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Nov 05th, 2024
ALLpaQ and the Importance of our ISO 9001 Renewal
ALLpaQ is proud to confirm that we have successfully renewed our ISO 9001:2015 certification (Cert. 23250).
This milestone wouldn’t have been attainable without our meticulous ALLteaM’s attention to detail, quality and innovation. Every ALLpaQ team member upholds our stringent standards at all times. In this way, we achieved zero non-conformances in our audit!
At a moment like this, it’s worth taking the time to mention why this matters and what it says about our business.
Table of Contents
Why so ISO?
More than just a certificate, our ISO 9001 accreditation represents ALLpaQ’s ongoing pursuit of exceptional quality.
ISO is a rigorous international standard for quality management systems, a framework that guides us towards consistent improvement, operational efficiency and, ultimately, the continued design and manufacture of pioneering bioprocess products and services which meet, and surpass, our customers’ exacting biopharma needs.
If you’d like to know more about ALLpaQ’s accreditations and have a look at our actual ISO 9001 certificate, you can find all the info here.
But why does ISO 9001 matter so much? Why is it more than just a badge of honour?
Demystifying ISO 9001
ISOs are issued by The International Organisation for Standardisation, which is an NGO that includes various national standards bodies in its membership, and is recognised in more than 160 member countries.
Fun fact: the name ‘ISO’ is not an acronym, because the initial letters for ‘International Organisation for Standardisation’ would be different in different languages (IOS in English, OIN in French, ION in German, etc). So, in order to standardise the standardisation, the standards are simply referred to as ISOs everywhere!
The organisation has formulated more than 24,000 ISO standards, addressing a wide array of subjects ranging from manufactured goods and technology to food safety, agriculture, and healthcare.
ISOs are, without doubt, the world’s gold standard for crafting robust quality management systems, a meticulous framework that guides us at ALLpaQ to consistently satisfy our clients’ needs and exceed their expectations.
But what does this mean for you, our partners and clients?
Simply put, ISO 9001 accreditation is a guarantee of consistency and quality in every ALLpaQ department and for every ALLpaQ product.
Earning an ISO 9001 certificate isn’t a one-and-done achievement; it’s a continuous commitment that informs and affects every aspect of our operation, every day. We meticulously document procedures, rigorously monitor performance and actively seek feedback in a genuine attempt to ensure every ALLpaQ product provides the service our clients need and the quality they deserve.
The ISO requirements also put the spotlight on continuous improvement. This helps drive everyone in the ALLpaQ ALLteaM towards ever-greater standards, efficiency and quality.
Ultimately, our ISO 9001 is way more than just a certificate hanging on our wall; it fuels our operational excellence, strengthens our clients’ supply chain and helps to foster an environment of mutual trust and shared commitment.
ISO 9001 Offers Peace of Mind
ISO 9001 isn’t just a technicality – it’s a tangible assurance that is baked into every product we produce. It holds us to the very highest of standards, which we embrace because our customers have the right to expect the very best from us. In practice, our ISO 9001 compliance involves:
Stringent Quality Checks:
Forget about spot checks and random samplings. ISO 9001 mandates continuous quality control measures throughout the entire manufacturing process, from raw material selection to final assembly. Think meticulous inspections, documented procedures and a culture of continuous training and improvement.
Transparency and Accountability:
ISO 9001 guarantees meticulous documentation of every step in the production journey. This creates transparency and accountability which, hopefully, builds trust and solidifies our partnerships.
Minimising Risk:
Our ISO accredited process requires us to actively identify and eliminate potential vulnerabilities in our supply chain and our workflow. This, in turn, offers reassurance to our customers’ supply chain.
Regulatory Compliance:The ISO standard demands seamless alignment with the latest and most stringent industry standards and quality regulations. By constantly monitoring our performance against these benchmarks, audits and inspections become more like formalities than major interruptions to our workflow.
All of this means we can continue to focus on what really matters: delivering excellence at every turn, whilst also conducting groundbreaking R&D for the next generation of our pioneering products.
Why Non-Compliance can be a Threat
While ISO 9001 helps ensure we stay on the straight-and-narrow path to biopharma excellence, the perils of non-compliance are very real. If customers buy products from suppliers who are not ISO accredited, whose products may not meet the exacting safety and quality standards that go along with the ISO standard, the repercussions could include:
Compromised Integrity:
In the biopharma sector, the stakes are very high. Billions can be spent in developing therapeutics and millions can be spent in producing a single batch of a genetically-engineered vaccine, for example. A compromised storage solution can lead to contamination, spillages, leaks and any number of hazards that put products, profits and, ultimately, patients at risk.
Recalls and Reputational Damage:
Contaminated totes or compromised materials can trigger costly recalls, eroding consumer trust and tarnishing a business’ hard-earned reputation. The financial losses pale in comparison to the potential harm to patient safety and the long-term erosion of public confidence. Don’t risk it by dealing with non-ISO compliant suppliers.
Regulatory Penalties: Beyond the costs to reputation and business, non-compliance can result in significant regulatory penalties. These can include fines, further public humiliation and even the removal of licences, depending on the seriousness of the contamination and the local laws.
By contrast, at ALLpaQ, our ISO accreditation demonstrates that we adhere to its rigorous standards, reinforcing our dedication to exceeding industry benchmarks and safeguarding your biopharma business.
Choosing ALLpaQ means choosing quality, consistent improvement and peace of mind. It means we prioritise not just our own operational efficiency, but our clients’ business workflow and patient safety.
Our customers are our partners – their concerns are our concerns, their values are our values.
ISOlating Excellence
In the life sciences, quality isn’t just desirable, it’s an absolute necessity.
That’s why biopharma companies need to know they are in partnership with other companies which are held to the very highest standards.
And that’s what ISO 9001 is all about: reassurance and excellence.
When you choose ALLpaQ, you’re not merely selecting a supplier; you’re entering a partnership with a manufacturer who is committed to meticulousness in every step of the production process, who welcomes scrutiny and who is dedicated to relentlessly improving our offering.
Everything we produce at ALLpaQ is designed and manufactured under the umbrella of ISO 9001:2015 and, of course, all under our roof.
Check out our full range of ISO-certified Shipping Containers, our folding Cleanroom Containers and our wide variety of 2D Accessories.
Further Reading:
General Information on ISO 9001:
- International Organisation for Standardisation (ISO): https://www.iso.org/standard/62085.html – Provides official information and resources about ISO 9001.
- UK Accreditation Council (UKAS): https://www.ukas.com/about-us/technical-advisory-committees/management-systems-certification/ – Offers UK-specific insights into ISO 9001 and its benefits.
- Forbes: https://www.forbes.com/sites/forbesbusinesscouncil/2021/10/07/how-iso-9001-can-transform-your-small-business-even-without-certification/ – Article highlighting the business value of ISO 9001 certification.
ISO 9001 in Biopharma:
- Pharmaceutical Technology: https://www.pharmaceuticalprocessingworld.com/5-things-pharma-managers-need-to-know-about-iso-90012015/ – Article discussing the importance of ISO 9001 for pharmaceutical companies.
Risks of Non-Compliance:
- Business Interruptions Caused by Non-Compliance: https://www.europeanpharmaceuticalreview.com/article/103616/regulatory-non-compliance-business-interruptions/ – Discusses the significant impact of regulatory non-compliance on biopharma or medical device manufacturers.
TAGS: Bioprocess Containers, ISO 9001, ISO9001:2015, Pharmaceutical, Plastic Bioprocess Containers,
