Five Rise Consultancy

The scope briefly explains the purpose of the International Standard, how it is written, and how it should be interpreted. The normative references for this standard are empty.

Terms and definitions will be useful for those unfamiliar with ISO standards and the language frequently employed, however these are not listed in this standard and can be found instead in ISO 9000:2015 (Fundamentals and vocabulary).

Section 4 considers the ‘big picture.’ What are the wider circumstances surrounding your organization and the management of quality there?

Here, the focus is on understanding the nature of your company:

• What do we do?
• What are our strengths and weaknesses?
• How are we affected by external factors, such as the economy or the political environment?
• Who are our interested parties and what are their needs?

Your understanding of company context will facilitate the effective planning, implementation, and maintenance of your quality management system. Why? Because organizational context feeds into the design of your processes, the allocation of responsibilities and authorities for those processes, and monitoring and measurement techniques, just to name a few areas.

In simple terms, without fully understanding your organizational context, your quality management system will be unfit for your company. Quality risks will not be properly addressed meaning some risks may be over-inflated and some may be under-inflated, making the mitigation of quality issues less effective.

There are a range of methods employed by companies to understand the organizational context, and there is no right or wrong method so long as the company context is sufficiently understood. A PESTLE analysis is a commonly employed technique. You can read more about PESTLE analysis by clicking here. We also see our clients using a ‘COTO’ (context of the organization) document which lists internal and external factors, their associated risk-level, and any interested parties affected.

Without the commitment of top management, there will be a lack of leadership and accountability for the establishment, implementation and maintenance of the quality management system. It may also lead to improper or lack of resources allocated to the management system which could lead to major nonconformities. Thus, you need to make sure your top management are committed and are demonstrably so with auditable evidence.

It is key that roles and responsibilities for the management system at all levels are clearly identified. This can be reflected by an organizational chart which is an easily auditable document that can be audited to demonstrate you have met this requirement.

From this, a clear quality policy can be established. This will disclose things like:

• How quality objectives will be set.
• How the objectives will support the company’s wider strategic direction and how it links to company context (section 4).
• A commitment to continuous improvement of the quality management system, often achieved through a plan-do-check-act (PDCA) cycle.

The planning section of the standard, as you can probably guess, is all about planning your quality management system in detail.

To help plan the details of the quality management system it is important to create a means to address risks and opportunities already identified in section 4.

It is also important to plan how wider changes to the organization will impact the quality management system, and mitigation strategies need to be ready to protect the integrity of the management system against these changes. For instance, if a company is expanding at a rapid rate through acquisitions, acquired companies must be quickly brought up to speed with the company’s wider management system if they are to be contained within the scope of the ISO 9001 certificate.

What is meant by ‘support?’ Simply, it is everything that is required to support the quality management system:

• How documented information related to the quality management system, such as a log of nonconforming products, will be controlled.
• Resources needed (such as machinery, software or raw materials).
• The knowledge and skills required by workers.
• The awareness amongst workers of the management system itself.
• How internal and external communication relevant to the management system will be achieved.

The ‘operation’ section is relevant to the day-to-day operation of the quality management system, so to speak.

For instance:

• Determining the requirements for products and services, reviewing these requirements and responding to any changes in these requirements.
• Processes related to design and development planning, inputs, controls, outputs, and changes.
• The machinery is calibrated at the correct intervals.
• Management of suppliers.
• If any functions and processes related to quality are outsourced, these partners must be controlled.
• How will wider changes to the company influence the management system.
• Control of nonconforming products, e.g., the use of a quarantine area within storage space for defective products (either rejected by the company or a customer).

Again, a fairly self-explanatory title! No matter how robust your planning of the management system was prior to the implementation of your quality policy, there will always be areas of improvement as the company and subsequent circumstances evolve over time.

Here, you evaluate how compliant your quality management system has been with the ISO 9001 standard and actions to address any non-conformities. This will need to involve everyone responsible for the management system… that includes you, top management!

Internal audits are a valuable way to measure your compliance with the management system and standard requirements. This can be outsourced to quality professionals (like us) or you can train internal staff so they can perform the internal audits themselves.

And once the evaluation is completed in section 9, corrective action to address any nonconformities is established and put into action. Again, continual improvement is the idea here, getting small details correct over a lengthy period of time after multiple management reviews.

ISO 9001 is the international standard for quality management systems from the international organization for standardization, ISO. It can be applied to any organization no matter the type, size or products and services it provides.

It provides assurance to your customers that you can provide products and services that meet both legal and customer requirements.

Engaging with the standard will enhance customer satisfaction.

You will find it easier to address opportunities and risks to your organization.

Actively advertise your company’s commitment to quality, customer requirements and continual improvement by demonstrating and verifying your compliance to the requirements of ISO 9001:2015. This is a key criterion in convincing potential clients to utilise you.

Increase in profits due to reduced waste and errors.

Efficient Process Management.

Reduction in risk.

Increased sales as new clients are sourced and lost orders are reduced.

More effective management as less time is wasted.

Access to opportunities otherwise restricted to ISO 9001:2015 certified suppliers – a common scenario.

Any organization needing to give assurance to customers that they can provide products and services that meet legal and customer requirements.

Any organization needing to drive improvement. This may sound broad, but improving your quality management has very broad implications for the organization.

Any organization looking to gain / improve their commercial advantage. You will win more work by having an ISO 9001 certified quality management system in place and well maintained.

Yes. It will reduce the cost of poor quality impacting an organization by:

• Getting it right first time.
• Reducing scrap and waste.
• Reducing re-work.
• Facilitating on-time, in full delivery.

Sometimes companies are dissuaded by the initial cost of implementing and maintaining a QMS, but they forget the long-term return that having an effective QMS will generate due to the reasons above, and many more.

Yes, as it is the international standard for quality. It demonstrates compliance with requirements for your product or service.

It gives assurance to your customers that you are meeting legal and customer requirements.

Set up a QMS (quality management system) in your organization according to the requirements of ISO 9001; use a consultant if you need help.

Find a certification body. Check what your industry requires in terms of level of accreditation of said body.

Get audited and achieve certification.

It is based on a plan-do-check-act cycle.

Referring to the contents section available above, plan encompasses sections 4-7, do encompasses section 8, check encompasses section 9, and act encompasses section 10.

It drives continual improvement and is based on seven principles of quality management:

• Engagement of people.
• Customer focus.
• Leadership.
• Process approach.
• Improvement.
• Evidence-based decision making.
• Relationship management.