ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS
What Is ISO 9001?
ISO 9001 is an internationally recognized standard for quality management systems (QMS). It is part of the ISO 9000 family of standards, which provides a framework for organizations to implement and maintain effective quality management practices. ISO 9001 specifies the requirements for establishing, implementing, maintaining, and continually improving a quality management system.
ISO 9001 is often used by organizations in various industries to enhance their quality management practices, improve customer satisfaction, and increase operational efficiency. Achieving ISO 9001 certification involves undergoing a formal audit by a certification body to ensure compliance with the standard’s requirements. Organizations that obtain ISO 9001 certification demonstrate their commitment to quality and their ability to consistently provide products or services that meet customer and regulatory requirements.
What Is New in ISO 9001:2015?
ISO 9001:2015 is the latest version of the ISO 9001 standard for quality management systems. It introduced several significant changes and updates compared to its predecessor, ISO 9001:2008. Some of the key changes and new features in ISO 9001:2015 include:
High-Level Structure (HLS)
ISO 9001:2015 follows a common high-level structure, which is also used by other ISO management system standards like ISO 14001 (Environmental Management). This structure, known as the Annex SL framework, allows for easier integration of multiple management systems within an organization.
Risk-Based Thinking
ISO 9001:2015 places a strong emphasis on risk-based thinking throughout the standard. Organizations are required to identify and assess risks and opportunities that could affect the achievement of quality objectives and the ability to deliver products and services that meet customer requirements.
Context of the Organization
Organizations are expected to define the internal and external issues that can impact their QMS. This includes understanding the needs and expectations of interested parties, such as customers, regulators, and suppliers.
Leadership and Commitment
The role of top management is highlighted more prominently, with a greater emphasis on leadership and their commitment to the QMS.
Process Approach
While the process approach was present in previous versions, ISO 9001:2015 further emphasizes a systematic and process-oriented approach to managing quality. It requires organizations to identify and manage their core processes and interactions.
Documented Information
ISO 9001:2015 replaces the term “documentation” with “documented information.” It gives organizations more flexibility in how they document their quality management system, making it less prescriptive in terms of documentation requirements.
Lifecycle Perspective
The new standard encourages organizations to consider the entire product or service lifecycle, from concept to disposal or recycling, where applicable. This can be particularly important in industries where sustainability and environmental impact are significant factors.
Performance Evaluation
ISO 9001:2015 emphasizes the importance of measuring and evaluating the performance of the quality management system. It also requires organizations to determine the effectiveness of their processes in achieving desired results.
Continual Improvement
The concept of continual improvement remains central, but ISO 9001:2015 places more focus on the organization’s ability to react to changes, adapt, and improve over time.
These changes in ISO 9001:2015 are aimed at making the standard more adaptable and relevant to a wide range of organizations and industries. They encourage a more strategic and risk-based approach to quality management and align with modern business practices. Organizations seeking certification to ISO 9001:2015 need to adapt their quality management systems to meet these new requirements.
Benefits of ISO 9001
Improved Quality Management
ISO 9001 provides a framework for organizations to establish and maintain a systematic approach to quality management. It helps ensure that products or services consistently meet customer requirements and comply with relevant regulations and standards.
Increased Efficiency
The standard encourages organizations to streamline their processes and eliminate waste. This can lead to greater efficiency in operations, reduced costs, and improved resource utilization.
Enhanced Customer Satisfaction
By focusing on customer needs and expectations, ISO 9001 can lead to increased customer satisfaction. This can result in repeat business, positive word-of-mouth referrals, and improved customer loyalty.
Greater Competitiveness
Stronger Employee Engagement
ISO 9001:2015 Requirements
ISO 9001:2015 outlines a set of requirements that organizations must meet to establish and maintain an effective quality management system. These requirements are organized into several key sections:
1. Scope
The standard begins with defining the scope of the QMS, making it clear which aspects of an organization’s operations are covered by the system.
2. Normative References
This section references other standards and documents that are applicable to ISO 9001.
3. Terms and Definitions
ISO 9001 provides a list of terms and their definitions to ensure common understanding of key concepts throughout the standard.
