You are on page 1of 29

AUTOMOTIVE CERTIFICATION

SCHEME FOR
ISO/TS 16949:2002

Rules for achieving IATF recognition

First Edition for ISO/TS 16949:2002

March 19, 2002


AUTOMOTIVE CERTIFICATION
SCHEME FOR
ISO/TS 16949:2002

Rules for achieving IATF recognition

First Edition for ISO/TS 16949:2002

March 19, 2002

AIAG
Edition
Contents Page
1 Certification Body ............................................................................................................................. 1
1.1 ..................................................................................................................................................... 1
1.2 ..................................................................................................................................................... 1
1.3 ..................................................................................................................................................... 1
1.4 ..................................................................................................................................................... 1
1.5 ..................................................................................................................................................... 2
1.6 ..................................................................................................................................................... 2
1.7 ..................................................................................................................................................... 2
2 Audit Process .................................................................................................................................... 2
2.1 ..................................................................................................................................................... 2
2.2 ..................................................................................................................................................... 2
2.3 ..................................................................................................................................................... 2
2.4 ..................................................................................................................................................... 3
2.5 ..................................................................................................................................................... 3
2.6 ..................................................................................................................................................... 3
2.7 ..................................................................................................................................................... 3
2.8 ..................................................................................................................................................... 3
2.9 ..................................................................................................................................................... 3
2.10 ................................................................................................................................................... 4
2.11 ................................................................................................................................................... 4
3 Audit Team ........................................................................................................................................ 4
3.1 ..................................................................................................................................................... 4
3.2 ..................................................................................................................................................... 4
3.3 ..................................................................................................................................................... 4
3.4 ..................................................................................................................................................... 5
3.5 ..................................................................................................................................................... 5
4 Other Requirements .......................................................................................................................... 5
4.1 ..................................................................................................................................................... 5
4.2 ..................................................................................................................................................... 5
4.3 ..................................................................................................................................................... 5
4.4 ..................................................................................................................................................... 5
4.5 ..................................................................................................................................................... 5
4.6 ..................................................................................................................................................... 6
4.7 ..................................................................................................................................................... 6
4.8 ..................................................................................................................................................... 6
4.9 ..................................................................................................................................................... 7
4.10 ................................................................................................................................................... 8
4.11 ................................................................................................................................................... 8
4.12 ................................................................................................................................................... 8
5 ISO/TS 16949:2002 Certificate Content Requirements .................................................................... 9
6 Forms and Tables ............................................................................................................................ 10
6.1 ................................................................................................................................................... 10
6.1.1 ............................................................................................................................................ 10
6.1.2 ............................................................................................................................................ 10
6.1.3 ............................................................................................................................................ 10

ANNEX 1 Rules for auditing quality management systems according to ISO/TS 16949:2002 .......... 11
1. Activities Before The Audit ......................................................................................................... 11
2. Audit Planning ............................................................................................................................ 13
3. Site Audit + Reports ................................................................................................................... 14
4. Nonconformities Management ................................................................................................... 16
5. Certification Issue ...................................................................................................................... 17

i
ANNEX 2 Criteria for third party auditor qualification to ISO/TS 16949:2002 .................................... 19
1. ISO 9001:2000 Auditor Qualification .......................................................................................... 19
2. Automotive Industry Specific Skills ............................................................................................ 19
3. Minimum Work Experience ........................................................................................................ 19
4. IATF Sanctioned Automotive Training for ISO/TS 16949:2002 .................................................. 20

ANNEX 3 Audit days for certification to ISO/TS 16949:2002 ............................................................. 21


Requirements on Audit Days .......................................................................................................... 21
“Corporate”/Considerations ............................................................................................................ 22
Audit Days Adjustment for Corporate” Audit Scheme .................................................................... 23

ANNEX 4 Decertification process to ISO/TS 16949:2002 .................................................................. 24

ii
Automotive certification scheme for ISO/TS 16949:2002
Rules for achieving IATF recognition (1st edition for ISO/TS 16949: 2002)

Below are the requirements, or “Rules for the automotive registration scheme for ISO/TS
16949:2002 certification bodies”, herein referred to as “Rules”, with regard to ISO/TS 16949:2002
implementation including criteria for certification body recognition, certification body audit process,
certification body auditor qualifications and, certificates. These requirements are binding on
certification bodies recognized by IATF for ISO/TS 16949:2002 certification.

These rules are subject to periodic review and may be modified at any time at the sole discretion of
IATF after consultation with appropriate stakeholders.

[Note: Within this document:


- the use of the term certification is synonymous with registration, and
- in order to be consistent with ISO 9001:2000, the term “organization” replaces the term
“supplier”.]

