ISO Introductory Awareness Training

ISO Introductory Awareness Training

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ISO awarenessISO awareness

Introduction

Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction.

A quality management system gives your organisation the framework they need to monitor and improve performance in any areas you choose.

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What is ISO

The ISO series of standards are the international standard for Quality Management , environmental & other management Systems

ISO is the “International Standards Organisation” based in Geneva, Switzerland with over 100 member countries. Their Technical Committees define internationally recognised standards for goods and services.

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ISO 9001 is by far the world’s most established quality framework, currently being used by around 897,000 organizations in 170 countries worldwide, and sets the standard not only for quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.



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Discover ISO

In 1946, delegates from 25 countries met in London and decided to create a new international organization, of which the object would be "to facilitate the international coordination and unification of industrial standards".

The new organization, ISO, officially began operations on 23 February 1947, in Geneva, Switzerland.


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ISO

"ISO" is a word, derived from the Greek isos, meaning "equal.”

ISO an acronym -International Organization for Standardization


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Global market

With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring imports meet internationally recognized levels of performance and safety.


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Purpose

ISO's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.


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Categorization

Standards can be broadly sub-divided into three categories, namely product, process and management system standards.

The first refers to characteristics related to quality and safety for example.

Process standards refer to the conditions under which products and services are to be produced, packaged or refined.


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Categorization - Continue

Management system standards assist organizations to manage their operations.

They are often used to help create a framework that then allows the organization to consistently achieve the requirements that are set out in product and process standards.

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ISO 9000 Series of Standards

ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.

ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.

ISO 9004 – Guidelines for performance improvement


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The benefits of implementing an ISO management system

Standards make an enormous and positive contribution to most aspects of our lives.


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The benefits of implementing ISO 9001

When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor quality, do not fit, are incompatible with equipment that we already have, are unreliable or dangerous.


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The benefits of implementing ISO 9001Continue

Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted. From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints. Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities.


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Why seek certification to ISO 9001?

Registration to ISO 9001 by certification body shows committed to quality, customers, and a willingness to work towards improving efficiency.

It demonstrates the existence of an effective quality management system that satisfies the rigours of an independent, external audit.


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An ISO 9001 certificate enhances company image in the eyes of customers, employees and shareholders alike.

It also gives a competitive edge to an organisation's marketing.

Why seek certification to ISO 9001?


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How do you start to implement ISO 9001? What is involved?

Planning & designing

Describing

Implementing

Improving


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How do you start to implement ISO 9001? What is involved?

Establish quality objectives and how they fit in to the operation of the business.

Identify the requirements of ISO 9001 and how they apply to the business involved.


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Produce a documented quality policy indicating how these requirements are satisfied.

Communicate them throughout the organisation.

How do you start to implement ISO 9001? What is involved? Continue


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Evaluate the quality policy, its stated objectives and then prioritise requirements to ensure they are met.

Identify the boundaries of the management system and produce documented procedures as required.



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Ensure these procedures are suitable and adhered to.

Once developed, internal audits are needed to ensure the system carries on working.



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STANDARD - ISO 9001 OR SIMILAR

QUALITY MANUALPolicy, objectives, organisation,outline of quality system

PROCESS DOCUMENTSAND PROCEDURES

INSTRUCTIONS

FORMS

Processes,practices,responsibilities,interfaces

Detailed instructionson how to carry out specific tasks

Qualityrecords

Design IT Support Installation Training

TYPICAL QMS STRUCTURETYPICAL QMS STRUCTURE

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REQUIREMENTS OF ISO 9001

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ISO awarenessISO awarenessREQUIREMENTS OF ISO 9001

4.1

The organisation shall establish, document, implement maintain

and continually improve a Quality Management System

4.2.2

A Quality Manual shall be established containing details of the

Quality Management System

4.2.3

Documents shall be controlled

4.2.4

Records shall be controlled

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REQUIREMENTS OF ISO 9001 (cont).

