Saturday, March 6, 2010

ISO 9001:2008 Documentation Requirements

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


Wednesday, March 3, 2010

Why implement ISO 9001:2008

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

Tuesday, March 2, 2010

Road Map 3: Selecting the Project Team

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

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