ISO 9001 Basics: Complete Beginner’s Guide to ISO 9001:2015 Quality management systems — Requirements

ISO 9001 Quality Management Systems (QMS) is an international standard that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9001 is held by thousands of businesses in Australia, we’ve helped them get Certified with minimal disruption, reducing project costs and raising revenues.

In this guide to ISO 9001 Quality Management Systems (QMS) for beginners, you’ll learn:

·       What is ISO 9001 and why it is important?

·       Reasons for use?

·       ISO 9001 QMS Policy Best Practices

·       ISO 9001 Certification Best Practices   

·       How to best Prepare for ISO 9001 : 2015 Certification

·       Common Technical ISO 9001 QMS Issues

·       How to Track & Measure ISO 9001 QMS Performance Evaluation, Compliance Evaluations and Report Results at Management Review Meetings.

·       Additional ISO 9001 Considerations (such as industry specific applications of the standard and ISO Best Practices)

What is ISO 9001 and why it is important?

Over one million organizations worldwide are independently certified to ISO 9001, making it one of the most widely used management tools globally.

Contents of ISO 9001:2015 are as follows:

·       Section 1: Scope

·       Section 2: Normative references

·       Section 3: Terms and definitions

·       Section 4: Context of the organization

·       Section 5: Leadership

·       Section 6: Planning

·       Section 7: Support

·       Section 8: Operation

·       Section 9: Performance evaluation

·       Section 10: Continual Improvement

Similar to its predecessor, ISO 9001:2008, the layout of the current version of the standard follows PDCA (plan–do–check–act or plan–do–check–adjust) principles. PDCA is an iterative four-step management method used in business for the control and continuous improvement of processes and products.

The ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.

Over time, various industry sectors have wanted to standardise their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them. Some examples include:

·       The TickIT guidelines

·       AS9000 is the Aerospace Basic Quality System Standard

·       PS 9000, QS 9000, ISO/TS 16949 now referred to as IATF 16949:2016 are the various Automotive Quality Management Systems

·       TL 9000 is the Telecom Quality Management and Measurement System Standard

·       ISO 13485:2016 Medical devices

·       ISO/IEC 90003:2014 Software engineering

·       ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries

·       ISO 22000 Food Safety Management Systems

·       ISO 17025:2017 is the Quality Management System applicable only to Testing and Calibration Laboratories

Reasons for use?

Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.

We've got the answers - Call our ISO 9001 Certification helpline now

ISO 9001 QMS Policy Best Practices

The ISO 9001:2015 Quality management systems standard requires the development a Quality Policy. A Quality Policy is a document developed by management to express the commitment of top management with respect to quality.

Section 5.2 of the ISO 9001:2015 standard requires a written, well-defined quality policy that is communicated and understood by all stakeholders and interested parties. Need help developing a Quality Policy for your business? Call ISOsafe 1300 789 132.

ISO 9001 Certification Best Practices

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

Common Technical ISO 9001 QMS Issues

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services, and processes. The auditor presents a list of problems (defined as "non-conformities", "observations", or "opportunities for improvement") to management. If there are no major non-conformities, the certification body issues a certificate. Where major non-conformities are identified, the organization presents an improvement plan to the certification body (e.g. corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it issues a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and displays the addresses to which the certificate refers.

How to Track & Measure ISO 9001 QMS Performance Evaluation, Compliance Evaluations and Report Results at Management Review Meetings.

The organization should determine the methods and frequency for monitoring, measurement, analysis, and evaluation of Performance Evaluation. Does this all sound like too much work? Call ISOsafe now to get help with your ISO 9001 accreditation.

Additional ISO 9001 Considerations (such as industry specific applications of the standard and ISO Best Practices)

So if you’ve gotten this far, you should know a lot of information about how ISO 9001:2015 Quality management systems.

What should you do next? Call ISOsafe on 1300 789 132 to get started on your ISO 9001 Certification.

How to get ISO 9001

Preparing your business for certification to standards such as ISO 9001 or ISO 45001 can seem daunting. If you’re looking to get ISO 9001 certified for the first time (or recertified due to a lapsed accreditation). We can help.

Below you’ll find a step-by-step guide on how to get ISO 9001 certified quickly all the while benefiting from the experience by improving the goods and services your business produces.

STEP ONE: CHOOSE THE RIGHT CERTIFICATION FOR YOUR BUSINESS

The first step for any organisation is making sure that the ISO or Australian Standard (AS) you’ve chosen is the right fit for your organisation. In many instances, your potential customers or clients may require your business to hold a specific endorsement, such as ISO 9001.