5.1 Management shall demonstrate commitment to the Quality

Management System 5.2 The organisation shall focus on the needs of the Customer 5.3 A formal Quality Policy shall be established by Top Management and communicated to all staff 5.4.1 Quality Objectives shall be set

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5.5.2 A Quality Representative of sufficient seniority must be appointed from within the organisation to administer the Quality Management System 5.5.3 Quality objectives shall be communicated to all staff 5.6 A periodic review shall held of the Quality Management System

and decisions actioned 6 Sufficient resources shall be provided

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6.2 Personnel shall be trained and competent 6.3, 6.4 Facilities and the work environment shall be appropriate

and properly maintained 7.1 The product realisation process shall be planned 7.2 Customer requirements shall be determined 7.2.3 Communication with Customers shall be maintained 7.3 The design and development process shall be controlled

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REQUIREMENTS OF ISO 9001(cont). 7.4 Purchasing and the receipt of purchased goods and services shall be controlled 7.5 Operations and their verification shall be planned and controlled 7.5.3 All work must be traceable (if required) and its status shall be identifiable at all stages 7.5.4 Customer property shall be properly cared for 7.6 Measuring and monitoring devices shall be calibrated and maintained 8.1 Quality performance data shall be identified 8.2.1 Customer satisfaction shall be determined

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REQUIREMENTS OF ISO 9001 (cont). 8.2.2 Internal audits of the Quality Management System shall be carried out 8.2.3 Operations processes and the product/service shall be monitored for

effectiveness 8.3 Non-conformance shall be controlled and corrected 8.4 Quality performance data shall be collected and analysed 8.5 Corrective and Preventive actions shall be determined and implemented in order to continually improve the Quality Management System.

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ROLE OF QUALITY REPRESENTATIVE Ensuring that the processes needed for the Quality Management System are implemented and maintained;

Reporting to Top Management on the effectiveness of the Quality Management System and the need for improvement;

Ensuring that the importance of meeting Customer requirements is communicated throughout the organisation It follows, therefore that the Quality Representative must be a member of the senior management team in whom the Chief Executive has confidence.

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SIGNIFICANCE OF MANAGEMENT REVIEW The Management Review meeting is the core of the whole process. It must be held regularly and must review: Quality policy and objectives Improvement Non-conformance and customer complaints Corrective and preventive action Internal and external audits. Planning and future resource requirements Training Supplier performance Customer satisfaction

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Chairing a meeting

Agenda – List of things to be discussed.

Minutes – Record of decisions taken and actions delegated.

Circulate agenda and other papers to all attendees in plenty of time for the meeting.

Get items of Any Other Business notified to yourself before the meeting.

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Chairing a meeting - Continue

Ensure all items on agenda discussed and decisions minuted

Try to make sure everyone has their say

Try to make sure no one (including yourself) dominates the discussion

Manage time so as not to overrun (it is a review meeting)

Ensure one person is responsible for each action agreed and that they report progress back to the next meeting

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Setting (SMART) objectives and measuring performance Identify Key Performance Indicators (KPIs) Set measurable targets Collect information and compare with target Initiate action if targets not met Review targets (suitability, practicality)

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SMART Objectives

Specific

Measurable

Agreed

Realistic

Time Oriented

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ISO awarenessISO awarenessCONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Clause 5

Clause 6 Clause 8

Clause 7

Service/Productrealization

Output

Customers

Satisfaction

Service

Product

Resource

Management

Measurement, analysis and improvement

Management responsibility

Customers

InputRequirements

Value adding activitiesInformation flow

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Continual Improvement It is a requirement that the Quality Management System be continually improved Improvements can be made to any of the Company’s activities:

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Continual Improvement - Continue

Customer requirements Design Planning Procurement Process control Storage, shipping, handling Internal and external communications, customer relations Documentation and records Software Facilities and equipment Recruitment, retention, training, personal development Etc. etc. etc.

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Continual Improvement - Continue

Initiatives for improvement can come from: Feedback from Customers Feedback from staff Evaluation of the competition Questionnaires or surveys Review of equipment in use, including down time Review of processes/procedures Costs (direct, indirect, rework, warranty, purchasing) Non-conformance/complaint levels On-time performance Internal and external audit reports Etc. etc. etc.

