ISO 9001 Requirements (2024)

What are the ISO 9001:2015 requirements?

To attain ISO certification, a company or organization must submit documents that report its internal processes, procedures and standards. These documents (or Quality Management System) determines that a company is able to provide quality products and services consistently.

Contents

• What is ISO 9001:2015?
• What are the ISO 9001 Requirements?
• Mandatory Requirements — Documents and Records
• Non-Mandatory Requirements — But Often Included
• ISO Quality Management Systems (QMS)
• ISO 9001 Clauses

Are you aiming to achieve ISO certification? Looking to find the latest ISO 9001 requirements? Well, they have changed considerably since the last version of ISO 9001. Everything you need to know about the latest requirements — monitoring, documents and records is right here.

There are mandatory and non-mandatory requirements; to find out which of the requirements you should document, please see below.

What is ISO 9001:2015?

Creating, implementing and maintaining your Quality Management Systems (QMS) is an important documentary requirement for any company. It formalizes the procedures and policies that promote the quality of products and services that a company provides.

One way to do this is to follow the ISO standard and gain ISO 9001:2015 certification.

The international standard that is known as the ISO 9001:2015 gives a list of requirements for a system that determines that a company is able to provide international-quality products and services consistently.

ISO 9001:2015

• Newest edition published in 2015
• International quality standard used world wide
• Improves customer experience and satisfaction
• Ten clauses of requirements

Through the implementation of the standard, ISO 9001:2015 aims to improve customer experience and satisfaction.

It also aims to improve the internal system of a company so that it is able to produce quality services and products while promoting a culture that is aimed towards growth and continuous improvement.

The ISO stipulates quality management principles, which, when complied with by certified companies, reassures clients that the company has established a proper Quality Management System.

To put it simply, ISO certification shows that your company can be trusted.

Moreover, it means that the products and services delivered by a company is of international-quality; aligned with different companies from countries all over the world.

What are the ISO 9001 Requirements?

All the ISO 9001 requirements are set out by ISO in ten clauses.

Mandatory requirements need to be complied with, while non-mandatory requirements may be submitted for documentation purposes. To be certified compliant with ISO 9001:2015, the following documents must be submitted.

ISO 9001 Mandatory Requirements — Documents and Records

1. Monitoring and measuring equipment calibration records
2. Records of training, skills, experience and qualifications
3. Product/service requirements review records
4. Record about design and development outputs review
5. Record about design and development inputs
6. Records of design and development controls
7. Records of design and development outputs
8. Design and development changes records
9. Characteristics of product to be produced and service to be provided
10. Records about customer property
11. Production/service provision change control records
12. Record of conformity of product/service with acceptance criteria
13. Record of nonconforming outputs
14. Monitoring measurement results
15. Internal audit program
16. Results of internal audits
17. Results of the management review
18. Results of corrective actions

Non-Mandatory Requirements — But Often Included

1. Procedure for determining context of the organization and interested parties
2. Procedure for addressing risks and opportunities
3. Procedure for competence, training and awareness
4. Procedure of equipment maintenance and measuring equipment
5. Procedure for document and record control
6. Sales procedure
7. Procedure for design and development
8. Procedure for production and service provision
9. Warehousing procedure
10. Procedure for management of nonconformities and corrective actions
11. Procedure for monitoring customer satisfaction
12. Procedure for internal audit
13. Procedure for management review

After reading through the lists above, you might be thinking that his must include a lot of paper work!

However, do note that because each company is unique and is run differently, having this certification lets other companies and people know that what your company does and produces passed an international standard of quality.

Not only does the ISO certificate benefit your consumers, it also benefits your company itself.

ISO 9001 Clauses - PLAN

• 1 Scope
• 2 Normative references
• 3 Terms and Definitions
• 4 Context of the organization
  • 4.1 Understanding the organization and its context
  • 4.2 Understanding the needs and expectations of interested parties
  • 4.3 Determining the scope of the quality management system
  • 4.4 Quality management system and its processes
• 5 Leadership
  • 5.1 Leadership and commitment
    • 5.1.1 Leadership And Commitment For The Quality Management System
    • 5.1.2 Customer Focus
  • 5.2 Policy
    • 5.2.1 Establishing the quality policy
    • 5.2.2 Communicating the quality policy
  • 5.3 Organizational roles, responsibilities and authorities
• 6 Planning
  • 6.1 Actions to address risks and opportunities
  • How to address risk in ISO 9001
  • 6.2 Quality objectives and planning to achieve them
  • 6.3 Planning of changes

ISO 9001 Clauses - DO

• 7 Support
  • 7.1 Resources
    • 7.1.1 General
    • 7.1.2 People
    • 7.1.3 Infrastructure
    • 7.1.4 Environment for the operation of processes
    • 7.1.5 Monitoring and measuring resources
    • 7.1.6 Organizational knowledge
  • 7.2 Competence
  • 7.3 Awareness
  • 7.4 Communication
  • 7.5 Documented information
    • 7.5.1 General
    • 7.5.2 Creating and updating documented information
    • 7.5.3 Control of documented information

