ISO9001:2015 is the globally renowned International Standard which details requirements for Quality Management Systems. The 2015 version is the fifth edition of the standard which was a technical revision overseen by the Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems, and which includes a revised clause sequence and the adaptation of the revised quality management principles and of new concepts.
ISO9001:2015 is a generic Quality Management System standard which aligns with the Annex SL format upon which many other management system standards are based. The clause requirements are designed to be applicable to any type of organisation, in any sector, and of any size. The clauses can be equally applied to service providers or product manufacturers.
The standard specifies requirements for a quality management system and should be adopted when an organisation needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
Every year the ISO organisation conducts a survey of management system standard certification, which details the valid certificates each year by management system standard and across each country. The ISO Survey counts the number of certificates issued by certification bodies that have been accredited by members of the International Accreditation Forum (IAF).
The 2021 results indicated that over 1.2M ISO9001 certificates are registered across the globe with China, Italy, Japan, Germany and the UK being the top 5 countries for volume, with China being responsible for nearly half the certificates issued. The top 5 sectors defined included Basic Metals & Fabrication, Wholesale & Retail trade, Construction, Engineering Services & Information Technology.
The standard specifies requirements for a quality management system and is based on the quality management principles described in ISO 9000. The quality management principles include:
The standard promotes the adoption of a process approach were when using the PDCA cycle to manage the whole system and incorporating risk-based thinking, organisations can take advantage of opportunities and prevent undesirable results.
Detailed requirements are defined within clauses and each are indispensable for its application, although some may be claimed as not applicable, dependent on the organisation’s purpose and scope. The requirements are detailed within the following sections:
Section 4. Context of the organisation
Section 5. Leadership
Section 6. Planning
Section 7. Support
Section 8. Operation
Section 9. Performance evaluation
Section 10. Improvement
The standard itself states that ‘the adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives’. The potential benefits to an organisation of implementing a quality management system based on this International Standard are:
ISO conducted research with case studies of 12 organisations in 2012 looking at a number of organisations across geographic regions and sectors, in order to quantify the economic benefits directly linked to the implementation of standards. There was a variance from slightly beneficial, <1%, through to very beneficial, 9%, in relation to returns as a % of total sales revenue.
As part of the review cycle of ISO9001, the Technical Committee Task Group (ISO/TC 176/SC 2/TG 5) utilised a user survey in which one of the questions considered whether it brought advantages across 16 criteria. Published in May 2021 the report “Preparing for a potential revision of ISO 9001” highlighted the positive results with the top 5 listed following.
Once an organisation has formed an agreement for certification services, as well as having established and implemented its management system, the initial certification activity is conducted in two stages, which provides the opportunity for the auditor and organisation seeking certification to review the system and plan for the main audit activity at stage two. The main audit activity will gather objective evidence against the requirements of the standard using techniques such as observation, document review and personnel interview, to evaluate conformance with those requirements. If there are any issues identified that don’t meet requirements, these are subject to corrective action and once closed out, the audit file goes for technical review and a decision made to grant certification.
The size, complexity and needs of the organisation can influence both the duration and timeline to achieve certification, and this is also influenced by the maturity and resources within the organisation seeking certification.
The actual process of certification is guided by the accreditation standard for Management Systems, ISO 17021-1 and it is highlighted in the illustration below.
Get in touch today if you would like to find out more about the services that we provide, or if you are ready to begin your journey in getting ISO 9001:2015 certified, you can use the online request to receive a tailored proposal for your certification needs.
To find out more about the standard, you can get it here.