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.

Documented information (records) requirements in ISO 9001:2015 and a tool to track their maturity. Click image to download PDF.

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

---

Documented information (records) requirements in IATF 16949:2016 and a tool to track their maturity. Click image to download PDF.

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