1 Certification Body

1.1 The certification body shall be accredited for ISO 9001:2000 certification activities by the national
accreditation body of its country of location. ISO/TS 16949:2002 certification activities shall be in
accordance with the certification body scope defined in that ISO 9001:2000 accreditation. Where a
certification body has multiple or affiliated offices, the following conditions shall be fulfilled. The
certification body shall use a common quality management system including the same procedures
for all the local offices. One of the offices shall be designated to interface with IATF, and be approved
by IATF, as the contracted office for the whole group and all the offices. This contracted office shall
be accredited to ISO 9001:2000 by the national accreditation body of its country of location. This
contracted office will be the only contact between IATF and the certification body and will be
responsible for the control of all ISO/TS 16949:2002 certification related activities for the whole
group. Breach of these rules by any part of a certification body organization shall result in
cancellation of the IATF recognition.

1.2 The certification body shall conform to ISO/IEC Guide 62:1996, “General requirements for bodies
operating assessment and certification of quality systems”, and these rules. These apply in particular
but are not limited to customer and organization complaints.

1.3 The certification body procedure for customer and organization complaints shall encompass, at a
minimum a documented corrective action process and a record of complaint resolution.

1.4 In order to avoid conflict of interest, certification bodies or affiliates that have provided quality
management system consulting services or site-specific auditor training within the prior two years to
a particular organization are not acceptable as a certification body for that organization, nor may they
supply auditors. This restriction includes related bodies of the same parent company or affiliates,
where the validity or reliability of an audit can be questioned because of a consulting relationship.
More than one pre-audit on any one site in the same company shall be considered consulting.

Note: Consulting is the provision of training, documentation development, or assistance


with implementation of quality management systems to a specific organization.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 1
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Training open to the public, not organization specific, and held at a public forum is not
considered consulting.

1.5 The scope of certification shall include all products supplied to customers subscribing to the
certification to ISO/TS 16949:2002.

1.6 The certification body shall have at least one member of those responsible for their certification
function as an automotive expert, approved by IATF, within its decision making function for issuing
ISO/TS 16949:2002 certificates. This representative shall exercise veto power with regard to all
ISO/TS 16949:2002 certification decisions made by the certification body and shall not be a
participant in the audit.

1.7 Each certification body contracted by IATF for ISO/TS 16949:2002 certification shall submit the
required information to the IATF database.

2 Audit Process

2.1 The certification process shall address all ISO/TS 16949:2002 requirements according to Annex 1:
“Rules for auditing quality management systems according to ISO/TS 16949:2002”.

Note 1: For exclusions, see clause 1.2 of ISO/TS 16949:2002.

Note 2: For OEM vehicle assembly, ”contract review” and the “contract” are represented by
the internally documented marketing requirements for vehicle brand, mix and volumes.

2.2 Any "site" may elect to pursue third party certification to ISO/TS 16949:2002, however, such "sites"
shall have demonstrated capability to conform to all ISO/TS 16949:2002 requirements. (See Annex
1). Conformance with ISO/TS 16949:2002 for third party certification shall be based on objective
evidence of meeting each applicable requirement, including customer specific requirements, at the
time of audit.

2.3 Supporting functions on site or remote, e.g., engineering, contract review, purchasing, warehouses,
shall be included in the initial and ongoing surveillance audits. Audit planning and execution shall
take into account all supporting sites and support activities, and the interfaces between them shall be
defined and audited. The certification body audit plan shall reflect all applicable clauses at each
location. Supporting functions shall be audited as they support a site but cannot obtain independent
ISO/TS 16949:2002 certification. Design function, on site or remote, shall undergo surveillance
audits at least once within each consecutive 12-month period.

For multiple site certification all sites shall be audited, the sampling of sites is not allowed. In
situations when a design center services many production sites, and these sites are audited by more
than one certification body, the certification body auditing any specific design center shall cover the
complete product scope of that center, consistent with the process based audit approach. Site-based
certificates can be issued based upon a design center audit conducted by another recognized
certification body. In such cases, the certification body issuing a certificate based upon a design
center audit by a different certification body, shall review the results of the audit of design and any
findings issued by obtaining these from the organization concerned. In such cases, the information
shall be in English.

2 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
2.4 A letter of conformance could be issued as an interim measure, in situations where
manufacturing sites(s) are audited prior to audit of the related design facility.

2.5 The entire quality management system shall be assessed at a minimum of once every three years.

2.6 It is permissible for each surveillance audit to re-examine part of the system so that the equivalent of
a total assessment is completed within each three year cycle. Each surveillance audit shall include
auditing on all shifts [see Annex 3, item 5]. The audit report shall clearly show the part of the system
that was audited on each surveillance visit. Surveillance audit frequency shall be conducted in
accordance with Annex 3 “Audit days for certification to ISO/TS 16949:2002 ”.

2.7 Certification body checklists shall include all questions contained in the “Checklist to ISO/TS
16949:2002”. Quality management systems shall not be registered to ISO/TS 16949:2002 if open
minor or major nonconformities to ISO/TS 16949:2002 exist. After certification, when a nonconformity
is identified by the certification body, then the decertification process shall be initiated (see annex 4).

Note: Such identification can occur as a result of a customer complaint.

2.8 A major nonconformity is one or more of:

- the absence of or total breakdown of a system to meet an ISO/TS 16949:2002 requirement.


