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Complying to ISO 9001

Quality management systems Requirements


by Pradip V. Mehta, P.E.
Fellow, American Society for Quality

Taste is a Matter of Choice; but Quality is a Matter of Fact

Complying to ISO 9001

ISO 9001:2008 Quality management systems - Requirements

Taste is a Matter of Choice; but Quality is a Matter of Fact

ISO 9000 Standards - Based on Eight Management Principles


        Customer Focus Leadership Involvement of People Process Approach Systems Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships
Taste is a Matter of Choice; but Quality is a Matter of Fact

Quality Management Principle


 A quality management principle is a fundamental rule or belief for leading and operating an organization.  The eight quality management principles addressed in the new standard are primarily aimed at continually improving performance over the long term by focusing on internal and external customers.
Taste is a Matter of Choice; but Quality is a Matter of Fact

1 Customer-Focused CustomerOrganization
 Strives to understand current and future customer needs, meet customer requirements, and exceed customer expectations.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Exceed your customers expectations. If you do, theyll come back over and over. Let them know you appreciate them.
Sam Walton Wal Mart Founder

Taste is a Matter of Choice; but Quality is a Matter of Fact

2 Leadership
 Leaders establish unity of purpose and direction within the organization to create and maintain an internal environment in which people can become fully involved in achieving the organization's objectives.

Taste is a Matter of Choice; but Quality is a Matter of Fact

3 Involvement of People
 People are the most important asset of an organization. Their full involvement enables their abilities to be utilized for mutual benefit.

Taste is a Matter of Choice; but Quality is a Matter of Fact

4 Process Approach
 A desired result is achieved more effectively when activities and related resources are managed as a process.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Process Approach

Taste is a Matter of Choice; but Quality is a Matter of Fact

4 Process Approach
You have achieved process approach when
 Processes are basis for management review, internal audits, general meetings, results monitoring, and forecasting  Internal customer concept is established  There is teamwork and open communication  There is self-sustaining continual improvement self Operating efficiency goes up and costs go down

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 System Approach to Management


 Identifying, understanding and managing interrelated processes as a system to achieve given objectives.

Taste is a Matter of Choice; but Quality is a Matter of Fact

6 Continual Improvement
 Continual improvement of the organizations performance should be a permanent objective of the organization.

Taste is a Matter of Choice; but Quality is a Matter of Fact

7 Factual Approach to Decision Making


 Management by fact. Effective decisions are based on an analysis of data and information.

Taste is a Matter of Choice; but Quality is a Matter of Fact

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.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Model for a Process Based Quality Management System


Continual Improvement of the quality management system

Management Responsibility

Customer Requirements

Resource Management

Measurement, Analysis, and Improvement

Customer Satisfaction

Product Realization

Product

Taste is a Matter of Choice; but Quality is a Matter of Fact

Requirements
     Quality management system Management responsibility Resource management Product realization Measurement, analysis and improvement

Taste is a Matter of Choice; but Quality is a Matter of Fact

4 Quality Management System


 4.1 General  4.2 Documentation

Taste is a Matter of Choice; but Quality is a Matter of Fact

Sample Process Chart


Determine customer requirements Manufacture product

Quote job & take order

Inspect & test

Schedule work Package, label, and store

Purchase supplies & materials Receive & verify materials

Ship product

Customer satisfaction

Taste is a Matter of Choice; but Quality is a Matter of Fact

Sample Processes

Taste is a Matter of Choice; but Quality is a Matter of Fact

Sample Processes

Taste is a Matter of Choice; but Quality is a Matter of Fact

Sample Processes

Taste is a Matter of Choice; but Quality is a Matter of Fact

4 Quality Management System


 4.1 General  4.2 Documentation

Taste is a Matter of Choice; but Quality is a Matter of Fact

4 Quality Management System


 Quality policy (clause 5.3)  Quality objectives (sub clause 5.4.1)  Quality manual (sub clause 4.2.2)

Taste is a Matter of Choice; but Quality is a Matter of Fact

Advantages of Quality Manual


 Educate employees about the structure of the quality management system, its processes, and its broad intentions  Define the system for third party registrars  Provide an initial basis for internal and external auditing  Instill confidence in existing customers by indicating the organizations commitment to continual improvement and customer satisfaction  Provide top management with a starting point for strategic planning and the development of key measures  Guide middle managers in the development of functional/departmental systems and procedures  Provide a road map to lower-level documents within the system lower Sell the organization to potential customers by revealing the organizations advantages over competitors
Taste is a Matter of Choice; but Quality is a Matter of Fact

4 Quality Management System


      Document control (sub clause 4.2.3) Record control (sub clause 4.2.4) Internal audit (sub clause 8.2.2) Control of non-conforming product (clause 8.3) Corrective action (sub clause 8.5.2) Preventive action (sub clause 8.5.3)

