2014

Sprintech Packaging Syed Mujtaba Ali Bukhari

8/12/2014

ISO 9001:2008 Awareness Training

ISO 9001:2008 Awareness Training 2014 Table of Contents Introduction .................................................................................................................................................. 4

Performance Objective ............................................................................................................................. 4

Key Quality Management Terminology ........................................................................................................ 5

ISO 9000 series standards: .................................................................................................................... 5

Quality: ................................................................................................................................................. 5

Quality assurance/Quality control (QA/QC):........................................................................................ 5

Quality audit: ........................................................................................................................................ 5

Quality management system (QMS): .................................................................................................... 5

Quality policy: ...................................................................................................................................... 5

Quality Management Principles .................................................................................................................... 6

Principle 1 - Customer-Focus .................................................................................................................... 7

Principle 2 – Leadership ............................................................................................................................ 7

Principle 3 – Involvement of People ......................................................................................................... 7

Principle 4 – Process Approach ................................................................................................................. 7

Principle 5 – System Approach to Management ...................................................................................... 7

Principle 6 – Continual Improvement ....................................................................................................... 7

Principle 7 – Factual Approach to Decision Making .................................................................................. 7

Principle 8 – Mutually beneficial supplier relationships ........................................................................... 7

PDCA Cycle .................................................................................................................................................... 8

Step 1: Plan ............................................................................................................................................... 8

Step 2: Do .................................................................................................................................................. 9

Step 3: Check ........................................................................................................................................... 10

Step 4: Act ............................................................................................................................................... 10

ISO 9001:2008 Requirements ..................................................................................................................... 11

4.1 General Requirements of a QMS ......................................................... Error! Bookmark not defined.

4.2 Documented Quality System ............................................................... Error! Bookmark not defined.

4.2.3 Document Control System ................................................................ Error! Bookmark not defined.

4.2.4 Records Control System .................................................................... Error! Bookmark not defined.

5.0 Management Responsibility ................................................................ Error! Bookmark not defined.

5.4 Planning ................................................................................................ Error! Bookmark not defined.

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ISO 9001:2008 Awareness Training 2014

5.5 Responsibility, Authority and Communication .................................... Error! Bookmark not defined.

5.6 Management Review ........................................................................... Error! Bookmark not defined.

6.0 Resource Management ........................................................................ Error! Bookmark not defined.

6.2 Human Resources ................................................................................ Error! Bookmark not defined.

7.1 Planning Production Processes ............................................................ Error! Bookmark not defined.

7.2 Customer Relationship Processes ........................................................ Error! Bookmark not defined.

7.3 Design Control System ......................................................................... Error! Bookmark not defined.

7.5.1 Production Process Control .............................................................. Error! Bookmark not defined.

7.5.2 Validate Special Processes ................................................................ Error! Bookmark not defined.

7.5.3 Identify Product through Product ..................................................... Error! Bookmark not defined.

7.5.4 Protect Customer-Owned Property .................................................. Error! Bookmark not defined.

7.5.5 Product Preservation ........................................................................ Error! Bookmark not defined.

7.6 Measurement Control System ............................................................. Error! Bookmark not defined.

8.1 Measure, Understand and Improve ..................................................... Error! Bookmark not defined.

8.2 Monitor and Measure .......................................................................... Error! Bookmark not defined.

8.2.2 Internal Audit System........................................................................ Error! Bookmark not defined.

8.2.4 Monitoring and Measuring Products ................................................ Error! Bookmark not defined.

8.3 Handling Non-Conformity .................................................................... Error! Bookmark not defined.

8.4 Data Analysis ........................................................................................ Error! Bookmark not defined.

8.5.1 Continual Improvement .................................................................... Error! Bookmark not defined.

8.5.2-8.5.3 Corrective and Preventive Action ............................................ Error! Bookmark not defined.

Questions and Answers .......................................................................................................................... 12

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ISO 9001:2008 Awareness Training 2014

Introduction

ISO 9001:2008 Quality Management System awareness training will enable you to demonstrate your commitment to quality and customer satisfaction, as well as continuously improving your company’s operations. The internationally recognized ISO 9001:2008 quality management system standard is the preferred solution for organizations worldwide. The following four sections are included in this module

1. Key Quality Management Terminology 2. Quality Management Principles

3. PDCA Cycle

4. ISO 9001:2008 Requirements

Performance Objective After completing this module, you will be able to determine the type and extent of documentation needed to support the operation of the processes of your organization that make up the quality management system.