A number of minor nonconformities against one requirement can represent a total breakdown
of the system and thus be considered a major nonconformity.
- any noncompliance that would result in the probable shipment of nonconforming product. A
condition that may result in the failure or materially reduce the usability of the products or
services for their intended purpose.

- a noncompliance that judgment and experience indicate is likely either to result in the failure
of the quality management system or to materially reduce its ability to assure controlled
processes and products.

A minor nonconformity is a failure to comply with ISO/TS 16949:2002, which based on judgment and
experience is not likely to result in the failure of the quality management system or reduce its ability
to assure controlled processes or products. It may be one of the following:

- a failure in some part of the organization’s documented quality management system relative
to ISO/TS 16949:2002.
- a single observed lapse in following one item of a company’s quality management system.

2.9 The audit plan shall be based upon the processes of the organization, and shall include all
requirements of the organization's quality management system implemented to meet automotive
customer needs of those customers recognizing ISO/TS 16949:2002 certification of their suppliers,
even when these requirements go beyond ISO/TS 16949:2002.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 3
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
2.10 The audit plan shall include evaluation of all of the organization’s quality management system
requirements for effective implementation of ISO/TS16949:2002 as well as for effectiveness in
practice. Assessment shall evaluate the effectiveness of the system, its linkages, its performance
and its requirements. Part of the evidence required is the result of at least one complete internal
audit and management review cycle.
Note: Effectiveness of the system should consider how well the system is deployed, as
demonstrated by the measures defined by the organization to meet customer satisfaction
and company objectives.

2.11 Each on-site audit, including initial and surveillance audits, shall include a review of:

- new customers since last audit,


- customer complaints and organization response,
- organization internal audit and management review results and actions,
- progress made toward continual improvement targets,
- effectiveness of the corrective actions and verification since the last audit.
Quality Management System contained in section 4, Management responsibility contained in section
5, and Product Realization Processes contained in 7.1 – 7.3 of ISO/TS 16949:2002 shall be
reviewed at least once during an on-site audit within each consecutive 12-month period.

3 Audit Team

3.1 All ISO/TS 16949:2002 audit teams, including surveillance, shall satisfy the following:

- consist of IATF qualified auditors to conduct audits in the name of the certification body. (See
Annex 2 “Criteria for third party Auditor qualifications to ISO/TS 16949:2002”)
Note: This requires satisfactory completion of the IATF sanctioned training and the exam to
ISO/TS 16949:2002 indicated by a certificate issued by IATF to the sponsoring certification
body. The audit team may use external technical experts as necessary. This will be
additional to the audit days requirement. (See Annex 3: “Audit days requirements”)
- have relevant sector specific experience for all commodity codes which apply to the scope of
registration at that site.
- no member of the audit team shall have provided consultancy for the organization in the two
years prior to the audit.
3.2 For consistency, at least one auditor of the initial audit team should participate in all visits of a three
years cycle. For each (three years) certification cycle, different team members should be selected.

3.3 As a driver for continual improvement, the certification body shall regularly evaluate auditor
performance in determining effective implementation of ISO/TS 16949:2002 requirements. Such
evaluations shall include feedback from witness audits, post-audit surveys, and feedback from
organizations audited and customers.

4 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
3.4 The audit team shall provide a full report on the operations audited consistent with the content of
Annex 1 “Rules for auditing quality management systems according to ISO/TS 16949:2002”to the
organization audited within 15 working days of each initial, surveillance, and re-certification audit
unless otherwise agreed by the organization. Third party auditors shall identify opportunities for
improvement, e.g., excessive scrap, as these become evident during the audit without
recommending specific solutions. These opportunities shall be included in the audit report to the
organization.

3.5 The contract between the certification body and the organization shall address the following items:

- The organization cannot refuse an IATF witness audit of the Certification Body,
- Access authorization for IATF representatives or their delegates,
- Confidentiality of information,
- Authorization to provide the final report (see Annex 1, section 3) to the IATF.

4 Other Requirements

4.1 Consultants to the organization cannot participate in the audit.

4.2 The certification body shall support the IATF oversight activities.

4.3 The certification body shall not violate copyright of any IATF documents and logotype related to this
certification scheme.

4.4 Before the certification body can be recognized and issue any certificate, the IATF oversight will
undertake a witness audit as validation of initial compliance. Any resulting corrective actions required
shall be verified for effectiveness before certification activities continue.

Note: The first witness audit shall occur during one of the first five ISO/TS 16949:2002
audits conducted by the certification body. This will normally be for any design responsible
organization audit.

4.5 Ongoing recognition of the certification body shall be verified through IATF oversight activities:

- Conduct ongoing surveillance witness audits, according to Table 4.4 below,


- Develop an audit schedule for these ongoing surveillance witness audits of its ISO/TS
16949:2002 recognized certification body offices taking into account all countries where
ISO/TS 16949:2002 certificates are issued by each certification body,
- Schedule ongoing surveillance witness audits to observe as many different auditors as
possible across all certification bodies.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 5
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
-

Table 4.5:
Annual Assessments of Certification Body

Annual number of
< 30 31-100 101-250 > 250
ISO/TS16949 Certificates

Minimum number of annual:

Office Assessments * 1 1 1 1
Witness Audits ** 1 2 3 4

* Office assessments of the ISO/TS 16949:2002 recognized certification body are to be


conducted at the contracted office where appropriate ISO/TS 16949:2002 records must be
accessible. Office assessments shall review certification body conformance with all requirements
of the Agreement, “Rules”, and all Annexes. (e.g. timely notification of registrations and changes
to the IATF database).

