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The Processes of Quality Management Systems

Info: 4716 words (19 pages) Essay
Published: 10th Sep 2021 in Information Systems

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Quality can be defined as the sum of all the characteristics or features a product or service present which are relevant to satisfy implicit needs. [1]

Quality Management Systems (QMSs) are a set of processes, procedures and responsibilities which aim to achieve quality objectives. They help to coordinate and direct a business’s activities to meet regulatory requirements and satisfy customer’s needs. Moreover, QMSs guarantee that all the services companies offer are defined and constantly controlled. When QMSs are carried out efficiently, results are produced consistently, costs are reduced, and mistakes are prevented [2] [3]

Depending on the nature of a company and its requirements, it may need one or more QMS. In this way, the performance of a certain company will be determined by the type of QMS it implements. [1] [2]

QMSs are critical procedures within a pharmaceutical industry since failing on developing high quality drugs, diagnostic kits, or medical equipment can end up in broken lives. [4] Furthermore, since it is impossible to test every single food product, these procedures are equally important in the Food industry, as it is the only way producers have of verifying the quality of a product. [1]

ISO 9000, GMP, GLP and HACCP are types of QMSs that include generic to more specific requirements. They are the types of QMSs that will be studied on this essay.

Comparison and Contrast

ISO 9001:2015, ISO 15378:2017 and ISO 22000:2018

ISO stands for International Organisation for Standardisation (IOS). ISO 9000 is a generic set of standards that ensure businesses meet customers and shareholders’ needs by implementing the elements that it describes. Moreover, it is internationally recognised and applicable to all businesses of any size (From taxi drivers to large pharmaceutical or food industries). This QMS is compound by 3 families: ISO 9001, ISO 9002, and ISO 9003 [1] [5] [6]

Although ISO 9001:2015 is a generic QMS, ISO 15378:2017 and ISO 22000:2018 introduce additional requirements that the Pharmaceutical/Healthcare and Food industry, respectively, may integrate.

ISO 15378:2017 is an international standard that refers specifically to ‘Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practise (GMP)’ while ISO 22000:2018 relates to ‘Food safety management systems – Requirements for any organisation in the food chain’ [7] [8]

Although, all the clauses in ISO 9001, ISO 15378 and ISO 2200 are the same, they are subdivided into categories which differ one from the other. These differences are depicted on Table 1

TABLE 1. Differences between ISO 9001, ISO 15378 and ISO 22000 (Shaded boxes mean that there is no differences between these documents)



ISO 9001

ISO 15378

ISO 22000

1. Scope


2. Normative References


3. Terms and Definitions


Specific definitions regarding the company’s activity, organisation, processes, and characteristics


4. Context of the organisation


The context of the company is defined (like on the other two ISOs) However, it is emphasised that this is a Food QMS not just a QMS



ISO 9001

ISO 15378

ISO 22000

5. Leadership

The personnel must be organised, comply with the assigned responsibilities and follow policy requirements

The leaders of the company must focus on the customer, and follow a way of organisation that complies with the assigned responsibilities by following policy requirements

Establishing and communicating food safety policies must be the focus point of all the workforce

6. Planning


7. Support

All the resources, competences, awareness and ways of communication must be considered

Based on ISO 9001, but in addition, it includes requirements such as the infrastructure, training of the personnel and the control of documented information, among others that must be considered

Based on ISO 9001, however, it also includes specifications required by the food industry such as the work environment, the external and internal communication, and the creating and updating documented information.

8. Operation

The plan proposed on Section 6 is executed. Processes must comply with all the requirements, designs, and controls required so they can be released

Based on ISO 9001, nevertheless, there is more emphasis on each of the requirements

The plan proposed on Section 6 is implemented. However, this clause is an operational plan itself. It specifies prerequisite programmes and a traceability system, it gives instructions on what to do in case of emergency, it defines hazard controls and it verifies that every single prerequisite has been complied

9. Performance evaluation


10. Improvement



All the ISO standards follow the model Plan-Do-Check-Act which can be described as follows:

  • Plan: Set the objectives of the quality system and all the processes required to achieve them, establish all the resources needed to deliver consistent results and analyse all the risks and opportunities associated with the entire process.
  • Do: Execute the plan.
  • Check: Follow and measure the resulting products and services, analyse all the data gathered and document the results.
  • Act: As necessary, implement actions to improve performance.