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ISO 9001:2008 Awareness Training 2014

Key Quality Management Terminology ISO 9000 series standards: A set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. The standards, initially published in 1987, are not specific to any particular industry, product or service. The standards were developed by the International Organization for Standardization. The standards underwent major revision in 2000 and now include ISO 9000:2005 (definitions), ISO 9001:2008 (requirements) and ISO 9004:2009 (continuous improvement).

Quality: A product or service free of deficiencies. According to Joseph Juran, quality means “fitness for use;” according to Philip Crosby, it means “conformance to requirements.”

Quality assurance/Quality control (QA/QC): Quality assurance is: all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. Quality control is: the operational techniques and activities used to fulfill requirements for quality. Often, however, “quality assurance” and “quality control” are used interchangeably, referring to the actions performed to ensure the quality of a product, service or process.

Quality audit: A systematic, independent examination and review to determine whether quality activities and related results comply with plans and whether these plans are implemented effectively and are suitable to achieve the objectives.

Quality management system (QMS): A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management.

Quality policy: An organization’s general statement of its beliefs about quality, how quality will come about and its expected result.

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ISO 9001:2008 Awareness Training 2014

Quality Management Principles ISO 9001:2008 is developed based on 8 Quality Management Principles:

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual Improvement

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships

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ISO 9001:2008 Awareness Training 2014 Principle 1 - Customer-Focus The customer is always the most important factor for any business, therefore the organization should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations (Refer to Clause 5.2; 7.2; and 8.2.1).

Principle 2 – Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives, whilst encouraging and recognizing employee’s contributions. (Refer to Clause 5).

Principle 3 – Involvement of People People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit. (Refer to Clause 6.2).

Principle 4 – Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process. The process should focus on resources, methods and materials which affect the key activities within the business. (Refer to Clause 4.1).

Principle 5 – System Approach to Management Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objective. Better understanding of the roles and responsibilities necessary for achieving the objectives should be continually improved by evaluating and measuring its performance. (Refer to Clause 4.1).

Principle 6 – Continual Improvement Continual improvement of the organizations overall performance should be a permanent objective of the organization. (Refer to Clause 8.5.1 and 4.1).

Principle 7 – Factual Approach to Decision Making Effective decisions are based on the analysis of data and information that are accurate and reliable. (Refer to Clause 4.1e and 8.4).

Principle 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. These mutually beneficial relationships allow the organization to benefit from optimized costs, resources , clear and open communication and being able to share knowledge and plans on market changes and consumer expectations. (Refer to Clause 7.4).

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ISO 9001:2008 Awareness Training 2014

PDCA Cycle The PDCA (plan–do–check–act) cycle is a four–step model for carrying out change. Just as a circle has no end, the PDCA cycle should be repeated again and again for continuous improvement.

It is also known as Deming circle/cycle/wheel.

The four phases in the Plan-Do-Check-Act Cycle involve:

• Plan: Identifying and analyzing the problem.

• Do: Developing and testing a potential solution.

• Check: Measuring how effective the test solution was, and analyzing whether it could be improved in any way.

• Act: Implementing the improved solution fully. Figure .1 The PDCA Cycle

The PDCA Cycle encourages you to be methodical in your approach to problem solving and implementing solutions. Follow the steps below every time to ensure you get the highest quality solution possible.

Step 1: Plan The purpose of this phase is to investigate the current situation, fully understand the nature of any problem to be solved, and to develop potential solutions to the problem that will be tested. Identify and prioritize quality improvement opportunities. Usually a team will find that there are several problems, or quality improvement opportunities, that arise when programs or processes are investigated. A prioritization matrix may help in determining which one to select. Once the quality improvement opportunity has been decided, articulate a problem statement. Revisit and, as appropriate, revise the problem statement as you move through the planning process.

a. Develop an AIM statement that answers the following questions:

i. What are you seeking to accomplish? ii. Who is the target population?

iii. What is the specific, numeric measure (s) you are seeking to achieve? iv. The measurable improvement objective is a key component of the entire quality

improvement process. It’s critical to quantify the improvement you are seeking to achieve. Moreover, the entire aim statement also will need to be revisited and refined as you move through the planning phase.

