ISO 9001:2015 Certification
PharmOut are proud to announce that we recently obtained ISO 9001:2015 certification from LQRA. Our Quality Management System (QMS) is now certified to the ISO 9001:2015 standard for the provision of engineering, architectural design and consultancy services.
Trevor Schoerie, the PharmOut Managing Director said: “I am delighted with the certification. Our clients who seek our Architectural and Engineering services increasingly want to see a robust quality systems-based approach to our service delivery.” He went on to thank QikSolve, a local Australian company specialising in Paperless SharePoint Quality Systems, “A huge thanks to the efforts and assistance provided by QikSolve.”
What is the ISO standard for a quality management system (QMS)? ISO 9001:2105 certification
- ISO 9001 is the world’s most widely recognised standard for a quality management system (QMS), with the latest edition, ISO 9001:2015, published on 23 September 2015.
- The ISO standard helps organisations consistently meet the needs of customers and other key stakeholders in the delivery and continuous improvement of products and services.
With over 1.1 million certificates issued worldwide, ISO 9001 is a tool to streamline processes and make them more efficient. On the ISO 9001 website, acting ISO Secretary-General Kevin McKinley explains: “ISO 9001 allows organisations to adapt to a changing world. It enhances an organisation’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success.”
Want to know more about about ISO 9001:2015 certification?
Take a look at the video from ISO on the newest version of ISO 9001.
Benefits of attaining ISO 9001:2015 certification
PharmOut decided to embark on the ISO 9001:2015 certification process to maximise the value of services to our clients in a practical way. In particular, we liked the change in focus of the 2015 standard to a practical outcome or evidence-based focus and less paperwork for the sake of paperwork.
This ensures that the PharmOut Paperless Quality Management System works to improve our business processes and are not just a set of procedures that gather dust. The core premise is that the Quality Systems is built into our electronic work flows.
Paperless Workflows | Sustainability Aims and Reduced Waste
We are finding that the paperless work flows are providing us and our clients practical benefits, incuding:
- PharmOut management have good quality metrics
- Responsibilities are clearly defined across the organisation
- We strongly seek and encourage more efficient and time saving processes
- Quickly highlights deficiencies
- Provides continuous assessment and improvement
We think the benefits to our customers are:
- Improved quality and service
- Delivery on time
- Right first time attitude
- An independent audit demonstrates commitment to quality
Help with ISO 9001:2015 certifications as well as GMP Audit Responses
Do you need help getting ISO certification for your quality management systems, GMP Audit responses, or other GMP / EU GMP manufacturing systems and validation processes in the pharmaceutical industry, EU GMP medicinal cannabis cultivation and production sector, medical devices or veterinary medicine manufacturing sectors?