1	"ISO 9001:2008 –" ISO 9001:2008 – Have You Updated Your QMS? Theresa McCarthy 04 February 2010
2	Background ISO 9001 first published 1987 Then…..1994 ISO 9001: 2000 Technical Revision 15 November 2008 is an Amendment- Clarify points in the text Enhance compatibility with ISO 14001:2004 700,000 worldwide certified 50,000 North America certified
3	Agenda Reason for Amendment Review Changes Did your QMS need Clarification?
4	Reason for Amendment ISO Periodic Review Process Initiated within 5 years of publication Provides greater clarity on requirements and Notes Incorporates 37 sanctioned interpretations from review Ease of Use with ISO 14001:2004 Your QMS What is your stated periodic review?
5	Introduction 0.1 General Adoption of a qms should be a strategic decision of an organization influenced by “organizational environment (business)” Change in that environment Risks associated with that environment Includes “statutory requirements” Applicable to the product
6	0.2 Process Approach For an organization to function effectively, it has to Determine and manage numerous linked activities To identify is to recognize To determine is to apply reason More analysis An activity or set of activities using resources …can be considered as a process Clarified process
7	Process Approach The application of a system of processes, together with identification and interaction and their management “ To produce the desired outcome” Safety Identity Safe and Effective Strength Purity Quality
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9	ISO 9001:2008 No longer refers to the two standards as having “similar structures” Designed to complement each other 9004 Provide guidance to management for achieving sustained success for an organization in a complex, demanding, changing environment. Not intended for certification
10	0.4 Compatibility with other QMS Update reference to ISO 14001:2004 Prior 1996 Annex A Shows correspondence between ISO 9001:2008 and ISO 14001:2004
11	1.0 Scope Includes “Statutory” and “Regulatory” What statutory requirements does your organization need to comply with?? AS9100 “It is emphasized that the qms requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements.
12	Note 1 The term product used to say A product intended for or required by, a customer New added…Note 1 Any intended output resulting from the product realization processes.
13	Note 2 Statutory and regulatory requirements can be expressed as legal requirements.
14	2 Normative References The following referenced documents For dated references only the cited edition applies. For undated references, the latest edition of the referenced document (including amendments) applies ISO 9000:2005 “Vocabulary”
15	3 Terms and Definitions No longer explain supply chain terms Supplier, subcontractor Organization, supplier For the purposes of this document (Intl Standard) – used to say
16	4 Quality Management System Identify has been replaced with Determine To identify is to recognize To determine ……more analytical
17	4 Quality Management System Monitor, “measure” where applicable…. Processes are monitored … Not always measured C2Q parameters Speed, agitation, temperature Others
18	4 Quality Management System Note 1 Deleted “should” Do include processes for management of activities, provision of …product realization and measurement analysis and improvement Consistency of titles and emphasize all qms processes
19	4 Quality Management System Note 2 - ?? Did it Need Explanation??? An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. Contract Laboratory HEPA Filter Recertification Purchasing-Corporate NJ Training
20	4 Quality Management System Note 3 Type and extent of control to be applied to the outsourced process can be influenced by Potential impact to provide conforming product Degree to which the control for the process is shared 7.4 – Capability of achieving necessary control Semiconductor??
21	4 Quality Management System 4.1 Outsourced processes Note 3: The type and extent of control to be applied to these outsourced processes shall be defined Quality Agreement? Purchase Order? ISO 13485- refers (8.5.1) Ensure continued suitability and effectiveness
22	Documentation Requirements 4.2.1 c. Documents and “Records” not a standalone sub clause (word determined again.) Note that a procedure can address more than one requirement Depends complexity Design Control Procedure Design Verification Procedure ECO Procedure
23	External Documents 4.2.3 Control of Documents Determined to be necessary for the planning and execution of the qms AAMI, ASTM, ANSI, ISO Does Doc Control SOP address control of external standards???
24	4.2.4 Control of Records Maintained (good condition) Shall be Controlled (regulate use) Identify Store Off Site – Retrievable Inspection
25	5.5.2 Management Representative “A member of the Organization’s management…. Any MRs here??
26	6.2.2 Competence Training Awareness Can be affected directly or indirectly by personnel performing (affecting conformity to product requirements) any task within qms Your Training Requirements Direct Indirect Both??? Where applicable…provide training May not be necessary
27	6.3 Infrastructure C. Shall determine and provide Support services including information systems
28	6.4 Work Environment Shall determine provide and maintain. Relates to conditions under which work is performed. Examples provided in Note: Noise Temperature Humidity Lighting Weather Environmental Monitoring????? Printing Pantone Matching System (PMS)
29	7 Product Realization 7.1 Planning of Product Realization Required V & V Added Measurement 7.2 Determination of Requirements related to Product Note added: Post Delivery Activities Actions under warranty Service contracts Final Disposal Any hazardous waste Destruction corporate identity??
30	Design and Development 7.3.1 Design and Development Planning Note added “Can be conducted and recorded separately or in any combination” Design Review Verification Validation
31	7.3 3 Design Outputs Form suitable for verification Versus Enable verification Note added to include preservation of product Packaging of product Drop Ship Testing
32	7.5.1 and 7.6 Control of “Equipment” ?Devices broader” Narrow scope Have identification In order to determine its cal status Status tags – Frequency, Critical, noncritical, reference Removed reference to ISO 10012 Note: Confirmation of software includes verification and configuration mgt Version control - wrong load in instrument what would happen??
33	8 Measurement Analysis and Improvement 8.1 “To Demonstrate Conformity to product requirements” (versus) 8.2.1 Note added: Monitoring customer perception can include input from surveys, data, Lost business, compliments, warranty and dealer reports
34	8.2.2 Internal Audit Plan, Perform, Establish Records and Reports “any necessary corrections and corrective actions” (not just actions) Immediate Long term Note - ISO 19011 Guidance (10011)
35	8.2.3 Monitoring and Measurement Process Note added to Consider type and extent of M&M appropriate to each process.. Based on impact Contamination???? Are Alarms Needed? More samples taken??
36	8.2.4 Monitoring and Measurement Product The release of product and delivery of service to the customer shall not proceed until.. Product release and service delivery shall not proceed until… (to the customer not in process)
37	8.3 Control of Nonconforming Product The sentence now begins with A documented procedure shall be established… Versus Ending in Shall be defined in documented procedure ??stronger??
38	8.4 Analysis of Data C. characteristics and trends of processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4) D. Suppliers (see 7.4)
39	8.5.2 Corrective and 8.5.3 Preventive Action Review the Effectiveness of Corrective Actions
40	Annexes A – ISO 14001:2004 B – Text changes from ISO 9001:2000 to ISO 9001:2008
41	Summary No new requirements Opportunity to Clarify Requirements Can your organization benefit??? Can your internal audit team benefit??
42	Thank You Thank you for your participation. Theresa.McCarthy@comcast.net