You are on page 1of 11

Objective Evidence Records

IATF 16949:2016
This document may neither be copied nor reproduced in any form;
it remains the intellectual property of Quality Austria.
 Copyright 2021, by Quality Austria Certification and Evaluation Ltd.

Purpose

☐ Self-assessment ☐ Recertification-audit
☐ Pre-audit ☐ Post-audit
☐ Certificate-audit ☐
☐ Surveillance-audit

Audit date (start/end):

Organization

Name:
Order Number:

Audit team

1. Auditor (Lead): Signature:

2. Auditor: Signature:

3. Auditor: Signature:

Observer: Signature:

No.: CL_27_01_162e Edition: 2021/07 Page 1 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Objective Evidence Record
This document contains only keywords (or abbreviated texts) on the individual requirements
Requirements results out of the following standards:
Q= ISO 9001&IATF; without special remark =Q= ISO 9001 (Q is not separate marked),
I = IATF 16949 check = this point was assessed
in the course of the audit and the
Standard requirement is met
S Reference Requirements Action
4.1 Determination of external and internal issues /
relevant to purpose / strategic direction of the
 
organization / that affect the ability to achieve the
intended results This point was assessed in the
Monitor and review the information about these A course of the audit and the
external and internal issues Standard requirement is not
4.2 Determination, under consideration of customer and H met (>Action protocol).
applicable statutory and regulatory requirements, of:

This point was assessed in the


S Reference Requirements Action
course of the audit and the
7.2 Determination of the necessary competence / Standard requirement is met,
affecting the performance and effectiveness of the but there is an opportunity for
QMS
improvement (>Audit report
Ensuring the competence
Hints).
 education

 training
This point was not assessed in
 experience
the course of the audit

(e.g. in SA).
IF there is not enough space in the section „ Reference / Findings / Nonconformities (No. of action protocol)
/ Hints / Recommendations, sheets of the qualityaustria notepad should be used.

Starting End point


point

Sources of Receivers of
Inputs Inputs Activities Outputs Outputs

PREDECESSOR MATTER, SUBSEQUENT


MATTER,
PROCESSES ENERGY, PROCESSES
ENERGY,
e.g. at providers INFORMATION e.g. at
INFORMATION
(internal or e.g. in the form customers
e.g. in the form
external), at of materials, (internal or
of product,
customers, at resources, external), at
service, decision
other relevant requirements other relevant
interested interested
parties parties

Possible controls and


check points to
monitor and measure
performance

Figure 1 (ISO 9001:2015) – Schematic representation of the elements of a single process

No.: CL_27_01_162e Edition: 2021/07 Page 2 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Current situation – developments since the last audit

No.: CL_27_01_162e Edition: 2021/07 Page 3 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Audit records

Vision:

Mission:

Policy:

Significant internal and external issues (context):

Strategic direction:

Programs:

Audit objectives (additional to the audit plan):

No.: CL_27_01_162e Edition: 2021/07 Page 4 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Auxiliary list IATF 16949:2016 requirements

Reference Objectives to fulfill Check

4.1 Understanding the organization and its context


4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.3.1 Determining the scope of the quality management system - supplemental
4.3.2 Customer-specific requirements (client’s process for gathering, communicating, and implementing customer-
specific requirements)
Rules 5.8j The process for gathering, communicating, and implementing customer-specific requirements
Rules 5.8i Implementation of requirements for new customers since the last audit
4.4 Quality management system and its processes
4.4.1 Inputs, outputs, interactions, performance indicators, etc.
Rules 5.8h Ensuring that key customer performance objectives/targets are met and that corrective action plans are in
place if these objectives/targets are not met
4.4.1.1 Conformance of products and processes
Rules 5.8l Focus on the processes which directly impact the customer
4.4.1.2 Product safety
4.4.2 documented information, maintain, retain

