What is ISO 9001:2015?
ISO 9001:2008 is the internationally recognized standard for Quality Management Systems (QMS). It provides your company with a set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction.
Who is ISO 9001:2015 applicable to?
Any organization can benefit from implementing ISO 9001:2015 as its requirements are underpinned by eight management principles:
• a customer focused organization
• leadership
• the involvement of people
• ensuring a process approach
• a systematic approach to management
• a factual approach to decision making
• mutually beneficial supplier relations
• continuous improvement
What are the benefits of registration?
• Customer satisfaction - through delivery of products that consistently meet customer requirements
• Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
• Improved stakeholder relationships - including staff, customers and suppliers
• Legal compliance - by understanding how statutory and regulatory requirements impact on the organization and its your customers
• Improved risk management - through greater consistency and traceability of products and services
• Proven business credentials - through independent verification against recognized standards
• Ability to win more business - particularly where procurement specifications require certification as a condition to supply
How to gain registration?
The process of registration follows three simple steps:
• Application for registration is made by completing the QMS questionnaire
• Assessment to ISO 9001:2015 is undertaken by HPA - the organization must be able to demonstrate that its quality management system has been fully operative for a minimum of three months and has been subject of a full cycle of internal audits
• Registration is granted by HPA and maintained by the organization. Maintenance is confirmed through a programme of annual surveillance visits and a three yearly re-certification audit.
Initial Certification Audit
The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:
Stage 1 - the purpose of this visit is to confirm the readiness of the organization for full assessment. The assessor will:
• confirm that the quality manual conforms to the requirements of ISO 9001:2015
• confirm its implementation status
• confirm the scope of certification
• check legislative compliance
• produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required.
• produce an assessment plan and confirm a date for the Stage 2 assessment visit.
Stage 2 - the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 9001:2015 in practice. The assessor will:
• undertake sample audits of the processes and activities defined in the scope of assessment
• document how the system complies with the standard
• report any non-compliances or potential for non-compliance
• produce a surveillance plan and confirm a date for the first surveillance visit
• If the assessor identifies any major non-conformance, the organization cannot be certified until corrective action is taken and verified.