Below is an article written by a respected co-worker of mine - My coworker's name is Joe Falcsik.
I wanted to share with the greater community some of the changes that have taken place in the automotive quality sector; specifically that which deals with ISO/TS 16949 and achieving recognition with the International Automotive Task Force (IATF).
-The Reg-
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Rules for Achieving IATF Recognition
New: A Second Edition for ISO/TS 16949:2002
BACKGROUND: The Rules for achieving IATF recognition for certification to the Second Edition for ISO/TS 16949:2002 (TS-2) are developed by the International Automotive Task Force (IATF). A new Second Edition of these rules was introduced to the qualified certification bodies (CB) on June 16 through 18, 2004 at a mandatory session in Southfield, Michigan. These Rules are subject to periodic review and may be modified at any time at the sole discretion of IATF.
SUMMARY: A summary of material changes, as indicated in the Second Edition of the Rules follows. Note: This summary is provided as an overview only, and is not intended in any manner to replace the exact wording or intent of the Second Edition Rules. The changes to the requirements are binding on all Certification Bodies (CB) by the IATF and the organization adopting TS-2. Only changes directly relating to the certified organization are mentioned in this summary of the various key sections of the Rules. Each affected organization can obtain a copy of the Second Edition Rules from AIAG (
www.AIAG.org), and become familiar with and apply the revised Rules.
Material changes affecting the organization are addressed by the original clause numbering used in the latest Rules:
1. Certification Body
CBs that have provided quality management consulting services or on-site training within the prior two years shall not contract as a CB for the company or any of its sites
Pre-audits/Pre-assessments (PA) cannot exceed 80% of the audit man-days for the stage 2 site audit
Auditors used for the PA shall not be part of the audit team for the initial certification audit
More than one PA is considered consulting, and is not allowed by certain CBs.
2. Audit Process
The initial certification audit will now be conducted in TWO STAGES (somewhat similar to the ISO 14001 approach):
Stage 1 Readiness Review, which includes review of Level 1 and 2 documents, will be an on-site assessment with a typical duration of one to two days. Contingent upon the size and complexity of the organization, on-site days may be adjusted.
Stage 1 on-site audit days may not reduce the number of Stage 2 on-site audit days
Stage 2 Registration audit event for quoted on-site audit days
For Corporate schemes, sampling of sites is not permitted
For the initial registration audit, remote supporting functions must be audited prior to the manufacturing site. All sequences and interactions must be appropriately addressed
Support functions are audited as they support a site, but may not obtain independent TS-2 certification
A design function, whether on-site or remote, must undergo, as a minimum, an annual surveillance.
Other remote/support functions must be audited at least once more during the certification period (typically three years) following the initial assessment
Additional audits may be necessary, based upon demonstrated performance
In situations where remote/support functions support many production sites and these sites are audited by more than one CB, the organization has two options:
o First option Each CB audits the remote/support location
o Second option CB may accept the audit of another recognized CB subject to the following;
Audit of the other CB must cover complete product scope
The organization must provide the CB a copy of the audit plan, report, C/A, and all verification actions in English
The organization must provide copies of surveillance and recertification audit reports of the remote/support locations
Verification of C/A must be conducted by the CB that audited the remote/support location
Letters of conformance may be issued for a maximum of 12 months only when a new site exists, and/or an organization is on an active bid list. The letter of conformance may be issued only after:
- The organization supplies Readiness Materials, including internal and external performance data plus one full cycle of internal audits and management review and the site has been audited to TS-2 and found compliant
Audit cycle must be based on the initial certification audit end date
Audits must be in the Process approach, and address all manufacturing shifts where they occur
All nonconformities must be recorded and shall NOT be closed during the audit
3. Audit Team
At least one auditor of the initial audit team should participate in all audits during the three year cycle.