** Witness audits are to be conducted, at a site, witnessing an audit team from a certification
body during an ISO/TS 16949:2002 audit to verify certification body conformance with all
requirements of ISO/TS 16949:2002, including the “Rules”, Annexes, and any ISO/TS
16949:2002 sanctioned interpretations subsequently issued.
The above table is the basis of IATF witness audits of the IATF certification scheme. IATF reserves
the right to undertake additional activities in response to corrective action follow up, or based upon
performance.

4.6 The certification body shall not operate as both a quality management system certification body and
as an accreditation body.

4.7 Certificates to ISO/TS 16949:2002 shall only be issued by IATF contracted certification body offices
for a maximum validity of three years.

4.8 Any subcontracted audits shall be performed according to the process of the certifying certification
body, and carried out by IATF qualified auditor(s) and processed by the IATF contracted certification
body office. No activity except the use of auditors shall be sub-contracted.

6 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
4.9 Upgrading of current certification by one of the IATF recognized certification bodies will be taken into
account prior to the initial assessment to ISO/TS 16949:2002, as follows:

Conditions for upgrading certification to


Existing certification(s)
ISO/TS 16949:2002
One or more of
national auto
ISO 9001 :
ISO/TS ISO
(AVSQ, EAQF,
1994 16949:1999 9001:2000
QS9000,
VDA6.1)
YES FULL INITIAL AUDIT as defined in the Annex 3

INITIAL AUDIT DAYS MAY BE REDUCED BY NO MORE


YES YES THAN 30% OF THE AUDIT DAYS OF AN INITIAL AUDIT
defined in the Annex 3 *
INITIAL AUDIT DAYS MAY BE REDUCED BY NO MORE
YES YES THAN 30% OF THE AUDIT DAYS OF AN INITIAL AUDIT
defined in the Annex 3 *
INITIAL AUDIT DAYS MAY BE REDUCED TO THE
YES AUDIT DAYS OF A RECERTIFCATION AUDIT
defined in the Annex 3 *
INITIAL AUDIT DAYS MAY BE REDUCED BY NO MORE
YES YES THAN 50% OF THE AUDIT DAYS OF AN INITIAL AUDIT
defined in the Annex 3 *
INITIAL AUDIT DAYS MAY BE REDUCED BY NO MORE
YES YES THAN 50% OF THE AUDIT DAYS OF AN INITIAL AUDIT
defined in the Annex 3 *

- * If the scope is unchanged, only the 5 cases above can have reduced audit days. Consistent
with the process approach, all additional requirements between the existing certification and
ISO/TS 16949:2002 shall be addressed, during “upgrade” audits. The audit must also fully
include the ISO/TS 16949:2002 clauses: 5.1, 5.4, 5.6, 6.2.2, 7.1, 7.3, 7.4.1.2, 7.4.3, 8.2.1,
8.2.2, 8.4, 8.5.1, and all customer specific requirements, and assess the remaining ISO/TS
16949:2002 requirements on a sampling basis.
- * If the scope is changed, 100% of the required audit days for the initial audit shall be applied.
The audit must fully include all ISO/TS 16949:2002 requirements, including customer specific
requirements; sampling of ISO/TS 16949:2002 requirements is not permitted.
- The certification body shall be the same for the former certification and for the new ISO/TS
16949:2002 certification.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 7
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
4.10 If an organization certified to ISO/TS 16949:2002, by a recognized certification body elects to change
certification bodies and to continue certification to ISO/TS 16949:2002, then the following steps must
be followed, in sequence
- The new certification body must be recognized by IATF,
- The existing certificate must be valid, with no open non-conformities,
- The new certification body must perform a review of the previous audit report and all findings
issued by the existing certification body,
- The new certification body must perform a basic document review and a review of key
indicators of quality management system performance,
- The “conversion audit” shall become either a surveillance audit, the content of which is based
in part upon information gathered during the review above, and of previously demonstrated
performance. The new certification body issues a certificate for the remainder of the current
certification period,
- Or; at the end of a certification cycle, a re-certification audit where a new certificate is issued,
- The new certification body must notify IATF of the change in certification.
- The process must in all cases continue to meet the “Rules”.
4.11 IATF reserves the right to send a delegate to the executive management committee of the
certification body to review the decision making process for ISO/TS 16949:2002 certificates. If a
certification body places an existing ISO/TS 16949:2002 certified company on probation because of
quality management system nonconformities or a violation of the rules of registration, the certification
body shall notify IATF, within 10 working days.

