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What is ISO 9001:2015 – Quality management systems?
ISO 9001 is an international standard that specifies requirements for a quality management system (QMS). StorTronics use this standard to maintain procedures to consistently produce products that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
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Who Uses the ISO 9001:2015 Revision?
ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.
Organizations of all types and sizes find that using the ISO 9001 standard helps them:
Organize processes
Improve the efficiency of processes
Continually improve
All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008.
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What does ISO 9001:2015 cover?
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as:
Requirements for a QMS, including documented information, planning and determining process interactions
Responsibilities of management
Management of resources, including human resources and an organization’s work environment
Product realization, including the steps from design to delivery
Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action
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| The Seven Principles of ISO 9001:2015 |
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The Principles of ISO 9001
As with other quality management methods, ISO’s requirements and improvements contain agreed upon principles. ISO 9001 includes seven principles, although some practitioners break out supplier relationships into a separate principle unto itself.
- Customer Focus: By making the customer the center of the business, organizations can understand needs and generate customer loyalty.
- Leadership: Good leaders create an environment that focuses on customers and involves all employees.
- Engagement of People: As with total quality management (TQM), Kaizen, and Lean, this principle should include all employees. In this way, people with a vested interest will be more committed to the venture’s success.
- Process Approach to Quality Management: When you view the goals and activities of a company through the lens of processes, the big picture becomes clear. Rather than focusing on silos or inspection at the finish, the process reveals issues and concerns on the way to product delivery.
- Continual Improvement: Organizations must regularly seek improvement beyond the changes they make to gain certification.
- Evidence-Based Decision Making: You should make data-driven decisions to provide a foundation for comparing results and build organizational confidence.
- Relationship Management: Actively managing all relationships with suppliers, partners, and others is critical to the success of your organization. This includes understanding their needs and providing feedback on services.
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ISO 9001 Certification
ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
- Maintains documentation
Certification to the ISO 9001 standard has enhanced StorTronic’s credibility by showing our customers that its products and services meet their expectations. In some instances or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015.
StorTronics has monthly meetings involving all management personnel to review any and all issues and then completes regularly schedule audits conducted by an independent registrar confirming that we have met those requirements.
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