ISO 9001 Management Systems

ISO 9001 Quality Management System Principles

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The 8 Management Principles
Customer Focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet requirements and strive to exceed customer expectations.
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.
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.
Process Approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
Continual Improvement
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
Factual Approach to decision making
Effective decisions are based on the analysis of data and information.
Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

ISO 9001 Internal Auditing

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The Audit Program
Writing the Internal Audit Procedure
A documented Internal Audit procedure is a requirement under Clause 4.2.4 of ISO 9001:2000. Clause 8.2.2 sets out the minimum requirements and purpose of the Internal Audit. When writing the Internal Audit procedure the following requirements may be taken into consideration. These will vary from industry to industry but most of them are generic. Where an integrated system is in place the requirements of the other standards, regulatory authority or other may be taken in to consideration to verify compliance, institute corrective, preventive action and continual improvement.
•    Customer requirements
•    Statutory requirements
•    Requirements of the Standard
•    Requirements of the organization
•    Requirements of the department
•    Regulatory requirements
•    Requirements of the shareholders
•    Product requirements
•    Employee requirements
•    Process requirements
•    ISO 19011:2000
•    Ensure consistent application of procedures across the organisation

ISO 9001 Top Management Processes

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ISO 9001 and Top Management

The revised versions of the quality management system starting from ISO 9001:2000 and ISO 9001:2008 have sought to change the tradition of leaving the quality management system to the quality assurance manager or some junior manager to Top management. Even then often times when the implementation of a quality management system is customer driven the organization pursues certification not as a business improvement system but to obtain a certificate. In such instances once a management representative has been appointed, top management pays lip service to the quality management system. This is aggravated by the fact that customers in most industries except the aerospace and automotive industries among the few do not audit their suppliers but relies on third party audits and often the supplier chooses its own registrar.
The result is that there is a lot of dissatisfaction with the system and often employees have two jobs ISO and their daily jobs.

A successful quality management system is one that involves every one in the organization starting with top management regardless of the reasons of implementing a quality management system. Who is top management depends on the company’s structure. This must be determined at the start of the project as top management buy in is absolutely necessary for an effective quality management system.
The response of top management to ISO 90001 is also reflected in middle and junior management behavior. If top management is negative or just tolerate or don’t care about ISO 9001, no matter how hard you try no one is going to care. The battle is thus lost before it is even begun. The involvement of top ensures success and commitment through out the organization.

ISO 9001:2008 Documentation Requirements

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ISO 9001:2008 Documentation Requirements

ISO has issued guidelines for those changing from ISO 9001:2000 to ISO 9001:2008. Whilst there are no major differences between the two standards, the new guide is worth reading. Here are the key points in the document.

ISO 9001:2008 Documentation Requirements. You must have these documents as a minimum.

A quality Policy
Quality Objectives
Quality Manual
Document Control Procedure
Record Control Procedure
Corrective Action Procedure
Preventive Action Procedure
Internal Audit Procedure
Control of non conforming products

The organization must then decide what other documents it needs to demonstrate conformity to the requirements of ISO 9001:2008

ISO 9001:2008 also requires records that show that the organization is indeed achieving what it set out to achieve.

Management reviews
Education, training, skills and experience
Evidence that the realization processes and resulting product fulfil requirements
Results of supplier evaluations and any necessary actions arising from the evaluations
The unique identification of the product, where traceability is a requirement
Customer property that is lost, damaged or otherwise found to be unsuitable for use
Results of calibration and verification of measuring equipment
Internal audit results and follow-up actions
Indication of the person(s) authorizing release of product.
Nature of the product non-conformities
Results of corrective action
Results of preventive action

Why implement ISO 9001:2008

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Road Map 0: Evaluate the organization’s reasons for Implementing ISO 9001

Implementing ISO 9001 costs time and money. The reasons for wanting to implement ISO 9001:2008 must therefore be clearly identified even when demanded by specific market segments such as the Aircraft Industry. The best place to start is your business objectives. ISO 9001 uses the term quality objectives and yet others call it the business dashboard

How to set Quality Objectives

Keep your objectives consistent with your mission - they must be realistic - how will you measure them?
Quality objectives or the Business dashboard must pass the SMART test
Communicate your Quality Objectives - consider a regular report
Documented quality objectives at relevant functions and levels within the organization
Ensured that quality objectives are consistent with the quality policy commitments?
Ensured consistency with business plan/mission?
Established a process for tracking and reporting progress?
Established and documented a procedure?