[1] [7] [8] 

However, despite these QMSs share the same model of action, the approach used on ISO 22000 is different to both ISO 9001 and ISO 15378. In this way, ISO 9001 and ISO 15378 follow a simple cycle (Figure 1), while ISO 22000 has two separate cycles working at the same time. (Figure 2)

Figure 1. Plan-Do-Check-Act on ISO 15378

Figure 2. Plan-Do-Check-Act on ISO 22000

Good Manufacturing Practice (GMP)

Nowadays, companies are bound to deliver products that are not only safe but also fit to their purpose. Therefore, current Good Manufacturing Practices (cGMPs) are a fundamental requirement for these companies as they ensure products companies produce are constantly controlled according to quality standards. GMP comprise every aspect of manufacturing a product, from raw materials throughout the sanitation of the premises and machinery to the training and personal hygiene of the personnel.  [9] [10]

CFR 21 part 211 and CFR 21 part 110

CFR stands for Code of Federal Regulations. It includes all the guidelines and regulations that are in effect in the United States. It is issued by agencies that are external to the central government and it is divided into 50 titles where title 21 refers to Food and Drugs. In this way, title 21 is issued by the Food and Drug Administration (FDA). [1] [11]

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At the same time, title 21 is divided into 3 Chapters where ‘Chapter I’ relates to ‘Food and Drug administration, department of health and human services’. Simultaneously, this chapter is compound by 1299 parts where part 211 and part 110 are associated to ‘Current Good Manufacturing Practice for Finished Pharmaceuticals’ and ‘Current Good manufacturing Practice in Manufacturing, Packing, or Holding Human Food’ respectively. [12] [13] [14]

CFR 21 part 211 is more extended than CFR 21 part 110 as the former is composed by 11 subparts (From A to K) while the later has only 6 subparts (From A to G). [13] [14]

Differences between subparts are depicted on Table 2

TABLE 2. Differences between CFR 21 part 211 and CFR 21 part 110




CFR 21 Part 211

Pharmaceutical/Healthcare industry

CFR Part 110

Food industry

A – General Provisions

Scope and Definitions

Scope, Definitions and information about current GMPs, Personnel and Exclusions


‘Organisation and Personnel’
Qualifications and responsibilities required by the workforce

‘Buildings and Facilities’
Sanitary operations and controls that the amenities require




CFR 21 Part 211

Pharmaceutical/Healthcare industry

CFR Part 110

Food industry


‘Buildings and Facilities’
Wide range of requirements from the design, throughout the ventilation, heating, plumbing, and sewage to the washing, sanitation and maintenance of the company’s facilities.

Equipment and utensils needed


Differentiation between the design, size, location and type of machinery and the cleaning and maintenance that they require


‘Control of Components and Drug Product Containers and Closures’
Each approved, unapproved and rejected drugs must be stored in specific containers during a specific period. This subpart also describes the different tests drugs must follow to be approved or rejected

‘Production and Process Controls’
Description of production steps and how products may be stored or distributed


‘Production and Process Controls’
In-Process materials and drug products must be sampled and tested and according to the results, yield is calculated, or if there is any contamination, it is controlled and reprocessed



CFR 21 Part 211

Pharmaceutical/Healthcare industry

CFR Part 110

Food industry


‘Packaging and Labelling Control’
Each drug must have the right label and it must go into the right box. Furthermore, the expiration date and instructions for consume must be included.

‘Defect Action Levels’
Natural or unavoidable defects produced during the process that are no harmful for human consume are described


‘Holding and Distribution’
Storing and distribution procedures that drugs follow


‘Laboratory Controls’
Conditions laboratory must comply, especially, regarding to the reservoir of samples or how to keep laboratory animals


‘Records and reports’
All the procedures previously described must be written down and reported


‘Returned and Salvaged Drug Products’
Returned drug products must be identified as well as the reason why they were not delivered. After testing, these drugs may be salvaged



Regulation No. 1252/2014 and Regulation No 2023/2006

In Europe, GMP for the Pharmaceutical/ Healthcare and Food industries are gathered in Regulation No.1252/2014 and Regulation No 2023/2006 respectively. These regulations, however, are very similar to their respective CFR 21 part 211 and 110. [15] [16]

In Ireland, the Health Products Regulatory Authority (HPRA) is the agency in charge of giving licenses to companies that comply with the former regulations. [1]

It is important to clarify that in the case of a European company exporting to the USA, it must comply with their own GMPs and vice versa, otherwise companies could lose their licenses. [1]

Good Laboratory Practice (GLP)

GLP is a set of principles which aim to assure the quality and integrity of all the laboratory studies that are carried out in the premises. GLP is also used to avoid the repetition of studies, stablish a common standard between laboratory practices and procedures, and facilitate a mutual acceptance of the generated data between different countries. It focuses on all the responsibilities to manage the personnel, facilities, and equipment required for good science and how experiments are planned, performed and reported. [1] [17] [18]

The FDA established a GLP for both Pharmaceutical/Healthcare and Food industries. This GLP can be found on CFR 21 part 58 which is named ‘Good Laboratory Practice for nonclinical laboratory studies’. [1] [19]

CFR 21 part 58 defines all the requirements for carrying out in vivo or in vitro experiments that support or are intended to support any research or marketing activities related to products that include food and colour additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. [19]