4.12 Cancellation of IATF recognition of a certification body for ISO/TS 16949:2002 may occur upon:

- Violation of any of the IATF contractual rules,


- Loss of ISO 9001 accreditation,
- Failure to conduct a minimum of twenty-five (25) ISO/TS 16949:2002 site audits (initial or
surveillance) per calendar year.
In the event of loss of IATF recognition, the certification body is responsible for the remedies for
any registrants affected, appropriate to the severity of the concern. These remedies will be agreed
by IATF.

8 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
5 ISO/TS 16949:2002 Certificate Content Requirements.
a. Scope statement(s) including all products and services being supplied to all companies
subscribing to this document,
b. Issue of the ISO/TS 16949:2002 edition, date of registration and date of expiration (audit end
date plus 3 years maximum), and permitted exclusions as defined in the clause 1.2 Application
of ISO/TS 16949:2002,
c. Include the phrase somewhere on the first page: “having been audited in accordance with the
“Rules for the registration scheme for ISO/TS 16949:2002 - First edition””,
d. List on the front page the company name and address. Any appendix/schedules that are a part
of the certificate, must note that more pages are included, e.g. Page 1 of 3 and be endorsed
with the certificate number,
e. Include for multiple site certificates every registered site, its location, and scope on a separate
annex,
f. Include any remote locations, e.g. design centers, purchasing, contract review, etc., which are
part of the quality management system and have been audited, their locations and scopes. If
a remote location supports more than one site, the remote location shall appear on each site
certificate,
g. Include the name of the contracted office of the certification body, (city / state / country),
h. List on a separate appendix any customer specific requirements used in the audit,
i. The IATF logo (equal prominence with other marks),
j. For multiple site certification, each site may receive a separate certificate, with a common
certificate number plus letter suffix e.g. 1234A,1234B,1234C…1234AA, 1234AB etc,
k. Have the certification body certificate number and the specific IATF certificate number given by
IATF.
Certificates shall not reference other documents for which the certification body is not accredited or
recognized.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 9
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
6 Forms and Tables

6.1 Reports by certification bodies

Certification bodies shall transmit to IATF on a regular basis, in a specified format and in English, the
reporting data per paragraphs 6.1.1, 6.1.2 and 6.1.3. for ISO/TS 16949:2002 certification as
electronic data.
6.1.1 Data on certification activities
Certification bodies shall provide the following:
General data

- organization name / scope as in clause 1.5 / scope of certificate (products and services) /
type of certificate / certificate number / date of issue / expiration date / site / remote location,
- total number of audit days per certification body by year,
- total number of audit days per auditor each year,
- meeting dates for certification functions,
- percentage of initial audits which passed first time,
- list of complaints about certification body by customers and organizations with corrective
actions,
- results of accreditation body witness audits for the ISO 9001/2 accreditation and their reports,
- auditor base 6.1.2,
- auditor activities 6.1.3,
- constantly updated audit schedule, showing at least the next two months activities.

6.1.2 Base data on auditors

Table 6.1.2
Name Full/part Scope Date of Language How many Last Last years
time years auto Organization audit days
Qualification
experience /date

6.1.3 Activity data of auditors

Table 6.1.3

Auditor name
Date of audit Scope used Certification Language Audit type Audit results On-site audit
body name used days

10 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Annex 1 Rules for auditing quality management systems according to ISO/TS 16949:2002

Phase description Time sched. Who What

1. Activities before the audit The Organization applying for the certification shall provide the
T0 (starting Organization certification body with the following information and
point) documentation:
Request for certification Information file including sufficient information on which to base
a quotation for certification in accordance with the ISO/TS
16949:2002 Certification Scheme Rules, including
• Number of employees address, etc.
• Scope of the certification
• Product Design responsibility
• Sites to be registered
• Remote activities
• Quality management systems certifications obtained

DESIGN DESIGN RESPONSIBILITY : For design responsibility


RESPONSIBILITY determination only 2 options are permitted:

• Organization responsibility (including subcontracted


design)

Contract between • Customer responsibility


certification body In the case of subcontracted design, the auditor must verify that
and organization both organization and design subcontractors have appropriate
capability to meet element 7.3 requirements in its totality,
including interfaces between organization and subcontractors.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 11
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002- DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What

Analyse readiness T1 Organization


The organization shall provide the following documentation to
for on-site audit the CB for review, and for use in planning the audit (see format
in the IATF Guidance to ISO/TS 16949:2002):
Document review
• Quality manual (for each site to be audited)
• Internal audit and management review planning and
results from previous twelve months
• List of qualified internal auditors
• List of customer specific requirements
Pre-audit • Customer complaints status
• Operational performance trends for the previous twelve
months, minimum
(optional) The certification body shall analyze the organization
documentation described above in order to determine:
Certification • The appropriate scope of the certification
body
• Readiness for on-site audit (In case of doubts, the
certification body and the organization may decide to
execute a pre-audit)
In this phase, the certification body can perform a “pre-audit” at
the organization’s sites.
In order to perform this pre-audit, the certification body shall
nominate an auditor agreed to by the organization.

