What is ISO9001:2015

ISO 9001 is the most well-known standard ever and is implemented by more than a million organisations in some 175 countries.

ISO 9001 is a genericstandard.

It means that the same standards can be applied:

• to any organisation, large or small, whatever its product or service.
• It can be any sector of business, whether it is a business enterprise, a public administration, or a government department.

ISO 9001:2015 is the internationally recognised quality management system for structuring an organisation to improve business efficiency and increase customer satisfaction.

ISO 9001 gives your customers the assurance that systems are continually assessed and approved. The certification of ISO 9001 will contribute to increased revenue and market share.

ISO standards generate an excellent contribution to the quality world. ISO standards enhance investment, propagate knowledge, support innovative developments in technology, and develop management and conformity assessment practices.

This International Standard ISO 9001 is based on seven Quality Management Principles.

---

The Quality Management Principles are:

Customer Focus

Good Customer Service Is Vital

Generally, every person who makes a complaint would share their displeasure with around 20 others, or so the saying goes.

Technology and smartphones allow virtually instant news and updates at our fingertips. For example, suggestions for dining out or entertainment, and the likes of TripAdvisor where users can post their opinion, reviews or complaints, and others can read it.

So, depending on the complainant, displeasure may meet the attention of more than 20 — many, many more.

Imagine a celebrity blogger with millions of followers, who experienced disappointment with your product or service, then wrote a negative article or produced a vlog (video blog) about their experience with your product. Possibly, irreversible damage in an instant.

One prime example was United Airways. Their baggage handlers broke a guitar belonging to a celebrity singer. After his efforts failed to gain any remuneration or even flight vouchers to the value of the repairs, he wrote a song about his experience. This song led to millions of views, and people were boycotting United Airlines.

It is therefore critical that we manage complaints quickly and professionally when we work in any industry, especially in quality-driven manufacturing sectors.

Get a free quote

How does ISO Certification help?

ISO standards communicate to us that a company is benefiting from extra engagement and support with their customers by understanding their customers’ needs and expectations. Engaging with the customer is one of the core principles of the ISO 9001 Quality Management System.

ISO9001:2015 is the internationally recognised quality management system for structuring an organisation to improve business efficiency and increase customer satisfaction. Therefore, gaining an ISO accreditation gives your customers assurance that your procedures and processes are continually assessed and approved, and your business operates with customer service as a fundamental principle. 

Leadership

Leadership is an important skill to motivate a group of individuals towards a common goal. Stable leadership is vital for the success of businesses. World’s most respected leaders have common qualities. Quality of shared vision is the most recognisable trait of all of them. Also,  initiate change, inspire a shared vision and encourage the team’s behaviours that are necessary to achieve the shared ideas. Good leaders are confident to empower others to commit and thrive.

A person or group of individuals, who lead the organisation at the highest level towards the common goal is called “Top management”.

The Quality Policy

Top management shall create, implement and maintain a quality policy:

• appropriate to the context of the organisation and supports its strategic direction;
• provides a framework for setting quality objectives;
• includes a commitment to satisfy applicable requirements;
• Consists of assurance to continual improvement of the system
  

The quality policy shall:

• be accessible and be maintained as documented information;
• be communicated, applied and understood within the organisation;
• be available to relevant appropriate interested parties, as necessary.

Roles and Responsibilities

Top management shall allocate the responsibility and authority to:

• Ensure that the processes are delivering their planned outputs;
• Determine opportunities for Improvement;
• Communicate the importance of customer focus to everyone;
• When planning ad implementing changes to the quality management system ensure that the integrity of the quality management system is maintained

Top management shall evaluate the organisation’s quality management system, at strategic intervals, to ensure its continuing suitability, capability, effectiveness and alignment with the strategic direction of the organisation.

Engagement of People

Engaging people means teams are committed and motivated towards the organisation’s goals and values. An engaged team experiences job satisfaction and feelings of empowerment and will contribute more towards growth.