4. Context of the Organization
Organizations are required to understand the internal and external context in which they operate. This involves identifying interested parties, understanding their needs and expectations, and determining the scope of the QMS.
5. Leadership
This section emphasizes the role of top management in providing leadership and commitment to the QMS. Top management is responsible for establishing the organization’s quality policy and objectives.
6. Planning
Organizations need to address risks and opportunities, set quality objectives, and plan actions to achieve these objectives. This section also covers change management.
7. Support
Organizations must provide the necessary resources, including human resources, infrastructure, and work environments. It also covers the importance of competence, awareness, and communication within the organization.
8. Operation
This section outlines the processes required to produce products or deliver services in accordance with customer requirements. It addresses areas such as product/service design and development, production, and service provision.
9. Performance Evaluation
Organizations are required to monitor and measure the performance of the QMS and the products or services they deliver. This includes internal audits and management review.
10. Improvement
This section emphasizes the need for organizations to continually improve their QMS and processes. It covers non-conformities, corrective actions, and preventive actions.
It’s important to note that ISO 9001:2015 is a flexible standard that allows organizations to tailor their QMS to their specific needs and context. The requirements are intended to be applied in a way that is proportional to the organization’s size, complexity, and the nature of its operations.
To achieve ISO 9001 certification, organizations must demonstrate compliance with these requirements and undergo an audit by a certification body to ensure that their QMS is effectively implemented and maintained. Organizations are also required to document their processes and procedures, but the standard is less prescriptive in terms of specific documentation compared to earlier versions, emphasizing the concept of “documented information” rather than rigid documentation.
How Phoenix Can Help with ISO 9001:2015
Phoenix offers comprehensive support for achieving and maintaining certification to ISO 9001:2015 and other quality standards, addressing the full spectrum of quality management needs. Our expert team can guide you through the QMS journey, whether it’s conducting Gap Analysis and Root Cause Analysis to identify and resolve issues, developing essential QMS elements such as procedures and core tools, performing internal or supplier audits, or providing both salaried and hourly staff training. We understand that quality staff often grapple with immediate problem-solving, leading to QMS neglect. At Phoenix, we aim to change the perception of your QMS, emphasizing its role as a toolbox of efficiency, not just a checklist of tasks. We’ll help your organization leverage the QMS to meet customer requirements more effectively, ensuring that it’s a valuable asset for improved quality performance and ISO 9001:2015 certification.
ISO 9001:2015 Training & Certification Case Studies
QMS Consulting
Metal suppliers
Ford Motor Company
Civil Affairs Battalion
Worldauto Steel
General Motors
Meet The ISO 9001:2015 Consultants
About Larry Przekora
Bio
Joining our team in 2015, Larry brought over forty years of manufacturing, manufacturing engineering, quality, production troubleshooting and cost reduction experience. Before coming to work for The Phoenix Group he spent thirty eight years with General Motors on Manufacturing assignments including machining, press operations, assembly activities and testing of all finished products. He was also instrumental in the startup of three new product lines and instituted Lean and Global Manufacturing Systems in several GM facilities.
Education
- BA – Management of Human Resource, Spring Arbor University
Experience
- 40 years Manufacturing (machining, assembly, stamping, heat treat and welding), Safety and Quality Management, Manufacturing Engineering, Industrial Engineering, Project Management, Material Handling and Logistics Management, Labor Relations
Skills
- Global Manufacturing System/Toyoda Production System Implementation
- Principles of Lean Manufacturing
- Statistical Process Control/6 sigma
- Red X Problem Solving
- Safety & Quality Management
- Team Concept Implementation
- Buffer and Constraint Management
- Level 2 containment; 2nd party audits
- Waste Reduction
- Workplace Organization
- Tooling Control
Certifications
- Global Manufacturing System
- Red X Problem Solving
- Lean Manufacturing
- Team Concept Implementation
- Six Sigma
- Statistical Process Control
Key Projects
- Formability Project Leader – Tier 1 Supplier, 2015 - 2016
- Ford Tool Die Council, 2016 – 2018
- AK Steel – Due Diligence Team, 2017
- Quality Containments – Tier 2 Supplier, 2017 - 2019
- Plant Assessments – Tier 2 Supplier, 2017 - 2019
- Data Collection and Problem Solving, Tier 2 Supplier, 2019
About Russ Balzer
Bio
Since 2007 Russ has provided expertise in various roles at The Phoenix Group. Russ began his career with Phoenix as a Lab Supervisor, then took on responsibility for Safety and Quality Compliance. In addition to supporting our Quality System services projects, Russ currently serves as Technical Director for WorldAutoSteel, a global consortium of steel producers serving the automotive market. As Technical Director, Russ manages a variety of engineering projects, and has tactical and strategic responsibilities in WorldAutoSteel’s efforts to use and promote Life Cycle Assessment (LCA).
