What is ISO 9001:2015 and why is it important for your company?
ISO 9001:2015 is the most widely recognised international standard specifically dedicated to quality management systems (QMS).
It has been developed by the International Organization for Standardization (ISO), a non-governmental organization based in Switzerland, dedicated to developing voluntary standards that ensure product safety and quality while encouraging innovation in a global marketplace.
It is the most recent iteration of the standard and supersedes ISO 9001:2008, making it more relevant to the needs of today’s marketplace and the changing business environment.
It is designed to provide a framework to ensure consistent quality of the products or services produced, with the aim of satisfying the requirements not only of customers, but those of all relevant stakeholders.
All the requirements of this standard are generic and are intended to be applicable to any company or organisation, regardless of its type or size, or the products and services it provides.
The ISO 9001:2015 Seven Quality Principles
The ISO 9001:2015 standard is based on seven quality principles, that underpin the entire quality management process within the company.
In brief the seven principles are:
1. Customer focus: this requires that all business objectives place customer needs first and foremost in order to consistently exceed their expectations
2. Leadership: senior management must be proactive role models and commit all necessary resources to quality projects in order to create and promote a culture of quality
3. Engagement of people: all employees must be encouraged and empowered to contribute to the quality activities
4. Process approach: this is vital to ensure predictable quality results and serves to highlight shortcomings that need improvement as well as identify and address risks to process outcomes
5. Improvement: a commitment to improvement ensures effective preventative and corrective actions are taken when inevitable changes occur internally or externally
6. Evidence-based decision making: compilation of accurate data and evidence ensure more objective and effective decisions are made
7. Relationship management: the relationships with stakeholders including partners, suppliers and vendors need to be carefully managed to fully understand the constraints, risks and opportunities associated with each party
All of these principles are important, but the priority placed on each will vary between companies, depending on their stage of development and a wide range of other factors.
Implementation of ISO 9001:2015
In terms of putting the principles into action, there are five tactical elements involved which integrate with one another to facilitate delivery of the standard:
1. The Plan-Do-Check-Act (PDCA) cycle
2. Risk-based thinking approach
3. Leadership participation
4. Unified structure
5. Clarified documentation requirements
PDCA cycle
The PDCA cycle is a four-step project planning model for carrying out change and is used on a repeated basis for continuous improvement.
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Plan: determine the objectives of the QMS, its processes and resources needed to deliver the desired results; identify and address risks and opportunities
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Do: implement the QMS in accordance with the plan
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Check: monitor and measure processes and outcomes against policies, objectives, requirements and planned activities and report the results
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Act: take necessary actions to correct any identified deviations or inefficiencies in order to improve the performance of the QMS
Risk-based thinking approach
Risk based thinking considers both risks and opportunities. Using this approach, the company can predict factors that may negatively impact on their planned processes and take preventative measures to minimise potential problems for maximum results.
Leadership participation
Leaders and senior management must play an active role in developing and implementing the QMS and ensuring that it is aligned to the context and strategy of the business and that sufficient resources are made available for successful implementation.
Unified structure
ISO have developed a unified high-level structure for its range of management system standards which has resulted in standardisation of clause titles, sequence of clause titles, text and terms and definitions, to make it easier for companies wishing to implement more than one management system standard.
Clarified documentation requirements
Documentation requirements have been clarified in ISO 9001:2015 compared with previous iterations, allowing companies to determine their own scope for documentation and to scale the requirements to their resources.
Key benefits of ISO 9001:2015
Implementing ISO 9001:2015 is an important, strategic decision, resulting in a major competitive advantage for companies adopting the standard.
The wide range of benefits include:
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Enhanced customer satisfaction: a better understanding of customers’ needs, based on feedback, combined with improved quality of product or service increases customer confidence
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Increased revenue: improved success in securing tenders and contracts together with improved process efficiency and reduced wastage
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Improvement of credibility: organisations, particularly those in the public sector, often stipulate the requirement for ISO 9001:2015 when selecting a new supplier
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International recognition: recognised worldwide, certification can facilitate access to international markets
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Increased efficiency: following industry best-practice and implementing processes and procedures with a quality focus maximises efficiency
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Improved decision-making: a focus on accurate data analysis means business decisions can be based on facts
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Better employee engagement: improving communication with employees and encouraging participation fosters a team mentality, improving morale and performance
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Stronger supplier relationships: certification will demonstrate to suppliers the use of best-practice processes, enhancing confidence
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Improved record keeping: ISO 9001:2015 ensures end to end documentation of all processes which enables improved process efficiency throughout the company
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Continuous improvement: a systematic approach with non-conformity reporting and trend analysis, reveals aspects requiring improvement to maintain a competitive advantage
The decision to implement ISO 9001:2015 cannot be taken lightly and it will take time, effort and significant financial commitment. However, the benefits are overwhelming and in an increasingly competitive marketplace, applying this standard will ensure the company remains resilient and sustainable and ahead of the competition.