements would be virtually impossible to

have evidence of without records, and yet records are not
required by ISO 9001:2015. These include context of the
 organization (4.1), interested parties (4.2), planning of changes
(6.3), and customer feedback (9.1.2).

 One of the strangest record issues of all is the omission of

calibration records in ISO 9001:2015. This has been replaced by
the requirement to ‘retain information on fitness of purpose for
measuring instruments,’ which would include calibration, among
other possible activities. I expect many people implementing ISO
9001:2015 will get a bit confused by this.

Do not let anyone tell you that the “correct” terminology is

retained documented information. If you like that term, then by all
means use it. If you prefer the term ‘records,’ you can use that in
its place. Always remember that documents and records are two
different things. That one fact alone will make any QMS easier to
use and understand.

About the Author

Craig Cochran has assisted over 5,000 companies since 1999 in
QMS implementation, problem solving, auditing, and performance
improvement. His most recent book is ISO 9001:2015 in Plain
English, available from Paton Professional.