Education
- B.S.S. Environmental Compliance, Ohio University
Experience
- 15+ years Mfg. Operations Management
- Engineering Project Management
- Safety & Quality Management Systems
Skills
- Materials Testing
- Project management
- Life Cycle Assessment (LCA)
- Safety & Quality Management Systems
- SQA - Level 2 containment
- 2nd party audits
Certifications
- Lead Auditor ISO9001:2015
- Lead Auditor IATF16949:2016
- Life Cycle Assessment Certified Professional
Key Projects
- QMS Auditing:
Midwest Fabricating – internal audit
Hayes Performance Systems – internal audit
AK Steel (AW) – internal audit
- Project Management:
WorldAutoSteel – manage global Life Cycle Assessment (LCA) policy project, including advocacy, and education, across a wide range of stakeholders (government, academia, industry).
WorldAutoSteel – manage modeling and engineering projects including component design, benchmarking, LCA and cost modeling.
About George Coates
Bio
Since 1991, George has been providing engineering and consulting services for industry leaders in the steel, automotive, and manufacturing industries. George’s areas of expertise include: management and strategic consulting, project management, automotive stamping throughput improvement, supplier metal conversion, metal formability and reference panel systems, and new vehicle launch manufacturing support. George is an active contributor to WorldAutoSteel technical programs, including project manager / instructor for AHSS Application Guidelines, Version 6.0.
Education
- B.S. Metallurgical Engineering, University of Cincinnati
- MBA coursework, Miami University (Ohio)
Experience
- Twenty-eight years with The Phoenix Group
- 10 years with a major US steel producer
- 5 years with the Procter and Gamble Company
- 10+ years Consultant to WorldAutoSteel
Skills
- Management and strategic consulting
- Leadership development
- Team installations
- Project management
- Metal formability and reference panel systems
- New vehicle launch support
- Technical director for the WorldAutoSteel program staff; emphasis on AHSS implementation solutions, strategic implications for steel in future mobility, materials and environmental impacts from vehicle light weighting.
Case Studies
About Kirk D. Wiley
Bio
Starting his career on the manufacturing line at General Motors, Kirk has experienced nearly every aspect of the automotive and manufacturing industries, developing a comprehensive perspective for clients. Kirk’s areas of expertise include: systems design and team processes, metal formability, stamping and assembly optimization, die shop management, throughput improvement, process engineering, manufacturing systems design and implementation, supplier metal conversion programs, manufacturing cost savings, production troubleshooting and die optimization, and tool and die training programs.
Education
- BBA Industrial Marketing, Western Michigan University
- Coursework completed, MS Manufacturing Management, Kettering University
Experience
- 25 years manufacturing experience
- Operating Systems design, implementation and maintenance
Skills
- Team concepts
- Leadership development
- Tool & Die training programs
- Formability
- Lean applications to maintenance departments
Key Projects
- Manufacturing Cost Savings project at Chrysler Sterling Stamping. Realized $3.4M savings on a 10 month, A Transfer press project , $1.5M savings on a 8 month, B Transfer press project.
- Formabiility System Installation at 12 OEM Stamping Plants. T&D training events at another 6. Significant savings recorded in individual case studies.
- Leadership Training design and delivery across the Ford Motor Company Stamping Business Unit plants.
- Pioneered application of Lean Manufacturing principles to Tool & Die department operation.
Case Studies
NEED HELP WITH ISO 9001:2015 CERTIFICATION? CONTACT PHOENIX TODAY!
If you’re interested in learning how The Phoenix Group can help your company, contact us today.
