Assignment # 2 Construction Quality & Productivity Management

ISO STANDARDS

1. ISO 9000:
ISO 9000 is defined as a set of international standards on quality management and quality
assurance developed to help companies effectively document the quality system elements needed
to maintain an efficient quality system. They are not specific to any one industry and can be
applied to organizations of any size.

ISO 9000 series Quality Management Principles:

The ISO 9000 series are based on seven quality management principles.
The seven quality management principles are:
1) QMP 1 – Customer focus
2) QMP 2 – Leadership
3) QMP 3 – Engagement of people
4) QMP 4 – Process approach
5) QMP 5 – Improvement
6) QMP 6 – Evidence-based decision making
7) QMP 7 – Relationship management

2. ISO 14000:
ISO 14000 is a series of environmental management standards developed and published by the
International Organization for Standardization (ISO) for organizations. The ISO 14000 standards
provide a guideline or framework for organizations that need to systematize and improve their
environmental management efforts.

Basic principles and methodology:

The PDCA cycle
The basic principles of ISO 14001 are based on the well-known Plan-Do-Check-Act (PDCA)
cycle.

Plan: Establish objectives and processes required

1
Assignment # 2 Construction Quality & Productivity Management

Prior to implementing ISO 14001, an initial review or gap analysis of the organization's processes
and products is recommended, to assist in identifying all elements of the current operation and, if
\

possible, future operations, that may interact with the environment, termed "environmental
aspects." Environmental aspects can include both direct, such as those used during
manufacturing, and indirect, such as raw materials.

Do: Implement the processes

During this stage, the organization identifies the resources required and works out those members
of the organization responsible for the EMS' implementation and control. This includes
establishing procedures and processes, although only one documented procedure is specifically
related to operational control.

Check: Measure and monitor the processes and report results

During the "check" stage, performance is monitored and periodically measured to ensure that the
organization's environmental targets and objectives are being met. In addition, internal audits are
conducted at planned intervals to ascertain whether the EMS meets the user's expectations and
whether the processes and procedures are being adequately maintained and monitored.

Act: Take action to improve performance of EMS based on results

After the checking stage, a management review is conducted to ensure that the objectives of the
EMS are being met, the extent to which they are being met, and that communications are being
appropriately managed. Additionally, the review evaluates changing circumstances, such as legal
requirements, in order to make recommendations for further improvement of the system.

3. ISO 13485:
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory
purposes is an International Organization for Standardization (ISO) standard published for the
first time in 1996; it represents the requirements for a comprehensive quality management
system for the design and manufacture of medical devices. This standard supersedes earlier
documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485
(1996 and 2003), and ISO 13488 (also 1996).

Core sections of ISO 13485

2
Assignment # 2 Construction Quality & Productivity Management

ISO 13485 is composed of eight clauses, the first three being introductory references. That leaves
five core sections that constitute the requirements for ISO 13485:2016:

Section 4: Quality management system

This section establishes the general requirements for a quality management system, including
how to document and record information.
Section four requirements,
1) Quality manual
2) Medical device file
3) Control of documents
4) Control of records

Section 5: Management responsibility

This is where the top management will find their responsibility requirements for implementing
and maintaining the QMS.
Section five requirements
1) Management commitment
2) Customer focus
3) Quality policy
4) Quality objectives & QMS planning
5) Responsibility, authority & communication
6) Management review

Section 6: Resource management

This section is relatively short, but it covers everything about resource control and management,
including HR, physical spaces, organizational infrastructure, and the working environment.
Section six requirements
1) Provision of resources
2) Human resources
3) Infrastructure
4) Work environment and contamination control

Section 7: Product realization

3
Assignment # 2 Construction Quality & Productivity Management

Product-specific requirements cover all components of the product (or service) design and
creation of medical devices.

This includes everything from planning and product design, to creating and rolling-out products
and services, to equipment control and servicing.
Section seven requirements:
1) Planning of product realization
2) Suitable planning for the organization’s operations
3) Design and development
4) Purchasing
5) Production and service provision
6) Control of monitoring and measuring equipment

Section 8: Measurement, analysis and improvement

Finally, section eight includes requirements for making sure you can understand how well your
QMS is performing, and have the systems in place to fine-tune and optimize what is or isn’t
working.
Section eight requirements:
1) General
2) Goal of monitoring, measurement, analysis for improvement
3) Analysis of data

4. ISO 19011:
ISO 19011 is an international standard that sets forth guidelines for management
systems auditing. The current version is ISO 19011:2018. It is developed by the International
Organization for Standardization. The standard offers four resources to organizations to "save
time, effort and money":

 A clear explanation of the principles of management systems auditing.

 Guidance on the management of audit programs.
 Guidance on the conduct of internal or external audits.

Guidelines for auditing management systems

4
Assignment # 2 Construction Quality & Productivity Management

a. Scope
This document provides guidance on auditing management systems, including the principles of
auditing, managing an audit programme and conducting management system audits, as well as
guidance on the evaluation of competence of individuals involved in the audit process.

b. Normative references
There are no normative references in this document.
c. Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
 ISO Online browsing platform: available at https://www.iso.org/obp

 IEC Electropedia: available at http://www.electropedia.org/

d. Principles of auditing
Auditing is characterized by reliance on a number of principles. These principles should help to
make the audit an effective and reliable tool in support of management policies and controls, by
providing information on which an organization can act in order to improve its performance.

5. ISO/TS 16949:
ISO/TS 16949 is an ISO technical specification aimed at the development of a quality
management system that provides for continual improvement, emphasizing defect prevention and
the reduction of variation and waste in the automotive industry supply chain. It is based on
the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999

Understanding the principles of continual improvement

The four phases in the Plan-Do-Check-Act Cycle involve:
Plan
Establish objectives and draft your plans (analyse your organization’s current systems, establish
overall objectives, set interim targets for review and develop plans to achieve them).
Do
Implement your plans within a structured
management framework.
Check

5
Assignment # 2 Construction Quality & Productivity Management

Measure and monitor your actual results against your planned objectives.
Act
Correct and improve your plans to meet and exceed your planned results tips on making ISO/TS
16949 work for you.