Quality control ISO-9001

Quality Management & Control

ISO 9001

History

ISO first published its ISO 9001 standard in 1987

published and updated version in 1994

ISO again updated its standard in 2000

ISO 9001 updated its standard in 2008

The newest version is ISO 9001: 2015

In the past, ISO had three sets of quality requirements: ISO 9001, ISO ISO 9002, and ISO 9003. 9003. However, now there’s there’s only one standard: ISO 9001 2015. ISO 9002 and 9003 have been dropped.

What is ISO 9001? ▪

▪

▪

One of the standards within the range of ISO 9000 standards Minimal set of quality standards considered necessary to assure that customer satisfaction is consistently met. Aims to help organisations become structured and efficient.

What is ISO 9000? ▪

▪

▪

▪

▪

A set of universally understood and accepted quality practices which, when well implemented, give customers confidence that suppliers can consistently meet their needs. It requires the organization’s output to meet customer specification. It requires that the quality system is consistently implemented and verifiable. It requires various measurement of the effectiveness of various aspect of the system. It requires continuous improvement of the company’s ability to meet customer needs

Principles of ISO 9001 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision 8. Mutually beneficial supplier relationship

Why implement ISO 9001?

1. Customer pressure – Electronics, pulp and paper,telecommunication, automobile manufacturing, defense – Key part of relationship between customer and supplier

2. Improve operations – Improves customer focus and process orientation within organization – Facilities continuous improvement – Creates consistency throughout organization – Strengthens relationship between suppliers and customers

Who will get benefits from ISO 9001?

Benefits to organisations ▪

Increase in your organization’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 complains

▪

Global recognition – ISO 9001 is a globally recognized quality standard that can open new market opportunities or just maintain current market share. Certification also attracts investment

▪

Employee engagement – ISO 9001 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 organizations

Focus on objectives and customer expectations

Benefits to the customers ▪

Customers get consistent, good quality products and services

▪

Delivery on time

▪

Fewer returned products and complaints

Where? ▪

Up to December 2013, at least 1 129 446 certificates had been issued in 187 countries and economies

▪

The 2013 total represents an increase of 3 % (+32 459) over 2012.

▪

Top three countries for the total number of certificates issued – China, Italy and Germany

▪

Top three for growth in the number of certificates in 2013 – Italy, India and the USA.

Who should apply? ▪

All organizations ( large or small and covers all sectors, including charities and the voluntary sector)

Department of Standards Malaysia (DSM) ▪

▪

The Department of Standards Malaysia (DSM) is mandated by the Government of Malaysia to function as the National Standards Body (NSB) as well as the National Accreditation Body (NAB) through the Standards of Malaysia Act 1996 (Act 549). DSM's vision is 'To lead the Nation to be an effective global player in Standards & Accreditation in consonance with Malaysia's Vision 2020'.

Which accredited certification bodies able to certify ISO 9001 in Malaysia? ▪

Certification bodies which have accreditations from the Department of Standards Malaysia (STANDARDS MALAYSIA) – SIRIM QAS International Sdn Bhd – Intertek Certification International Sdn. Bhd. (formerly known as Moody International Certification (Malaysia) Sdn. Bhd.) – CI International Certification Sdn. Bhd. – SGS (Malaysia) Sdn. Bhd. – TUV NORD (Malaysia) Sdn. Bhd. – Lloyd's Register of Shipping (M) Bhd. – Independent European Certification (M) Sdn. Bhd. – AJA EQS Certification (M) Sdn. Bhd. – Bureau Veritas Certification (Malaysia) Sdn. Bhd. – BM Trada (Malaysia) Sdn. Bhd. – NQA Certification Services (M) Sdn. Bhd. – CARE Certification International (M) Sdn. Bhd – AGM Certification Sdn. Bhd. – KGS Certification Sdn. Bhd. – BSI Services Malaysia Sdn. Bhd.

ISO 9001 certification Process:

Commit to get ISO 9001

Audit the system

Choose an auditor

Appoint an internal project manager

Develop the system

Have the external audit

Create a plan

Get the certificate and maintain

Do a gap analysis

What is the cost of registering ISO 9001 ▪

Many factors affect the cost of registration.

▪

Implementation will cost more if: – Company has more than one location – Company has no quality system now – The company is undergoing significant corporate change (Downsizing, merger/ acquisition, implementing new processes, relocating/ reconfiguring)

▪

Save cost by getting experienced help

 Give some thought to how departments work together. -people in your organization does not work in isolation. Top management commitment is vital if this system is to be introduced successfully. -Make sure senior managers are actively involved, approve resources and agree the key processes of the business.  Good internal communication channels and processes within the organization. -Staff are involved and kep informed of what's going on. Train the staff to carry out the audits of the system. -Auditing help individual's development and understanding.

•

•

•

•

How ISO 9001 are effective for you?

How can you have confidence that your supplier meets ISO 9001? ▪

▪

'Supplier's declaration confomity."-This declaration can be based on your supplier’s internal audit system, or on second party or third party audits. Second party assessment-supplier assessed directly by customer to check if its QMS meets ISO 9001 and your own requirements.

▪

▪

Third party assessment- supplier hires an impartial party to conduct an assessment to verify conformity to ISO9001 requirements. Additional confidence may be derived from the fact that some certification bodies. Many accreditation bodies have multi-lateral arrangements under the umbrella of the International Accreditation Forum (IAF) to promote worldwide mutual recognition in support of World Trade Organization (WTO) free trade principles.