ISO 9001 Requirements

ISO 9001 certification has become a symbol of commitment towards quality and customer satisfaction for organisations across the world, as it reflects a structural, process-oriented and risk-based approach to business. The ISO 9001:2015 standard provides requirements and parameters for quality management systems (QMS) so organisations can claim certification after demonstrating compliance to various requirements. Organisations and companies can get certified to ISO 9001 regardless of their size. How do you get certified? And what are the ISO 9001 requirements for certification? Let’s talk about it.

Identify Context of the Organisation

Review your business environment, internal and external issues, interested parties, and the needs and expectations of the interested parties. Identify risks to the organisation if those issues and needs are not being effectively addressed. Identify the scope of your QMS to define boundaries. You can identify the risks and opportunities that arise from context, processes, services and products, operations and changes. Depending on complexity, the actions taken to address these risks and opportunities can be done with regular review of risks and opportunities.

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Establish Quality Policy, Quality Objectives and Key Performance Indicators

When considering the commitment of the organisation towards its customers, employees, improvement plans, and compliance to all applicable requirements, a statement of intent known as a Quality Policy is to be defined; it is what an organisation wants to achieve and where they want to be. Communication of your Quality Policy is important, and employees must be aware of it.

Organisation-level, department-level, process-level, and project-level quality objectives need to be established to provide a measurement-oriented work environment. These quality objectives need to be SMART – Specific, Measurable, Achievable, Relevant and Time Bound. For every quality objective, your organisation should plan to identify objectives and communicate them to relevant employees. Tracking of the objectives against targets is to be carried out at regular intervals to ensure identification of extent of achievement and what further actions are required for an organisation to realise their achievements. At regular intervals, quality objectives are required to be reviewed to identify when new objectives are to be established.

Manage Documented Information

Your first requirement is to identify the level and structure of your documented information. The new ISO 9001:2015 standard allows for a lot of flexibility in documentation and less prescriptive requirements. A quality manual and six mandatory documented procedures among other things are no longer mandatory requirements of the standard. Some forms are still included if some organisations decide to continue using the earlier standards. Documentation should be done in such a way that it satisfies the quality management system as well as the quality goals of the company. It should discuss the company’s processes, procedures, work instructions, flow charts, templates, forms, manuals and templates as required and practical. It should portray that your company is continuously improving in quality management system performance through better products and services, thereby achieving customer satisfaction. We make ISO 9001 documentation simple and automated with Effivity.


Proper employee training is required so employees work as per your quality management systems. Consider awareness training, implementation training, internal auditor training and lead auditor training to raise the competence of your employees. Training needs should be based on competence evaluations. Role, responsibility, authority and accountability management is to be done through maintenance of your training records such as attendance training and training effectiveness evaluation.

Get Audited

This is the final requirement of certification regarding regular internal audits and at least an annual certification audit by the ISO registration body. The number of auditors either for internal or external audit depends on the processes, past performance and size and number of employees in the company. During an ISO 9001 audit, auditors will verify the effectiveness of your QMS with the ISO 9001:2015 standard and carry out a process-based audit. Auditors may find some non-conformances or improvement opportunities, observations in your documentation or records and your implemented system. In the final certification stage 2 audit, depending on the severity of audit findings, you may or may not get certified. With Effivity, certification is a breeze and simple to achieve. Our software has been validated by almost every global certification body by auditing our client organisations successfully on the Effivity platform for all ISO 9001 documents and records as well as compliance against master templates, forms, manuals, procedures, work instructions and flow charts wherever and if applicable.

The ISO 9001:2015 standard does not have explicit requirements for a quality manual, but many organisations prefer a quality manual as part of their ISO documented information for a greater linkage to business operations and QMS. This manual includes company scope, policies, working procedures, and in some cases, clause by clause compliance with ISO 9001 standards and polices/documented systems implemented by the organisation. Some organisations prepare a quality manual which either includes all the procedures, SOPs and flow charts in the manual itself while some organisations only include a reference to them. For more information, you can also download a free ISO 9001 manual with our compliments when you buy a subscription to Effivity – ISO 9001 software which offers attractive pricing plans starting at just $19 US per month for a biannual subscription package.

In today’s world, outpacing the cut-throat competition, quality and consistency of products and services are essential parts of current business culture. Millions of companies across the globe are implementing and practicing ISO certification, but maintaining compliance with ISO standards requires a lot of attention and effort. Effivity, an ISO compliance software by Effivity Technologies Pvt. Ltd., automates implementation, certification and maintenance of the ISO 9001:2015 standard and addresses the issue of maintenance effectively. This cloud-based software helps in implementation of ISO standards, thus handling compliance and powering up efficiency, profitability, and performance.

Effivity is available as a Software as a Service (SaaS) and meets the requirements of all types of organisations including trading, manufacturing, service, telecom, construction, contracting, logistics, transportation, auto industry, hospitality, and the medical sectors. If required, Effivity can be customised to address the specific requirements of different domains and sectors, thus making it suitable for all industries. It is a tool which saves you money, enhances performance, minimises level of risk, and ensures compliance. Customers who already use Effivity appreciate all 12 modules, the various user-friendly features that take care of complications, the ease of automation and the resultant organisational compliance. So, if you want to use an automated ISO compliance tool to keep pace with technological expansion, Effivity is for you. Enjoy smooth ISO implementation with this software to properly handle compliance, thus keeping your company always audit-ready. This software works for all company sizes whether a small firm with a few employees or an organisation with branches in several countries.

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