5.1 Leadership and commitment


5.1.1 accountability for the effectiveness, policy, ensure achieving intended results, promoting improvement
5.1.1.1 corporate responsibility, anti-bribery policy, ethics escalation policy
5.1.1.2 Process effectives and efficiency
5.1.1.3 Process owners
5.1.2 Customer focus
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3.1 roles, responsibilities, and authorities – supplemental, personnel with the responsibility and authority to
ensure that customer requirements are me
5.3.2 Responsibility and authority for product requirements and corrective actions
Rules 5.8b Management’s responsibility for their policies
Rules 5.8d Linkage between the policy, performance objectives and targets, responsibilities, competence of personnel,
operations, procedures, performance data, internal audit findings and conclusions, and changes in the client’s
organization or management

6.1 Actions to address risks and opportunities


6.1.1 consider of context and interested parties, assurance to achieve intended results
6.1.2 Actions addressed to risks and opportunities shall be proportionate to potential impact (effectiveness, action
proportional to the impact, risk analysis from lessons learned, preventive action)
6.1.2.1 Risk analysis: lessons learned from recalls, product audits, field returns and repairs, complaints, scrap, and
rework
6.1.2.2 Preventive action: potential nonconformities, evaluating the need for action taken, effectiveness, similar
processes (see ISO 9001, Section 7.1.6)
6.1.2.3 Contingency plans: according to risk, key equipment failures (also see section 8.5.6.1.1), interruption from
externally provided products, processes, and services; recurring natural disasters; fire; utility interruptions,
cyber-attacks on information technology systems, labor shortages; or infrastructure disruptions notification
process, periodically test for effectiveness, reviews (at a minimum annually) using a multidisciplinary team
including top management
6.2 Quality objectives and planning to achieve them
6.2.1 Measurable, monitored, communicated, updated
6.2.2 planning how to achieve its quality objectives
6.2.2.1 to meet customer requirements, minimum annual quality objectives and performance targets
6.3 Planning of changes

No.: CL_27_01_162e Edition: 2021/07 Page 5 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Reference Objectives to fulfill Check

7.1.2 People
7.1.3 Infrastructure
7.1.3.1 Plant, facility, and equipment planning
„lean manufacturing“, designing plan layouts ( material flow, cyber protection) multidisciplinary approach
Manufacturing feasibility assessments shall include capacity planning
7.1.4 Environment for the operation of processes
7.1.4.1 Environment for the operation of processes – supplemental
7.1.5 Monitoring and measuring resources
7.1.5.1 General: suitable for the specific type of monitoring and measurement, maintained to ensure their continuing
fitness for their purpose
7.1.5.1.1 Measurement systems analysis, reference manuals, Other analytical methods if approved by the customer
7.1.5.2 Measurement traceability
7.1.5.2.1 Calibration/verification records
7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory
7.1.5.3.2 External laboratory
7.1.6 Organizational knowledge

7.2 Competence
7.2.1 Competence – supplemental: achieving competence of all personnel performing activities affecting conformity
to product and process requirements
7.2.2 Competence – on-the-job training
7.2.3 Internal auditor competency
7.2.4 Second-party auditor competency
7.3 Awareness
quality policy, relevant quality objectives, implications of not conforming with the quality management system
7.3.1 Awareness – supplemental
all employees are aware of their impact on product quality and the importance of their activities in achieving,
maintaining, and improving quality
7.3.2 Employee motivation and empowerment

7.4 Communication
(on what, when, with whom, how, who)
7.5 Documented information
7.5.1 General
7.5.1.1 Quality management system documentation:
quality manual, scope & exclusions, processes, CSR (table, list or matrix)
7.5.2 Creating and updating
7.5.3 Control of documented information
7.5.3.1 Controlled, availability, protection
7.5.3.2 distribution, storage, changes, retention
7.5.3.2.1 Record retention:
shall satisfy statutory, regulatory, organizational, and customer requirements

Retained for the length of time that the product is active for production and service requirements, plus one
calendar year, unless otherwise specified by the customer or regulatory agency.
7.5.3.2.2 Engineering specifications: review, distribution, and implementation, Review completed within 10 working days

