1. ISO 9001:2008 Quality Management Systems
Management Overview
ISO 9001:2008 Quality Management Systems

2. What is ISO 9001?
ISO 9001 is a quality management system that can be adopted by any kind of organization.
The system is focused on meeting customer require- ments and enhancing customer satisfaction.
The standard has been written in an effort to be adaptable to any kind of business, even service businesses. The main focus of ISO 9001 is meeting customer requirements and ensuring customer satisfaction through continual improvement.

3. What is ISO 9001?
The Quality Management System (QMS) becomes certified to ISO 9001, not the product, process or personnel.
It’s important to remember that our Quality Management SYSTEM becomes certified to ISO, not the product, our processes or our personnel.

4. Monitor, measure and analyze our execution of the plan
What is ISO 9001?
ISO 9001 requires us to:
Plan what we want to do
Follow that plan
Monitor, measure and analyze our execution of the plan
Improve the plan
ISO 9001 is based on the Deming’s PDCA cycle.
Plan Do
Check
Act

5. Why Do We Need ISO 9001?
ISO 9001 provides a system of doing things in a consistent manner in order to be more effective.
ISO 9001 provides managers with a tool that is designed to continually improve their business performance.
A well designed and a well implemented quality management system can and should ELIMINATE:
Ineffectiveness
Inefficiencies
Problems
Errors
Inconsistencies
Uncertainties
Why do we need ISO 9001?
A functional ISO certified system ensures consistent processes which produce consistent results.
ISO 9001 provides the framework for continuous improvement of the business processes
Properly functioning system will eliminate inefficiencies, errors and inconsistencies among other things.
And…customers sometimes require it.
So why do customers require it?

6. Why Customers Want ISO Compliance
Compliance to ISO 9001
demonstrates our ability to consistently provide products meeting customer & regulatory requirements
enhances customer satisfaction through continual improvement and assurance of conformity to their requirements as well as legal requirements
Customers want us to be ISO 9001 compliant because then they know that we have a system in place that will consistently provide products to them that meet their requirements.
They know that we will be striving to continually improve our quality while maintaining conformity to their requirements.
As a strategic decision, it makes sense to choose ISO 9001 certification. Many companies require or at least prefer that their suppliers be certified to the ISO 9001 standard. It opens the door for more opportunity.

7. 8 Quality Management Principles
Customer Focus
Mutually Beneficial Supplier Relationship
Leadership
Quality Management System
Factual Approach to Decision Making
Involvement of People
Continual Improvement
ISO 9001 is also based on 8 Quality Management Principles.
1. Customer Focus: We depend on our customers and therefore we need to understand their current and future needs. We need to meet their requirements and strive to exceed their expectations.
2. Leadership: Leaders establish the direction of the company. Their role is to create and maintain an internal environment in which employees are involved in achieving the company’s goals.
3. Involvement of People: All employees are essential for the success of the company. Their full involvement ensures that their abilities are utilized for the benefit of the company.
4. Process Approach: The process approach is a more efficient method of obtaining desired results because activities and related resources are managed together rather than individually.
5. System Approach: A system is a set of interrelated processes and the output of one process can be the input to one or more subsequent processes, so it is critical to manage the interface between processes to ensure that the overall system is effective.
6. Continual Improvement: Continual improvement of the company’s performance should be a permanent objective. As Mark Twain said, To stand still is to fall behind.
7. Factual Approach to Decision Making: Decisions base on the analysis are more effective.
8. Mutually Beneficial Supplier Relationships: An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Process Approach
System Approach

8. Overview of Auditable Clauses
Now we’re ready to get into the meat and potatoes of the standard. These are the 5 clauses that contain the actual requirements.
We start with Clause 4, Quality Management System which is part of the planning stage in the PDCA cycle. It contains general requirements and documentation requirements.
Control of monitoring and measuring equipment

9. Clause 4 Quality Management System
General Requirements
The organization shall…
Determine the QMS processes
Determine the sequence and interactions
Determine the methods of operations and control
Provide resources to ensure effective operations
Monitor, measure and analyze processes
Improve the effectiveness of the processes
We must determine what our processes are and the sequence and interactions between those processes as well as the methods of operation and control.
We must provide all the necessary resources and monitor, measure and analyze our processes, making improvement based on the results of analysis.

10. Clause 4 Quality Management System
Documentation Requirements
Documentation shall include…
Quality policy
Quality objectives
Quality manual
Procedures required by this standard
Control of documents
Control of records
Control of nonconforming products
Corrective action procedure
Preventive action procedure
Auditing
Documents that we decide are necessary
The earliest versions of ISO required that everything be documented. Since year 2000 version, there are only 6 required documented procedures in addition to a quality manual, objectives and policy.
However, documents that are necessary to ensure the effective planning, operation and control of our processes are also required. We get to decide what needs to be documented and to what extent.
The extent of documentation will be affected by the size of the company, complexity of processes and the competence of employees.
The 6 required documented procedures are control of documents and records, control of nonconforming products, corrective and preventive actions and auditing.

