What are the primary requirements of ISO 9001?

International Organization for Standardization (ISO) standards provide a strong foundation for organisations to develop their management system following international and national regulations. ISO 9001 requirements are a group of standard elements that help organisations implement, maintain and improve their Quality Management System (QMS). The ISO 9001 requirements are designed to suit any type of organisation, regardless of size, industry, economic sector, manufacturing or service type.

Requirements of ISO 9001; QMS different cluses

The requirements modify the company’s policies, procedures and processes so that its QMS meets the needs of its customers and stakeholders. The ISO 9001 requirements are broadly categorised into 11 clauses or sections. Clauses 0 to 3 are not considered mandatory for the implementation of the QMS. Clauses 4 to 10, on the other hand, are considered mandatory and therefore are known as the primary requirements of ISO 9001. Here, clause eight is viewed as an exception because it is not compulsory as it contains recommendations that may or may not apply to the individual circumstance of the company.

1. Clause 4: Context of the organization; ISO 9001 primary requirements

An organisation cannot be considered an isolated or closed system. In other words, an organisation is not an independent entity; rather, it lives in an ecosystem where it must balance customer expectations, objectives, and regulator definitions. Hence, clause 4 of ISO 9001 deals with how external and internal issues can influence an organisation’s attempt to meet its goals. It also delineates the interaction of different parties with the QMS, focusing on the scope of QMS, its characterisation and process mapping. If you want to improve your organisation, you have to be familiar with QMS concept. Click on the ISO 9001 meaning and read about it.

2. Clause 5: Leadership and commitment; Demystifying liabilities and authorities

Clause 5 of ISO 9001 outlines the top management’s expectations, roles and responsibilities. It includes promoting a policy that focuses on customer needs throughout the organisation. It also provides for the development of a quality policy that creates direction and alignment for the entire organisation and commits to it through concrete action steps. Lastly, it includes demystifying responsibilities and authorities throughout the organisation so that there is clarity regarding decision making, rules, responsibilities, duties and functions of everyone within the system.

3. Clause 6: Planning for the QMS; ISO 9001 requirements

Clause 6 of QMS identifies the ISO 9001 requirements needed to determine and integrate risks and opportunities that may present themselves with time. It also includes the development of quality objectives that helps the organisation align with the quality policy. The gap between the desired quality objectives and the existing quality policy is eliminated through the creation of palpable action plans.

4. Clause 7: Support and resource management; How to deliver high-quality service?

Clause 7 of ISO 9001, which is rightfully titled “support,” particularly talks about documented information that needs to be determined to evaluate the effectiveness of the QMS. This helps the organisation deliver high-quality services or products which meet the customer requirements. These resources include human resources, infrastructure, organisational knowledge, communication and records. For any organisation to have a smooth operation, it requires critical support for all systems. The lack of skilled resources can cause a high attrition rate.

5. Clause 8: Operational planning and control; ISO 9001:2015 requirements

Clause 8 of ISO 9001 is the only non-mandatory section. It allows organisations to select or exclude recommendations within the requirements. Examples of such sections include the design requirement if the organisation does not need to do design work. The requirements focus on planning for service or product creation, including identifying and reviewing product/service requirements, design and development, purchasing, manufacturing, and supply. This section also includes requirements that focus on quality control and the identification of non-conformities.

6. Clause 9: Performance evaluation; Necessities of ISO 9001

Clause 9 of ISO 9001 outlines the recommendations for assessment of customer satisfaction, requirements for internal audit, and recommendations for monitoring, analysis and evaluation of process performance. It also includes the recommendations for management review, including specific tips for mandatory inputs and outputs of the managerial study.

7. Clause 10: Improvement actions; Amplification the benefits of QMS

Clause 10 of ISO 9001 focuses on a collection of policies, procedures and processes that can improve the QMS through tangible corrective actions. Here, companies can select improvements and integrate them with their existing processes to meet customer requirements and enhance customer satisfaction. These recommendations can improve the product or services, correct existing mistakes or strengthen the effectiveness of the QMS.

ISO 9001:2015 clauses related to effectivness

Clauses 0 to 3 include the introduction, scope statement, references and terms and definitions of ISO 9001. These clauses present a process approach that utilises the “plan-do-check-act “cycle where organisations can utilise the recommendations outlined in the primary clauses to identify, analyse, and monitor the effectiveness of their QMS.

ISO 9001 procedures; What are ISO requirements?

There are six mandatory ISO 9001 procedures that organisations must implement to gain certification. The first step is to control documents to maintain effective communication for seamless business operation. The second step is to control the records showing enhanced accessibility of data for the easier demonstration of compliance. The third step is the internal audit which helps to identify and mitigate any threats that may negatively affect the organisation’s internal and international standard compliance. The fourth step is to take control of the non-conforming products through a stringent internal audit which eliminates the delivery or consumption of products or services which fail to match specified quality requirements. The fifth step is corrective action which focuses on defining a problem, determining its cost and developing appropriate interventions to prevent this issue from re-occurring. The final step is preventive action, which aims to eliminate nonconformities’ potential causes.

Benefits of ISO 9001:2015 requirements

As the requirements help organisations to implement, evaluate and monitor the effectiveness of the QMS, it reduces mistakes and increases communication or reporting. As annual assessments maintain standards, it leads to better quality products and services. Hence, it allows for enhanced customer satisfaction, customer retention and acquisition. The recommendations which focus on reducing the delivery or consumption of non-conforming products or services create a more reliable production scheduling and delivery.

ISO 9001 certification cost; Depends on what matters?

The fee of ISO certification may vary from organisation to organisation depending upon its size, industry and other specifications.