TL 9000:2016 Transition Guidance for Clients

Planning a smooth transition starts with understanding the new standard and your options!

As you are likely aware, the revision of the ISO 9001 standard published in September 2015 has driven a corresponding revision of the TL 9000 Requirements Handbook. The new version of the standard, known as TL 9000:2016 (R6), also includes more than a dozen new or substantively changed TL-specific additional requirements, along with the merging or deletion of other “adders” and the rewording of still others to relax requirements or to clarify wording. (There is no change to the measurements at this time: MHB R5.0 remains current.)

Many of you will have questions about how the changes in R6 will affect your company and how the transition process is going to be undertaken.

In alignment with IAF and ANAB guidance, NQA believes these changes to be significant in nature and thus will require an evaluation of companies’ existing management systems to confirm the degree of conformity with the new risk based approach as detailed in ISO 9001:2015.

This document will discuss NQA’s philosophy associated with the changes to the standard, the options available to you, our client, and explain the expectations for registered organizations during the transition process.

Background for the change – the impact of Annex SL

In April 2012, the International Organization for Standardization (ISO) published Annex SL (previously ISO Guide 83) of the Consolidated ISO Supplement of the ISO/IEC Directives. This document provides identical structure, text and common terms and definitions for management system standards to follow for future revisions.

Over the years, ISO has published many management system standards for topics ranging from quality and environment to information security, business continuity management and records management. Despite sharing common elements, ISO management system standards come in many different shapes and structures.

This, in turn, results in some confusion and difficulties at the implementation stage. This new approach will ensure consistency among future and revised management system standards and make integrated use of these standards far simpler. It will also make the standards easier to read and better understood by the users.

General guidelines for transition

1. The TL 9000:2016 (R6) standard allows for fewer documented procedures than RHB R5.5. As you prepare for the transitioning of your QMS documentation for conformity to the new standard, it is acceptable to change the wording to comply with R6. However, you must not delete procedures required by RHB R5.5 until R6 conformity is achieved.

2. All NQA clients will be required to complete the TL 9000:2016 (R6) checklist to list process, procedure or work instruction references pertinent to the new requirements. This exercise serves both to ensure that all requirements have been addressed in the management system and to provide easy reference to requirements during future audits.

3. All current existing certificates to TL 9000 R5.5/R5.0 will expire on September 14, 2018, two years after the publication of TL 9000:2016 (R6).

4. Until the transition is complete, the organization’s QMS must maintain conformity to TL 9000 R5.5/R5.0. Where a lack of conformity is identified, a nonconformity will be raised and must be addressed per the current corrective action process.

5. If your organization’s current TL 9000 certificate expires before you are able to fully transition to the R6 standard, you may be re-registered to the R5.5/R5.0 version. This new certificate will only remain valid for the remainder of the two year period after release of the R6 version, September 14,
2018, as mentioned above.

6. A new certificate to TL 9000:2016 (R6) will be issued when it can be satisfactorily shown that your organization has fully met the requirements of the new standard. As is the current practice, no major nonconformities can be in place and corrective actions for any minor nonconformities must be
received and reviewed at NQA prior to issuance of a certificate.

7. Where transition audits are carried out in conjunction with scheduled surveillance or reassessment activities, additional time will be added to the audit schedule to ensure that all activities are covered for the existing and new standards.

Transition Checklist

With the TL 9000 standard being restructured and reworded, NQA feels it is important to provide clarity as to which of the clauses are new and significantly modified requirements from the previous revision. With this in mind, the Transition Checklist was developed. We ask that your organization use this document to perform evaluations to determine the areas within your QMS that are in need of revision. Also note that there are several documents, articles and discussions on R6 and on ISO 9001:2015 that are available on the NQA website.

By evaluating the identified topics and areas, your organization should be able to develop a fairly simple implementation plan that addresses any procedural or system changes, and also to identify training and improvement needs. Once the Transition Checklist is completed, forward it to your Client Support Representative (CSR) and Lead Auditor prior to your organization’s transition audit. This form can be downloaded from the NQA website: www.nqa.com.

Pre-assessment

Once your transition plan is completed, you may want to have the plan evaluated by an NQA auditor in a Pre-assessment.

During the implementation of the R6 transition process, NQA can provide a Pre-assessment of your organization’s revised Quality Management System. This activity would determine the level of conformity of your QMS to the requirements of the standard. This may be discussed with the auditor;
however, the preferred method would be to contact your CSR for details and cost if a Pre-ssessment is desired.

Auditor Interactions

NQA is providing formal transition training to all auditors and office staff. The auditor will have the knowledge and authority to deal with most areas of the transition process. As always, there may be unique situations that develop that your auditor may not be able to support. In these cases, the NQA
office is at your disposal to support any of your unique transition needs.

Transition Audit Timing & Cost

Based on guidance from the IAF, NQA is encouraging all clients to transition at the next Reassessment visit. Additional audit time will be required to ensure that all activities are covered for the existing and new standards. Other options such as transitioning during a surveillance or via a special audit are also available. If you have any questions regarding the timing or duration of your R6 transition audit, please contact your CSR to discuss other arrangements.

Multisites

For customers that are registered with a multisite certification, the transition approach will be similar. Due to the added complexity of the multiple facilities requiring transition support, the process will be coordinated differently. The Transition process for the organizations that are covered by the Multisite program will be handled by your assigned NQA Multisite CSR or Program Manager. This individual will be in touch with your organization to assist in the planning effort.

We appreciate the effort your organization will go through to implement the requirements of the new standard. The staff here at NQA looks forward to providing you the service you have come to expect in supporting your efforts in this transition process. If you have any questions or concerns regarding
the transition process or the Transition Package, please contact your Client Support Representative.

Additional support

We are here to support you throughout the transition process. If you have any questions or need any help we can support you with:

• Technical Advice. Please call us with any questions you have.

• Pre-Assessment / Gap Analysis. We can provide a Pre-Assessment or Gap Analysis of your revised Management System to determine the level of compliance of your System to the requirements of the new standard.

If you have any questions or just want to speak to someone regarding your transition please give us a call.