ISO 9001 Basics: Complete Beginner’s Guide to ISO 9001:2015 Quality management systems — Requirements

ISO 9001 Quality Management Systems (QMS) is an international standard that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9001 is held by thousands of businesses in Australia, we’ve helped them get Certified with minimal disruption, reducing project costs and raising revenues.

In this guide to ISO 9001 Quality Management Systems (QMS) for beginners, you’ll learn:

·       What is ISO 9001 and why it is important?

·       Reasons for use?

·       ISO 9001 QMS Policy Best Practices

·       ISO 9001 Certification Best Practices   

·       How to best Prepare for ISO 9001 : 2015 Certification

·       Common Technical ISO 9001 QMS Issues

·       How to Track & Measure ISO 9001 QMS Performance Evaluation, Compliance Evaluations and Report Results at Management Review Meetings.

·       Additional ISO 9001 Considerations (such as industry specific applications of the standard and ISO Best Practices)

What is ISO 9001 and why it is important?

Over one million organizations worldwide are independently certified to ISO 9001, making it one of the most widely used management tools globally.

Contents of ISO 9001:2015 are as follows:

·       Section 1: Scope

·       Section 2: Normative references

·       Section 3: Terms and definitions

·       Section 4: Context of the organization

·       Section 5: Leadership

·       Section 6: Planning

·       Section 7: Support

·       Section 8: Operation

·       Section 9: Performance evaluation

·       Section 10: Continual Improvement

Similar to its predecessor, ISO 9001:2008, the layout of the current version of the standard follows PDCA (plan–do–check–act or plan–do–check–adjust) principles. PDCA is an iterative four-step management method used in business for the control and continuous improvement of processes and products.

The ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.

Over time, various industry sectors have wanted to standardise their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them. Some examples include:

·       The TickIT guidelines

·       AS9000 is the Aerospace Basic Quality System Standard

·       PS 9000, QS 9000, ISO/TS 16949 now referred to as IATF 16949:2016 are the various Automotive Quality Management Systems

·       TL 9000 is the Telecom Quality Management and Measurement System Standard

·       ISO 13485:2016 Medical devices

·       ISO/IEC 90003:2014 Software engineering

·       ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries

·       ISO 22000 Food Safety Management Systems

·       ISO 17025:2017 is the Quality Management System applicable only to Testing and Calibration Laboratories

Reasons for use?

Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.

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ISO 9001 QMS Policy Best Practices

The ISO 9001:2015 Quality management systems standard requires the development a Quality Policy. A Quality Policy is a document developed by management to express the commitment of top management with respect to quality.

Section 5.2 of the ISO 9001:2015 standard requires a written, well-defined quality policy that is communicated and understood by all stakeholders and interested parties. Need help developing a Quality Policy for your business? Call ISOsafe 1300 789 132.

ISO 9001 Certification Best Practices

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

Common Technical ISO 9001 QMS Issues

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services, and processes. The auditor presents a list of problems (defined as "non-conformities", "observations", or "opportunities for improvement") to management. If there are no major non-conformities, the certification body issues a certificate. Where major non-conformities are identified, the organization presents an improvement plan to the certification body (e.g. corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it issues a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and displays the addresses to which the certificate refers.

How to Track & Measure ISO 9001 QMS Performance Evaluation, Compliance Evaluations and Report Results at Management Review Meetings.

The organization should determine the methods and frequency for monitoring, measurement, analysis, and evaluation of Performance Evaluation. Does this all sound like too much work? Call ISOsafe now to get help with your ISO 9001 accreditation.

Additional ISO 9001 Considerations (such as industry specific applications of the standard and ISO Best Practices)

So if you’ve gotten this far, you should know a lot of information about how ISO 9001:2015 Quality management systems.

What should you do next? Call ISOsafe on 1300 789 132 to get started on your ISO 9001 Certification.