STEP TWO: FAMILIARISE YOURSELF WITH THE STANDARD

Buying a copy of the standard can be useful, but isn’t necessarily required. In truth, the jargon involved may even put you off! This is where ISOsafe can add value to the process. We are able to guide you and your business through the ISO 9001 certification process from start to finish. As part of our service we are able to bring experience and professionally prepared systems to ensure your business is certified, without disruption and unnecessary costs.

STEP THREE: LEADING THE WAY

Implementing an ISO management system needs to be an organisation-wide. This can only be done with the involvement of management at each level.

ISOsafe are able to deliver training to all staff and management at your location to ensure good habits are formed.

STEP FOUR: USING A CONSULTANT

We provide consultancy services in addition to training and the documentation needed to get certified to ISO 9001.

Beware of ‘ready made’ management systems which may not suit your organisation.

STEP FIVE: SELECT A CERTIFICATION BODY

It’s important to know exactly what you’re getting when engaging a certification body. JAS-ANZ recognised certification bodies are best placed to issue ISO 9001 certificates.

ISOsafe are able to recommend the most appropriate certification body for your business based on your business’ needs.

STEP SIX: DEVELOPING A MANAGEMENT SYSTEM

The ISO management standards are designed to be generic, applicable to organisations of all sizes and industry sectors. Whilst the standards provide a framework for good management practice, they do not provide detailed steps or information the ISO 9001 auditor may be looking for.

ISOsafe’s experts are able to advise and prepare tailored documents avoiding costly failed audits; making for a faster, smoother certification process.

STEP SEVEN: THE INTERNAL AUDIT

Before any certification audit it is important to have internally audited your ISO system.

ISOsafe’s 9001 experts are able to internally audit your management system, providing a detailed report and documenting all meetings to ensure your certification audit is a success.

STEP EIGHT: GETTING ISO 9001 CERTIFIED

The process starts with what’s known as a ‘Stage 1 Audit’. This is when an certification body auditor reviews your existing systems and provides you with a gap analysis report which will identify the actions required to meet the standard. ISOsafe are able to close any gaps following this audit, making the necessary changes to satisfy the requirements of the relevant ISO standard.

At this point your organisation will be ready to proceed to ‘Stage 2 Audit’. This audit will reveal the effectiveness of your management system and whether it meets all the requirements of the specific ISO standard you wish to be certified to (e.g. ISO 9001 and/or ISO 14001). If you are fully compliant, you will be recommended for certification. The auditor’s report will then be checked via an approvals process and if no anomalies are identified, certification is officially awarded.

STEP NINE: MAINTAINING YOUR CERTIFICATION

The maintenance of your management system is where the hard work really starts. Continued buy-in from everyone is important for implementation to succeed, and for you to gain the true benefit of becoming certified.

ISOsafe are able to provide your business with the ongoing support and training needed to consistently achieve certification.

WHY ISOsafe?

ISOsafe are Australia's leading HR, Employment Law and Health & Safety consultancy firm. We have helped over 3000 businesses with expert training, advice & compliance documentation.

We also develop, implement and audit ISO Quality (ISO 9001), Safety (ISO 45001 / OHSAS 18001 / ASNZS 4801), Environmental (ISO 14001) and Integrated Management Systems (IMS).

ISO 9001:2015 - How we can help you get there

ISO 9001 is the internationally recognised standard for Quality Management Systems (QMS). It is the most widely used standard in the world, with over 1.1 million certificates issued to organisations in 178 countries.

ISO 9001 provides a framework and set of principles that ensure a common-sense approach to the management of your organisation to consistently satisfy customers and other stakeholders. In simple terms, it provides the basis for effective processes and effective people to deliver an effective product or service time after time.

ISO 9001:2015 was released on 15th September 2015. Organisations currently registered to ISO 9001:2008 will have 3 years to make the transition to the 2015 version. In support of the transition process, we wanted to answer some of the more common questions that we have received.

 Why was ISO 9001 revised?

All ISO standards are revised every five years to keep them current and relevant to the marketplace.

When should my organisation start the transition process and how will ISOsafe assist me through the transition?

Immediately! The first step is to contact ISOsafe – we’ll work with you on the transition timeline. The next step is to sit back while our expert consultant prepares all the necessary documents and delivers the ISO training your staff require. We will run the ISO project, on your behalf, through to issue of certificates.

Can our organisation upgrade in 2016 during a re-certification or surveillance audit?

Yes, providing your quality management system meets the requirements of ISO 9001:2015. Organisations may transition during a surveillance, recertification or special audit.  Transition audits will take place in 2016, 2017 and 2018.

