Understanding The ISO/TS 16949:2002 Standard 

8.2.2 Internal Audit  

You shall: 

Conduct internal audits of your QMS at planned intervals, to determine if it: 

a)        - Conforms to planned arrangements (see 7.1); 

       - Conforms to TS 16949 requirements;  

       - Conforms to your organizations QMS requirements  

b)       Is effectively implemented and maintained 

Plan and adjust your audit program taking into consideration the: 

Þ           status and importance of the processes and areas to be audited 

Þ           results of previous audits 

Your audit program must: 

Þ           Have a documented procedure that defines responsibilities and requirements for: 

► Planning and conducting audits 

► Reporting of results and maintaining records  

Þ      Ensure that management responsible for the area audited takes corrective actions without undue delay to eliminate detected nonconformities and their causes 

Þ      Have follow-up activities that include verifying the actions taken and reporting verification results (see clause 8.5.2) 

Þ      Define the audit criteria, scope, frequency, and methods to be used 

Þ      Select auditors and conduct audits in a manner that ensures the objectivity & impartiality of the audit process. Ensure that auditors do not audit their own work 

Note: See ISO 19011 for guidance  

8.2.2. QMS Audit 

You shall audit your QMS for conformity to TS 16949 & any additional QMS requirements. 

8.2.2.2 Manufacturing Process Audit 

You shall audit each manufacturing process to determine its effectiveness  

8.2.2.3 Product Audit 

Conduct product audits at a defined frequency, at appropriate stages of production & delivery, to verify conformity to all specified requirements such as product dimensions, functionality, packaging and labeling.

8.2.2.4 Internal Audit Plans 

Schedule audits on an annual plan, to cover all QMS processes, activities & shifts 

Increase audit frequency when internal/external nonconformities or customer complaints occur 

Note : Specific checklists should be used for each audit 

8.2.2.5 Internal Auditor Qualification 

Use internal auditors who are qualified to audit to the requirements of TS 16949 

Key Explanation Points and Tips: 

Þ      Internal audit is the second tool to gauge the health of your QMS. You must have a documented procedure for your internal audit process. Your procedure must address the following control requirements:  

Þ      The scope of your internal audit program must cover: 

Þ      Audit of the QMS - to determine conformity to the TS 16949 standard 

Þ      Audit of the QMS – to determine conformity to organizational requirements 

Þ      Audit of QMS processes and their interaction – to determine if the QMS has been effectively implemented and maintained. 

Þ      Audit of each manufacturing process to determine its effectiveness 

Þ      Audit of product across all stages of production and delivery- to determine conformity to requirements specified by the customer and regulatory bodies. 

Þ      All shifts involved in activities affecting product or process quality. Note that there may be shifts for product realization processes as well as support processes.  

Þ      You must adjust the audit frequency (and perhaps even the audit scope), of specific QMS processes; manufacturing processes; shifts; and products when: 

Þ      You experience internal or external nonconformities 

Þ      Get customer complaints 

Þ      Have critical or high risk processes 

Þ      Have frequent or significant changes to processes and product 

Þ      OEM customers may also specify the scope, frequency, criteria, responsibility, etc of internal audits. Review specific requirements at OEM customer or IATF websites.  

Þ      Your annual internal audit program should consider the following: 

Þ      Input from audited area and related areas 

Þ      Key customer oriented processes (see notes to clause 4.1)  

Þ      Process and product performance results and expectations 

Þ      Analysis of quality cost data (see clause 5.6.1.1; 8.4.1) 

Þ      Capability of processes and use of statistical techniques 

Þ      Effective and efficient implementation of processes (lean manufacturing techniques) 

Þ      Opportunities for continual improvement 

Þ      Relationships with customers 

Þ      Over the Certification Body’s (or Registrar) audit cycle (3 years), the CB must audit all of your organization’s processes and their applicable IATF OEM customer-specific requirements. 

Þ      Your internal audit program should be more detailed and exhaustive than the external CB audit. With this outlook in mind, your internal audit program should consider auditing all your QMS processes at least once within the CB 3 year audit cycle (preferably once a year) and some processes more often based on the criteria covered above.  

