ISO 9001:2015

Quality Management System

New standard is introduced with new “Annex SL” and “High Level Structure” in ISO 9001:2015 standard. ISO new version main objective is to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services and to enhance customer satisfaction.

New ISO 9001:2015 standard characterize a technical revision compared to 2008 edition. It also adopts revised clause sequence, quality management principles and addition of new concepts.

Some concepts introduced in new standard are:

• Integration of Risk Management

• Resource Management

• Systematic problem solving and learning

• Voice of the customer

• Knowledge management

• Measures (examples are performance, satisfaction and ROI.)

Major Changes in ISO 9001:2015

• High Level Structure is used in text writing (i.e. clause sequence, common text and terminology). New clause sequence is adopted in new version which is consistent with Annex SL, highlighted in main body of the text (clause 1 to 10).

• No specific reference and text for possible exclusions of requirements

• No specific requirement and text for documented procedures and records. Both have been replaced throughout by the text documented information.

• Role of Management Representative has been Now the activities of Management Representative should be performed by one of group of Senior Management.

• No mention of a Quality Manual in new ISO 9001:2015 Standard.

• Quality policy / objectives shall be compatible with strategic direction.

• Integration of QMS requirements into business processes.

• Change of tem product to product and services. New term include all output categories i.e. hardware, services, software and processed materials

• Organization needs to determine the knowledge necessary for the operation of the QMS and its processes and to achieve conformity of process

• Risk-based thinking introduced in all clauses for all processes.

• Organization needs to determine the risks to conformity of goods and services and to customer satisfaction and opportunities in place of preventive action.

BENEFITS OF ISO 9001:2015

• Realize organizational policy and objectives

• Provide confidence to existing and potential customers

• Enhance customer satisfaction

• Continually monitor and improve performance

• Proactive and systematic alignment to changing market conditions

• Achieve consistency and stability in processes

• Reduce dependencies of results on people and rather improve focus on processes

• Prevention of errors instead correction