Quality Management: ISO 9001

Benefits of ISO 9001 Quality Management System include:

An ISO 9001 Quality Management System implemented within your organisation can have many benefits:

Increase in your organisation’s performance and productivity – certification improves efficiency through reduction of waste and systematic measurement of performance. Having a robust system in place gives more time to invest in making money
Enhanced customer satisfaction – Customers know what to expect from a quality certified company. ISO 9001 systematically tracks errors and prevents them thus reducing the number of customer complaints
Global recognition – ISO 9001 is a globally recognised quality standard that can open new market opportunities or just maintain current market share. Certification also attracts investment
Employee engagement – ISO 9001 Quality management system encourages communication and increases morale among the employees
Competitive advantage – certification provides an advantage over competitors or the opportunity to compete on the same basis as larger organisations (e.g. ability to tender or submit price quotations)
Focus on objectives and customer expectations – greater emphasis on meeting customer requirements and implied needs through continuous incremental improvement

Key Principles of ISO 9001 Quality Management System

Plan >Do > Check> Act

These 8 principles below are not auditable but they are fundamental attributes of any quality management system. The principles have been taken from ISO 9000:2005 Quality Management Systems – Fundamentals and vocabulary and have served as a basis for the ISO 9001:2008 standard. The 8 principles include:

Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

Plan

The PDCA cycle starts with management because they identify appropriate processes and relevant areas of focus.

Process Identification:

An essential requirement for a practical system is an appropriate process and the key is starting with two processes which are Management and Operations. Next decide if sub-processes are required instead of working “bottom up”. An owner is required for every process who is responsible for the activities that relate to the success criteria of the process.

Planning and Review:

A quality manual and a number of documents outlining procedures are required before implementation in order to successfully plan your quality system. The areas of documentation are:

Document control
Records control
Internal audits
Non – conforming product
Corrective action
Preventative action

Fundamental direction:

The fundamental direction of the QMS should be established by owners or managers of your organisation using the quality policy. When designing the Quality Policy there are several aspects that have to be thought through such as:

Strategy – should follow from the Quality Policy and the business environment
Process criteria – should be aligned to the strategy
Customer focus – system processes have to be designed to ensure customer satisfaction
Resources – human, technological and environmental resources have to be put in place. The QMS requires that each company establish a way that their staff are competent

Do:

The system has to be used to see that it works the way it was intended to. It will be necessary to use the procedures, forms, equipment and instructions in the way it was planned. This part of the process should be fairly easy to implement with the direction from your management and the assigned resources. It is important that the processes all along the supply chain should be planned and defined. This might include:

Sales
Purchasing
Research and Development
Manufacturing
Delivery

Some of the steps might not apply to your organisation as ISO 9001 certification is designed for every type of organisation.

Check

The results of the QMS should be reviewed at appropriate intervals. When the system is new the intervals will be short but can be longer once the QMS becomes mature. The reporting of results against the process success criteria should be done regularly and then be used by management to ensure that the business is on track. The records should be appropriately designed to facilitate prompt recording as well as the early detection of problems.

The management review is a key milestone in evaluating the QMS and it is a meeting which assesses whether the QMS has succeeded in meeting:

Strategic objectives
Process success criteria
ISO 9001 requirements

A key metric that has to be reviewed is perceived customer satisfaction. Handling complaints is not enough as customers could just move their businesses to a competitor. Internal audits are probably the most important characteristic of a successful quality management system. If an organisation does not carry out internal audits it is likely that the organisation will have their certification revoked as their system is probably out of control.

Act

Corrective action or preferably preventative action can be used to tackle challenges. Corrective actions must be recorded and preventative actions should be designed for recurring problems. The following questions should be asked as a checklist:

Customer focus – Have you found out what the customer’s current and future need and expectations are at a strategic level?
Quality policy – Does it really suit your organisation and reflect your customer’s expectations, your vision and mission – and the requirements of the standard?
Objectives – Are all the objectives measurable and linked to both the processes and to the strategies?
Plan the system – Have all the responsibilities been identified and communicated? Does everyone know what they need to do to contribute to the success of the business – and the QMS?
Review at regular intervals – Are the results of the QMS being reviewed and compared against planned results? Is action being taken to improve areas where results are not quite as good as planned?
Principles – Management should review the 8 principles mentioned earlier and how well the system delivers against these

Key steps to getting certified for ISO 9001 Quality Management System

In order to get certified for ISO 9001 Quality Management System there are a number of steps involved:

Applying

The first step involves the application for certification

Gap Assessment

This is where:

An on-site analysis of your current system is conducted
This will then be assessed against the standard
A report is then prepared to highlight the gaps between your current system and the standard

The gap assessment is optional and is not required for the certification process.

Preliminary Assessment – Stage 1

Your documentation has to be inspected and various areas have to be reviewed including:

The proposed scope of your registration
The status of implementation of your management system
The appropriate regulatory and legal requirements
Your management policies and objectives
Whether the system addresses the key areas of your business
Your site-specific activities – top level process review
Your key management elements, e.g. internal audits, reviews and complaints procedures
Your readiness to move onto Stage 2 of the assessment, the Registration Assessment

There should be a period of several weeks between preliminary assessment and registration assessment so that any issues can be sorted in relation to the preliminary assessment. If there are major non-conformities a second preliminary assessment will have to be carried out.

Registration Assessment – Stage 2

This involves a full review of your management system in order to confirm that your management system is controlled. When the registration assessment is complete a notified body issues a detailed report along with the outcome which recommends registration or not. If any issues arise during the assessment you will be expected to submit an action plan which should describe what changes are to be made to the management system in order to reduce or eliminate the risk of the same issues occurring again.

Surveillance & Re-assessment

A notified body visits each company at least once a year to make sure the management system is being maintained and that it is achieving it’s expected outcomes. A part of the management system is reviewed in depth during each visit.

There is an expiry date on the certificate and the certificate expires every three years. Before the expiry date occurs a detailed assessment of the whole management system is undertaken to ensure every element of the system is performing satisfactorily and the results of the previous visits are taken into account.

During the registration period, changes are inevitable. In order to make sure the management system remains sound the notified body works with each registered organisation . Usually change can be reviewed and assessed during routine surveillance visits. The notified body reserves the right to suspend or revoke certification in cases where change leads to the breakdown of the system