ISO 9001 in a Nutshell

Requirements for Quality Management Systems - a simple overview of the ISO

9001 Standard
This 'nutshell' version is for the 2008 version of ISO 9001.
4 Overall Requirements for the System
4.1 Establish a quality management system: develop it, implement it and improve it.
4.2 Document the quality management system.
4.2.1 Create documents including a quality policy, objectives, manual, procedures and records
4.2.2 Have a quality manual
4.2.3 Control documents
4.2.4 Create and maintain records of the system.
5 Requirements for Management
5.1 Demonstrate commitment to the quality management system
Communicate the importance of quality
Establish a quality policy and objectives.
Plan and do reviews of the system.
Make available adequate resources.
5.2 Focus on customers
Identify customer requirements.
Aim to enhance customer satisfaction.
5.3 Adopt and use a quality policy
Define a suitable quality policy.
Commit to meeting the system's requirements and to continual improvement.
Communicate and manage the quality policy.
5.4 Plan for quality
5.4.1 Set measurable objectives (aims/goals).
5.4.2 Have plans that are suitable to achieve the objectives
5.5 Define and communicate 'who does what'
5.5.1 Identify who has what responsibility and authority
5.5.2 Have a top manager responsible for the quality system itself
5.5.3 Have effective means of communicating internally.
5.6 Review the quality management system (management review)
5.6.1 Review your system at planned intervals
5.6.2 Include reviews of customer feedback, performance including nonconformity, results of
audits, status of actions, changes and improvements
5.6.3 Record outcomes of these reviews, including actions and decisions.
6 Resource Requirements
6.1 Identify and provide the resources needed to implement, maintain and improve the system,
and enhance customer satisfaction.
6.2 Have suitably competent people
6.2.1 Anyone whose work affects product/service conformity must be competent
6.2.2 Decide what competencies are required, provide and maintain them
6.3 Provide infrastructure: Identify what you need, provide and maintain it.
6.4 Provide the work environment you need for product/service conformity.
7 Requirements for Products or Services
7.1 Plan
Plan and develop the processes you need for your products/services.
7.2 Have effective customer-related processes
7.2.1 Identify requirements that apply to your products/services
7.2.2 Ensure you can supply or deliver before accepting an order
7.2.3 Have effective arrangements to communicate with customers.
7.3 Have effective processes for designing & developing your products/services
7.3.1 Plan design/development.
7.3.2 Define what inputs are needed to design/create/develop
7.3.3 Have a 'design' or plan in a form that enables verification (see 7.3.5)
7.3.4 Review the design/plan at suitable points
7.3.5 Make sure the result meets requirements (verification)
7.3.6 Validate design (where practicable).
7.3.7 If there are changes to design, manage them.
7.4 Control any purchasing of goods, materials or services that affects product/service
conformity; 'purchasing' includes outsourcing and subcontracting
7.4.1 Make sure what you purchase meets the requirements you specified; assess and monitor
the suppliers you use.
7.4.2 Describe what you intend to purchase adequately.
7.4.3 Verify that what is purchased met the requirements.
7.5 Control your operations
7.5.1 Have effective ways to control what you do (providing products/ services)
7.5.2 Validate production/service provision where required.
7.5.3 Identify and track products/services where appropriate
7.5.4 Take care of any property supplied by customers
7.5.5 Care for products/components during storage/delivery, etc.
7.6 Control measuring and monitoring equipment
Identify what monitoring/measuring equipment and processes are needed to obtain valid
results. If equipment is required, choose & use suitable equipment and ensure the results are
and remain accurate.
8 Requirements for Analysis and Improvement
8.1 Have processes that are suitable for ensuring conformity of products/services and the
quality management system, including improvement.
8.2 Monitor and measure to establish whether you achieved the results you planned
8.2.1 Monitor customer satisfaction.
8.2.2 Plan and implement a program of internal audit
8.2.3 Monitor and measure processes appropriately
8.2.4 Monitor and measure products/services at suitable points.
Release final product/service only after requirements have been met.
8.3 Control nonconformity
Identify and control product/service nonconformity with suitable methods, including a procedure.
8.4 Analyse information from your system
Define the information needed to show your system is working and to improve.
Collect, analyse and use the information.
8.5 Continually improve.
8.5.1 Improve your system.
8.5.2 Have a systematic approach to fix nonconformity and stop it recurring.
8.5.3 Have a systematic approach to prevent potential nonconformity from happening.

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From our new employee orientation materials:

What Is ISO?

ISO - International Organization for Standardization.

ISO is based in Geneva and composed of more than

100 member countries, each having a single vote.

The American National Standards Institute (ANSI), is the United States

representative to ISO.

ISO’s objective is to create common standards worldwide.

The ISO Series Standards were released in 1987 and last revised in 2000.

What Is ISO 9001?

The ISO 9001 standard describes the minimum requirements an organization needs
to have in place for a Quality Management System.

A Quality Management System is the organizational structure, responsibilities,

processes, procedures, activities, capabilities, and resources that are needed to
ensure that production and services satisfy requirements or implied needs.

An organization becomes certified to the ISO 9001 standard by developing,

documenting, and effectively implementing their quality system to meet the
requirements of the standard and then successfully completing an audit by a third
party registrar.

What Is your Role?

Every employee plays an important part. Your role in assuring compliance with ISO
9001 may include:

Helping to define where written procedures and/or work instructions are necessary
or beneficial.

Defining and documenting the proper procedures and work instructions to provide
correct, complete, and consistent ways to perform work and maintain high levels of
quality.

Following the quality management system documentation once it is approved and

implemented.

Maintaining complete and accurate records.

Educate and guide others to use the ISO 9001 Quality Management System
correctly.

Identify ways to improve the ISO 9001 Quality Management System.

Suggest ideas for process and quality improvement.

Participate in Internal Quality Audits, answer questions honestly, and provide

information which can help improve our Quality Management System.

Understand the Quality Policy, related objectives, and how you contribute to them.