5. QUALITY SYSTEMS IN LABORATORY

ISO stand for

• International Standardization for organization

• International Organization for Standardization

• International Standard Operation

• International Of Standard

Choose correct statement for ISO.

• Develop Malaysia Standards, such as MS 45001

• Involved in organization certification, and issue certificates

• Has produced a number of standards related to the certification process, which are used by certification bodies

• ISO certified by organization

Choose the correct name for the ISO 9000 series.

• ISO 9001 Quality management systems—Evaluation

• ISO 9004 Quality management systems - Products

• ISO 9000 Quality management systems—Findings

• ISO 9001 Quality management systems—Requirements

Which of the following statement is not true about ISO 9001:2015 certification.

• All size of organization can apply for the certification.

• Only manufacturing company can apply.

• It is NOT a membership group

• It is NOT a standard for products

Choose the incorrect statement for ISO 9001:2015.

• A requirement when organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements

• Aims to enhance customer satisfaction.

• Assurance of conformity to customer and applicable statutory and regulatory requirements.

• Provide safe workplace for worker.

Which is not the element of ISO 9001:2015

• Relationship management

• Process approach

• Safety and health

• Leadership

Which of the following is not the scope of ISO 17025?

• Sampling

• Testing

• Calibration

• Maintenance

Choose the correct statement for ISO/IEC 17021.

• Conformity assessment — Requirements for accreditation bodies

• A certification body must be government agencies.

• Provides Certification Bodies (CB) with a set of requirements that will enable them to ensure that their management system certification process is carried out in a competent, consistent and impartial manner

• Was publish by Jabatan Standard Malysia (JSM)

Choose correct statement for ISO 17065

• Requirements for bodies certifying products only.

• Certification bodies operating to this International Standard have to offer all types of products, processes and services certification.

• Certification bodies operating to this International Standard must be non government organization.

• Requirements for the competence, consistent operation and impartiality of product, process and service certification bodies

MS 1514 : 2009 refer to

• GMP for Cosmetics

• GMP for Pharmaceutical products

• GMP for food products

• GMP for rubber products