38 Required Records of ISO 9001:2015 (20) and IATF 16949:2016 (18)
UPDATED 2/22/23: ISO 9001:2015 has changed several terms and definitions. One of the key terms with the latest version is “documented information”, which I find to be confusing and unnecessary. With a focus to ensure service industry organizations feel included (i.e. they buy copies of the ISO 9001 standard), ISO/TC 176 uses the term documented information to include what was previously referred to as documented procedures, records and other documentation.
In ISO 9001:2008 and 2000, the practitioners could use the terms “(see 4.2.4)” and the word “record” to easily spot where there was a record requirement to be fulfilled. That indicator is no longer in the standard, so we’ve extracted all of the record requirements below.
QMS - ISO 9001:2015
0 4.4 - Confidence (as needed)
1 7.1.5.1 - Accurate measurement resources
2 7.1.5.2 - Basis used for calibration
3 7.2 - Competence of people
4 8.2.3.2 - Requirements review
5 8.3.2 - D&D Requirements met
6 8.3.3 - D&D Inputs
7 8.3.4 - D&D Controls
8 8.3.5 - D&D Outputs
9 8.3.6 - D&D Changes
10 8.4.1 - External provider (supplier) monitoring
11 8.5.2 - Unique ID
12 8.5.3 - Unsuitable customer or supplier property
13 8.5.6 - Changes to product or service
14 8.6 - Authorized release
15 8.7 - Nonconformity & action authority
16 9.1.1 - QMS performance evaluation
17 9.2.2 - Audit program results
18 9.3.3 - Management Review
19 10.2.2 - Nature & action of nonconformities
20 10.2.2 - Corrective action results
IATF 16949:2016 builds on the records requirements by adding 18 more records at a minimum that must be retained.
Automotive QMS – IATF 16949
21 6.1.2.1 - Risk analysis
22 6.1.2.3(g) - Contingency plans
23 7.1.5.1.1 - MSA
24 7.1.5.2.1 - Calibration/verification records
25 7.1.5.2.1(d) - Calibration/verification validity of previous measurement results
26 7.2.3 - Internal auditor competency
27 7.5.1.1 - QMS documentation - series of documents list
28 7.5.3.2.2 - Engineering specifications
29 8.2.3.1.1 - Review of requirements for products & services - supplemental
30 8.3.2.3 - Development of product with embedded software
31 8.3.4.4 - Product approval process
32 8.4.2.3.1 - Automotive product-related software or automotive products with embedded software
33 8.4.2.4.1 - Second-party audits
34 8.5.1.3(e) - Verification of job set-ups
35 8.5.2.1(d) - Identification & traceability - supplemental
36 8.7.1.4 - Control of reworked product
37 8.7.1.5 - Control of repaired product
38 9.1.1.1 - Monitoring & measurement of manufacturing processes
Additional Records implied in IATF 16949
39 8.3.6.1 (2nd P) - Documented approval or waiver from customer regarding design changes
40 8.3.6.1 (3rd P) - Documented revision level of software & hardware as part of change record
41 8.5.2.1 (d) - Record of identification & traceability for timely retrieval (i.e. customer/regulatory response time)
42 8.7.1.6 - Documented event of customer notification that N/C product has been shipped