Importance of audits in a QA system: [Essay Example], 482 words GradesFixer
This essay has been submitted by a student. This is not an example of the work written by professional essay writers.

Importance of Audits in a Qa System

downloadDownload printPrint

Pssst… we can write an original essay just for you.

Any subject. Any type of essay.

We’ll even meet a 3-hour deadline.

Get your price

121 writers online

Download PDF

Audits in a QA system are known as quality audits. They are a systematic examination of a quality system which is carried out by an external quality auditor or an audit team. The main purpose of which is ensuring that procedures correctly mirror documented standards. Audits are an important part of a QA system and are a key part in the ISO quality system standard ISO 9001.

Pssst... we can write an original essay just for you

Any subject. Any type of essay.

We’ll even meet a 3-hour deadline.

121 writers online

Quality audits are becoming more regular in todays, pharmaceutical industry due to increasing complex regulations and expanding globalization. Companies in the pharmaceutical industry often undergo developments and new research cycles for manufactured products and as a result these companies must establish quality assurance departments ensuring process quality is efficiently maintained. Regular quality audits of the QA procedures provides’ an effective way for management to evaluate the efficiency of these procedures.

Quality audits consist of

  • system
  • audits Process
  • audits Product
  • audits compliance

System audits

A quality system audit is defined by ISO10011-1 (1990) as a “systematic and independent examination used to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. It is “a documented activity performed to verify, by examination and evaluation of objective evidence, that applicable evidence of the quality system are suitable and have been developed, documented and effectively implemented in accordance with specific requirements.”

It is the role of quality system audits to ask such questions as; How is the system defined? Who is the responsible party for producing the product? What is the extent of involvement of the managerial department in the daily running of a quality system? Who is the responsible party for ensuring that the quality of the produced products is up to customer standards? What kind of direct and indirect processes are used in the production of the product/s. What are the procedures put in place to help the organisation production efforts. How are these procedures maintained and updated, and by whom? Where can the procedures be found?

Need help with writing?

You can order professional work according to specific instructions and 100% plagiarism free.

Quality system audits tend to focus on the macro nature of a quality management system i.e. the general and broad range rather than a small limited scope.

Process audits

Process audits are analytical in nature, unlike the more general system audits they are much more readily defined and narrowed down. The central focus of these audits is that of; people, material and machines. It must verify how these factors are brought together in order to produce a reliable product. It must compare and contrast the active processes in which the products are produced to that of the written procedures. It is essentially a guide for the manufacturing process.

It is also focused on the process itself. It must ask whether or not the process is valid and reliable. Is the process producing expected results on a consistent basis? Do the processes need to be changed or updated in order to fit the current and/or future needs of the customer.

infoRemember: This is just a sample from a fellow student.

Your time is important. Let us write you an essay from scratch

100% plagiarism-free

Sources and citations are provided

Find Free Essays

We provide you with original essay samples, perfect formatting and styling

Cite this Essay

To export a reference to this article please select a referencing style below:

Importance of audits in a QA system. (2019, January 03). GradesFixer. Retrieved April 16, 2021, from
“Importance of audits in a QA system.” GradesFixer, 03 Jan. 2019,
Importance of audits in a QA system. [online]. Available at: <> [Accessed 16 Apr. 2021].
Importance of audits in a QA system [Internet]. GradesFixer. 2019 Jan 03 [cited 2021 Apr 16]. Available from:
copy to clipboard

Sorry, copying is not allowed on our website. If you’d like this or any other sample, we’ll happily email it to you.

    By clicking “Send”, you agree to our Terms of service and Privacy statement. We will occasionally send you account related emails.


    Attention! this essay is not unique. You can get 100% plagiarism FREE essay in 30sec

    Recieve 100% plagiarism-Free paper just for 4.99$ on email
    get unique paper
    *Public papers are open and may contain not unique content
    download public sample

    Sorry, we cannot unicalize this essay. You can order Unique paper and our professionals Rewrite it for you



    Your essay sample has been sent.

    Want us to write one just for you? We can custom edit this essay into an original, 100% plagiarism free essay.

    thanks-icon Order now

    Hi there!

    Are you interested in getting a customized paper?

    Check it out!
    Having trouble finding the perfect essay? We’ve got you covered. Hire a writer uses cookies. By continuing we’ll assume you board with our cookie policy.


    Haven't found the right essay?

    Get an expert to write you the one you need!


    Professional writers and researchers


    Sources and citation are provided


    3 hour delivery