8.1 Operational planning and control


8.1.1 Operational planning and control –supplemental:
customer product requirements, technical specifications, logistics requirements, manufacturing feasibility,
project planning (refer to ISO 9001, Section 8.3.2), acceptance criteria
8.1.2 Confidentiality
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.1.1 Customer communication – supplemental
8.2.2 Determining the requirements for products and services
any applicable statutory and regulatory requirements
8.2.2.1 Determining the requirements for products and services – supplemental
include recycling, environmental impact, and characteristics identified, all applicable government, safety, and
environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of
material
8.2.3 Review of the requirements for products and services
8.2.3.1 shall conduct a review
requirements specified by the customer, requirements not stated by the customer, requirements specified by
the organization, contract or order requirements differing
8.2.3.1.1 review of the requirements for products and services – supplemental
documented evidence of a customer-authorized waiver
8.2.3.1.2 Customer-designated special characteristics
8.2.3.1.3 Organization manufacturing feasibility
multidisciplinary approach, feasibility analysis for any manufacturing or product technology new or changed
8.2.3.2 retain documented information results of the review any new requirements for the products and services
8.2.4 Changes to requirements for products and services

No.: CL_27_01_162e Edition: 2021/07 Page 6 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Reference Objectives to fulfill Check

8.3 Design and development of products and services


8.3.1.1 Design and development of products and services – supplemental
Documentation of the design and development process
8.3.2 Design and development planning
8.3.2.1 multidisciplinary approach
8.3.2.2 Product design skills
8.3.2.3 Development of products with embedded software
8.3.3 Design and development inputs
8.3.3.1 Product design input
product specifications, identification, traceability, packaging, assessment of risks with the input requirements *)
*) only relevant targets for conformity to product requirements, including preservation, reliability, durability, serviceability,
if product design health, safety, environmental, development timing, and cost
is applicable
statutory and regulatory requirements of the customer-identified country of destination, if provided
embedded software requirements
8.3.3.2 Manufacturing process design input
product design output data, special characteristics, targets for productivity, process capability, timing, and
cost, experience from previous developments, new materials, product handling and ergonomic requirements,
Design for Manufacturing, Design for Assembly
8.3.3.3 Special characteristics
Documentation, development of control and monitoring strategies, customer-specified approvals – when
required
8.3.4 Design and development controls
8.3.4.1 For monitoring of design and development of products and processes:
summary results of Measurements at specified stages
8.3.4.1- Monitoring, Design and development validation, Prototype program, Product approval process
8.3.4.4
8.3.5 Design and development output
8.3.5.1 Design and development outputs – supplemental
FMEA, reliability study, product special characteristics, error-proofing, 3D models, 2D drawing, etc.
*) only relevant *)
if product design
is applicable
8.3.5.2 Manufacturing process design output
Specifications and drawings, special characteristics, Tooling and equipment, capability studies, flow charts /
layout, including linkage of product, process, and tooling, capacity analysis, process FMEA, maintenance plans,
control plan, work instructions ,error-proofing
8.3.6.1 Design and development changes – supplemental
8.4 Control of externally provided processes, products and services
8.4.1 evaluation, selection, monitoring of performance, and re-evaluation of external providers
8.4.1.1 General –supplemental:
include in the scope: subassembly, sequencing, sorting, rework, and calibration services
8.4.1.2 Supplier selection process:
Risk, quality and delivery performance, quality management system, multidisciplinary decision making,
software development capabilities, if applicable
8.4.1.3 Customer-directed sources (also known as "Directed-Buy")
All requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) are applicable,
unless specific agreements are defined
8.4.2 Type and extent of control
8.4.2.1 Type and extent of control – supplemental:
process to identify outsourced processes and to select the types and extent of controls
8.4.2.2 Statutory and regulatory requirements
8.4.2.3 Supplier quality management system development (risk-based model, defined minimum level, development
progression)
8.4.2.3.1 Automotive product-related software or automotive products with embedded software:
process for software quality assurance, software development process, software development capability self-
assessment
8.4.2.4 Supplier monitoring
8.4.2.4.1 Second-party audits
8.4.2.5 Supplier development
performance issues, audit findings, risk analysis
8.4.3 Information for external providers
8.4.3.1 Information for external providers – supplemental
applicable statutory and regulatory requirements and special product and process characteristics to their
suppliers

