2. Neoteric Enterprises Inc. ISO 9001 - Quality Management Systems

3. ISO 9001 - An Introduction ISO stands for International Organization for Standardization. ISO 9001:2008 is an international standard for the implementation and management of a quality assurance system. ISO is the only series of standards of this nature that are accepted for accreditation by a government body (the Standards Council of Canada).

4. ISO 9001 - General Overview The ISO Quality Management Standards have been around since 1987 and have quickly become a major element of supplier management strategy for business along with becoming the central regulatory approach for many jurisdictions.

5. ISO 9001 - General Overview An example of the impact created by the initiation of ISO Standards is that most government, military, European, and multi-national company contracts make it mandatory to possess registration to one (or more) of the standards.

6. ISO 9001 - General Overview As well, in the late 1990’s, the three major North American automotive companies (GM, Ford, and Chrysler) made it mandatory for all of their first tier suppliers (23,000) to acquire ISO/TS 16949 (formerly known as QS 9000) registration (a customized version of the ISO 9001 standard).

7. ISO 9001 - General Overview In the years since the introduction of ISO 9001, several issues have arisen, including the application of the standards to cover services, software development, pharmaceutical, processing industries, the concept of an expanded stakeholder accountability beyond customers, the needs of the smaller organizations, and the needs of other specialized industry sectors, such as Medical Devices (ISO 13485) and Aerospace (AS 9100).

8. ISO 9001 - The Quality Loop Customer/ Consumer Producer/ Supplier Marketing and Market Research Disposal after Use Sales and Distribution Design/Specification Engineering and Product Development Procurement Process Planning And Development Production Inspection, Testing, And Examination Packing and Storage Installation and Operation Technical Assistance and Maintenance

9. ISO 9001 - Objectives The objectives of any good quality management system are the following: Assure that the customer receives the service or product that is expected and remains satisfied Prevent errors in all operations Prevent delivery delays Reduce costs of operation Increase productivity Increase the reliability of service or product Meet all the quality requirements specified by the customer

10. ISO 9001 - Prerequisites of a Quality Management System Whatever the definition of quality, one must first focus on three fundamental elements: Quality Policy, Quality Management, and Quality System.

11. ISO 9001 - Prerequisites of a Quality Management System Quality Policy: Overall quality objectives and direction of an organization pertaining to key elements of quality such as fitness for use, performance, safety and reliability, as formally expressed by top management.

12. ISO 9001 - Prerequisites of a Quality Management System Quality Management: That aspect of the overall management function that establishes and implements the quality policy.

13. ISO 9001 - Prerequisites of a Quality Management System Quality System: The organizational structure, responsibilities, procedures, processes, and resources used for implementing quality management.

14. ISO 9001 - The Philosophy Basically, there are two mindset approaches to ISO 9001 registration. First, to view the ISO 9001 standard as an entity that needs to be addressed sooner or later. This first approach is invariably and primarily motivated by a commercial / marketing / business set of convictions.

15. ISO 9001 - The Philosophy The other approach sees the ISO 9001 standard as something more than just a model for quality assurance. This philosophy will more often than not see in ISO 9001 an opportunity to improve managerial style. Most experts speak of ways in which the ISO 9001 model can help a company reduce internal cost and/or increase efficiency thereby boosting profits.

16. ISO 9001 - Documentation Policies, Procedures, and the Manual: Basically, the quality documentation consists of varying stages or tiers. There are typically 3 or 4 tiers comprised of different levels of information.

17. ISO 9001 - The Documentation Pyramid Tier 1 Tier 2 Tier 3 Tier 4 States Policy and Objectives for each of the pertinent ISO elements Departmental Procedures & responsibilities Forms, Work Instructions & Equipment Instructions Business supporting documents

18. ISO 9001 - Documentation Tier 1 consists of the Quality Policy, business unit policies and objectives.

19. ISO 9001 - Documentation Tier 2 consists of the departmental procedures and responsibilities for each of the pertinent ISO elements. (It is the combination of Tiers 1 & 2 which comprise the Quality Manual)

20. ISO 9001 - Documentation Tier 3 consists of the procedures reflecting the individuals’ day-to-day business activities (Work Instructions, Plant Equipment Instructions, etc.).

21. ISO 9001 - Documentation Tier 4 (sometimes not applicable) consists of any business supporting documentation (Accounting data, scheduling, etc.).

22. ISO 9001 - Execution When people realize that a significant portion of the executing efforts required to achieve registration consist of documenting what you say you do, some individuals develop an allergic reaction to ISO (my paperwork is going to triple, I’ll need to write a memo just to go to the washroom, etc.).

