Quality System Audits

A quality assurance audit is an assessment where an auditor examines and validates numerous records and processes associated with an organization's quality assurance system.

 

In general, the objective of a process quality assessment is to find out whether the company is complying with its stated quality objectives and that its quality systems is ensuring consistent delivery against these objectives.  If the organization is not achieving its quality objectives, it must modify its system to ensure that it does.

 

An organization should conduct both high level and detailed examination of its systems and processes in order to determine whether it is in compliance with the required standards. For instance, like those established by the International Organization for Standardization (ISO). Simply put, International Standardisation Organization is an independent body which publishes agreed global standards that companies can use to ensure compliance with formally agreed and recognised standards.

 

Quality auditing programmes are usually carried out at pre-set time durations and make certain that the organization has clearly described and actionable procedures which lead to the execution of the desired level of quality within a process or finished manufactured product.

 

These audits aid management and help them determine if their organization is operating in accordance with the required standards. Such audits will typically include detailed, results-based finding based on close examination of all aspects of operational processes.

 

Following the update of the ISO 9001 from its 1994 to 2015 requirements, audit processes themselves have evolved from merely step-by-step “box ticking” methods towards driving improvements in quality. This realised by creating a collection of processes within an organization that are specifically created to construct an appropriate “quality policy” for an organization. Then the associated processes that will lead to the achievement of quality goals all with the customer’s needs firmly in mind are developed. This is known as a Quality Management System or QMS.

 

Typically, a quality assessment is normally conducted by impartial and experienced auditors that have the required experience and expertise within the field of operation being audited. In addition, an organization could also choose to carry out regular internal audits testimonial of its QC systems.

 

Members of the management auditing team are professionals that have detailed expertise relative to auditing techniques, procedures and reporting. Such individuals then subject themselves to “hands-on” activities studying, assessing, confirming and reporting on whether each part of a quality system is compliant or non-compliant.

 

During a typical quality auditing process, the auditor first conducts a strategic system analysis. Typically, this method usually details the scope, procedures and the systems and processes to be evaluated.  The strategic analysis also clearly identifies the requisite published certification standards that should be utilised.  

 

As an example, an auditor usually should evaluate any one of an organization’s agreed quality administration standards, techniques and guides. When the strategy has been prepared, the auditor transmits it to the organization for approval.

 

When the audit assessment strategy has actually been accepted, the auditor embarks on the auditing process with their team and solicits the support of many different people within the organization that may be responsible for organization's quality system. The auditor additionally investigates all operational records. Normally such a process is carried out using a contemporary audit management system. See an example here  - https://auditform.com/features.php

 

If audit findings indicate that the organization is not complying with any aspect of its quality system, auditors will examine, document and report on this information to senior management.

 

Normally at the end of the quality auditing process, the auditor publishes a report which generally consists of an overview of the overall audit results together with details feedback concerning activities which are operating satisfactorily and those which require remedial measures to bring them up to scratch. 

 

Generally speaking, the evaluation details the auditor's overall verdict and ranks the organization’s quality system often benchmarking it against other organisations that operate in a similar field.


News

The ISO/IEC’s service management system series gets an upgrade with key standards newly revised
Improving customer service, productivity and efficiency are just a few of the many benefits of a service management system. ISO has updated two standards in its service management series, with new features,...
>> Read More

How Hilton is going green
Energy spend is a hotel’s second-highest operating cost. Hilton has achieved significant energy reductions through low-cost, high-impact steps, and a portfolio-wide certification to ISO 50001.
>> Read More

Our common roadmap
Nearly three years after the official launch of the post-2015 agenda, which plots the path for a better world by 2030, people are still grappling with how to make the ambitious Sustainable Development...
>> Read More

Redefining the city landscape
Imagine your favourite city. Now imagine the same city with more people. Lots and lots more people! A United Nations study predicts that global urban population will increase from 3.9 billion in 2015 to...
>> Read More

Raising the bar on sustainable consumption
Companies are in the business of selling products and consumers of those products want the best possible value for money, but this puts a strain on already depleted natural resources and supply chain transparency....
>> Read More

Latest ISOfocus maps global goals for sustainable development
“As an independent, non-governmental organization, ISO plays a key role in defining standards that will help support innovation. This is fundamental in accelerating results,” says Michael Møller, Director-General...
>> Read More

New International Standard for determining infant formula ingredients just published
Infant formula is perhaps one of the most highly regulated foodstuffs in the world, so checking the exact composition is a rigorous affair. ISO is developing a series of standards for verifying many of...
>> Read More

New International Standard for traditional Chinese medicine just published
Moxibustion is a form of acupuncture that has been used in traditional Chinese medicine by doctors and therapists for thousands of years, and its usage is increasing worldwide. To ensure the safety and...
>> Read More

FDA plans to use ISO 13485 for medical devices regulation
The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.
>> Read More

Reducing carbon footprint made easier with new International Standard
We are all suffocating in the heat of global warming, as the recent European heatwave lays testament to – and it may soon become the norm. A study showed that if greenhouse gas emissions continue to rise...
>> Read More

ISO 50001 for energy management gets a boost
Reducing energy consumption and improving energy efficiency are at the forefront of the global climate change agenda. ISO 50001, the flagship International Standard for improving energy performance, has...
>> Read More

Ready for lift-off: first international guidelines for small spacecraft just published
Space is all the rage, so it seems. The number of small spacecraft – including satellites – being manufactured has rocketed in recent years, and future forecasts are equally explosive. The first-ever internationally...
>> Read More