Possible reasons for implementing ISO 9001:2008 quality management system

Repeated customer complaints
Frequent warranty returns
Delayed deliveries
Too high inventories
Frequent production hold-ups or
A high level of rework or rejection of products or services.
Market that is demanding a certified quality management system
Safety
Regulatory
Legal
Improved quality performance
Reduced liability
Competitive advantage
Improved compliance
Reduced costs
Employee involvement
Improved public image
Enhanced customer trust
Meet customer requirements

Road Map 3: Selecting the Project Team

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Road Map 3: Selecting ISO 9001 Project Team

• The ISO 9001 Project Team leads in planning, implementing and maintaining the quality management system. These should be drawn from all the departments that will be covered by the quality management system.

Role of the Project Team

• Delegating the tasks to their subordinates,
• Help in establishing deadlines,
• Collecting and evaluating the work,
• Providing training, guidance and assistance where needed.
• The Team functions in an advisory capacity
• Helps in developing the project plan
• Help in enlisting buy-in from employees
• Collecting quality management systems information and disseminating it across the organization
• Providing guidance and leadership as the requirements are being addressed
• Gather, organize, and disseminate information
• The EMS experts and development leaders
• Delegate EMS tasks and general responsibilities
• Collect and evaluate the work
• Advise, coordinate and facilitate
• Manage reaction to change

Characteristics

• Experts and champions.
• Have sufficient organizational knowledge and authority in their respective departments.
• A clear understanding of their roles and responsibilities in order to
• Ability to plan and lead the implementation effort.
• Have received in-depth quality management system training to ensure that they have a clear understanding of the intent of the ISO 9001:2008 Standard and how each of the clause can be integrated with the existing management system

What is the Core Team?
• Appropriate management personnel from across the organizational structure representing every function of the organization
• chosen for their skills and aptitudes related to developing an Quality management system
• The QMS experts and cheerleaders in each functional area
• The organization’s change agents
Typical Responsibilities

Qualifications
• “In the know” in their functional areas
• A good communicator and sympathetic listener
• Available, enthusiastic, and committed
• Respected and trusted by employees and managers
• Pleasant personality, can handle stress
• Able to meet deadlines
• Who can give credence to your program?
• Who do employees trust?
• Who has responsibility for environmental issues?
• Which managers are most directly concerned with or potentially affected by environmental issues?
• What are the most critical environmental issues and where in the fenceline are they?
• Are the key functions represented?

Lessons Learned
• It takes time and effort to develop a team dynamic (QMS skills and “soft skills”)
• The Project Team needs training
• Each team member has to understand and be accountable for his/her EMS role and responsibility
• The project Team facilitates the QMS effort; they are not responsible for completing all the EMS requirements
• Be prepared for resistance: organizations do not like change
• Remember the KISS rule
• The Environmental staff often thinks that they can do this without involving employees
• The Implementation Team is pivotal to the success of the QMS program
• The Team must have authority as well as responsibility

Management Representative

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Road Map 2: Appoint a management representative

ISO 9001 requires that Top management appoint a Management Representative. Must be a member of the management team. Do not employee just for ISO 9001

Responsibilities of the Management Representative
• Build and lead the quality management system Project Team
• Plan the quality management system project and implementation schedule
• Be the “internal consultant”
• Report to top management
• Gather, organize, and disseminate information
• Delegate tasks and establish deadlines
• Collect and evaluate work
• Organize training
• Facilitate top management visibility and involvement
• Obtain cross-functional support and buy-in

Qualifications of the Management Representative
• Knowledge of overall operations and ISO 9001
• Excellence in project management
• Excellent organizational skills
• Good communicator up and down the ladder
• Available, enthusiastic, and committed
• Trusted by employees and managers
• Pleasant personality
• Thick skinned

Positive Attributes
• Goal-oriented and patient
• Driven - either has authority or takes it
• Not afraid to fail - can handle setbacks
• Willing to ruffle feathers if necessary
• Team builder
• Respected at all levels of the organization