Þ      The design process (whether onsite of off-site) should be audited at least once within each consecutive 12 month period. Your internal QMS audit program should include all off-site processes and subcontract ‘sites’ that support your facility. These audits may be done by others, such as head office, sister facility or qualified subcontract auditors.  

Þ      Audit criteria , refers to the specific QMS policies, objectives; TS  requirements; documentation; customer and regulatory requirements, etc., that the audit is referenced to or conducted against. Audit criteria may relate to the whole audit program as well as each individual audit. 

Þ      Audit methods refer to the specific techniques that auditors use to gather objective audit evidence that can be evaluated to determine conformity to audit criteria (see above paragraph). Examples of audit methods include – interview of personnel, observation of activities; review of documents and records; etc. 

Þ      The qualification/training requirements may vary for the different types of audits required by this standard. You must define the minimum qualification/training requirements for internal auditors for each type of audit : 

Þ      Personnel performing QMS audits or manufacturing process audits must have adequate training on - the requirements of the TS 16949 standard; training on the automotive process to auditing; audit practices and audit experience as defined by ISO 19011 and IATF guidance; QMS processes and their interaction; customer requirements and applicable regulatory requirements. Also review specific internal auditor training requirements at OEM customer or IATF websites. 

Þ      Personnel performing product audits must have training on - production and delivery processes; audit practices and techniques; product specific customer requirements and applicable regulatory requirements. Product specific auditors do not necessarily need training on the requirements of the TS 16949 Standard.  

Þ      You must have appropriate resources to carry out your annual audit program. These include - having sufficient trained auditors available to conduct scheduled audits; sufficient time to perform audits; availability of process personnel to be audited; time and tools to prepare audit records and reports; etc.  

Þ      Auditor Independence - Auditors can audit their own department provided their objectivity and impartiality is not compromised, but they cannot audit their own work. You must ensure auditor independence when assigning personnel to specific audits.  

Þ      Process owners must take timely corrective action on nonconformities found in their area. They should use the corrective action procedure (clause 8.5.2) to determine root cause, take action and follow-up to determine if results indicate that the root cause has been eliminated.  

Þ      Audit results must be summarized and reported for management review (see clause 5.6.2). The Management Representative must also report any opportunities for QMS improvement (see clause 5.5.2b. The MR must analyze the results of each audit as well as the annual audit program to determine strengths and weaknesses in QMS processes, interactions, functions, products, etc., to identify and prioritize opportunities for improvement. 

Þ      Audit records include – annual audit schedule; audit planning- (criteria, scope, frequency, methods, auditor selection and assignment, etc); auditor competence and training; audit checklists and forms; audit notes and other evidence gathered; audit findings; nonconformity reports; audit reports; corrective actions and follow-up of internal audit nonconformities; analysis of audit program performance indicators and trends; and identified improvement opportunities. 

Þ      You should be aware that the Certification Body (CB) is required to audit your organization using the process approach and each site audit by the CB must include: 

Þ      Implementation of requirements of new customers since the last audit 

Þ      Customer complaints and organizational response 

Þ      Your internal audit and management review results and subsequent actions 

Þ      Progress made towards continual improvement targets 

Þ      Effectiveness of the corrective actions and verification since the last audit 

Þ      Effectiveness of the QMS in achieving both organizational and customer objectives 

Þ      Like all QMS processes (see clause 4.1), you must have performance objectives (indicators) to measure the effectiveness of your internal audit process and monitor trends in these indicators, to continually improve your audit program. Performance indicators may include reducing the number of - late or delayed audits; incomplete audits; incomplete audit records and late reports; auditor errors; auditee complaints; and use of untrained auditors; etc. 

Þ      The output of the TS 16949 internal audit program may be used as performance indicators to: 

Þ      Determine the degree of conformity of the QMS to TS  16949; customer and regulatory requirements. 

Þ      Determine the effectiveness of QMS implementation and maintenance.  

Þ      Determine the degree of conformity of product to contractual and regulatory requirements. 

Þ      Identify areas of the QMS that need improvement.