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ISO 9001

Quality Management System (QMS)

If you are looking to make quality improvements in your business, then you have come to the right place.

When your business holds ISO 9001 certification, you automatically demonstrate to your stakeholders that you are serious about the quality of your products and services and consistently deliver a defined level of customer satisfaction through the Quality Management System (QMS). This enables organisations of any kind to manage the quality of their services/products and improve supply chain opportunities.

What is ISO 9001

What is ISO 9001?

ISO 9001 is a globally recognised Quality Management System (QMS) standard. Attainment of this certification provides evidence to customers and stakeholders that a business is committed to delivering on quality products and/or services, which in turn ensures that the customer experience is enhanced.

Revised in 2015, the framework facilitates the structuring of business operations with a defined level of quality, and allows for the development of procedures and policies that will enable the company to consistently meet and deliver on these objectives — verified by an independent third party.

A business can, in theory, set any internal standards that it deems necessary, but a customer would not know if they were good, bad or indifferent. The standards set by the International Standardization Organization (ISO) are therefore usually implemented, as they are recognised universally. Of the ISO 9000 group of standards, only 9001 lists actual requirements and therefore needs to be certified — the rest are supporting guidelines.

The standard was updated in 2015, and therefore is most often noted as ISO 9001:2015, to indicate that an organisation meets the latest requirements. It’s based on the seven quality management principles that underlie this family of standards.

ISO 9001 certification demonstrates that a business meets the criteria and requirements for quality. Organisations use the Quality Management System (QMS) to define how they can meet and exceed the requirements for their customers and any other stakeholders — aligning their processes, policies, and procedures to meet these goals.

The ISO 9001 QMS does not focus on product quality, but rather on good management practices that will result in consistency in the products and/or services that the business offers and therefore improve customer satisfaction.

The adoption of this standard into the day-to-day operations of a business will help to improve the overall performance and provide a sound basis for sustainable development initiatives.

The ISO 9001 framework can be used by any organisation or business that is looking to improve on — or certify — its quality procedures, and it’s often stipulated by customers that a supplier holds ISO 9001 certification.

There are over one million organisations across the world that are currently independently certified as adhering to the ISO 9001 standard, showcasing its effectiveness as a means of providing consistent quality products and services.

Why ISO 9001

Why would a business need ISO 9001 certification?

There are many individual reasons why a business might need or want ISO 9001 certification, but the overall benefits of meeting the standard will be felt throughout the organisation — such as improving products and services, enhancing customer satisfaction, and driving growth.

The standard also allows the certified business to operate more competitively within its key verticals, as well as opening up opportunities such as access to tendering frameworks that stipulate ISO 9001 is required, securing new business, and overall boosting the bottom line.

Facilitate continual improvement to achieve better results

Good business practice dictates that an organisation should always be striving to become better and implementing and maintaining ISO 9001 will support a business to continue to exceed its quality objectives and consistently achieve improvement objectives.

Gain a competitive edge

When it comes to a choice between two suppliers offering a similar product or service, a customer will always choose the business that can evidence good quality via its ISO 9001 certification, ultimately boosting the bottom line. As such, ISO 9001 provides an advantage over competitors that do not have the certification, or levels the playing field with those that do.

Enhance customer satisfaction

With an ISO 9001 Quality Management System (QMS) in place, and the quality of a business’s products and/or services continually improving, customer satisfaction levels will soar — meaning reviews and word-of-mouth recommendations will too, therefore securing new business and expanding reach within the industry or sector.

Improved chances of getting onto tendering frameworks and Approved supply chain lists

ISO 9001 is often a requirement to gain access to tendering frameworks or other similar supply chain structures, and with certification of quality standards, businesses with this certification are more likely to be successful in the tendering process as a result — and to achieve preferred supplier status.

Securing long-term business growth

With improvements in the quality of the products and/or services offered, as well as enhanced customer satisfaction, securing of new business, and success in the tender process, 80% of Synergos customers that attain ISO 9001 report business growth as a direct result of the QMS, evidencing that it’s certainly worth taking the time achieve the certification.

ISO 9001 Requirements

What are the requirements to gain ISO 9001 certification?

The ISO 9001 framework consists of seven main principles that make-up the requirements for a comprehensive quality management system. This includes information such as organisational context, leadership, planning, support, operation, performance evaluation and improvement.

Each of these sections will need to be documented and evidenced to achieve ISO 9001 certification, but the good news is that most businesses already have these formally or informally in place, so it’s a matter of curating them into a cohesive QMS that acts as a manual for running the organisation.

Context of the organisation

What does the business do? How does it operate? Who are its customers? Who are the key stakeholders? What is its strategy and purpose? These are the questions that must be answered and documented in clause 4 of the ISO 9001:2015 standard.

An organisation will need to assess factors internally and externally that may affect it — often carrying out a SWOT or PESTLE analysis — as well as identifying who the key stakeholders such as staff, suppliers, etc. Finally, a business must understand its customer and their needs and lay these out within clause 4.

Someone completely unfamiliar with the business should be able to read this section and understand who it is, what it does, and why it exists — in context.

Leadership

The commitment of the senior management team is key to any business’ success. That’s why it’s vital that they’re all engaged with the development and implementation of the QMS. This will include establishing the policies and objectives appropriate to the purpose of the business, and then communicating these to the rest of the organisation — and anybody else responsible for maintaining the quality of the products and services on offer.

In clause 5, engagement of the senior management team will need to be documented and evidenced, and the team will need to maintain the quality management system for annual review.