No.: CL_27_01_162e Edition: 2021/07 Page 7 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Reference Objectives to fulfill Check

8.5.1 Control of production and service provision


8.5.1.1 Control plan
Rules 5.8p The effective implementation of the control plan, FMEA, and associated documents during the audit of
manufacturing
Rules 5.8o Linkages between customer concerns and relevant process documents (i.e. control plan, FMEA, etc.), including
the effective implementation of any changes
8.5.1.2 Standardized work – operator instructions and visual standards
8.5.1.3 Verification of job set-ups
8.5.1.4 Verification after shutdown
8.5.1.5 Total Productive Maintenance (TPM)
identification of process equipment necessary to produce
availability of replacement parts
resource for machine, equipment, and facility maintenance
packaging and preservation of equipment, tooling, and gauging
applicable customer-specific requirements
documented maintenance objectives
and Preventive Maintenance compliance metrics
regular review of maintenance plan and objectives
corrective actions where objectives are not achieved
use of preventive / predictive maintenance methods
periodic overhaul
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment
System for production tooling management
maintenance and repair facilities and personnel
storage and recovery
set-up
tool-change programs for perishable tools
tool design modification documentation, including engineering change level of the product
tool modification and revision to documentation
tool identification, such as serial or asset number; the status, such as production, repair or disposal;
ownership; and location
customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently marked in a
visible location
system to monitor these activities if any work is outsourced
8.5.1.7 Production scheduling
relevant planning information: e.g., customer orders, supplier on-time delivery performance, capacity, shared
loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration
8.5.2 Identification and traceability
8.5.2.1 Identification and traceability – supplemental
conduct an analysis of internal, customer, and regulatory traceability requirements for all automotive products,
including developing and documenting traceability plans
8.5.3 Property belonging to customers or external providers (identify, verify, protect, report if lost, damaged, etc.)
8.5.4 Preservation
8.5.4.1 Preservation – supplemental
Assess at appropriate planned intervals the condition of product in stock.
obsolete product is controlled in a manner similar to that of nonconforming product
8.5.5 Post-delivery activities
8.5.5.1 Feedback of information from service
8.5.5.2 Service agreement with customer
8.5.6 Control of changes
8.5.6.1 Control of changes – supplemental
Verification, validate changes before implementation, risk analysis, production trial run
8.5.6.1.1 Temporary change of process controls
risk analysis, approvals, Standard work instructions, daily quality focused audits
8.6 Release of products and services
8.6.1 Release of products and services – supplemental
8.6.2 Layout inspection and functional testing
8.6.3 Appearance items
Resources, masters, maintenance, personnel
8.6.4 Verification and acceptance of conformity of externally provided products and services
8.6.5 Statutory and regulatory conformity
8.6.6 Acceptance criteria

No.: CL_27_01_162e Edition: 2021/07 Page 8 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Reference Objectives to fulfill Check

8.7 Control of nonconforming outputs


8.7.1 nonconforming outputs, correction, segregation, containment, informing the customer, obtaining authorization
for acceptance under concession
8.7.1.1 Customer authorization for concession
8.7.1.2 Control of nonconforming product – customer-specified process
8.7.1.3 Control of suspect product
8.7.1.4 Control of reworked product (risk analysis, accordance to control plan, documented process, instructions,
retain documented information)
8.7.1.5 Control of repaired product (risk analysis, accordance to control plan, documented process, instructions,
customer authorization, retain documented information)
8.7.1.6 Customer notification
8.7.1.7 Nonconforming product disposition
8.7.2 documented information, nonconformity, actions taken, concessions obtained

