What is required as an absolute minimum for ISO 9001:2015 certification?

It is a common misconception that every process within an organisation (business) must be documented in order to gain ISO 9001 certification. This is simply not the case. With the shift towards risk based thinking, the 2015 revision of the standard is more adaptable than ever before. We’ve put together a list of the required documents for ISO 9001 below

Policies and Records required by ISO 9001:2015
Policies	Clause
Scope of the Quality Management System	4.3
Quality Policy	5.2
Quality Objectives and Plans for Achieving Them	6.2
Procedure for Control of Externally Provided Processes, Products and Services (outsourced processes)	8.4.1
Records	Clause
Record of Maintenance and Calibration of Monitoring and Measuring Equipment	7.1.5.1
Competence Records	7.2
Product/Service Requirements Review Record	8.2.3.2
Record of New Requirements for Product or Service	8.2.3.2
Design and Development Inputs Record	8.3.3
Record of Design and Development Controls	8.3.4
Design and Development Outputs Record	8.3.5
Record of Design and Development Changes	8.3.6
Record of Evaluation of External Provider (supplier)	8.4.1
Record of Product/Service Characteristics	8.5.1
Record of Changes on Customer’s Property	8.5.3
Record of Changes in Production/Service Provision	8.5.6
Evidence of Product/Service Conformity	8.6
Record of Nonconformity	8.7.2, 10.2.2
Monitoring Performance Information	9.1.1
Internal Audit Program and Results	9.2.2
Management Review Results	9.3
Nonconformities and Corrective Action	10.2.2

Feeling overwhelmed?

Contact ISOsafe for help with your ISO 9001 project on 1300 789 132. Don’t risk a failed ISO audit

ISO 9001:2015—An Introduction

ISO 9001 is an internationally recognised quality management system (QMS) standard. It comprises fundamental quality assurance practices that can be applied by any business. In the past ISO9001 has been hugely successful within the manufacturing sector, however, the latest iteration (version 5) has seen the standard heavily revised to appeal to businesses in all sectors.

Without a QMS, businesses have little chance of sustaining any improvements or innovations they might realise. ISO 9001:2015 helps organisations standardise operational functions from input, through to output whether a good or service is being delivered. With the inclusion of risk based thinking, it takes into consideration exogenous and isolated events that many businesses would not usually plan for.

The ISO 9001 standard leaves a great deal of discretion to the business in terms of how it will design its processes and procedures. This enables businesses to customize it to ensure individual success, instead of just blindly following a rigid set of rules.

If you are looking for better overall performance in your business, ISO 9001 is the key. Contact ISOsafe today at enquiries@isosafe.com.au to unlock your business’ true potential.