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ISO 9001:2008 Awareness Training 2014

b. Describe the current process surrounding the problem in order to understand the process and identify areas for improvements. Flow charts and value stream mapping are two examples of methods to accomplish this.

c. Collect data on the current process. Baseline data that describe the current state are critical to further understanding the process and establishing a foundation for measuring improvements. The data may address, for example, time, people, space, cost, number of steps, adverse events, and customer satisfaction. A host of tools are available to collect and interpret data on the process, such as Pareto charts, histograms, run charts, scatter plots and control charts. The data collected must be aligned with the measures listed in the aim statement.

d. Identify all possible causes of the problem and determine the root cause. While numerous causes will emerge when examining the quality improvement opportunity, it is critical to delve in and carefully identify the underlying, or root, cause of the problem, in order to ensure that an improvement or intervention with the greatest chance of success is selected. Brainstorming is a useful way to identify possible causes and a cause and effect /fishbone diagram and the 5 Whys are useful for determining the actual root cause.

e. Identify potential improvements to address the root cause, and agree on which one to test. Once the improvement has been determined, carefully consider any unintended consequences that may emerge as a result of the implementing improvement. This

step provides an opportunity to alter the improvement and/or develop countermeasures as needed to address any potential unintended consequences. Revisiting the aim statement and revising the measurable improvement objectives are important steps at this point.

f. Develop an action plan indicating what needs to be done, who is responsible, and when it should be completed. The details of this plan should include all aspects of the method to test the improvements – what data will be collected, how frequently data are collected, who collects the data, how they are documented, the timeline, and how results will be analyzed.

Step 2: Do The purpose of this phase is to test the action plan.

a. Generate possible solutions. b. Collect and document the data. c. Document problems, unexpected observations, lessons learned and knowledge gained.

"Do" means "Try" or "Test". It does not mean "Implement fully." Full implementation happens in the "Act" phase.

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ISO 9001:2008 Awareness Training 2014 Step 3: Check In this phase, you measure how effective the solution has been, and gather together any learning’s from it that could make it even better.

Once you are finally satisfied that the costs would outweigh the benefits of repeating the Do-Check sub-cycle any more, you can move on to the final phase.

This phase involves analyzing the effect of the intervention. Compare the new data to the baseline data to determine whether an improvement was achieved, and whether the measures in the aim statement were met. Pareto charts, histograms, run charts, scatter plots, control charts and radar charts are all tools that can assist with this analysis.

1. Reflect on the analysis, and consider any additional information that emerged as well. 2. Compare the results of your test against the measurable objective. 3. Document lessons learned, knowledge gained, and any surprising results that emerged.

Step 4: Act This phase marks the culmination of the planning, testing and analysis regarding whether the desired improvement was achieved as articulated in the aim statement, and the purpose is to act upon what has been learned. Options include:

Adopt: Standardize the improvement if the measurable objective in the aim statement has been met. This involves establishing a mechanism for those performing the new process to measure and monitor benchmarks on a regular basis to ensure that improvements are maintained. Run charts or control charts are two examples of tools to monitor performance.

Adapt: The team may decide to repeat the test, gather different data, revise the intervention, or otherwise adjust the test methodology. This might occur, for example, if sufficient data weren’t gathered, circumstances have changed (e.g., staffing, resources, policy, environment, etc.), or if the test results fell somewhat short of the measurable improvement goal. In this case, adapt the action plan as needed and repeat the “Do” phase.

Abandon: If the changes made to the process did not result in an improvement, consider lessons learned from the initial test, and return to the “Plan” phase. At this point the team might revisit potential solutions that were not initially selected, or delve back into a root cause analysis to see if additional underlying causes can be uncovered, or even reconsider the aim statement to see if it’s realistic. Whatever the starting point, the team will then need to engage in the Plan cycle to develop a new action plan, and move through the remaining phases.

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ISO 9001:2008 Awareness Training 2014

ISO 9001:2008 Requirements

Figure .2 Key requirements of ISO 9001:2008

ISO 9001:2008 Clauses 1.0 Scope 5.0 Management Responsibility 2.0 Normative Reference 6.0 Resource Management 3.0 Terms and Definition 7.0 Product Realization 4.0 Quality Management System 8.0 Measurement , Analysis and Improvement

Standards of ISO 9000 Series ISO 9000 Quality Management Systems Fundamentals and Vocabulary

ISO 9001 Quality Management Systems Requirements

ISO 9004 Quality Management Systems Guidelines for Performance Improvements

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ISO 9001:2008 Awareness Training 2014

Questions and Answers

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