For each subsequent audit cycle different auditors should (preferred by the IATF) be used
The contract between the CB and the organization must agree that:
The organization shall notify the CB of any material changes, legal, commercial, organizational status or ownership
Organization cannot refuse an IATF witness audit
Access authorization for the IATF and their representatives
Authorization to provide the final report to the IATF
Only use of the IATF logo is as displayed on the certificate issued by the IATF qualified CB
4. Other Requirements
If an organization certified by a recognized Certification Body and elects to change CB and continue certification to TS-2, the following steps must be followed in sequence:
New CB must be recognized
Existing certificate must be valid with no open non-conformities
New CB must conduct a document review and review of key indicators of QMS performance
New CB must conduct an audit equivalent of a re-certification audit
New CB must notify the IATF of the change
Process must meet the rules
New CB must enter the previous IATF certificate number into the IATF database
If an organization is placed on Suspension (replaces Probation), the date of suspension is the date of the concern, not the date of notification
The CB is required to verify on site the effective implementation of the C/A before removing the Suspension
If the CB withdraws the certificate, the CB must:
o Enter the info into the IATF database
o Require the organization to return the certificate
o Require the organization to send out written notice that it is no longer certified to its customers requiring certification
Annex 1 Rules for Auditing quality management systems according to ISO/TS 16949:2002
Phase description
T0 - Team of two auditors minimum if auditor man days exceed 5
o Audit days are increased by 20% when a translator is used
o Readiness for Stage 2 audit determined at Stage 1, Readiness Review
o Proper scope determined at Stage 1
o Maximum 90 days from end date of Readiness acceptance to registration/certification audit
T1- Stage 1 Readiness
The organization shall have a system to provide the following information to the audit team for review on site:
o Descriptions of processes showing the sequence and interactions, key indicators, and performance trends for the previous 12 months
o Evidence that all requirements of TS-2 are addressed by the organization
o Quality Manual (level 1 and 2)
o Internal audits and management review from previous 12 months (must include a full cycle of internal audits (QMS, Manufacturing, Product) to TS-2 in the process approach
o List of qualified internal auditors and how they were qualified
o List of customer specific requirements
o Customer satisfaction and complaint status, including customer reports and scorecards
o Based on the Readiness Review, the audit team determines;
The appropriate scope of the audit
Readiness for the stage 2 site audit
And develops the audit plan for stage 2
T2 - Audit Stage 2 Site Audit
Initial certification audits must be conducted according to the following:
o Within 90 days of T1
o Use the automotive Process Approach (Checklist use not permitted)
o Audit all processes for the initial assessment
o Within the process, audit all clauses
o Review effectiveness of implementation and practice, related to planned and achieved quality performance
T3 Post Stage 2 Audit
At the end of the site audit, conduct the final presentation and provide a draft report that includes as a minimum;
o Description all non conformities
o Audit team recommendation to the certification committee
Issue final report within 15 working days from the closing meeting
The audit Team may require a follow up visit to verify the effective implementation of the corrective actions
Certification Issue
Certificate, if issued, must be issued within 90 days of the end of the site audit
Annex 2 Criteria for third party auditor qualification to ISO/TS 16949:2002
Qualification Criteria changes affect third party auditors only
Annex 3 Audit days for certification to ISO/TS 16949:2002
Initial certification audit days adjusted (smoothed out)
Recertification audit table revised
o Requirement on audit days and introduction to the two stage approach
o On site review of C/As arising from previous audit. Read
added time on site to verify effective corrective action
o Variation where portion of a site is dedicated to automotive manufacture and completely separated in terms of employee activity
o Total number of surveillance days over the three year certification period equal the number of initial audit days minimum, with at least one surveillance audit per year (-3 months, + 1 month) and are of equal duration and rounded up to the nearest half day
Annex 4 Decertification Process to ISO/TS 16949:2002
Suspension (replaces probation) is a temporary status not exceeding 120 days
Corporate Certificates are replaced by Corporate Site Certification Term change only, but certificates may only be issued to sites where value added activities occur, and certificates cannot list all certified sites as a grouping. Each certified site will have its own certificate with unique numbering
Annex 5 Automotive Process Approach auditing
No changes, only incorporation of the automotive approach into the Rules
Annex 6 Selections from ISO/IEC DIS 17021
Excerpts are taken from ISO/IEC 17021, the future guidance document for all accredited registrars. It is expected that ISO/IEC Guide 62 will be replaced with ISO/IEC 17021. Dates for finalization and implementation are as yet unknown.
Rules for Achieving IATF Recognition - A Second Edition for ISO/TS 16949:2002
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