The following rules shall be respected:


• The pre-audit shall not be considered as part of the
initial certification audit
• Time dedicated to the pre-assessment will not reduce
audit days requirement (see Annex 3)

12 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What

If there is insufficient readiness to conduct the initial audit, the


Certification
No site visit. Organization can stop the process, in consultation with the
no
body
Certification Record on certification body.
audit? certification The certification body shall record this fact in its database.
body database
yes

2. Audit planning The certification body shall comply with specified requirements
for on-site audit days considering:
Certification
body • Number of employees including all staff and all shifts for
Audit days all activities on the site (see audit days table in Annex 3)
calculation
• The initial audit shall be completed within a three month
period from the document review. Multiple visits for
initial audit are not permitted
The certification body shall comply with the audit team
Certification
requirements according to the “Rules for the automotive
body
Establish certification scheme for ISO/TS 16949:2002”, section 3, and
Audit team Annexes 2 and 3 and:
• Team of two auditors minimum if auditor-days
requirements exceed five (see audit days table in Annex
3)
• Language capability shall be adequate
Audit team leader shall prepare the audit plan prior to site visit
Define Audit plan Audit team
and communicate it to the organization.
leader

The certification body shall verify audit plan adequacy to audit


Certification
days table and audit team composition.
Prepare monthly body
audit schedule The certification body shall prepare monthly audit schedule (to
forward to the IATF common database)

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 13
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002- DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What

3. Site audit + reports Initial certification audit activities shall be conducted according
T2 Audit team
the following rules:
Within 3 • Use of the “Checklist to ISO/TS 16949:2002”
Hold opening meeting months from
T1 • Check list to be covered in each site included in
certification scope (no site sampling allowed)
• Review effectiveness of the implementation of the
Complete initial ISO/TS 16949:2002 requirements and for effectiveness
certification audit in practice, related to planned and achieved quality
performance

There should be regular communication between organization


Audit team and the audit team regarding progress and results of the audit.
Provide feedback
Any non-conformity or opportunity for improvement shall be
identified to the organization when detected by the auditor.
Major nonconformities may provide a basis for termination of
the audit by the organization in consultation with the audit team
leader.
Audit stopped.
Continue no In this case audit team Leader will stop the certification process
Record on
the audit? immediately: a report will be prepared for the certification body
database
(copy for the Organization)
The certification body will record the reasons for termination in
yes their database and report to IATF. When this occurs, any re-
audit shall commence from the beginning of the process.

14 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What

At the end of the site visit the Lead auditor conducts the final
T3 Audit team presentation and releases a draft report including:
leader
• Description of all nonconformities
Conduct closing T2 + number
of days as • Opportunities for improvement
meeting.
Draft report programmed • Audit team recommendation to certification committee
Under no circumstances can a nonconformity be identified as
an opportunity for improvement.

Audit team leader, within fifteen working days after the end of
T4 Audit team the site visit, will send to the organization and the certification
Produce Final report leader body the final report in accordance to ISO/10011-1 and
Within 15 detailing the following:
working days • Scope – products – customer specific requirements with
from T3 issue level
• Summary of audited elements and related results
• Nonconformities as evidenced during the audit process
• Opportunities for improvement
• Audit team (plus additional technical experts if any)
• Cross-references to organization quality management
system documentation
Nonconformities shall be acknowledged by the organization
whose representative will sign the report and receive a copy of
it.
Audit team
The auditor shall record all nonconformities identified on the
audit report even if the corrective action is implemented
immediately.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 15
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002- DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What
T5
4. Nonconformities management For each nonconformity the Organization shall perform a root
Within 90 Organization
cause analysis and define corresponding corrective actions to
days from T4
be implemented as soon as possible, in any case within three
months from the end of the site visit. The organization will
inform the audit team of corrective actions and target date for
implementation.
Corrective actions
definition and
implementation
Audit team
Upon verification of corrective action, a supplementary report
shall be issued by the audit team to accompany the final audit
report.
T5
The audit team may propose to the certification body a follow-
Within 90 Audit team
up visit in order to verify the implementation of corrective
days from T4
Submission of supplementary actions.
report and completion
The audit report is completed, if appropriate, by the submission
of audit team report.
to the certification body of the supplementary report detailing
verification of corrective actions.

16 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What

5. Certification issue The certification body may require additional information in


Certification
order to clarify any aspect of the audit team final report, before
body
a certification decision can be made. The audit team leader
shall report on all specific issues raised by the certification
function.
Certification
decision

Audit team
leader Audit team leader shall submit the required information to the
certification body within seven days.
no Supplement
information
needed?
Certification Certificates will be issued only if there is 100% compliance to
body requirements, which means that nonconformities found during
yes no
the audit are 100% resolved within ninety days of the issue of
the final report.