• Engaging people means employees are satisfied and dedicated to their organisation’s goals, missions and strategy. Happy employees play a significant role in your organisation, as ambassadors of the company.
• Engaged employees are often top performers, their absenteeism lowers, leading to increased productivity and would ‘go the extra mile’ to accomplish business success.
• Engaged and satisfied employees will become more loyal. Therefore, more likely to stay with the organisation for longer resulting in less turnover of staff.
• Engaged employees bring passion to their job, which leads to innovation in the workplace and efficiently makes a great effort to create new products, services and processes.
• Engaged employees become more productive and efficient, positively affecting the organisations’ bottom line. Therefore, incline to have higher profits by lowering operating costs and increasing the profit margin.

---

Process Approach

Processes are dynamic-they cause things to happen. A structured process helps to accomplish any objective efficiently and effectively. It helps to define the required steps essential to obtain desired outcomes. It helps to establish clear responsibility and accountability for managing key activities. It helps to monitor, measure and evaluate risks of the process.  It helps to focus effort on critical processes and opportunities for improvement.

All processes and the Quality Management System (ISO 9001:2015) can apply Plan, do, check, Act (PDCA).

Briefly,  the description of PDCA is as follows:

Plan:  Plan the objectives of the system and its processes, and the resources required to deliver results by tracking customers’ requirements and the organisation’s policies;
Do:  Implement the  plan;
Check:  Monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and analyse the outcomes;
Act: Take actions to improve performance, as required.

Improvement

The organisation should have a consistent approach to development on the road to growth. The organisation should provide team training to improve their abilities and should work towards the development of products, processes, and systems.

Evidence-based Decision-making

“Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.” Evidence is information that shows or proves that something is true or false. Evidence should consist of observations, measurements and tests. Decision making should be evidence-based. The organisation should ensure that information is sufficiently accurate and reliable and accessible to those who need them. The organisation should use appropriate tools to make decisions based on evidence of data, together with experience.

---

Relationship Management

“For sustained success, organisations manage their relationships with interested parties, such as suppliers. “An interested party is a person or group that has a stake in the success or performance of an organisation. 
Interested parties can be from inside or outside of the organisation. Examples of interested parties include customers, suppliers, partners, owners, employees, unions, bankers, or members of the community. Interested parties are also known as stakeholders. Managing relations with interested parties means sharing knowledge, vision and values. The organisation establishes a relationship that balance short-term gains with long term considerations. The organisations need to determine the needs and expectations of interested parties.

Understanding the Organisation and its Context

The organisation shall determine internal and external issues appropriate to its planned path and what can affect to accomplish the intended result(s). The organisation shall monitor and review information about these external and internal issues. Issues can be positive or negative factors.

External issues that exist outside of the organisation that can affect the organisation’s ability to achieve sustained success. e.g. statutory and regulatory requirements, competition, social, economic, political and cultural factors etc.

Internal issues that exist within the organisation itself that can affect the organisation’s ability to achieve sustained success. e.g. size and complexity, strategy, type of products and services, resources etc.

---

Internal Audits

An audit is a systematic examination of statutory records and documents to ascertain how far the system/process present an accurate and fair view of the concern.
The organisation shall conduct internal audits at strategic intervals to provide evidence that the Quality Management System is efficiently implemented and maintained and conforms to the organisation’s requirements for its quality management system. The organisation should take necessary corrective actions without unjustifiable delay and retain documented information as proof of the completing of the audit programme and the audit results.

Nonconformity and Corrective action

Nonconformity

Nonconformity in the management system (occasionally referred to as a fault/failure) is a deviation from an ISO standard, a requirement, or a result. In other words, any failure to meet a condition/requirement is called nonconformity — i.e. Failure to follow a procedure.

