What is ISO 9001:2015 certification and does my organisation need it?
What is ISO 9001 Certification?
The International Organization for Standardization, better known as ISO, is an independent, non-governmental organisation that works with global industry experts to develop relevant International Standards. The ISO Standards are created to support innovation and provide solutions to global challenges.
Part of the ISO 9000 family of standards, ISO 9001:2015 helps to lay the foundation for a quality management system (QMS) that can be certified to, offering international recognition. Implementation of the ISO Standard in a healthcare or human services setting is a simple process that yields great benefits for an organisation and its consumers.
ISO develops the standards but is not responsible for certifying to their standards. Certification is provided by an external organisation known as a Certification Body (CB). The process requires an organisation to provide a self-assessment to determine audit readiness.
This is followed by an on-site certification audit to evaluate the business’s QMS. A decision will then be made to award certification. Find out more about the certification process.
Does my organisation need ISO 9001:2015 certification?
The ISO 9001:2015 Standard is applicable to any organisation, regardless of size and type. From small businesses such as general practices to larger operations like hospitals, ISO 9001 certification provides countless benefits to any organisation.
The ISO quality management system standard is used by organisations to manage their processes and procedures. This ensures that the services provided are delivered to a quality standard, in the way the service was designed to be delivered.
What are the benefits of QMS certification?
Many health and human services organisations choose to undergo ISO 9001:2015 certification due to the standards’ strength as a powerful business improvement tool.
Having an effective quality management system in place leads to many improvements in an organisation. Establishing a QMS requires the development of a quality policy and quality goals, quality manual, procedures, work instructions and records.
ISO 9001:2015 involves a process-oriented approach to documenting and reviewing the structure, responsibilities, risks, and opportunities, and procedures required to achieve effective quality management in an organisation.
ISO certification is well recognised by governments, commissioners, and referrers who use ISO 9001:2015 certification as a mark of quality to identify technically competent, safe, efficient, and consumer-focused services that meet regulatory requirements.
By supporting continuous improvement ISO 9001:2015 certification with QIP Certifications can help health and human service organisations to:
- Meet the needs of their consumers
- Assure their consumers of the level of care provided
- Increase productivity and efficiency
- Improve consumer experience and increase consumer satisfaction
- Increase employee satisfaction and morale
- Streamline operations
- Gain assurance regulatory requirements are being met
- Create cost savings resulting in increased profits, and
- Enhance organisation reputation.
As a result of these improvements, organisations become more competitive in tender submissions, lower organisational costs, create more repeat business, and increase sales and additional income for the business.
How does my health or human services organisation prepare for ISO certification?
To become ISO 9001:2015 certified, your organisation will follow a certification process outlined by your CB which includes a self-assessment and an on-site certification audit. But how do you prepare for these? There are three main steps to preparing for an ISO 9001 internal audit.
Step 1: Defining an organisation’s QMS
To begin preparing a health or human services organisation to implement ISO 9001:2015, the organisation needs to define how it appropriately applies the requirements outlined in the ISO 9001:2015 Standard.
All organisations certified to ISO 9001:2015 have the following documents:
- Quality Manual
- Control of Document Procedure
- Control of Records Procedure
- Control of Nonconformities Procedure
- Corrective Action Procedure
- Preventive Action Procedure
- Internal Audit Procedure
These are the seven documents that lay the base of a QMS.
Step 2: Implementing the QMS
Once the seven documents have been developed, they need to be implemented into the day-to-day operations of the organisation. All staff should learn these documents and understand what is expected of them as a result of the QMS. It is common for top management to provide a formal management review to support the implementation of procedures.
Step 3: Internal verification of the QMS
Once an organisation has developed and implemented the Quality Manual and Procedure Documents, it’s time to prepare for the internal audit. The internal audit function is critical in ensuring the QMS is implemented and effective. The internal audit is often referred to as a self-assessment.
Choosing the Certification Body that is right for your organisation is essential. Not only for an enjoyable certification experience but to gain insight and knowledge throughout the journey.
Finding an industry experienced CB that is JAZ-ANZ accredited ensures that they themselves are implementing continuous quality improvement.
QIP Certifications is JAZ-ANZ accredited and backed by Quality Innovation Performance Limited (QIP), Australia’s most comprehensive not-for-profit health and human services accreditation organisation.
We have more than 25 years’ experience across the community services sector, as well as over 10 years’ experience working with primary, secondary and tertiary healthcare providers.