Planning

Risk-based thinking is integral to any good quality management system, which means having parameters in place to assess any risk or opportunity that may arise. That’s why clause 6 requires businesses to document any potential risks to the organisation, the likelihood it may occur, and the level of threat that it poses. The QMS must also outline any plans to mitigate these risks, or to practice damage-control should they inadvertently arise.

Any risks, opportunities, and plans must consider the interested parties, as well as how they may help or hinder the quality objectives. Again, communication throughout the business of quality objectives is vital — and must be in line with the quality policy.

Support

Clause 7 stipulates that a business should have the appropriate and relevant infrastructure and adequate resources to maintain and operate an effective quality management system. This includes documenting robustness, efficient working environments, and good HR practices.

Overall competency and communication will be reviewed, and will form the basis for ongoing continuous improvement and the success of any sustainable development initiatives.

Operation

In this section — clause 8 of ISO 9001:2015 — a business must state the work that it does to provide customers with good and/or services. This includes documenting the entire process, from sales enquiry to final invoicing and delivery, whatever that may look like.

The processes will lay out what employees must do to ensure they are consistently delivering on quality at every stage, including what guides and resources they will need, how they will be monitored, and the manner in which results will be recorded and stored.

Performance evaluation

Without measuring the success of a quality management system, it’s impossible to know if it is effective in maintaining and exceeding its quality objectives. That’s why in clause 9 of the framework, a business must state the way it will analyse its processes and how the results will be recorded.

This will consist of carrying out internal audits, documenting meetings, and gaining feedback from customers on performance. This information will serve to demonstrate that the company conforms to ISO 9001 standard, that it applies all aspects of the QMS, and to support continual improvements across the board.

Improvement

Improvement is integral to business growth, so it’s imperative that an organisation always strives to continue to better the quality of its goods and/or services. The final clause of ISO 9001:2015 outlines the measures a business should put in place to improve products and services, meet the ever-evolving needs of the customer — therefore increasing satisfaction levels — and document instances when processes do not meet their objectives, and act upon these by updating them.

The way that this is documented varies from business to business, but typically might consist of maintaining a complaints or issues register and regularly reviewing the severity of the listed problems and how they may be addressed or mitigated in future.

How can ISO 9001 be achieved?

Gaining ISO 9001 certification is easier than many think. At Synergos, we support all our clients from start to finish, guaranteeing a positive outcome. From developing your management system to being formally certified, and everything in between, our experienced consultants are there every step of the way.

We can help you to develop your quality management system, implement it into your day-to-day business operations, prepare for your stage one audit, and be on hand to assist in making any amendments before completing your stage two audit. And we’ll continue to support you during your annual audits going forward.

How to get ISO 9001

This step includes defining policies and procedures, ensuring that they meet the business goals. At this stage, the business will carry out audits, chair meetings, and identify and document risks, resources, suppliers, and objectives.

This can seem overwhelming, but by taking a methodical approach a clear picture of the business can be gained — making any amendments to policies and procedures in a systematic manner so as not to be inundated with change requests.

The ISO 9001 framework is there to support a business in how it currently operates, so will not require a complete overhaul of how things are currently done, but instead offers a quality management system that facilitates a consistent approach to trading.

UKAS is the national accreditation body for the United Kingdom and is appointed by the government to assess and accredit businesses against internationally recognised standards. It’s vital that the certifying body a business chooses to carry out its ISO audits is UKAS accredited, to evidence that the business is seriously committed to quality.

A UKAS accredited body has proven it complied with best practice, and will deliver a competent and impartial service based on internationally recognised standards. Any customer or client looking for ISO 9001 certification from a supplier will typically want to see that the certification is UKAS accredited to ensure it’s credible.

Before the stage one audit, businesses must review their QMS to ensure that no vital information has been missed, cross-referencing against the standards laid out in ISO 9001.

It’s important during both the development of the QMS and the preparation for the stage one audit that everyone within the organisation is brought on board as the procedures, policies, and processes will affect everyone — and it’s the responsibility of the teams delivering managing day-to-day operations to keep documents up-to-date to ensure that an audit will be passed. Communication, training, and development are key to ISO 9001 certification.

An auditor from a UKAS accredited certification body will attend the site that is undergoing ISO 9001 implementation to carry out each of these audits. During the stage one audit, the auditor will check for preparedness for the stage two certification audit.

Audits can often seem daunting, but the stage 1 audit offers a clear view of how your ISO 9001 QMS is working within the business, and where improvements can be made in the case that any area does not meet what is specified in the framework. The feedback provided is invaluable in helping you to not only grow and improve as a business, but to go on to achieve your ISO 9001 certification.

During the stage two audit, the auditor will return to comb through all the work you have done so far, expecting all recommendations from the stage one audit to be rectified. At this stage, this should just be a check that everything is in place, as the stage one audit will have highlighted any areas that do not meet the ISO 9001 criteria for the business.

If the stage two audit is successful, the business will receive its ISO 9001:2015 certification.

The UKAS accredited certification body will return annually to ensure that the quality management system still meets the specified standard, and that the business still meets or exceeds the defined criteria. This ensures that quality is consistently maintained and delivered.

Gaining ISO 9001 accreditation should not just be for the sake of the certificate itself, but for continuous improvement and dedication to quality within the business. Therefore it’s vital that all the work that has gone into achieving the certificate does not go to waste, and that adherence to the QMS is maintained year-round.

You Can Put Your Trust in Our Team

You can put your trust in us, as we’ve worked hard to build a solid reputation helping clients like you achieve their business goals. Working across a wide range of business sectors, we collaborate with you to ensure a great outcome for everyone.

We guarantee*
we will get you through ISO 9001 certification or we will refund 100% of all monies paid to Synergos Consultancy.

*subject to our terms and conditions

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