Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations
What does ISO 16949 do?
ISO 16949, in conjunction with ISO 9001:2015, defines the quality management systems’ requirements for the design & development, production and, when relevant, installation and service of automotive-related products.
ISO/TS 16949 benefits to your business
If you are contractually obliged to gain certification, looking to gain new business or enter new markets, certification to this standard helps deliver
- Reduced costs
- Increased confidence
- Easy integration
- Competitive advantage
ISO/ TS 16949 offers organizations in the automotive industry, the opportunity for standardization and improvement.
Who can use ISO 16949?
ISO/ TS 16949 is applicable to sites of organizations where customer-specified parts, for production and/or service are manufactured. Supporting functions, whether on-site or remote including design centers, corporate headquarters, and distribution centers, form part of the site audit but can’t obtain stand-alone certification to ISO/TS 16949.
ISO/TS 16949 can be applied throughout the automotive supply chain. If you want to supply many of the world’s largest automotive manufacturers, you will need to achieve this standard because it is a contractual requirement for many of them.
How can we help you in achieving certification against ISO 16949
Management systems are becoming increasingly linked to the success and survival of organizations. In parallel, CEO’s and MD’s worldwide are placing greater emphasis on the independent assessment that helps ensure management systems are ‘fit for purpose’. Our unique assessment methodology helps organizations manage their systems and risks to improve and protect their current and future performance.
The Process of Development & Implementation of QMS against ISO 16949
Gap Analysis against ISO 16949
- Business Excellence' team will conduct an initial assessment/gap analysis according to the scope of services with reference to the STANDARD including office as well as sites
- A comprehensive written report will be presented to the Top Management on the status of the compliance against standard’ requirements in order to know as to what are the gaps
Awareness Training on ISO 16949:2009
- Business Excellence's team will provide awareness training to the key process owners and relevant staff, on the requirements of the standard
- Further to this, they'll explain how these requirements apply to their business
Business Excellence' team will provide full assistance for the development of documentation according to the requirements
These documents will be of different types at different levels (in the order of importance) including policies, manual, system element procedures, and associated 'forms' including RACI matrix, process maps, risks & opportunities register, KPI’s, etc
Support for Implementation of Documented Management Systems
Business Excellence' team will extend its full support in regards to the implementation of the aforementioned documented management systems in letter and spirit
This may include SWOT analysis, process mapping, setting objectives & targets, development of RACI matrices, training need analysis, internal audit, corrective action including root cause analysis, management review meeting etc
Internal Audit against ISO 16949
- Finally, an internal audit by the 'Business Excellence' team will be performed before third-party arrives
- The detailed report of which shall be submitted to the management and will help rectify the non-conformities & concerns
- However, management to ensure rectification of the identified concerns within the time frame, as agreed
Third Party Audit by the Certification Body against ISO 16949
- The selected third party to review documentation including records
- Lastly, conduct an onsite audit
Closing-out of Non-conformities
- Consequent upon the independent review and assessment by the relevant authority, the corrective action plan to be developed for each of the non-conformities
- Business Excellence to provide guidance to implement the corrective action plan
Key Deliverables (Development & Implementation of QMS against ISO 16949)
Gap Analysis Report against ISO 16949
To evaluate the existing systems to ascertain as to what is in compliance and what're the gaps and submitting a comprehensive report to the client
The templates for documents of all types (at all levels) including policies, manuals, system element procedures, work instructions, RACI matrices, forms, process maps, checklist, registers, etc.
Training on ISO 16949
On the requirements of the international standard and how these apply in the context of the business
Review of Documentation and Associated Records
- Business Excellence' team will review each & every provided document prior to finalization
- However, after review by us; the client shall also review these documents prior to approval
Support for Implementation
Business Excellence's team will extend its full support in regards to the implementation of the documented management systems in letter & spirit. This may include SWOT analysis, process mapping, risk assessment, objectives and targets, RACI matrices, training need analysis & training plan, internal audit, corrective action, management review etc
Internal Audit against ISO 16949
Finally, a mock assessment by Business Excellence' team will be performed before the third-party assessment and a detailed report of this shall be submitted to the management in order to help rectify the non-conformities & concerns
Business Excellence' team shall help develop and implement corrective actions to closeout findings consequent upon 3'rd party review &/or audit till approval of the management systems and issue of the certificate