Difficult Situations
• Lack of upper management support
• Unclear or insufficient authority
• EMS champion decides to do it alone
• Skimping on training
• Lack of time and/or resources
• Employees brought in at the last minute
• Neglecting to account for culture change issues

Requirements for Success
• Totally committed to the success of the quality management system
• Needs authority that matches responsibility
• Must have sufficient training
• Must have time to commit to the EMS development
• Communicate “good news” regularly – build a business case
• Ask for assistance
• DELEGATE!!!ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edition

Road Map 1: Top Management Commitment

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Road Map 1: Get Top Management Commitment The revised versions of the quality management system starting from ISO 9001:2000 have sought to change the tradition of leaving the quality management system to the quality assurance manager or some junior manager to Top management.

Top management must drive the implementation of ISO 9001 quality management system otherwise it is a waste of time. This should not be about getting a certificate but a genuine commitment to the culture of quality. Top Management must demonstrate their commitment by providing the necessary resources and on-going support by attending some of the project team’s meetings.

The ISO 9001 quality management system must be aligned with corporate goals and strategy. Clear and quantifiable business objectives, often abbreviated “SMART” will help keep the process and people focused.

Top management must assign responsibility and authority for quality initiatives, planning, problem identification, solution implementation and control. The Management Representative has the ultimate responsibility for the project. The ISO 9001 "management representative" must report directly to top management.

ISO 9001:2008 Quality Management System: A Do It Yourself Guide.

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Implementing ISO 9001

ISO 9001 may best be implemented as a project with a Project Manager, definite start and end date. The Management Representative may not necessary be the Project Manager. If that is the case then the Project Manager must work with the Management Representative as the Management Representative is responsible for maintaining the system.

Some organization may require a Consultant who work as the Project Manager prior to engaging the Registrar. Where such is the case the organization must ensure that the Consultant documents the organization’s system.

Road Maps

Road Map 1: Get Top Management Commitment

Road Map 2: Evaluate objectives and targets for implementing a quality management system.

Road Map 3: Obtain knowledge about ISO 9000/9001

Road Map 4: Organise resources and get commitment.

Road Map 5: Appoint Management Representative.

Road Map 6: Appoint Project Team.

Road Map 6: Select Registrar

Road Map 7: Raise awareness

Road Map 8: Provide training

Road Map 9: Initial review/gap analysis

Road Map 10: Analyse and document product realisation process

Road Map 11: Plan time frame and communicate it

Road Map 12: Draft the Quality Manual and develop policy

Road Map 13: Design the QMS and implement it

Road Map 14: Develop an Internal Audit Program

Road Map 15: Develop a Management Review Program

Road Map 16: Implement System Changes

Road Map 17: Conduct periodic audits Initiate corrective action

Road Map 18: Pre-assessment

Road Map 19: Evaluation,

Road Map 20: Maintain and continually improve system

Road Map 21: Finish

Road map 22: Celebrate Success

Appendix 1: Sample Quality Manual

Appendix 2: Resources

Appendix 3: Employee Handout

ISO 9001 Management Systems, Employee Handout

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The best way to involve your employees is by issuing any Employee Handout. Here is a free employee handout.

Begin the Employee Handout by stating the company's Mission, Vision and Strategy.

Follow up with the company's Quality Policy as it should provide a framework for setting and reviewing the company's business objectives

What is ISO

ISO, International Organisation of Standardisation, is a non – governmental network of National Standards bodies/institutes of each nation (one per nation). The name ISO comes from the greek word "isos" meaning equal. It has 157 members and develops standards on behalf/together with member bodies of which ISO 9000 is one of them.

What is ISO 9001?

ISO 9000 is a group of standards and guidelines for quality management and quality assurance which was developed by the International Organization for Standardization (ISO) of which ISO 9001:2008 is the most recent. It replaces ISO 9001:2000. ISO 9001:2000 replaced ISO 9001, 9002 and 9003. ISO 9001:2000 and ISO 9001:2008 will run concurrently for 24 months after which ISO 9001:2000 will be phased out

Management has adopted the ISO 9001 series of standards to help focus on the following three key elements of quality

Customers.

Processes.

Employees.