• 8 Operation
  • 8.1 Operational planning and control
  • 8.2 Requirements for products and services
  • 8.3 Design and development of products and services
  • 8.4 Control of externally provided processes, products and services
  • 8.5 Product and service provision
  • 8.6 Release of products and services
  • 8.7 Control of nonconforming outputs

ISO 9001 Clauses - CHECK

• 9 Performance evaluation
  • 9.1 Monitoring, measurement, analysis and evaluation
    • 9.1.2 Customer Satisfaction
  • 9.2 Internal Audit
  • 9.3 Management Review

ISO 9001 Clauses - ACT

• 10 Improvement
  • 10.1 General
  • 10.2 Nonconformity in ISO 9001
  • 10.2 What is Non-conformance?
  • 10.2 Corrective Action
  • 10.3 Continual Improvement

How many Requirements are there in ISO 9001?

There are over 350 individual ISO 9001 requirement clauses that businesses can use to implement a quality management system as a formal stepping-stone to begin to continually improve performance and enhance customer satisfaction.

Formal ISO certification to international standard ISO 9001:2015 follows after successful QMS implementation, operation and certification body assessment.

What are the Documents Required by ISO 9001?

Within ISO 9001 2015, there are 25 occurrences of the requirement to retain and maintain documented information.

What is an ISO Audit Checklist?

We define an ISO audit checklist as an elemental internal audit checklist that comprises a tabulated list of ISO 9001 requirements that is used monitor the compliance status of each clause against an organization's processes when implementing and assessing a new quality management practices.

What are Mandatory Documents?

For ISO 9001 certification, the mandatory quality management documentation requirements includes documented information such as the quality policy, quality objectives, scope of the quality management system, a description of the organization's processes, management review minutes, internal audit reports,

How can I Prepare ISO 9001:2015?

Effective processes are at the core of ISO 9001:2015. You should begin by reviewing and updating your quality manual, QMS documentation, and undertaking a thorough gap analysis of your existing processes to determine the extent to which quality management systems meet the ISO 9001 requirements.

What are the 3 Key Components of ISO?

Successful quality management and ISO 9001 certification requires risk based thinking, customer focus, process approach

What are the Most Popular ISO standards?

Whilst there are many international standards that specify requirements, ISO 9001 remains the most widely adopted quality management system standards in the world. Other popular standards include ISO 14001 - environmental management, ISO 45001 - occupational health and safety, and ISO 27001 - IT security and data management systems.

How many Requirements does the ISO 9001:2015 have?

There are over 350 individual ISO 9001 requirements that businesses should adopt and integrate into their business processes when implementing an effective quality management system. However, business must also consider and adopt any relevant contractual or customer requirements, and relevant statutory and regulatory requirements that affect the functionality of products and services.

What are the 7 Key Principles of Quality?

There are 7 key principles of quality management that form the foundation of ISO 9001:2015 and are relevant to the entire organization.

1. Customer focus - is about how you meet customer and regulatory requirements, assessing customer satisfaction and exceeding their expectations by the quality of your products and services

2. Leadership - is about establishing strategic direction and operational purpose

3. Engagement of people - is about providing sufficient training, knowledge, competence, and empowerment to improve quality

4. Process approach - is about the Plan, Do, Check, Act (PDCA) cycle and the sequence and interaction of inputs, activities and outputs

5. Continual improvement - is about innovation, identifying customer needs, opportunities, root cause analysis, and ability to react to change to ensure continuous improvement

6. Evidence‐based decision making - is about analyzing process data, levels of customer satisfaction, process performance assessment, and risk-based thinking

7. Relationship management - is about maintaining relationships with relevant interested parties and providers in the supply chain

Why do I need ISO 9001?

Conformity assessment to ISO 9001 certification is carried out by an independent certification body who must be accredited to ISO 17025 . The requirement for attaining ISO 9001 certification is driven by the need for commercial competitiveness.

What means QMS?

QMS is an anacronym for Quality Management System.

What is the full form of TQM?

What is ISO 9000 quality management system?

ISO 9000 is a family of quality management standards. ISO 9001:2015 specifies requirements, while ISO 9000 clarifies the fundamental terms and definitions of successful quality management.

What are Quality management principles

The ISO 9000 quality management principles are embodied with in the individual requirements of ISO 9001:2015. Apply the principles in the context of your business's own particular operations by reviewing and documenting its activities in the context of each principle.

Who is Responsible for Quality?

As stated in the ISO 9001 requirements, top management are clearly responsible for the quality management system, whilst all employees are responsible for delivering quality to their individual aspects of work. Depending on company culture, Top management usually delegate, by appointing quality professionals to upper level management teams.

A Quality Manager is often responsible for analyzing quality management system data and performance evaluation by monitoring and measuring the achievement of the quality objectives, quality policies, undertaking internal audits and for improving the quality of products and services.

Video — Introduction to ISO 9001:2015 Quality Management System Requirements