1.

Scope: This clause specifies no requirements but rather details the general intent and application of the standard 

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2.

Normative References: This section of the standard details additional references which provide additional guidance but are supplemental to the standard itself.

3.

Terms and Definitions: Reference to ISO 9000:2015 is made here, which details fundamentals and vocabulary used throughout the standard.

4.

Context of the organisation: This section details the high level considerations within an organisation, that if not understood, may have a significant impact on its ability to provide the products and services it offers

5.

Leadership:  This clause sets out requirements imposed upon the leadership (key decision makers) within an organisation and requirements for commitment from them in order to ensure the organisation achieves requirements when the standard is implemented

6.

Planning: This clause considers requirements for mitigation of risks to some of the considerations had in clause 4, including the planning requirements to address actions related to these in order to positively affect results.

7.

Support: This clause details requirements in terms of resources required within an organisation in order to support the provision of the services and products it provides. This includes requirements for competence, awareness, communication and documentation.

8.

Operation: The largest section of requirements setting expectations for managing key operational activities within an organisation in terms of: Planning operational activities, handling customer requirements, Design of services and products, Control of suppliers and managing purchasing activities, Controlling services / products, non conformance management.

9.

Performance Evaluation: This clause outlines requirements to consider activities carried out for the purpose of making decisions for improvement. Requirements include those for Monitoring activities, analysing and evaluating performance, internal auditing and management review

10.

Nonconformity and corrective action: This clause sets forth requirements for addressing deficiencies within processes for providing products and services, as well as requirements for determining potential for continual improvement.

Benefits of implementation

All “management ISO’s” have a similar fundamental benefit. They provide a framework of action that; if implemented appropriately, provides internal control.

Adopting a customer focus however as a key requirement throughout ISO9001:2015, adds value for customers and is likely to enhance their satisfaction and loyalty.

Repeat business is less costly to achieve than new business so it pays to keep your current customers happy.

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Not only can a Quality Management System (QMS) enhance your customers’ satisfaction, it will also have a positive impact on your reputation. Being able to demonstrate a formal commitment to quality is often a pre-requisite for formal tendering procedures, in particular for public sector contracts.

Having a certified QMS can open doors to a range of contract opportunities and therefore potentially boost your revenue and market share.

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Implementing a QMS can also help you to be more efficient. Using resources, this includes people, materials, time, money and external partners and suppliers, as effectively and efficiently as possible has a direct positive impact on profitability.

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Involving the people within your business fosters deeper engagement with operations. This can lead to reduced turnover of staff, better productivity, enhanced trust and collaboration and a skilled and happy workforce.

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Consistent and predictable outcomes lead to greater understanding of capability and capacity. Understanding organizational capability and capacity can help you to manage growth and the associated risks.

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Focusing on root cause analysis when investigating problems ensures solutions are robust and improvements are effective. Ongoing monitoring and measuring provides evidence of the effectiveness of processes and can demonstrate the effectiveness of previous decisions and actions. (Remember the quality principle of evidence-based decision-making.)

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A QMS also helps you to manage your supply chain. Encouraging strong, effective communication between parties ensures expectations and requirements are clear before everyone is committed. This leads to improvement opportunities for mutual benefit.