ISO 9000 has become an international reference for quality management system requirements some companies demand that an organization’s quality management system be certified before doing any business.

Customers

Customers define quality. Customers expect performance, reliability, competitive prices, on-time delivery, service, clear and correct transaction processing. We must know what our

customers’ want and delight our customers by meeting and even exceeding their expectations. No customer no business.

Employees

Quality is the responsibility of every employee. Involving all employees is essential to all quality activities. We are committed to providing equal opportunities and incentives for

employees to focus their talents and energies on satisfying customers.

Processes

Process refers to all our activities e.g. the generation of an Invoice is a process. The manufacturing of any product is a combination of many processes so is the performance of a service. We must strive to eliminate process variation and product

defects by

• Accurately defining customer stated and implied

requirements.

• Accurately measuring our processes and products, that

way we remove opinions and emotions and replace them with

facts and figures.

• Analyzing product and process records and implement

measures to reduce/eliminate process variation and product

defects

Management has introduced a Quality Management System based on ISO 9001 family of standards to help us improve our performance, processes, products and services. This requires hard work, factual data and a disciplined problem solving approach. Your commitment, support and understanding of our Quality Management

System is critical to our success.

What are the benefits of implementing a Quality Management System?

• Consistently meet or exceed customer requirements.

• Keep processes under control.

• Resolve quality problems.

• Ethical: It's is a good thing to do.

• National and international market recognition of a world-class quality system.

• Reduction of multiple customer audits at the company.

• Provision of procedures and work instructions to reduce errors and misunderstandings.

• Improve teamwork and communications and contribute to quality and reliability.

ISO 9001:2008 has 5 major clauses as follows

Clause 4: Quality management system (QMS): Requires that the

organization

• Establish, document, implement, maintain and continually improve the effectiveness of the QMS as a means of ensuring that product conforms to requirements.

• Identify sequence and interaction of core processes of the QMS.

• Establish a documented procedure for defining controls

for the approval, issue change and modification of documents.

• Establish a documented procedure for identification, collection, indexing, filing, and storage of quality records.

• Prepare a Quality manual

Clause 5: Management Responsibility:Requires that top management

• Communicate to all employees the importance of meeting customer, statutory and regulatory requirements.

• Establish a Quality Policy: Our Quality Policy is displayed on all our Notice Boards.

• Establish specific and measurable Quality Objectives (targets) for the company and the departments.

• Review periodically the quality management system to ensure the continuing suitability and effectiveness.

Clause 6: Resource Management: Requires that the organization

• Ensure that employees performing work that affects product quality are competent on the basis of appropriate education, training, skills and experience

• Identify, provide and maintain the infrastructure needed to achieve conformity of the product.

• Manage the work environment to achieve product conformity

Clause 7: Product Realization: Requires that we

• Determine customer, legal and regulatory relating to the

product.

• Establish procedures for product identification and

traceabilty where it is a customer requirement.

• Ensure that purchased products conform to specified

requirements. This is accomplished through supplier

assessments, clear and accurate purchasing data, and

verification of purchased products.

• Establish procedures for verification, validation,

monitoring inspection and testing of products to ensure

conformance to customer requirements.

• Establish procedures/methods for identification,

handling storage and protection to preserve the conformity of

the product..

• Establish procedures for selection, control, calibration, and

maintenance of measurement and test equipment.

Clause 8: Measurement analysis and improvement: Requires that we implement

• A system to evaluate & monitor customer perception.

• Procedures for investigating causes of nonconformance, taking action to rectify them, and creating controls to prevent recurrence.

• Procedures for the control of non-conforming product to

ensure it is not inadvertently used or released, this

includes identification, segregation and evaluation.

• A documented system of internal audits to verify whether

quality activities comply with planned requirements.

and to determine the effectiveness of the quality system.

• Analysis of the collected data to demonstrate the

suitability and effectiveness of our Quality Management System

and for continual improvement.

What do we need to do to get certified?

• Document and implement ISO 9001:2008 quality management system model.

• Internally audit our quality management system at specific intervals.

• Fully implement and operate our system.

• Successfully pass a final audit by a registrar.

• Continue to pass unannounced biannual audits by our

registrar.

• Our Quality Policy and Our Corporate mission statements are on

the notice boards. Please familiarize yourself with them.

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