This GLP is divided into different subparts that are described as follows:

  • A – General Provisions: Purpose and definitions of the management system
  • B – Organisation and Personnel: How the facilities and the personnel involved are organised
  • C – Facilities: Cleanliness and contamination control in the different places where the studies are carried out
  • D – Equipment: Specifications about the good use of all the instruments and machinery throughout the studies
  • E – Testing Facilities Operation: Standard and Animal care procedures
  • F – Test and Control Articles: Test and Control  of the objects that experiments are studying
  • G – Protocol for and Conduct of a Nonclinical Laboratory Study: Objectives and scientific methods for conducting the study
  • J – Records and Reports: Documents reflecting the study results must be reported and stored safely
  • K – Disqualification of Testing Facilities: If a testing facility fails when complying with the regulations stablished by the GLP, it may be prompt to disqualification

[19] [20] 

In Europe, GLPs are found on two documents namely ‘Directive on Harmonisation of Good Laboratory Practice 87/18/EEC’ and ‘Directive on Inspection and Verification of Good Laboratory Practice 88/320/EEC’. The Organisation for Economic Cooperation and Development (OECD) is the institution in charge of guaranteeing that every single OECD country implement and proceed studies that comply these regulations. [1] [21]

Hazard Analysis and Critical Control Point (HACCP)

HACCP is an internationally recognised management system related to food safety. It refers to all the procedures and analysis for biological, chemical and physical hazards that may incur throughout the manufacture, storage, and distribution of a food product. [22] [23]

Although, traditionally, HACCP plan has been related to food safety, its principles have progressively been applied to other industries such as the chemical and pharmaceutical industries as the overall objective is to guarantee that drugs produced in the Pharmaceutical/Healthcare industry such as antibiotics, hormones, among other substances are safe for human use. Moreover, it also ensures the safety of the workforce involved in the manufacturing of pharmaceutical products. [24] [25]

Principles of HACCP

HACCP is composed of 7 Principles which are described as follows:

  1. Conduct a Hazard Analysis

All biological, chemical and physical hazards that may be introduced in the processes are identified through an analysis that is divided in two steps. Firstly, Hazards are identified and secondly, evaluated.

  1. Determine Critical Control Points (CCP)

CPP are all the stages at which controls can be applied to eliminate hazards. Errors at this level may result in an unacceptable health risk.

  1. Establish Critical Limits

Critical limits refer to the criteria that should be met at each of the CPP to eliminate the hazard

  1. Establish Monitoring Procedures

To prove that Critical Limits have been met, CCPs must be constantly monitored.

  1. Establish Corrective Actions

If at any CCP, a clinical limit is not met, corrective actions must be undertaken to ensure any food product that may be unsafe is not released. Moreover, the cause that produced the deviation should be identified and eliminated.

  1. Establish Verification Procedures

In order to ensure that HACCP is effective, verification procedures should be carried out by testing all the controls and certifying that they are working properly.

  1. Record Keeping Documentation Procedures

Written documentation describing every single stage of the process should be produced and stored safely

[1] [26] 


ISO (9001, 15378, and 22000), GMP, GLP and HACCP are QMSs that are different one from another. The requirements that they include go from generic in ISO to more specific in the rest. Each QMS ensures that every single process of an industry activity is carried out at a quality standard. Therefore, depending on the characteristics of the companies, one or more QMSs may be implemented.

ISO 9000 is a generic QMS that specifies a variety of aspects (from quality management to quality assurance) that must be considered when developing a product. For this reason, both Pharmaceutical/Healthcare and Food industries may use it.

ISO 15738, CFR 21 part 211, CFR 58 and HACCP are QMSs that can be applied to the Pharmaceutical/Healthcare industry. In this way the whole process of developing a product from the acquisition of raw materials to its delivery and storage is carried out at a quality standard.

Since it is impossible to test the quality of every single final food product, ISO 22000, CFR 21 part 110, CFR 58 and HACCP are QMS which contemplate specific requirements that ensure food products are controlled throughout their production. Thus, the implementation of these QMSs is critical within a food industry.


[1] C. Carroll, BG5107 – Quality Management Systems for Biotechnology:, Galway: NUI Galway, 2018.

[2] American Society for Quality, “What is a Quality Management System (QMS)? — ISO 9001 & Other Quality Management Systems: American Society for Quality,” 2018. [Online]. Available: http://asq.org/learn-about-quality/quality-management-system/. [Accessed 28 October 2018].

[3] The 9000 Store, “ISO 9001 Quality Management System: The 9000 Store,” 2018. [Online]. Available: https://the9000store.com/iso-9001-2015-requirements/what-is-iso-9001-quality-management-system/. [Accessed 28 October 2018].