There two types of nonconformities. Major Nonconformance and Minor Nonconformance

A Major Nonconformance also referred to as NC is an absence of a procedure in your Quality Management System, therefore not the ISO 9001 requirements. For example: not implementing a part of the standard or a process.  

A Minor Nonconformance is an occurrence which does not meet the ISO 9001 requirements but does not have any significant consequences. i.e. a single incident of not having proper paperwork for inspecting equipment.

There are various common fundamentals between ISO 9001, ISO 14001, ISO 45001 and ISO 27001. E.g. Document control, management review, , corrective action and the requirement for competent personnel. According to Annex SL, a new high-level structure, you can combine these standards into a single joint system.

Benefits of Integrated Management Systems

• Integrated Management Systems will have a constructive impact on the outcomes of the ISO Management Systems.
• will be able to align common components of management system standards. E.g. policies, objectives, processes and resources. Also, you may be able to have a single procedure for, document control, management reviews, training, internal audits or improvements.
• Maintaining the system will become easy to understand. Therefore, there will be more focus on achieving objectives that are central to the organisation.
• Organisations will be able to have a systematic approach to changes. Therefore, decision making will be more comfortable.
• Organisations will be able to conduct integrated audits and assessments. Therefore, optimise processes and resources. And will result in less interruption and thus decrease costs.
• Resources will focus on process implementation and add value rather than additional system maintenance.
• Will require less maintenance for continuing compliance checks to ensure that you are maintaining the management system standards requirements. Therefore, there will be more focus on improvements rather than maintaining multiple systems.

What is Annex SL?

Annex SL a new high-level structure for all ISO Management System Standards in future.

Annex SL is not an ISO standard. However, it is a guide to help  ISO consultants and organisations to implement multiple/integrated (MMS/IMS) Management Systems Standards. Over the years, ISO has published several management system standards for areas of quality, environment, information security, health and safety and many more.  ISO management system standards share common fundamentals. However, they are not sufficiently aligned, so they were difficult to integrate at the implementation phase. The most significant disadvantage was the duplication of work. The guideline of Annex SL will help you to create a system that entails less maintenance and resources, e.g. producing one document or process instead of many.

“It is the publication of Annex SL (formerly ISO Guide 83) which outlines the framework for a generic management system. All new ISO Management System Standards (MSS) will follow to this framework, and all current MSS will migrate to the structure at their succeeding revision.

In future, all ISO Management System Standards (MSS) should be consistent and compatible - they will all have the same look and feel. Annex SL guidelines could be the commencement of the end of the conflicts, duplication, confusion and misunderstanding arising from slightly different requirements across the various ISO Management System Standards.”

Reference IRCA briefing note Annex SL

Annex SL (a high-level structure ) is created to incorporate more than one ISO standard. Several organisations seek to implement and certify multiple management system standards such as ISO 9001, ISO 14001, ISO 27001 and ISO 45001. Implementation of more than one standard has led to the necessity to combine or integrate them effectively and efficiently. Annex SL (a high-level structure ) helps the organisations to incorporate these standards. Annex SL defines the outline for a conventional ISO Management System.

The Annex SL structure and commonly used terms and definitions will make it easier to comply with and maintain the ISO standards requirements with less time and at a lower cost.
The most popular standards using Annex SL are:

• ISO 9001:2015 Quality Management System (QMS)
• ISO 14001:2015 Environmental Management System (EMS)
• ISO 27001 Information technology Management System (ISMS)
• ISO 45001:2018 Occupational Health & Safety Management System Standard (OHSMS)

At Forefront, we believe that certification should add value to your organisation. We are not merely offering a compliance audit, however, by also maintaining a commitment to impartiality, we will dedicate our expertise towards your business, so you feel your accomplishment of achieving certification means something and not just a badge on the wall.

At Forefront, we commit to fixed daily rates with no hidden fees. However, we calculate the number of days according to the UKAS specified guidelines which depend on the scope (What exactly you do) and the size of the organisation (e.g. the number of employees and number of shifts and sites).