Professional Documents
Culture Documents
If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
5.1.1 Process Efficiency
Does organization's top management monitor the > Review of product realization and
process realization processes and the support support processes by top management.
processes to assure their effectiveness and > Indicators and records.
efficiency? > Reporting process.
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
5.4.2 2) Are the organization's quality objectives > Quality cost indicators and quality
measurable and consistent with the quality indices.
policy? > Quality objectives
included/Linked to the business plan.
5.4.3 3) Did top management define any quality > Quality objectives included/linked
objectives and measurements? to the business plan.
> Scope of the Quality objectives
5.5 Responsibility, Authority & Communication
5.5.1 1) Does the organization's top management > Responsibilities and authority as
ensure that the responsible and authorities are defined in the descriptions,
defined and communicated with in the responsibilities matrices, procedures,
organization ? and accountabilities documents.
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
5.6 Management Review
5.6.1 1) Does the organization's top management > Review of all the elements of the
review its quality management system, at quality system to insure its continuing
planned intervals, to ensure its continuing suitability and effectiveness.
suitability, adequacy and effectiveness? > Review of quality cost indicators.
> Management review meeting
minutes, attendance and adequate
frequency.
> Action plans and follow-up
5.6.3 3) Are the organization's records from > Retention of management reviews
management reviews maintained? meeting minutes.
5.6.5 5) Do the management reviews include > Policy business plan and customer
monitoring of quality objectives, and the regular satisfaction metrics reports.
reporting and evaluation of cost of poor quality? > Product results (quality, cost,
time) against quality policy goals and
customer specified targets.
5.6.6 6) Are the results of the management reviews > Trends in metrics (business and
recorded to provide, as a minimum, evidence of customer satisfaction).
the achievement of : > Basic for continuous improvement
- objectives specified in the quality policy? projects.
- objectives specified in the business plan? > Management review meeting
- customer satisfaction with product supplied minutes.
Action plans and follow-up.
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
5.6.9 9) Does the output from the organization's > Examples of continuous
management review include any decisions and improvement projects initiated from
actions related to : management reviews.
a) improvement of the effectiveness of the > Examples of product
quality management system and its processes? improvements initiated from
b) improvement of product related to customer management reviews.
requirements?
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Has the organization established a documented > Document approval authority.
procedure to define controls needed: > Document approval records.
a) to approved documents for adequacy prior to > Availability of documents in
issue? various locations.
B) to review and update as necessary and re- > Knowledge of document location.
approved documents? > Document accessibility.
C) to ensure that changes and the current revision > Storage and disposal of obsolete
status of documents are identified? documents.
d) to ensure that relevant versions of applicable > Process for
documents are available at points of use? notification/distribution of documents
4.2.4 e) to ensure that documents remain legible and from internal and external origins.
readily identifiable? > Review and approval of revised
f) to ensure that documents of external origin are documents.
identified and their distribution controlled?
g) to prevent the unintended use of obsolete
documents, and to apply suitable identification to
them if they are retained for any purpose?
Are records legible, readily identifiable and > Quality management system
retrievable? records legibility.
> Identification of quality
management system records.
> Environment and storage
4..2.8
conditions must be compatible with
the file storage medium (ex: hard
copy, floppy disk, etc.)
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Has the organization established a documented > Quality manual according to
procedure to define the controls needed for the ISO/TS 16949:2002.
identification, storage, protection, retrievals, > Defined record retention time
retention time and disposition of records? compared to customer/regulatory
requirements.
> Record disposal after retention
4..2.9 period expires.
> Including identification of
obsolescence documents.
> Ident
Does the organization treat quality records as a > Evidence of quality records being
special type of document and control them maintained and controlled per quality
4..2.10 according to the requirements given in questions manual.
4.2.7 and 4.2.8?
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
8.4 Analysis of data
Does the organization determine, collection and > Internal performance data such as:
analyze appropriate data to demonstrate the - Poor quality cost indicators,
suitability and effectiveness of the QMS and the - Effectiveness and efficiency of
evaluate where continual improvement of the production processes,
effectiveness of the quality management system - Test results,
can be made? - Process capability data,
- Quality audits,
- Results of product inspections,
- Internal and external quality data,
- Subcontractors rating,
- Customer reports,
- Employee's information.
Does the organization's data analysis include > Data analysis report.
data generated as a result of monitoring and
measurement and from other relevant sources?
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If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
8.5.1 Continual Improvement
Has the organization define a process for > Procedure as stated in quality
continual improvement? manual
8.5.6 Has the organizations established a documented > List of customer complaints.
procedure to define requirements for: > Root Cause Analysis and records.
a) reviewing non-conformities (including > Determination of corrective action
customer complaints)? needed.
b) evaluating the need for action to ensure that > Corrective action taken.
non-conformities do not recur? > Corrective action effectiveness.
c) determining and implementing action needed?
d) records of the results of action taken ?
e) reviewing corrective action taken?
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