Documentation Requirements

38 Required Records of ISO 9001:2015 (20) & IATF 16949:2016 (18)

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

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

New IATF 16949 Documented Policies and Documented Processes

3 Documented Policies required by IATF 16949:2016
#     Clause     Requirement
1      5.1.1.1       Corporate Responsibilities policies, including (minimum)
                         a.    Anti-bribery Policy
                         b.    Employee Code of Conduct Policy
                         c.    Ethics Escalation (“whistle-blowing”) Policy
2      5.2.1        Quality policy
3    7.5.3.2.1     Record Retention policy


21 Documented Processes required by IATF 16949:2016

#    Clause        Requirement
1    4.4.1.2       Product safety
2    7.1.5.2.1    Calibration/verification records
3    7.2.1    Competence - supplemental
4    7.2.3    Internal auditor competency
5    7.3.2    Employee motivation and empowerment
6    7.5.3.2.2    Engineering specifications
7    8.3.1.1    Design and development of products and services – supplemental
8    8.3.3.3    Special characteristics
9    8.4.1.2    Supplier selection process
10    8.4.2.1    Type and extent of control - supplemental (outsourced processes)
11    8.4.2.2    Statutory & regulatory requirements
12    8.4.2.4    Supplier monitoring
13    8.5.6.1    Control of changes - supplemental
14    8.5.6.1.1    Temporary change of process controls
15    8.7.1.4    Control of reworked product
16    8.7.1.5    Control of repaired product
17    8.7.1.7    Nonconforming product disposition
18    9.2.2.1    Internal audit program
19    10.2.3    Problem solving
20    10.2.4    Error-proofing
21    10.3.1    Continual improvement - supplemental