ISO 9001:2015 specifies requirements for a quality management system where an organization:
- Needs to demonstrate its ability to provide a product that meets customer and applicable regulatory requirements consistently
- Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
Companies that go through the ISO 9000 QMS certification process have given a lot of thought to their processes and how to maximize quality and efficiency. Once certified for QMS, the processes are established and guidelines in place for anyone to follow easily, making training, transitions, and troubleshooting easier.
Studies have shown that ISO QMS certified companies experience increased productivity and improved financial performance, compared to uncertified companies.
Defined roles and responsibilities, accountability of management, established training systems and a clear picture of how their roles affect the quality and the overall success of the company, all contribute to more satisfied and motivated staff.
The International Organization for Standardization (ISO) is recognized worldwide as the authority on quality management.
05Factual Approach to Decision Making
The ISO 9000 QMS standards set out clear instructions for audits and process reviews that facilitate information gathering and decision making based on the data.
Mutually beneficial supplier relationships are one of the key attractions to ISO certification. Following the processes for documentation and testing ensure quality raw materials go into your production system. The process also requires a thorough evaluation of new suppliers before a change is made and/or consistency with respect to how and where orders are placed.
The ISO QMS standard requires documentation of all processes and any changes, errors, and discrepancies. This ensures consistency throughout production and accountability of all staff. This also guarantees traceable records are available in case of non-compliant products or raw materials.
One of the foundations of ISO; All processes from research and development, to production, to shipping, are defined, outlined and documented, minimizing room for error. Even the process of making changes to a process is documented, ensuring that changes are well planned and implemented in the best possible way to maximize efficiency. Recommendations in the biotech industry to use XML authoring or similar software formatting for data collection, reports, and product labeling, minimizes the risk of obsolete documents/labels being mistakenly used.
Client confidence is gained because of the universal acceptance of the ISO standards. Customer satisfaction is ensured because of the benefits of ISO 9000 QMS to company efficiency, consistency, and dedication to quality service.
The ISO 9001:2015 QMS outlines audit processes, management review and improvement processes based on collected data. Improvements are carefully planned and implemented based on facts, using a system of documentation and analysis, to ensure the best decisions are made for your company.
Top 10 Benefits of Get ISO 9000 QMS Certification
The International Organization for Standardization (ISO) is an independent, non-governmental international organization primarily known for developing and publishing standards that govern specifications for products, services, and systems to ensure their quality, safety, and efficiency. Some ISO standards come with the ability to be certified, which carries its own benefits for your business. One of those is the ISO 9001:2015, which sets out the criteria for your quality management system.
ISO 9000 Quality Management Family of Standards
The ISO 9000 family of standards specifically address aspects of quality management that can be used by any business, regardless of the industry. While this family is made up of several ISO standards, only one offers a certification option: ISO 9001:2015, which has replaced previous versions of the standard, including ISO 9001:2000 and ISO 9001:2008.
Here are the top 10 reasons to consider getting the ISO 9001:2015 Quality Management Standards (QMS) certification. Once you have decided that ISO QMS certification is right for your company, you will be ready to read up on how to get ISO certified and start preparing your documentation.