Taste is a Matter of Choice; but Quality is a Matter of Fact

Simple Rules for Documentation


 A written procedure is not necessary for every process.  Dont write a procedure for the sake of writing one. Learn and understand when a procedure is required.  Dont write a procedure around how you want to do a process or think a process should be done. The procedure should reflect what you actually do.  Create the documentation in a format that makes most sense to the people using the document. Dont be afraid to use pictures and videos, and dont be afraid to call them training materials.  Appearance and formatting are not important. Its content that matters. (Kelly, 2009)
Taste is a Matter of Choice; but Quality is a Matter of Fact

Examples of Scope & Exclusion


 The scope of the XYZ, Inc.s quality management system includes sales, manufacture, testing & inspection, warehousing, and servicing of all clothing produced at the ______ plant in ______.  Design & development has been excluded from the quality management system because those activities do not take place at XYZ, Inc. All product designs are received directly from customers in the form of sketches, markers and specifications.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
     5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication
Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.1 Management Commitment      Empowerment Contingent Reward Charisma Intellectual Stimulation Management-ByManagement-By-Exception

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.1 Management Commitment  Empowerment
+ Providing subordinates with sufficient training to achieve goals + Providing subordinates with sufficient resources to achieve goals + Supporting the professional growth of employees + Sharing information with employees + Enabling employees + Ensuring good working environment + Clearly explaining what is expected from employees

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.1 Management Commitment  Contingent Reward
Clarifying what is expected from followers and what they will receive if meet expectations.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.1 Management Commitment  Charisma
Inspiring followers and providing them with a clear sense of purpose, being a role model for ethical conduct, building identification with the leader and his vision.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.1 Management Commitment  Intellectual Stimulation
Getting employees to question the tried ways of solving problems and encouraging them to question the methods they use.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.1 Management Commitment Management-By Management-By-Exception
Monitoring task execution and any problems that might arise and correcting those problems to maintain current performance.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
 5.2 Customer Focus

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.3 Quality Policy  Policy A guide to managerial action.  Quality Policy Overall intentions and directions of an organization related to quality as formally expressed by top management.
-- ISO 9000

Taste is a Matter of Choice; but Quality is a Matter of Fact

Ann Taylor
Quality Policy
We are committed to meeting evolving needs of women who want feminine, stylish and versatile fashions that are of great quality and value and that inspire women to look as beautiful as they feel.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Prakash Steelage Ltd.


Quality Policy
Endeavour to enhance customer satisfaction through supply of technologically advanced and cost effective quality products

Taste is a Matter of Choice; but Quality is a Matter of Fact

Texas Instruments (TI)


Quality Policy
We will achieve business excellence by
 Encouraging and expecting the creative involvement of every Tier  Listening to our customers and meeting their needs  Continuously improving our processes, products, and services

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.4 Planning  Quality Plan - A document or a set of documents that describe the standards, quality practices, resources and processes pertinent to a specific product, service or project.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.4 Planning
Identify the customers, both external and internal. Determine customer needs. Develop specifications that meet customer needs. Establish quality goals that meet customer needs and do so at a minimum cost.  Develop a process that can meet the needs of the customers.  Prove process capability prove that the process can meet     quality goals under operating conditions.

Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
5.4 Planning - Quality Goals  Reduce customer returns by 5 % per year (25 % over five years). Annual targets are established for each product line.  Reduce internal scrap (as measured in cost/unit) by 10 % from the previous year.  Ensure 100 % adherence to the ISO quality system audit program.
Taste is a Matter of Choice; but Quality is a Matter of Fact

5 Management Responsibility
 5.5 Responsibility, authority and communication

Taste is a Matter of Choice; but Quality is a Matter of Fact

6 Resource Management
    6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment

Taste is a Matter of Choice; but Quality is a Matter of Fact

7 Product Realization
      7.1 Planning of Product Realization 7.2 Customer-related Processes Customer7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Measuring and Monitoring Devices

Taste is a Matter of Choice; but Quality is a Matter of Fact

8 Measurement, Analysis & Improvement


     8.1 General Requirements 8.2 Monitoring & Measurement 8.3 Control of Non-Conforming Product Non8.4 Analysis of Data 8.5 Improvement

Taste is a Matter of Choice; but Quality is a Matter of Fact

Compliance to ISO 9001

Transition from ISO 9001:2000 to ISO 9001:2008 is An opportunity to improve Quality Management System through a better understanding of the requirements.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Complying to ISO 9001


2000 Version 6.2 Human Resources 6.2.1 Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. 2008 Version 6.2 Human Resources 6.2.1 Personnel performing work affecting conformity to product requirement shall be competent on the basis of appropriate education, training, skills and experience. Note: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Complying to ISO 9001

ISO 9001:2000 sometimes used the term regulatory requirements. This has been consistently changed to statutory and regulatory requirements.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Transition Guideline
 One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) must be to reISO 9001:2008. Two years after publication by ISO, any existing certifications issued to ISO 9001:2000 will not be valid.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Transition from ISO 9001:2000 to ISO 9001:2008


