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Has your company been using GMPs (Good Manufacturing Practises)? If the response is yes, be aware that there is an additional benefit that you might have neglected in addition to the ones that are obviously obtained by adhering to these recommendations. Since many of the essential features of ISO 9001:2015 Quality Management Systems directly relate to the vital GMP components, your company will be close to achieving the requirements of the standard, which will save you time and money in your quest for an internationally acknowledged ISO Certification in UAE.
The 5Ps, which stand for People, Products and Primary Materials, Processes, Procedures and Premises and Equipment, are the main elements of Good Manufacturing Practises. Each step of the production process is managed using these components as a guide, guaranteeing that the finished product can meet all quality and safety requirements.
Every manufacturing company needs employees to carry out its operations, and it is the management's responsibility to establish clear roles and responsibilities that are consistent with the company's objectives.
This is the most important element of GMP and ISO 9001:2015. After all, the fundamental materials and how they are used during the production processes influence the product's quality. As a result, the company should incorporate quality control into every phase of production.
In every aspect of your organisation, ISO 9001 uses a risk-based methodology. Every stage of the business processes should undergo a risk assessment. From the time raw materials are received until the product is delivered to the end user, manufacturing risks should be detected. It is critical to have safeguards in place to reduce potential hazards including cross-contamination, adulteration, and mislabelling, which can have a negative impact on the company, the product, and the client.
The need for documented procedures and recurring audits is emphasized by both GMP and the ISO 9001 Standard. To achieve compliance, a company should have standardized procedures that are well-documented and conveyed to the staff.
Having established processes makes it simpler to monitor and examine deviations as well as to identify and control risks. Additionally, it encourages effective knowledge transfer and guarantees that the company can uphold quality at each stage of the process.
Clause 7.5 of ISO 9001 and GMP both mandate that the business document its practises in addition to the prior topic. These may include instructions, procedures, flowcharts, and steps for carrying out crucial tasks or processes.
Consistent results are ensured by having documented procedures since any substantial manufacturing-related variations can be quickly tracked down, analysed, and corrected. These are frequently referred to as standard operating procedures (SOPs). Operators must be trained to complete the necessary records for traceability in an accurate and timely manner during these processes.
The work environment must meet the requirements of ISO 9001 Clause 7.1.4. By describing the conditions essential for facility management, GMP connects to this requirement. Manufacturing businesses should make an effort to design their buildings and machinery so that adequate cleaning and cross-contamination are possible.
Having a maintenance and calibration programme in place is another requirement of the ISO 9001:2015 Standard for the company. This is essential for the confirmation and verification of results, particularly those from laboratory tests.
Hire best ISO certification consultant in UAE, Dubai or call us at 00971526325363 right away to learn more about how your GMP can assist your company with becoming certified to the ISO 9001:2015 certification in Dubai, UAE or send us an email.