The Benefits of ISO 9001:2015 Certification for Health and Social Care Providers

What is BS EN ISO 9001:2015?

BS EN ISO 9001:2015 is an internationally recognised Quality Management Standard, the adoption of this standard within an organization helps to improve the overall performance of the organization and provide a foundation for development and continual improvement.

The History of Quality Standards in the Health Sector

The outgoing quality standard ISO 9001:2008 was adopted by many Healthcare providers as a structure for service provision, compliance and improvement and was used as a quality assurance monitoring tool.
 
The standard has been used successfully by a full range of clinical; services such as Cancer Services both hospital and community based, Fertility Services, Radiology Services, Hospital Theatres, Rehabilitation Services, Dental Services, Mental Health and Psychological Services, Medical Engineering and Medical Device Training, Hospital Essential Support Services such as Estates, Catering, Cleaning, Laundry, Procurement and Delivery Services.

The standard has been used successfully by Care Home, Home Care and Community Health service providers and third sector community services to help them to manage risk and compliance with the full range of requirements that they need to meet, whilst working in partnership with Clinical Services.
 
The ISO 9001:2008 standard ceases to exist on 14th September 2018. Existing certificated Health & Social Care providers are currently in the process of transition to the 2015 standard.

What can 9001:2015 Certification do for my organization?

The ISO 9001:2015 standard has at its core well lead, risk based, customer centred provision of high quality services, which are the core principles of all Health & Social care provision.

The argument for ISO 9001:2015 certification to act as a structure for policies, procedures, monitoring and measurement within services has never been stronger as services are asked to meet every changing, more demanding, statutory and regulatory requirements and are having to bid for service provision against other neighbouring services.

Having an internationally registered independently assessed quality standard that is recognised by the CQC and the Department of Health is a definite advantage.
 
The standard is applicable to all Health and Social Care providers across the UK and internationally.
It will help the organization implement the structure to comply with all legal, regulatory and local policy requirements including the following:

• The Department of Health DOH
• The Care Quality Commission CQC
• The Care and Social Services Inspectorate Wales CSSIW
• The Healthcare Inspectorate Wales HIW
• Healthcare Improvement Scotland HIS
• The Healthcare Environment Inspectorate Scotland HEIS
• The Regulatory and Quality Improvement Authority Northern Ireland RQIA
• The Medicines and Healthcare Regulation Authority MHRA
• NICE National Institute for Health and Care Excellence
• NHSLA The NHS Legal Authority

As an example the standard has direct correlations with the requirements of the Health & Social Care Act 2008 Regulated activities Regulations 2014, The Care Quality Commission Registration Regulations 2009 and the Fundamental Standards of Quality and Safety  that are assessed in Health Care Provider Audits by the CQC. See Below for correlation:

What does ISO 9001:2015 require and how can it assist the planning and running of a Health and Social Care service?

• Clause 4 – ISO 9001:2015  requires the organization to define the context of its services and the interests of all interested parties such as  Patients, Relatives, Other NHS and Private health colleagues, Commissioners, Insurers, NHSLA and Regulatory Bodies such as CQC, MHRA etc. customers such as Community Health services, patients, families, commissioners, community services and regulatory bodies , helping to ensure that all needs are being met. This will then help in planning the processes for service delivery. CQC RR Regulations 12, 13 and 15

• Clause 5 – ISO 9001:2015 requires the organization’s Leadership to demonstrate understanding of the service requirements, to establish policies and to ensure sufficient resource to provide the service, to define roles, responsibilities and authorities ensure effective communication. HSCA Regulation 5 , Regulations 7, 17 , 18, 19,20.

• Clause 6 – ISO 9001:2015 requires the organization to define and manage its risks associated with service provision including clinical, resource, equipment, and infrastructure. HSCA Regulation 15.

• Clause 7 – ISO 9001:2015 requires the establishment of sufficient support services including ensuring that  competent staff and effective  training arrangements are in place, suitable  infrastructure, suitable  and sufficient equipment and working environments, staff wellbeing and communication. HSCA Regulations 13, 17, 18, 19. It also requires effective management and control of documents and records that support service delivery.

• Clause 8 – ISO 9001:2015 requires effective service and care  planning and control at  both a service and patient/service user level. HSCA Regulations 9 ,10 and 11,12,13 and 14. ISO 9001:2015 requires the effective design and development of service processes and patient or service user specific care plans. It also requires regular review and change management. ISO 9001:2015 requires effective control of any externally provided processes such as service and maintenance of equipment and control of any health Care provision that is subcontracted to another professional or provider. HSCA Regulations 9 ,10 and 11,12,13 and 14. ISO 9001:2015 requires the effective identification and traceability of documents records patient and service uses and property. HSCA Regulations 9 ,10 and 11,12,13 and 14.

• Clause 9 – ISO 9001:2015 requires  performance evaluation  including audits and patient / service user satisfaction measurement and management review. HSCA Regulation 20A.

• Clause 10 – ISO 9001:2015 requires the effective management of  complaints, incidents, non-conformities and the implementation of correction and improvement measures. The aim being continual reduction in risk and improvement of the service. HSCA Regulations 16 and  20. CQC RR Regulations 16,17 and 18. 

Authored by: Lynn Jones, NQA Health Sector and Asset Management Principal Assessor
Reviewed by: Terry Fisher, NQA Occupational Health & Safety Principal Assessor