ISO 9001 QUALITY MANAGEMENT SYSTEMS FOR ANY ORGANIZATION
Our simple approach to ISO 9001 compliance:
Are you interested in becoming ISO 9001 certified?
ISO 9001 is the most well established and widely recognised of all standards for quality management. Becoming ISO 9001 certified is a significant accolade and can open doors to new business opportunities. Many organisations have heard of the ISO 9001 standard but still only a minority have actually achieved approval. Would you like to add UKAS accredited ISO 9001 certification to your business credentials? This page is all about about the ISO process, including ISO 9001 audits and ISO 9001 consultancy. For help with ISO 9001 or to speak with an ISO 9001 consultant, use the enquiry button at the bottom of the page.
What is ISO 9001 and why is it important?
ISO 9001 is an internationally recognised standard for the design, development and implementation of a quality management system (QMS). It can be applied to any type or size of organization in any business sector. Its clauses define the baseline requirements for a QMS in functional terms, i.e. it describes what you need to control without telling you how to run your business. The importance of ISO 9001 derives from its universal recognition as a badge of quality, coupled with a declared intent to encourage continual improvement of quality and business performance. Of all the ISO standards and quality programmes available, ISO 9001 is the most suitable for SMEs taking their first step to establish the structures and processes necessary for future growth.
Already certified but need to simplify or modernise?
If you are one of those more mature businesses for whom ISO 9001 has long been a fact of life, we invite you to consider if your current quality management system has evolved with your business and taken advantage of the changes in the ISO 9001 standard that allow a more dynamic and flexible approach. QFactorial is adept at modernising and simplifying legacy quality management systems to meet the changing needs of organizations as their business context evolves and stakeholders and other interested parties become more demanding.
Benefits of ISO 9001, quality management systems and certification
Most business leaders answer this in terms of customer and market demand. “I need ISO 9001 to prequalify for a tender process” or “In this market we are up against competitors who already have ISO 9001, and this seems to give them an edge.” Even if neither are true, you may have an opportunity to get ahead of the competition by being the first to be awarded an ISO 9001 certificate. But the certificate is only half the story. The real value is in having a quality management system that brings control, compliance, governance, assurance and continual improvement to the way you do business. With or without certification, ISO 9001 is a great starting point for developing a mature QMS to support your business strategy and objectives.
Key features and requirements of the ISO 9001 standard
ISO 9001 is the mother of all ISO management system standards. This doesn’t mean it is the biggest or even the meanest. In fact, it is one of the smallest and easiest to implement. But it is the mother standard in the sense that many of its characteristics and features can be found in other ISO management standards that have been deliberately designed to align and integrate with ISO 9001. Some of the key features of ISO 9001 include: leadership, policy, objectives, planning, resources, competence, communication, documentation, operations, design, purchasing, outsourcing, production, service delivery, product release, nonconformance, performance evaluation, internal audit, management review and improvement.
Certification and accreditation
The first thing you need to know about certification and accreditation is that ISO certificates are not all created equal. The world is not a perfect place and there are good and bad ISO certificates. The bad ones are those that cost a few pounds/dollars and require virtually no work to gain and retain. Obviously, these have no real value and carry the risk of embarrassment or loss of a contract if anyone checks the credentials of the “certification body”. To avoid this minefield, make sure you get a UKAS-accredited certificate. The UKAS accreditation mark is an important indicator of the validity of any ISO 9001 certificate issued in the UK. It demonstrates that the certification body awarding the certificate is approved (accredited) by UKAS to carry out audits and issue certificates. Other international accreditations may be valid by multi-national agreement, but only UKAS has this authority granted directly by the UK Government.
Choosing an ISO 9001 consultant
There are many good reasons for partnering with an experienced and knowledgeable consultant when implementing ISO 9001. The first is that it is very easy to over-egg the ISO pudding if you try to implement the standard clause by clause. In fact, the standard itself warns against a clause-by-clause approach. You must also avoid consultants who clone solutions from templates or impose standard documentation that does not look or feel like the way you want the business to run. A good consultant is able to translate and interpret the jargon of ISO 9001 into business language in the most cost-effective and pragmatic way for your business. A good consultant will give you the tools to make your QMS work and show you how to use them. Finally, you need a consultant who will challenge you during internal audits and be your advocate in external audits.
Choosing an ISO 9001 auditor (certification body)
An important task for any ISO consultant is to advise you on the selection and appointment of a suitable UKAS-accredited certification body. This needs to be done with due diligence, just like any other critical purchase. One of the founding fathers of quality management, W Edwards Deming, said we should end the practice of awarding business on the basis of price. This rule should apply equally when selecting auditors – and indeed consultants! Other factors include sector experience, resource availability, peer recognition, geographical coverage and scope of accreditation.
Working with your ISO 9001 consultant - the QFactorial approach
At QFactorial we have a very simple approach to ISO projects, regardless of the size or type of client, the maturity of your QMS or the complexity of your systems and processes. We use our unique Q!Diagnostic method to generate a detailed and specific Quality Roadmap. This will be our guide through the collaborative design, development and implementation of your new or revised quality management system.
Stage 1 ISO certification – passing the desktop audit
All certification bodies follow a two-stage model, starting with the Stage 1 documentation audit. This is often known as a desktop audit as it mainly consists of the auditor visiting your premises to read and review the documents that describe and demonstrate your policies, objectives, metrics (KPIs), processes, procedures, instructions, plans, decisions, check points and other QMS controls. The general approach during the ISO 9001 Stage 1 audit is “explain how you have implemented each element of the standard and where you have documented it in your QMS”. Questions will be asked at this stage, but detailed investigation and evidence of the QMS in action is reserved for Stage 2.
Stage 2 ISO certification – passing the physical audit
Having established the theoretical compliance of the QMS with ISO 9001 during the Stage 1 audit, Stage 2 is more about checking that the QMS is fully and consistently implemented in practice. Typically, this will involve interviews with members of your team at all levels of the organisation, sampling from a range of processes and functions. The general approach during the ISO 9001 Stage 2 audit is “tell me how this works, take me to where it happens, introduce me to the people, show me the evidence”.
Remote ISO consultancy and remote audit under Covid-19 restrictions
During the coronavirus pandemic the ISO audit process has moved online with both stages taking place via MS Teams, Zoom or other video conferencing tools. These have become widely known as remote audits and are considered just as valid as the site visits previously undertaken. Now that remote auditing has been proven to work, it is expected to remain as part of the audit toolbox, especially for Stage 1 and perhaps Stage 2 where there is only office activity and no production, construction or service delivery to be witnessed.
To learn more about gaining ISO 9001 certification or upgrading your quality management system, simply click the enquiry button and a QFactorial consultant will contact you to discuss your specific needs.
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