Conduct follow-up 100% resolved means the following;


yes
verification
• Containment of the condition to prevent risk to the
customer
No • Documented evidence such as an action plan,
certification. instructions, records to demonstrate the elimination of
Record in the non conformity condition, including assigned
yes database responsibilities or verification follow-up visit

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition 17
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002- DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Phase description Time sched. Who What

The certification body shall inform the organization of the


Certification
decision.
Record in body
IATF In case of positive decision:
database • The certification body shall record the certificate
information in the IATF database
• After receiving from IATF a specific IATF certificate
number, the certification body can issue the certificate
and send it to the Organization

Certificate
issued

18 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Annex 2 Criteria for third party auditor qualification to ISO/TS 16949:2002

Qualification Criteria

- qualified according to ISO 10011-Part 2 and/or ISO 19011 and the relevant
accreditation body rule
- competency in:
1) ISO 9001:2000
Auditor - ISO quality standards
Qualification - audit management
- team work techniques and presentation
- interview techniques

2) Automotive
Industry specific - Automotive core tools knowledge and competence
skills

Related to ISO 9001:2000 auditing experience:


At least 3 (three) ISO 9001: 2000 third party audits at a minimum of 10 (ten)
audit days, with 1 of these audits as a lead auditor.

AND in addition, either of the conditions A or B, below:

A) For new automotive auditors


3 years full time appropriate practical experience (excluding training) in the
3) Minimum work automotive industry (OEM, Tier 1, Tier 2) or industries with equivalent
experience requirements in chemical, electrical or metallic commodities including 2 years
dedicated to Quality Assurance activities. This experience must have been
completed in the last six (6) years.
B) For existing automotive auditors
at least 15 third party system audits in the automotive sector to one of the
automotive quality system standards (AVSQ 94, EAQF 94, QS 9000, VDA 6.1,
ISO/TS 16949:1999) in the last three years at a minimum of 45 audit days, with
two of these audits as a lead auditor.
The local IATF oversight may issue waivers during the 1st year after
launch of ISO/TS 16949:2002 certification

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949 :2002 First Edition 19
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
- Auditor training is only open to an auditor sponsored by an IATF
contracted certification body, accreditation body witness auditor or IATF
nominees.
- To apply to attend an IATF training session, the sponsoring certification
body shall provide to the IATF for each candidate a file containing a copy
of their existing qualifications including records demonstrating audit and
work experience.

4) IATF - Only candidates with an accepted file will be allowed to attend the training
and qualification course.
Sanctioned
Automotive - Note: abbreviated IATF sanctioned automotive training courses are
Training for allowed for auditors previously qualified to ISO/TS 16949:1999.
ISO/TS - All auditors must successfully complete the common IATF ISO/TS
16949:2002 16949:2002 sanctioned auditor examination, irrespective of existing
qualification.
- An auditor qualification certificate will be valid for a period of three years.
Auditor recertification is required within this period.
- Failure to conduct a minimum of three (3) ISO/TS 16949:2002 audits with
a minimum total of six (6) audit days, per year, will result in withdrawal of
the qualification certificate.

20 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Annex 3 Audit days for certification to ISO/TS 16949:2002

Audited Initial Audit Surveillance Re-certification


Audits [years 1 Audit [year 3]:
Entity: (On-site audit
and 2]:
days) (On-site audit
Number of
(On-site audit days)
Employees
days within each
12 Month Period)
1-15 2 2 2
16-30 4 2 2
31-60 5 3 3
61-100 6 3 4
101-250 8 4 5
251-500 10 5 7
501-1000 12 6 8
1001-2000 15 7 10
2001-4000 18 9 12
>4001 21 11 14

For the purposes of calculation, one audit day is considered to be eight working hours i.e. not
including travel, breaks, etc, and is considered the normal working hours in any twenty four hour
period. The only exception is on days when shift working, per item 5 below, is being covered.
Requirements on audit days
1. Initial Audit (On-site audit days) cannot include pre-audit and/or document review.
2. On-site review of corrective actions arising from the initial audit will be additional to the specified
audit days.
3. The only deviations permitted from this chart are only either upgrade from the current third party
certifications as detailed in 4.9 or adoption of the “corporate” scheme detailed below.
4. In cases such as simple processes, or demonstrated performance, the specified audit days table
shall be applied for the initial audit, and if in the light of certification body experience a good case
can be made for reduced audit days for the balance of the cycle, application shall be made prior to
the audit to the local IATF oversight office.
5. Each audit shall include auditing on all shifts. If weekend crews are dedicated and non-rotating, then
auditing of the weekend shifts is also required.
6. Non-design responsible organizations may reduce on-site audit days by 15%.
7. Entity in the table above means site and supporting functions remote or not. The number of
employees is the total of those on site and in supporting activities.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949 :2002 First Edition 21
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
“Corporate” Considerations
A “Corporate” Audit Scheme can be applied where multiple manufacturing sites are assessed together
with supporting locations to be provided a single certificate.
The following additional rules apply before a certification body can apply a “Corporate” certificate for
ISO/TS 16949:2002.
In order to adequately assess the quality management system, it is necessary to visit every site but it is
recognized that the number of audit days required to effectively assess each site may be less per site
than the number given in the audit days Table above.