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SIGNIFICANCE OF INTERNAL QUALITY AUDITS Internal Quality Audits must be held regularly to ensure that:

The organisation remains compliant with the ISO 9001 standard The procedures are being followed The written procedures are correct and meeting the requirements of

the Organisation Areas for improvement are identified Management receives accurate and unbiased information for decision making

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WHAT IS AN AUDIT? An audit is the planned and systematic examination of the written procedures and comparison of these with the actual procedures in use. An audit is the search for objective evidence to prove that the requirements or procedures are being complied with. Objective evidence is obtained by the examination of records and other documents, interviews, physical observation.

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CHARACTERISTICS OF AN AUDIT

Audits should be :-

Formalised and official

Regular

Systematic

Objective

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SELECTION OF AUDITORS Auditors should be :-

Prepared, Open minded, Analytical, Patient , Industrious,

Human, Unbiased,Trained Auditors must not audit their own area of responsibility Auditors must have the authority and the time to carry out audits

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STRUCTURE OF AN AUDIT Planning Preparation Carrying it out Agreeing action Reporting Follow up (close out)

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PLANNING Responsibility of the Quality Representative to: Plan to allow for each element of the Quality Management System to be audited at least annually. Plan to spread auditing evenly throughout the year. Published and circulate the plan.

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PREPARATION FOR AUDIT Always use a checklist based on the area to be audited. Obtain copies of any previous internal or external audit reports. Give the personnel involved prior warning of the audit (but always remember, you are auditing the procedure, not the person).

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PREPARATION OF CHECKLIST Study the procedure to see:

Who is involved.What documents are involved and where are they kept.What are the essentials of the procedure and what is mere comment.

Make a list of: The people you want to see. The size and nature of the evidence you want to seek.

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CARRYING OUT AN AUDIT

Check that all personnel are familiar with the procedure.

Observe what actually occurs.

Ask questions and verify the answers (“Show me please”).

Verify corrective action resulting from previous audits.

Be prepared to depart from the checklist (Do not be afraid to “look over the fence” at other activities).

Take detailed notes on your checklist (objective evidence).

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CARRYING OUT AN AUDIT (cont.)

Determine the significance of any non-conformances.

Do not go out of your way to find non-conformances

Try to assess the effectiveness of the procedure (does it meet Company requirements).

Be alert to any procedure/process improvements that can be made.

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BEING AUDITED Cooperate with the Auditor, be open and honest. It is the Procedure that is being audited (not you). Accompany the Auditor at all times and ensure his or her safety. Have the necessary documents to hand (you should always receive warning of the audit).

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BEING AUDITED - Continue

Do not take offence at “silly” questions or if any non-conformances are detected. Be prepared to discuss and challenge the findings but do not get involved in an argument (escalate to the Quality Representative if necessary). Correct any non-conformances promptly.

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CATEGORIES OF NON CONFORMANCE

Category 1 - Major non conformances

Category 2 - Minor non conformances

Category 3 - Observations

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AGREE ACTION Agree with the person responsible that a non-conformance exists. Specify what quality requirement has been breached. Agree on the corrective action (by whom and by when). Try and agree preventive action. In case of disagreement, refer problem to the Quality Representative.

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PREVENTIVE ACTION May not be possible to agree during the audit Always has longer term implications. May require additional resources or management approval. May involve other departments/functions. May require additional research. Quality Representative may need to take to Management Review.

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REPORTING Complete the Internal Audit Report (for each audit). Submit to the Quality Representative for comment and further action if necessary. Have available for reporting to the Management Review Meeting.

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FOLLOW-UP (CLOSE-OUT) After the agreed time for the implementation of corrective action: Re-visit the area where the non-conformance was detected. Ensure that the corrective action has been completed within the agreed timescale. Ensure that the preventive action is effective (or is on the agenda of the next Management Review Meeting). Report close-out to the Quality Representative.

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UNSCHEDULED AUDITS Audits may be carried out at times other than those scheduled in the audit plan If preventive action needs to be verified. If a problem with a procedure is suspected. To confirm that a newly introduced procedure is working satisfactorily. If a problem is suspected with a Supplier.