23. ISO 9001 - Execution The real issue lost here is total quality management. To achieve that objective, everyone must be involved to solve a multitude of problems which may have accumulated over several years. And if your amount of paperwork increases significantly, then the implementation of the Quality Management System was incorrect.

24. ISO 9001 - Execution Such criticisms are not well founded for several reasons. First of all, the ISO standard is a model for the management of a quality assurance system designed to insure that at a minimum, a series of steps are taken to ensure that you do indeed satisfy your customer requirements.

25. ISO 9001 - Execution Whereas it is true that ISO 9001 will never question your technical ability to satisfy your customer specifications, some of its paragraphs have specifically been written to verify that you have an effective system in place to do so.

26. ISO 9001 - Execution Role of Employees: In its simplest form, by saying what they do and doing what they say, the employees effectively ensure the continued success of any quality system. This holds true for ISO 9001 as well. In fact, it is the foundation upon which registration lies.

27. ISO 9001 - Execution Role of the Internal Quality Assurance Individual(s): The requirement for internal audits is clearly specified by ISO 9001. To ensure compliance, most companies enroll their designated quality assurance individual(s) into one of the many Quality Auditor courses currently offered by the few “officially approved” agencies or Registrars. The individual(s) shall also be responsible for the upkeep and maintenance of all the documentation included in the company’s quality manual and quality records, ensure that the system continues to function effectively over time, and act as the main liaison with the Registrar.

28. ISO 9001 - Execution Role of the Registrar: Once the quality assurance system has been documented, implemented and checked, an accredited Registrar must be consulted to conduct a review of the quality manual and to perform a third party audit. Accreditation in Canada is granted by the SCC (Standards Council of Canada). At present there are around 16 accredited registrars in Canada alone.

29. ISO 9001 - Execution As most businesses begin to implement a quality assurance system, they quickly notice that a vast network of internal customer/supplier relationships begin to develop. When done properly and in a spirit of cooperation, the setting- up of an ISO 9001 quality assurance system can lead to a sharing and exchange of information across previously impermeable departmental barriers.

30. ISO 9001:2008 - The Standard The ISO 9001:2008 Standard consists of 5 main sections addressing some 23 different ‘main’ elements of compliance.

31. ISO 9001:2008 - The Standard The Main Sections: Section 4 - Quality Management System Section 5 - Management Responsibility Section 6 - Resource Management Section 7 - Product Realization Section 8 - Measurement, Analysis and Improvement Section 1 identifies the ‘Scope’ of the standard, Section 2 deals with the ‘Normative Reference’ of the standard, and Section 3 addresses the ‘Terms and Definitions’ of the standard.

32. ISO 9001:2008 - The Standard Section 4 - Quality Management System: This Section deals with the establishment, implementation, and maintenance of the QMS with regards to the control of documentation and records Section 5 - Management Responsibility: This Section serves to provide evidence of management’s commitment to the development and implementation of the QMS and to continually improve its effectiveness Section 6 – Resource Management: This Section covers the organization’s provision of requirements such as Human Resources, Infrastructure, and Work Environment

33. ISO 9001:2008 - The Standard Section 7 - Product Realization: This Section serves to confirm how the organization plans and develops the processes needed for product realization Section 8 - Measurement, Analysis and Improvement: This Section deals with the planning and implementation of the monitoring, measurement, analysis and improvement processes needed to (a) demonstrate conformity of the product, (b) ensure conformity of the QMS, and (c) continually improve the effectiveness of the QMS

34. ISO 9001 - The Strategy Basically there are 6 working phases to successfully map out any worthwhile Quality Management System:

35. ISO 9001 - The Strategy * Phases * System Investigation – existing processes System Analysis – gap analysis System Design – format and content System Development – new processes System Implementation – launch and audit System Maintenance – document control, calibration, preventive maintenance, corrective & preventive action, data analysis, internal auditing and management review

36. ISO 9001 - Summary study current documentation conduct interviews and/or perform surveys observe individuals actually performing the activities create new documentation meet with executive management of responsibility to critique & approve the new documentation finalize and control new documentation train all staff perform internal audits of the ISO 9001:2000 Standards’ elements identify all major and/or minor non-conformances recommend corrective actions perform ‘follow-up’ internal audits to confirm the effectiveness of the corrective actions have the Quality Manual reviewed and approved by an accredited ISO Registrar have the QMS audited by the Registrar

37. ISO 9001 - Summary Basically, for a company to achieve Registration to an ISO Standard, it’s quite simple: “Comply to the Standard, say what you do, and do what you say…”