ISO 9001:2015 Overview

ISO 9001:2015 – Quality

ISO 9000 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001:2015 is one of the documents in this set.  It states the requirements the organization must meet to be in compliance with the standard.  ISO 9001:2015 is the current version of the Standard. Past versions of ISO 9000 included ISO 9002 and ISO 9003, but those are no longer in use. Companies are now only registered to ISO 9001:2015 from Sep 2018, which superseded ISO 9001:2008.

An ISO 9001:2015 compliant Quality Management System (QMS) is a set of controls developed, implemented and monitored to ensure that the processes used to provide services or to manufacture products meet customer expectations consistently and in the most efficient, cost-effective way.

ISO 9001:2015 start with creating a Quality Policy, which is supported by a Quality Manual and supporting procedures which define management and employee responsibilities and how the processes are controlled. The system is designed to guarantee a company’s service or product quality goals. This QMS provides companies with a method for consistently improving both service and product quality; thereby surpassing customer expectations.

The Standard itself consists of a set of requirements.  These requirements specify what a company must do, but not how.  For example, it says you must plan how you will achieve quality, but it does not say specifically how you must plan, nor specify a format for the planning.

The Standard is based on these 8 underlying principles:

  • Customer focus
  • Leadership
  • Enagagement of people
  • A process approach
  • Improvement
  • Evidence based decision making
  • Relationship Management

Because the standard states generic requirements, and is intended to apply to all kinds of businesses, some interpretation and experience is required to apply it to your particular business.

Most of the requirements are just sheer good business sense. For example, there are requirements that you must know what your customers want, and deliver it to them. You must make sure your people are competent and that they have the right skills, training and experience.  You need processes suitable for producing and delivering your products or services.

Why Implement 9001?

Why Implement ISO 9001?

Top reasons given for registration:

  • Internal operational efficiency improved
    Lower production costs because of fewer nonconforming products, less rework, lowered rejection rates, streamlined processes and fewer mistakes.
  • Access to new markets
  • Some markets require ISO 9001 Registration, some markets favour companies with ISO 9001 Registration
  • Customer request – Many organizations are asked by a customer to obtain registration as a requirement to continue or to start doing business with them.
  • Reduced cost – Organizations are recognizing that an effective Quality Management System leads to reduced costs and greater operating margins

What will ISO 9001:2015 do for my organization?

A well designed and implemented Quality Management System, based on ISO 9001:2015 has been shown to provide organizations with the following benefits:

Reduced costs through:

  • - Improved product reliability
  • - Better process control and flow
  • - Better documentation of processes,
  • - Greater employee quality awareness
  • - Reductions in product scrap, rewords and rejections

Can I do ISO 9001 myself?

Getting ISO 9001:2015 certification does take time, effort and resources. You must know what the Standard says, identify your gaps, and work out how to fill them. You’ll also need to know how to interpret the Standard and apply it to your business. But it will take you time to figure out what’s involved, so expect it to take longer, and it may involve more effort and cost.

Who gives the certificates?

The organisations that do this are called certification bodies. Only companies who are accredited (by UKAS in the UK) can award certifications – provided of course you meet the requirements at the audit. You make a formal application with them, agree on the particular Standard (e.g. ISO 9001) and a suitable scope, pay the fees, and jointly agree the scheduled date(s) for assessment.

Are all certification bodies the same?

Definitely not. While they all assess you against the same Standard, they are service providers, and there are differences between them. You should choose who you want to use. Contact at least 2, preferably 3, discuss your needs, and choose one you think will suit your business. See the Certification link for more information.

What do consultants do?

Certification bodies award the certificates: think of them as something like an examiner – they test (audit) your system, and provided it meets requirements, they give the certificate. They don’t coach you, or help prepare you, or tell you how to ‘pass’! But good certification body auditors will adopt a partnering-type approach, rather than a dictatorial or inspector-like attitude. However, they cannot advise you.

Consultants assess your system against the requirements, tell you where the gaps are, give advice, help you with the process, prepare you for the external audit, show you how to meet the various requirements, and will usually coach you too. A good consultant can add enormous value, speeding up the process and making it easier and more efficient, and thus will save you time and money. They should make sure you avoid the common mistakes. And good consultants should help you get a system that supports you, as well as getting certification.

Why Implement 14001?

Why Implement ISO 14001:2015?

An Environmental Management System (EMS) helps you to:

  • Manage environmental risk
  • Reduce costs
  • Gain competitive edge
  • Minimise environmental impact

The process involved in implementing an EMS will include:

  • Creation of an ‘Environmental Policy’
  • Evaluation and recording of the operation’s environmental aspects/effects
  • Setting of measurable goals and targets that will comply with legislation
  • Documentation of policy objectives and proposed action
  • Audit and review of policy

ISO 14001:2015

ISO 14001:2015

ISO 14001:2015 is the most comprehensive standard for Environmental Management Systems (EMS) recognised on an international basis. It replaces ISO 14001:2004, and is designed to more closely align with ISO 9001:2015. The adoption of ISO 14001 publicly demonstrates a commitment to environmental concerns, equipping the organisation with both a valuable management system and a most powerful marketing tool.

The process of implementing and maintaining an EMS highlights opportunities for significant cost savings regardless of industry sector

ISO 9001:2015 and ISO 14001:2015 Management Systems

M-Tek UK Ltd are an independent business improvement consultancy based in Scotland but operating throughout the world. We specialize in providing Management Systems to meet the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2017. These can be a stand-alone system to meet the requirements of one standard, or an Integrated Management System (IMS) that combines the requirements of more than ones standard. As well as meeting the requirements of the applicable standard, we firmly believe that the prime requirement is to implement systems that improve the performance of YOUR business.

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We do not supply ‘standard’ solutions. Our approach is that we cannot advise on improvements to your business unless we understand how it currently operates and we have a complete appreciation of the problems and issues that you face.

We are able to provide assistance and advice in a wide range of situations (for industry sector experience go to the About us section), and have taken more than 100 organizations through to certification over the last 15 years.

Have you heard that getting ISO 9001 is a ‘lot of work’ or ‘really difficult’? If so, forget what you’ve heard! Yes, it can be hard, but it definitely doesn’t have to be.

M-Tek UK Ltd can help you develop a Quality Management System (QMS) that will obtain ISO 9001 certification, while also being practical, sensible & simple.

We don’t set up systems with huge, wordy quality manuals and masses of bureaucracy and forms. We can’t stand them and we bet you can’t either!

We deliver a system that works for you not just today, but next week, next month and next year. Not a system that only the consultant understands! If you already have a horrible system or one that’s too complex, we can help you streamline and simplify it.

We find that the majority of successful companies today already have systems in place to control many of their core processes. In today’s competitive environment, if you don’t have this you probably won’t survive. Thus the implementation of a Quality Management System does not mean huge changes in practice. In addition to gaining the prestigious ISO 9001 certification, a good system does deliver a method of measuring and improving the performance of the organization.

The bottom line is more business and increased profits !