This handout contains definitions of key terms and a summary of the main points of ISO 9001:2015 Employee Training.
Quality Management System (QMS)
Our QMS is a structured method for top management to control and improve our company’s ability to meet requirements.
The QMS includes:
- understanding customer requirements;
- providing services, fulfilling contracts;
- fixing problems and the causes of those problems;
- monitoring and measuring our products and services;
- hiring and training people;
- maintaining equipment;
- having a standard approach; and
- keeping records.
ISO 9001 is a document that is a structured improvement program – an ongoing process of
- measuring company performance.
- updating or improving business processes, and
- seeing what impact changes have on overall company performance.
An audit verifies that our company is meeting ISO requirements. An audit verifies the effectiveness of our QMS. The auditor will compare what we planned with what is actually happening.
Our Quality Policy is a brief statement of our intention to meet ISO requirements and to continuously improve. Our Quality Policy is provided in Exhibit 1.
An auditor may ask you about our Quality Policy. Questions may include “what is your Quality Policy” and/or “how do you apply it?”
If an auditor asks you about our Quality Policy you could say something like, “I apply our Quality Policy as I do my job. I apply the Quality Policy as required. I am always looking for ways to improve our performance in order to enhance customer satisfaction and achieve our objectives.”
Our organization established quality objectives at the relevant functions, levels, and processes needed for the quality management system. Our quality objectives are:
- consistent with our Quality Policy,
- compliant with applicable requirements,
- relevant to conformity of products and services and to the enhancement of customer satisfaction,
- communicated, and
- updated as appropriate.
Our quality objectives are provided in Exhibit 2.
Exhibit 2: Our Quality Objectives
|Quality Objective||Target||Relevant Areas, Functions, or Departments|
|Achieve Compliance||Time Reporting, Administrative Onboarding||All Employees (Time Reporting), Executive Office Operations (Administrative Onboarding)|
|Maintain Client Satisfaction||Time Reporting, Administrative Onboarding||All Employees (Time Reporting), Executive Office Operations (Administrative Onboarding)|
|Maintain QMS Effectiveness||Quality Process||All Employees (Quality Management System)|
The Process Model and Process Approach
ISO promotes a process approach for developing, implementing, and improving the effectiveness of a company’s QMS. The process approach is intended to enhance customer satisfaction by fulfilling the customer’s requirements. The process approach considers the interrelated processes of the system that contributes to a company’s effectiveness and efficiency and its ability to achieve intended results. Exhibit 3 illustrates the Process Model and Process Approach, showing the managed, controlled, interrelated processes that make up the system. The Process Model shows how the output of one process becomes the input to another in the Process Approach.
If an auditor asks you about the Process Approach you could say something like, “[t]he Process Approach is when business activities are interconnected; that is, the output of one process becomes an input to a subsequent process.
Risk-based thinking is a forward-thinking point of view that looks for risks, concerns, and opportunities. Risk is the effect of
uncertainty. Uncertainty can have positive or negative effects. A positive effect from a risk can provide an opportunity.
Risk-based thinking is essential for achieving an effective QMS. It means we plan for risk and are ready to implement
actions that will address risks and opportunities. You apply risk-based thinking by being aware of changes,
inconsistencies, or anything concerning.
An auditor may ask you what risk-based thinking is and how you apply it to your job.
If an auditor asks you about risk-based thinking you could say something like, “risk-based thinking is looking for changes,
inconsistencies, or concerns, and identifying opportunities for improvement.”
Summary of Key QMS Concepts
- Quality Management System (QMS) – how your organization provides products and services that meet customer
- Conformance – completing tasks as planned to produce the best results
- Employees’ contributions to the QMS include:
a. following the process and completing paperwork,
b. applying risk-based thinking and making recommendations for improvement,
c. understanding the process approach, and
d. knowing our quality objectives and how you help achieve them
- Implications of not conforming to QMS requirements:
a. lose customer business
b. lose money
c. lose ISO 9001 certification
Top Things for You, as a Blue Rose Employee, to Know
- Quality Policy and how my job supports the Policy: Stated above. Your job supports the policy by providing high-quality services in alignment with the policy
- Quality Objectives and current status: Quality Objectives are stated above. We are currently doing initial analysis of results.
- Company’s ISO Management Representative:
Chris Casey, Managing Partner
- Job responsibilities / description (if available): Managing Partner, Solutions Design and Business Operations
- Documents used and where to obtain current copies: Posted on Blue Rose Intranet site and C2 Essentials Portal.
- How to request a change to a document: Requests for changes may be submitted to Blue Rose’s Business Coordinator, Devon Pina.
- Paperwork/forms used and how to complete them: All forms used for execution of key processes are on-line forms available in the specific systems noted in the Key Process documents which are available on the Employee Portal. Any suspected or reported nonconformities or opportunities for improvement should be reported (preferably via email) to Blue Rose’s ISO Management Representative (Managing Director, Business Operations, Christopher Casey).
- Training completed: Everyone here has completed time reporting training. Everyone here has now been briefed on ISO 2015:9001 and their respective role.
- How to handle/report a customer complaint (if responsible): Refer all customer complaints to your direct supervisor and/or to Blue Rose’s Managing Partner and CEO, Todd Weiler
- How to handle, identify, and report a nonconformance or nonconforming product including records: Suspected instances of non-conformance should be reported to the Process Owner (identified in the applicable process document for each key process) or to the Managing Partner, Business Operations. Anyone may and should make such a report if/when they observe an activity or event that does not appear to conform to a written stated ISO 9001:2015 process (Time Reporting, Administrative Onboarding, Quality Management). Instances of suspected nonconformance should be submitted via email to establish a written record.
- What a corrective action is and how to initiate one: A corrective action is an activity undertaken to modify: (1) a nonconforming service/action associated with an ISO 9001:2015 process (e.g., an output/outcome of a process that falls outside of the acceptable range of performance); and/or (2) a process itself to attempt to ensure that non-conforming services/actions (e.g., flawed outputs/outcomes) do not re-occur. Corrective Action Reports (CARs) are initiated once a suspected instance of non-conformance (referred to as an “Exception” at Blue Rose) is substantiated. A CAR is created by the Managing Partner, Business Operations. As described, anyone may and should report a suspected instance of non-conformance, including outlining any suspected causes and/or steps the individual(s) believe should be taken to correct the suspected non-conformance. Instances of suspected non-conformance should be submitted via email to establish a written record.