The conditions required of the organization for a “Corporate” certificate include:


a) The quality management system must be centrally structured and managed, and subjected to
regular ISO/TS 16949:2002 compliant internal audits at all sites.
b) The quality management system must comply with ISO/TS 16949:2002.
c) The balance of activities which could be centrally managed include:
1) contract review, where local acceptance of orders is permitted;
2) approval of organizations;
3) evaluation of training needs (activity may have local aspects);
4) quality management system documentation (Level 1 and Level 2) and changes in same;
5) management review;
6) evaluation of corrective actions;
7) internal audit planning and evaluation of the result;
8) quality planning and continuous improvement activities (activity may have local aspects); and
9) design activities.
Note: Variations are acknowledged due to size and/or organizational structure.
The certification body must establish, during the quotation process, how the multiple site company
falling under the “Corporate” scenario meets these requirements.

22 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Audit days adjustment for “Corporate” Audit Scheme
“Corporate” schemes apply only to multiple site registrations based on a “corporate” quality
management system. As a minimum, for a “corporate” certificate, the on-site audit days per site are not
expected to be less than the percentage of the audit days values, per site, shown in the Audit days
Table. The same logic applies to the surveillance audit days in the Audit days Table. Remote activities,
e.g. Engineering, Purchasing, must be audited as they support a site(s).

Table: Audit days Adjustment for “Corporate” Audit scheme

Number of sites Percent reduction to

2 to 9 80

10 to 19 70

20 and above 60

The certification body/registrar should treat these audit days as true minimums. Deviations shall be
approved by IATF prior to commencement to the audit. The actual on-site initial audit days must be
reported in the audit report.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949 :2002 First Edition 23
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
Annex 4 Decertification process to ISO/TS 16949:2002

In addition to the documented process already existing in clause 2.1.5.3 of the ISO/IEC Guide 62 :1996
(or EN 45012) which content is:
“The certification/registration body shall have procedures to
a) grant, maintain, withdraw and, if applicable, suspend certification/registration;
b) extend or reduce the scope of certification/registration;
c) Conduct reassessment in the event of changes significantly affecting the activity and operation
of the organization (such as change of ownership, changes in personnel or equipment), or if
analysis of a complaint or any other information indicates that the certified/registered
organization no longer complies with the requirements of the certification/registration body.”
All IATF recognized ISO/TS 16949:2002 certification bodies shall apply the following definitions and
documented process:
Decertification process: actions or decisions to be taken by the certification body when events occur
indicating that the initial conditions of the issue of the ISO/TS 16949:2002 certificate to an organization
are no longer satisfied. The starting point could be information coming from the organization
(significant changes of ownership, interruption of activity…), from the certification body (major non
conformity observed during an audit, delayed surveillance audits requested by the organization, non-
compliance with a clause of the certification contract by the organization…), from an ISO/TS
16949:2002 recognizing customer (poor quality performance of the organization…) or from claims from
other customers of the organization or information from the field.
Granting of a certificate: A certificate is issued by a certification body, with a defined period of
validity and with a defined scope of certification.
Maintaining a certificate: A certificate’s validity is subject to the ongoing surveillance audits, re-
certification audits, and other conditions defined in the contract with the certification body.
Probation: Decision to put a certificate on probation, without affecting its validity. The probation is a
temporary status (not exceeding 90 days) that can only end by the full reinstatement, or withdrawal of
the certificate.
Withdrawal of a certificate: definitive interruption of the validity of an ISO/TS 16949:2002 certificate,
as a sanction from the certification body following an organization non-compliance of the certification
contract.
Cancellation of a certificate: action to nullify a certificate at the request of the certified company to
interrupt the certification contract, or by decision of the certification body after verification of the
definitive end of the certified activity. This is not a sanction.
In the case of withdrawal or cancellation, the previously certified entity (site or whole company when
subject to a corporate certificate) is delisted from the current certified database of the certification body
(for the time of suspension in this case).
Corporate Certificates: In the event of corporate certification, if a single site looses their certificate
based upon performance issues, then all related sites loose their certification.

24 19 March, 2002 Rules for Certification Bodies to ISO/TS 16949:2002 First Edition
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved
IATF recognized ISO/TS ISO/TS 16949:2002
Time IATF oversight
16949:2002 Certification body Certified organization
Starting point
- Field information,
Customer - postponed surv.audit Organization
claim - Non conformity… request

Analysis

No action Suspension
Decision

yes
+ 1 month max notification

Corrective
action plan

Verification of
corrective When
needed Unscheduled
actions
audit

3 months decision
minus 10 days

10
days withdrawal
max
reinstatement

notification
+ 3 months max

Any deviation from this process is to be submitted before application to the IATF and approved by
oversight waiver.

19 March, 2002 Rules for Certification Bodies to ISO/TS 16949 :2002 First Edition 25
© 2002-ANFIA, © 2002-CCFA/FIEV, © 2002-SMMT, © 2002-VDA,
© 2002-DaimlerChrysler, © 2002-Ford Motor Company, © 2002-General Motors Corp. All rights reserved

You might also like