9.1.1.1 Monitoring and measurement of manufacturing processes


9.1.1.2 Identification of statistical tools
as part of the advanced product quality planning, in risk analysis and control plan
9.1.1.3 Application of statistical concepts
For employees involved in the collection, analysis, and management of statistical data
9.1.2 Customer satisfaction
9.1.2.1 Customer satisfaction – supplemental:
quality performance, customer disruptions, field returns, recalls, and warranty, delivery performance,
customer notifications
monitoring
customer performance data including online customer portals
9.1.3 Analysis and evaluation
9.1.3.1 Prioritization: trends shall be compared and lead to actions to support improving customer satisfaction
9.2 Internal audit
9.2.1 quality management system effective, implemented, maintained
9.2.2 audit program, define audit criteria , conduct audits, impartiality, audits are reported to relevant management,
appropriate correction and corrective actions without undue delay
9.2.2.1 Internal audit program
covers the entire quality management system including quality management system audits, manufacturing
process audits, and product audits, based upon risk, organization shall include software development
capability assessments in their internal audit program
9.2.2.2 Quality management system audit
process approach, organization shall sample customer-specific quality management system requirements for
effective implementation
9.2.2.3 Manufacturing process audit
all shifts, shift handover effective implementation of the process risk analysis control plan, effective
implementation of risk analysis
9.2.2.4 Product audit (use customer-specific approach if required)
Rules 5.8e Process-based internal audits and analysis of the effectiveness of implemented corrective actions
(verify the effectiveness of internal audits also onsite)
9.3 Management review
planned intervals, suitability, adequacy effectiveness, alignment with strategic direction
9.3.1.1 Management review – supplemental: at least annually, frequency increase based on risk or performance
Management review inputs
9.3.2 previous management reviews, changes, performance and effectiveness of quality management system
trends in: feedback from interested parties, audit results, performance of external providers
Management review inputs – supplemental
9.3.2.1 cost of poor quality, process effectiveness and efficiency, product conformance, manufacturing feasibility for
changed operations and new facilities(see section 7.1.3.1), customer satisfaction (see ISO 9001:2015, section
9.1.2), performance against maintenance objectives, potential field failure, actual field failures and their
impact on safety or the environment
9.3.3 Management review outputs
9.3.3.1 Management review outputs – supplemental: action plan when customer performance targets are not met
Rules 5.8c Management review results for effectiveness and actions

No.: CL_27_01_162e Edition: 2021/07 Page 9 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Reference Objectives to fulfill Check

10 Improvement
10.1 In general

10.2 Nonconformity and corrective action


10.2.3 Problem solving
Rules 5.8f Effectiveness of the corrective actions since the last audit
Rules .8g Customer complaints and the client’s responses, including a review of the applicable IATF OEM customer
performance reports online (e.g. scorecards, special status)
10.2.4 Error-proofing
10.2.5 Warranty management system (when required, warranty part analysis, NTF)
10.2.6 Customer complaints and field failure test analysis
10.3 Continual improvement

MIND: Requirements acc. to the General Terms and Conditions qualityaustria, respectively ISO 17021:
Are the relevant appeals and complaints regarding the management system in the course of this assessment addressed and
documented?
Does the utilization of certification and certification logo comply with the requirements, resp. aren´t they used misleading?

No.: CL_27_01_162e Edition: 2021/07 Page 10 of 10 Customer Service Center: A-4020 Linz, Am Winterhafen 1
Telefon: +43 732 34 23 22, Fax: +43 732 34 23 23,
Created: Dragosits Reviewed: Stöhrmann Released: Kreiter www.qualityaustria.com E-Mail: office@qualityaustria.com
Audit participants

Company: Date:

Document
Plant tour
Opening
meeting

meeting
Closing
review
Participant’s name Position Signature

No.: FO_27_01_118e Edition: 2014/09 Page 1 of 1 A-4020 Linz, Am Winterhafen 1, Telephon: (+43 732) 34 23 22,
Fax: (+43 732) 34 23 23, E-Mail: office@qualityaustria.com
Created: Steinberger Reviewed: Steinberger Released: Kreiter Internet: www.qualityaustria.com,

You might also like