QUALITY AUDITING

AND
TS 16949
TABLE OF CONTENT:
 QUALITY AUDITING
 INTRODUCTION
 TYPES OF AUDIT
 GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS
 CERTIFICATION BODIES
 STEPS TO CERTIFICATION
 ANALYSIS OF REGISTRATION REQUIREMENTS
 TS 16949
 INTRODUCTION
 IATF 16949
 COMPLIANCE TO IATF 16949
 IMPLEMENTATION OF IATF 16949
INTRODUCTION:
 Auditing: Onsite verification activity, such as inspection or
examination, of a process or quality system, to ensure
compliance to requirements.
 An audit can apply to an entire organization or might be
specific to a function, process, or production step.
 Quality auditing: Systematic examination of an organization's
quality management system (QMS).
 ISO Audit: Checking to ensure whether the management
system comply with the relevant ISO standard and quality
objectives.
 ISO 19011:2011 Vs. ISO 19011:2002
 Purpose of Audits
TYPES OF AUDIT:
 Combined Audit and Joint Audit
 Three types of Audit:
• PRODUCT AUDIT:
Examination of a product or service
• PROCESS AUDIT:
Evaluates an operation or method against predetermined standards
• SYSTEM AUDIT:
Audit conducted on management system. Eg. Quality management
system audit, food safety system audits
• INTERNAL AND EXTERNAL AUDITS:
1. First Party Audits: Internal Audits
2. Second- and Third- Party Audits: External Audits
ISO 19011:2011 Vs. ISO IEC 17021:2015
Purchase Audit Format:
GUIDELINES FOR AUDITING
MANAGEMENT SYSTEMS ISO 19011:2011
 Audit Terms & Definitions:
 Auditee, Auditor, Audit Client, Audit team, Guide, Observer, Technical
expert
 Audit conclusions, Audit criteria, Audit evidence, Audit findings, Audit
plan, Audit program, Audit scope
 Competence, Conformity, management system, nonconformity, risk
 Audit Principles:
 Integrity
 Fair presentation
 Due professional care
 Confidentiality
 Independence
 Evidence- based approach
GUIDELINES FOR AUDITING
MANAGEMENT SYSTEMS ISO 19011:2011
 Managing Audit Programme:
GUIDELINES FOR AUDITING
MANAGEMENT SYSTEMS ISO 19011:2011
 Performing an audit:
GUIDELINES FOR AUDITING
MANAGEMENT SYSTEMS ISO 19011:2011
 Competence and Evaluation of Auditors:
 Personal Behaviour:
Ethical, Open-minded, diplomatic, observant, perceptive,
versatile, tenacious, decisive, self-reliant, acting with fortitude,
open to improvement, culturally sensitive, collaborative
 Knowledge & Skills:
 Generic knowledge and skills of management system auditors
and audit team leaders
 Discipline and Sector- specific knowledge and skills
 Establishing criteria and selecting method for auditor evaluation
 Conducting auditor evaluation
 Maintaining and improving auditor competence
CERTIFICATION BODIES:
 Certification body: Accredited by accreditation body/ bodies on the basis of
its compliance and managerial and technical resources
 The International Organization for Standardization’s Committee on
Conformity Assessment (CASCO) has produced a number of standards
related to the certification process, which are used by certification bodies.
 Accreditation is the independent evaluation of certification bodies against
the standard ISO/ IEC 17021:2015 to ensure their impartiality, competence,
and consistency.
 National Accreditation Board for Certification Bodies (NABCB) provides
accreditation to the inspection and certification bodies.
 Some of the certification/ inspection bodies accredited by NABCB:
 Bureau Veritas (India) Pvt. Ltd.
 TUV India Pvt. Ltd.
 SGS India Pvt. Ltd.
STEPS TO CERTIFICATION:

Establish
Make the Review the Communicate
training
right choice standard the goal
requirements

Develop a Select a
Use a
Stage 1 Audit management certification
consultant
system body

Maintain your
Stage 2 Audit management
system
REGISTRATION PROCESS:

Application
Document Pre-
for
Review assessment
registration

Follow-up
Registration Assessment
surveillance
INTRODUCTION TO TS 16949:
 ISO TS 16949:2009, in conjunction with ISO 9001:2008, defined
the quality management system requirements for the design and
development, production and, when relevant, installation and
service of automotive-related products.
 The requirement was applicable to any organization that
manufactures components, assemblies and parts for supply to the
automotive industry.
 ISO/TS 16949:2009 can be applied throughout the automotive
supply chain.
 There are over 65,000 suppliers worldwide which are currently
certified to ISO/TS 16949, some of which include Ford, GM,
Renault, Fiat, BMW and Volkswagen.
 ISO TS 16949:2009 is now revised to IATF 16949:2016 and ISO
9001:2008 to ISO 9001:2015.
IATF 16949:
 IATF 16949:2016 is an independent QMS standard that is fully aligned
with the structure and requirements of ISO 9001:2015. It specifies the
quality system requirements for the design/ development, production of
automotive-related products.
 IATF 16949 was jointly developed by The International Automotive Task
Force (IATF) members and submitted to the International Organization
for Standardization (ISO) for approval and publication.
 The primary focus of the IATF 16949 standard is the development of a
QMS that provides for continual improvement, emphasizing defect
prevention and the reduction of variation and waste in the supply chain.
 The standard is based on seven Quality Management Principles,
including customer focus, leadership, engagement of focus, process
approach, improvement, evidence-based decision making, relationship
management.
COMPLIANCE TO IATF 16949:
The compliance to IATF 16949 may require organization to pass through
following phases. The tentative duration of each phase is mentioned
alongside:
IMPLEMENTATION OF IATF 16949:
 Implementation of IATF 16949 can be done specifically by company when:
 Customers specify this requirement as part of the contract
 Organizations want to improve their products and customer satisfaction

 Reasons to implement IATF 16949 may include:

 Demonstrate its ability to consistently provide products that meet customer
and applicable statutory, regulatory and product safety requirements
 Enhance customer satisfaction through the effective application of the
system
 Implement processes for improvement of the system
 Identify and address the risks associated with your organization
 Work in a more efficient way to increase productivity and efficiency, bringing
internal costs down
THANK YOU