ISO 9000 &14000 and cGLP 2025

ISO 9000 and ISO 14000 are families of __________.

standards.

ISO 9001:2015 specifies requirements for a __________ management system (QMS).

quality

ISO 14000 is primarily concerned with __________ management.

environmental

Neither ISO 9000 nor ISO 14000 are __________ standards.

product

ISO does not certify companies but provides __________ for management systems.

standards

The seven quality management principles include Customer focus, Leadership, Engagement of people, Process approach, Improvement, Evidence-based decision making, and __________ management.

Relationship

Successful organizations have an ongoing focus on __________.

improvement.

Decisions based on __________ of data and information are more likely to produce desired results.

analysis

The primary focus of quality management is to meet customer requirements and to strive to exceed __________ expectations.

customer

To minimize harmful effects on the __________ caused by its activities is the goal of ISO 14000.

environment.

ISO 14001 requires companies to develop an environmental __________ with a commitment to compliance.

policy

ISO 14000 series includes standards for __________ performance evaluation and life cycle analysis.

environmental

The goal of a quality management system (QMS) is to enhance customer __________.

satisfaction.

ISO 9000 and 14000 standards are implemented by some __________ organizations in 161 countries.

887,770.

The organization must ensure that employees are __________ and capable of carrying out their environmental responsibilities.

trained.

The __________ approach seeks to identify and eliminate major sources of waste.

Lean.

ISO standards are designed to be __________ to any organization, large or small.

generic.

The key benefits of the Process approach include enhanced ability to focus on __________ processes.

key.

The __________ of the organization must be factored in to maintain compliance with legal requirements.

environmental aspects.

ISO 14000 is a series of standards for structuring an organization's __________ management system.

environmental.

The final report of a nonclinical laboratory study must include statistical methods, test article identification, and __________ of all data calculations.

description.

Every aspect of customer interaction provides an opportunity to create more __________ for the customer.

value.

The organization must identify environmental attributes of its products and __________.

activities.

ISO 9001 is implemented by over a million companies, and the standards apply to any organization that needs to demonstrate its ability to consistently provide __________ that meets customer requirements.

product.

ISO standards provide a framework for __________ improvement.

continual.

Tools of Six Sigma include Voice of the Customer (VoC) which measures what value the customer is receiving or __________.

not receiving.

ISO stands for International Organization for __________.

Standardization.

Elements of the ISO-14001 standard require creating a commitment to prevention of __________ and continual improvement.

pollution.

ISO guidelines promote practices to __________ the environment and enhance organizational performance.

improve.

A well-managed supply chain provides a stable flow of __________ and services.

goods.

Key principles of quality management systems are documented in ISO 9000, ISO 9001 and related ISO quality management __________.

standards.

Records must be kept of EMS performance to allow factual __________ making.

decision.

The role of the __________ Assurance Unit includes monitoring studies for compliance with regulations.

Quality.

Utilizing documented information helps ensure effective management of __________ and other system documents.

procedures.