Quality Management System Procedures

The Quality Management System Procedures provide a framework for maintaining and continually improving the company’s quality management system, processes, and policies. Organizations must establish and implement the procedures effectively to achieve the management system’s goals and objectives.

Each QMS procedure is essential for effectively implementing, monitoring, and controlling a Quality Management System (QMS) that meets ISO 9001 and IATF 16949 standards requirements.

Quality Management System Procedures based on the ISO 9001 and IATF 16949 quality management system requirements are listed below with reference clause number.

Quality Management System Procedure – ISO 9001

The common procedures as per ISO 9001 standard requirements are:

• Internal Quality Audit Procedure (Clause 9.2)
• Control of Documents and Records/Documented Information (Clause 7.5)
• Employee Training and Competence (Clause 7.2)
• Customer Satisfaction Procedure (Clause 9.1.2)
• Risk Management/Risks and Opportunities (Clause 6.1)
• Non-conforming Products Handling/Control of Non-Conforming Product (Clause 8.7)
• Nonconformity and Corrective Action (Clause 10.2)
• Communication Procedure (Clause 7.4)
• Production Planning, Control, and Service Provision (Clause 8.1, 8.5.1)
• Product Design and Development Procedure (Clause 8.3)
• Supplier Selection, Monitoring, and Development Procedure (Clause 8.4)
• Change Management/Control of Changes (Clause 8.3.6, 8.5.6)

Some other quality system procedures that are not mandatory for ISO 9001 are:

• Calibration Procedure/Monitoring and measuring resources (Clause 7.1.5)
• Continual Improvement Procedure (Clause 10.3)
• Management Review Procedure (Clause 9.3)
• Machine Maintenance Procedure

Quality Management System Procedure – IATF 16949

The mandatory procedures as per IATF 16949:2016 standard requirements are:

• Training and Awareness (Clause 7.2.1, 7.3.1 )
• Employee Motivation and Empowerment (Clause 7.3.2)
• Internal Auditor Competency (Clause 7.2.3)
• Internal Audit Process (Clause 9.2.2.1)
• Continual Improvement (Clause 10.3.1)
• Product Safety (Clause 4.4.1.2)
• Calibration Procedure ( Clause7.1.5.2.1)
• Engineering Specification (Clause 7.5.3.2)
• Product Design and Development (Clause 8.3.1.1)
• Special Characteristic Defining
• Outsources Process (Clause 8.4.2.1)
• Supplier Selection Process (Clause 8.4.1.2)
• Supplier Monitoring Process (Clause 8.4.2.4)
• Statutory and regulatory requirement (Clause 8.4.2.2)
• Change Management/Control of changes (Clause 8.3.6, 8.5.6)
• Rework Procedure (Clause 8.7.1.4)
• Repaired Procedure (Clause 8.7.1.5)
• Disposition of non-conforming products (Clause 8.7.1.7)
• Problem Solving (Clause 10.2.3)
• Error Proofing/Poka Yoke (Clause 10.2.4)
• Machine Maintenance Procedure (8.5.1.5)

Some other quality system procedures as per the IATF 16949 standard requirements are:

• 4M Change Management/Temporary Change (Clause 8.5.6.1.1)
• Die/Tool Design, Development and Maintenance (Clause 8.5.1.6)
• NPD/Advanced Product Quality Planning (APQP) Procedure (Clause 8.3.2.1)
• Failure Mode Effects and Analysis (FMEA) Procedure (Clause 8.3.2.1)
• Measurement System Analysis (MSA) Procedure (Clause 7.1.5.1.1)
• Production Planning and Approval Process (PPAP)
• Initial Product Part (IPP) Control Procedure
• Initial Supply Control (ISC) Procedure