[4] RS Calibration, “The Importance of Quality System Design in Pharmaceuticals,” 19 February 2016. [Online]. Available: https://www.rscal.com/the-importance-of-quality-system-design-in-pharmaceuticals/. [Accessed 05 November 2018].

[5] American Society for Quality, “What is the ISO 9000 standards series?: American Society for Quality,” 2018. [Online]. Available: http://asq.org/learn-about-quality/iso-9000/overview/overview.html. [Accessed 28 10 2018].

[6] CEBOS, “What is ISO 9000?: cebos,” 2018. [Online]. Available: https://www.cebos.com/blog/what-is-iso-9000/. [Accessed 28 October 2018].

[7] ISO, International Standard ISO 15378, Vernier, Geneva: ISO, 2017.

[8] ISO, International Standard ISO 22000:2018, Vernier, Geneva: ISO, 2018.

[9] Bioquell, “Good manufacturing practice is essential to any company in the pharmaceutical industry,” 2018. [Online]. Available: http://healthcare.bioquell.com/en-ie/life-sciences/life-science-resources/risk-mitigation/good-manufacturing-practice-essential-any-company-pharmaceutical-industry. [Accessed 30 October 2018].

[10] ISPE, “GMP Resources: ISPE,” 2018. [Online]. Available: https://ispe.org/initiatives/regulatory-resources/gmp#. [Accessed 28 October 2018].

[11] Gallagher Law Library, “U.S. Administrative Law Research,” 30 July 2018. [Online]. Available: http://guides.lib.uw.edu/law/usadmin/cfr. [Accessed 31 October 2018].

[12] GOVINFO, “21 CFR 820 – QUALITY SYSTEM REGULATION,” Government Publishing Office, 1 April 2011. [Online]. Available: https://www.gpo.gov/fdsys/search/pagedetails.action?collectionCode=CFR&searchPath=Title+21%2FChapter+I&granuleId=CFR-2011-title21-vol8-part820&packageId=CFR-2011-title21-vol8&oldPath=Title+21%2FChapter+I%2FSubchapter+H%2FPart+820&fromPageDetails=true&coll. [Accessed 31 October 2018].

[13] FDA, “CFR – Code of Federal Regulations Title 21 Part 211,” FDA U.S. Food & Drug Administration, 09 April 2018. [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211. [Accessed 31 October 2018].

[14] FDA, “CFR – Code of Federal Regulations Title 21 Part 110,” FDA U.S. Food & Drug Administration, 09 April 2018. [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110. [Accessed 31 October 2018].

[15] J. M. Barroso, “Commission Delegated Regulation (EU) No 1252/2014,” Official Journal of the European Union, vol. 57, pp. 1-7, 25 November 2014.

[16] M. Kyprianou, “Commission Regulation (EC) No 2023/2006,” Official Journal of the European Union, vol. 49, pp. 75 – 79, 29 December 2006.

[17] ADDINSTRUMENTS, “What is GLP?: Addinstruments,” 2018. [Online]. Available: https://www.adinstruments.com/support/knowledge-base/what-glp. [Accessed 28 October 2018].

[18] N. Teuscher, “What is GLP (Good Laboratory Practise)?: Certara,” 9 December 2013. [Online]. Available: https://www.certara.com/2013/12/09/what-is-glp-good-laboratory-practice/?. [Accessed 28 October 2018].

[19] FDA, “CFR – Code of Federal Regulations Title 21 Part 58,” 09 April 2018. [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1. [Accessed 01 November 2018].

[20] A. Ghignone, Composer, 21 CFR Part 58 – The Good Laboratory Practices (GLP) Regulation. [Sound Recording]. 2014.

[21] OECD, “About the OECD,” 2018. [Online]. Available: http://www.oecd.org/about/. [Accessed 01 November 2018].

[22] FDA, “Hazard Analysis Critical Control Point (HACCP): U. S. Food & Drug Administration,” 29 January 2018. [Online]. Available: https://www.fda.gov/food/guidanceregulation/haccp/. [Accessed 28 October 2018].

[23] NHB, “HACCP Definition and Procedures: National Honey Board,” 2018. [Online]. Available: https://www.honey.com/honey-industry/regulation/haccp-definition-and-procedures. [Accessed 28 October 2018].

[24] P. Rasika, G. H. V, K. H. C and S. K, “Planning of Haard Analysis Critical Control Point (HACCP) in Pharmaceuticals,” International Journal of Pharmaceutical Sciences Reveiew and Research, vol. 37, no. 1, pp. 149 – 154, March – April 2016.

[25] WHO Technical Report Series, “Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals,” WHO Expert Committee on Specifications for Pharmaceutical Preparations, vol. 908, pp. 99-113, 2003.

[26] Vinca LLC, “What is HACCP?,” 22000 – Tools by Vinca, LLC, 2018. [Online]. Available: https://www.22000-tools.com/what-is-haccp.html. [Accessed 01 November 2018].


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