My organisation is thinking of getting certified to ISO 9001 in 2016, what version should we be using?

We suggest you consider ISO 9001:2015 but this is your decision and ISOsafe will support an initial certification to ISO 9001:2008.

If you are seeking ISO 9001 certification for the first time, you can expect the following benefits: operational efficiency, customer satisfaction, process improvement, product improvement, reduced wastage, enhanced risk management at all levels in your business and new business / contracts – as this globally recognised certification will give your business a competitive edge in the market.

How can I get a copy of the ISO 9001:2015 Standard?

ISOsafe recommend purchasing Standards from an Australian supplier, such as SAI Global.

What are notable changes when transitioning to ISO 9001:2015?

The new ISO 9001 standard aligns with high-level organizational structure, requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. Additionally, there is a greater emphasis on risk-based thinking as a basis for the management system, more focus on achieving value for the company and its customers, increased flexibility regarding use of documentation, and a more approachable structure for service businesses.

ISOsafe have helped many organisations seamlessly transition to the revised Standards. Don’t wait till its late call us today on 1300 789 132

Why quality management is essential for your small business

With ever-increasing demands for small and micro-businesses to deliver on quality, price and service, the most effective way to enhance the confidence of your customers is through a structured certificated Quality Management System (QMS). For small businesses, this is not as daunting as it might appear, as it should always be based on how your business systems currently operate.

You can manage quality, whatever the size of your business, with a standard that’s recognised the world over. With ISO 9001 Quality Management you can:

•   save money

•   increase profit

•   win more business

•   satisfy more customers

The ISO 9001 Quality Management Standard is the foundation for:

•   A real opportunity for increasing business, and thereby profitability, by being able to pursue contracts with those customers for whom certification is a contractual requirement.

•   Providing you with the opportunity to gain a clearer understanding of your business through the information that the QMS gives you. A QMS will facilitate customer focus, enhanced risk management, increasing efficiency, productivity, cost savings, and reducing and overcoming product or service problems.

•   Developing a system which provides the building blocks a small or micro business needs to progress in that it enhances the recognition of your team members through involving them in considerations, development and implementation. This in turn significantly improves communication and understanding together with a faster response in resolving any issues that arise. All of this is achieved through your confidence that the system provides reliable, recorded information and data to base potential improvements on.

Adopting a QMS should be seen as a business development opportunity, regardless of your business size

Benefits of working with an ISO expert

There are nearly twenty thousand standards covering everything from manufactured products and technology to food safety, agriculture and healthcare.

Use of the standards aids in the creation of products and services that are safe, reliable and of good quality. The standards help businesses increase productivity while minimizing errors and waste. By enabling products from different markets to be directly compared, they facilitate companies in entering new markets and assist in the development of global trade on a fair basis. The standards also serve to safeguard consumers and the end-users of products and services, ensuring that certified products conform to the minimum standards set internationally.

On paper, it can look an onerous task to be able to meet these standards. In practice, it can mean many hours finding, creating and pulling everything together. For many, the time is well spent with accreditation or certification awarded. But, there can also be disappointment. Just when you thought you had jumped the final hurdle, you find there are many more to come.

How can an ISO consultancy company such as ISOsafe help?

There are many advantages to investing time and money with an ISO expert:

•   Important for your business – receiving an ISO certification can have a huge positive impact on your business. It can open many new doors and present your company with a wealth of exciting opportunities. Working with an ISO expert company can help to reach this important milestone faster.

•   Fresh perspective – you know your systems inside and out. You know that your environmental policy is robust, and your quality management systems are all in place. But, do they reach the standard? Are they as robust and versatile as you need and want them to be? Can they really withstand the pressure of interstate and international business? The perspective provided by a fresh pair of objective eyes will make a huge difference.

•   Actionable advice – gaining ISO certification is not rhetoric. They are important business standards that speak volumes about your business's ability to deliver your product or service. When something is so important, you need clear, actionable advice and guidance.

•   Invest for great rewards – when budgets and operating margins are tight, it can be counter-intuitive to pay for a service that essentially, you may think, you can do yourself. It just means slaving away over your desk… but support, guidance and advice from a company who works daily in the fast-paced world of ISO standards will save you time, and money.

Your business is everything. Gaining accreditation and certification such as ISO 9001:2015 and ISO 14001:2015 will speak volumes to your trade partners, as well as propelling you beyond the reach of your competitors. Why not speak to ISOsafe today on 1300 789 132 or email enquiries@isosafe.com.au to see how much easier gaining certification is with an expert by your side