What is ISO9000 Quality Management?

This article explains briefly what is ISO9000 Quality Management.

The series of ISO 9000 is defined as a set of international standards (e.g. ISO 9001, etc.) on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system.

The ISO 9000 family of quality management systems (QMS) helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service.

ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles that underlie the family of standards, including ISO 9001 and others more specific.

ISO 9000 is not specific to any one industry and can be applied to organizations of any size.

What is the ISO 9001:2015 Quality Management Standards?

ISO 9001:2015 is the most recognized and implemented quality management system standard in the world to handle quality management systems (QMS).

The ISO 9001 is the guideline that establishes the methodology for documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization.

Learn How to Implement the ISO 9001:2015 in 5 steps?

How to obtain the ISO 9001 Certification

Need ISO 9001 Training

Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment.

Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems.

Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.

• ISO 9001:2015 – Auditor Transition Training
• Documentation in ISO 9001:2015
• More ISO 9001 training

ISO 9001:2015 Videos

• ISO 9001:2015 – 15 Things You Must Know Now
• Transforming a QMS Using ISO 9001

Other standards related to quality management systems include the rest of the ISO 9000 series (including ISO 9000 and ISO 9004), the ISO 14000 series (environmental management systems), ISO 13485 (quality management systems for medical devices), ISO 19011 (auditing management systems), and ISO/TS 16949 (quality management systems for automotive-related products).

 Need help or templates to create a quality manual and procedures, visit us,

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For more details on specific FDA expectations and how to create quality management system documents, follow us.

Three (3) Options to Create Quality Management System Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the ISO9000 Quality Management?.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Management Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about ISO9000 Quality Management, refer to:

httpss://asq.org/quality-resources/iso-9000

httpss://the9000store.com/what-are-iso-9000-standards/

httpss://www.iso-9001-checklist.co.uk/iso-9000-standards.htm

httpss://en.wikipedia.org/wiki/ISO_9000

httpss://the9000store.com/iso-9001-2015-requirements/what-is-iso-9001-quality-management-system/

httpss://asq.org/quality-resources/quality-management-system

httpss://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100080.pdf

httpss://www.fda.gov/files/drugs/published/Overview-of-Quality-System-Regulation.pdf

httpss://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

httpss://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

httpss://ispe.org/initiatives/regulatory-resources/gmp

httpss://www.fda.gov/media/73141/download

Food and Drug Administration References: ISO9000 Quality Management?

1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
5. httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
6. httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1