11. Clause 4 Quality Management System
Documentation Requirements
Quality Manual
Scope of our QMS
Reference to our documented procedures
Description of process interactions
Winegard QMS
Quality manual must include the scope of our QMS and details of any exclusions. It also must have a reference to our documented procedures and a description of our process interactions (which can be a diagram).
This is all that is required to be in a quality manual. Many companies write massive quality manuals, but it only needs to include these three items.
Winegard’s Integrated Business/Quality Manual is 20 pages and includes company history, philosophy and guiding principles. It is doubling as a marketing tool. Nothing wrong with that.
Since we are not asking for certification to our QMS for all product lines, we should consider a separate QM for TVRO.

12. Overview of Auditable Clauses
Next is management responsibility. This section on management responsibility is also in the planning stage of the PDCA cycle.
Control of monitoring and measuring equipment

13. Clause 5 Management Responsibility
Top management must:
Be committed to the QMS
Be customer focused
Establish a quality policy
Establish quality objectives
Ensure that the QMS plan is carried out.
Ensure responsibility is assigned and communicated
Provide suitable communication channels
Review the QMS performance
1 – Communicate importance of meeting requirements, establish quality objectives/goals/targets, conduct management review, and ensure the availability of resources
2 – Ensure customer requirements known and met.
3 – Quality policy must be relevant, include commitment to comply to requirements and improve, provide a framework for quality objectives, is communicated and reviewed periodically
4 – Objectives must be measurable and consistent with the quality policy.
5 – The integrity of the QMS must be maintained when changes occur
6 – A management representative must be assigned. This person ensures that processes are established, top management is informed, and all employees are aware of customer requirements
7 – Internal communication must include the effectiveness of the QMS
8 – Review the QMS at planned intervals, assessing opportunities for improvement and the need for changes, including changes to quality policy and objectives.

14. Overview of Remaining Clauses
Resource management covers the provision of resources, human resources, infrastructure and the work environment. Like the previous 2 clauses, resource management is also part of the planning stage of the PDCA cycle.
Control of monitoring and measuring equipment

15. Clause 6 Resource Management
Provision of resources
Human resources
Infrastructure
Work Environment
The company has to determine what resources are required and then provide those resources.
Human resources: Employees must be competent to do the work assigned to them. If the person does not have the necessary skills, we must provide the training to them and evaluate whether the training was effective.
Infrastructure: We are required to determine what infrastructure is needed and it must be provided and maintained.
Work Environment: The environment must meet the needs of the product. For example, lighting must be adequate that the employee can see what they are doing, the temperature and humidity must be in a range that does not affect product conformity, etc.

16. Overview of Remaining Clauses
So we have our QMS in place, management knows what they’re supposed to do, we have our people, buildings, equipment ready in a suitable environment. Let’s start thinking about making something. With this clause, we are still doing some planning but then we will be moving into the Do stage of PDCA cycle.
Control of monitoring and measuring equipment

17. Clause 7 Product Realization
Planning of Product Realization
Customer Related Processes
Design & Development
Purchasing
Production and Service Provision
Control of Monitoring & Measuring Equipment
Think of Product Realization as “Production”. This is the control of our day to day core processes
Planning of product realization is operational planning,
Customer related processes includes handling contracts, enquiries and customer communication systems,
Design and Development controls the steps necessary to design the product,
Purchasing is the management of supplies and suppliers,
Production and Service Provision is operational controls and
Control of Monitoring and Measuring Equipment is calibration.
This clause of the standard is very detailed and requires numerous records to verify conformance to the standard.

18. Overview of Remaining Clauses
This final clause of the standard contains both the check and act stages of the PDCA cycle.
Control of monitoring and measuring equipment

19. Clause 8 Measurement, Analysis and Improvement
Collection and constructive use of data Measure product & process Monitor customer satisfaction Internal audits Control of nonconforming product Analysis of data Corrective / Preventive Action Continuous Improvement
This clause requires that we collect and analyze data in order to show our product actually meets the customer’s requirements and that our quality system actually conforms to our requirements. This is done through inspection and testing, customer satisfaction analysis and internal audits.
We must control and isolate nonconforming product and initiate corrective and preventive actions, all with the object of continuous improvement.

20. Clause 8 Measurement, Analysis and Improvement
Continual Improvement
Quality
Policy
Objectives
Audit
Results
Corrective
Action
Preventive
Management Review
Analysis
of Data
Improvement
Continuous improvement is to be driven by analysis of data, the quality policy and objectives, audit results, corrective and preventive action, and management review.

21. PLAN DO CHECK & ACT Overview of Clauses
In comparing the clauses of the standard to the PDCA cycle, you will notice that clauses 4, 5, and 6 are all 3 in the planning step. Clause 7 is Do, and Clause 8 contains both Check and Act.
This emphasizes the fact that planning is crucial to a company’s success.
CHECK & ACT
Control of monitoring and measuring equipment
PLAN DO

22. Contact: Mary Fox
Ext 827