    Get acquainted with the new edition of the standard. Use Annex B in ISO 9001:2008 to facilitate identification of the clarifications. Was your former interpretation of ISO 9001:2000 different from the clarifications provided by ISO 9001:2008? If not, communicate to both internal and external parties the conclusion and results of your implementation of ISO 9001:2008 If yes, determine the impact of the clarifications of the new version on your current use of ISO 9001 and plan any necessary remedial actions. Verify your remedial actions

Taste is a Matter of Choice; but Quality is a Matter of Fact

Typical Reasons for Non-compliance Non       Can not explain system and/or documentation Lack of management involvement Poor communication and/or training Personnel not following documentation Lack of documentation No or inadequate document control Poor record keeping

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


       Who is the accrediting authority? How long has the registrar been in business? How many audits/certifications have they done in your industry? What are registrars requirements for auditor qualifications? How many organization has the typical auditor certified? How many auditors does the registrar have? What is the turn over rate for auditors in the registrars company?
Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


     How are auditor substitution handled? Does the registrar provide training for auditors? Will the registrar make the lead auditor available for an interview for you to assess his/her suitability? Are the auditors full time employees of the registrar or on contract? Will your company have the same lead auditor for every audit?

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


   How far in advance will they notify you of an impending audit? What quality system does the registrar have in place? Will they provide you with their internal audit schedule and results of audit and corrective and preventive actions? How long will it take them to issue a certificate once they have recommended you for certification?

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


 How long does it take their office to respond to questions? If it becomes necessary to speak with the lead auditor, how is that done and how soon after the request will the lead auditor contact you? Is there a complete re-audit every three years or do rethey audit on a continuous basis? How frequently are surveillance audits conducted and how much is covered in each audit?

 

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


  How shall we be notified of non-conformances or nondeficiencies? What is the typical response time allowed for initial response to a non-conformance identified during an nonaudit ? Will a non-conformance during the initial assessment nonrequire a partial or follow up assessment to verify corrective action? If yes, what shall be the cost of follow up audits be?

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


 How are disputes with an audit finding handled? Ask them to explain their system. Request a copy of their procedure. How does the registrar ensure consistency of interpretations within their company? If you will one day be going for ISO 14000 or SA 8000, does the registrar support these standards as well? Will the registrar able to combine all these audits?

 

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions to Ask Registrars


  Ask the registrar to explain the details of their billing. When you get a copy of the registrars contract, read it very carefully and try to imagine worst possible scenario.
XXXX reserves the right to increase charges during the certification period approximately 45 days prior to the anniversary date of certificate issuance, XXXX shall notify the client in writing of the annual cost to maintain the certificate
Taste is a Matter of Choice; but Quality is a Matter of Fact

Compliance Essentials
    You can not give someone responsibility without publicly conferring authority to act. If top management does not care, no one else will. If planned meetings are not attended, someone is not serious about their part in compliance. Track the compliance publicly. Publicize status regularly.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Compliance Essentials
   Communicate, communicate, communicate If people do not have time to begin with, they will not have time for compliance. Must complete at least one full internal audit prior to registration audit. Show at least one example of where a nonconformance was identified and corrected. Verify the effectiveness of the corrective action. Use internal audit as a method of training departmental managers and others. As you go through the audit, you explain the basics of that persons responsibility with respect to ISO 9001.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Accreditation in India

NABCB Assessors Registrars


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Publicizing ISO 9001:2000 Registration


 ISO 9001:2008 and certification marks of conformity should not appear on products, product labels or product packaging, or in any way that might be interpreted as denoting product conformity.

Taste is a Matter of Choice; but Quality is a Matter of Fact

Publicizing ISO 9001:2000 Registration


 The management system governing the manufacture of this product is ISO 9001:2008 certified.  The management system governing the provision of this service is ISO 9001:2008 certified.  ISO 9001:2008 certified quality management system.  ISO 9001:2008 Quality Management System.  ISO 9001:2008 certified processes.
Taste is a Matter of Choice; but Quality is a Matter of Fact

Benefits of ISO 9001 Registration


 A Spanish fashion house called Roberto Verino received such positive results from its ISO 9000 implementation that the company has published a book in Spanish entitled Quality as a Strategy: Experience of Roberto Verino.
(IMS 2002)

Taste is a Matter of Choice; but Quality is a Matter of Fact

Questions?

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Taste is a Matter of Choice; but Quality is a Matter of Fact

References
  Cochran, Craig. 2008. ISO 9001 in Plain English. English. Paton Professional; www.patonprofessional.com Cianfrani, Charles A., Tsiakals, Joseph T. and West, John E. Jack. 2009. ISO 9001:2008 Explained. Quality Press, American Society for Quality. Kelly, Bretta. 2009. ISO 9001 Documentation Is Like a Box of Chocolates. Quality Digest. February. www.qualitydigest.com/print/7434 (Accessed on 2 Sept. 2009) Hunt, Lorri., Robitaille, Denise., Williams, Craig. 2008. The Insiders Guide to ISO 9001:2008. Quality Digest. October. www.qualitydigest.com/print/4488 (Accessed on 2 Sept. 2009)

Taste is a Matter of Choice; but Quality is a Matter of Fact