SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS MANUAL INCLUDES A LIST OF TOPICS AND FORMS

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1 US$ How to Order: Online: By Phone: ISO 9001 Quality Procedures For Quality Management Systems The Bizmanualz ISO 9001 Quality Procedures for Quality Management Systems provides you with easy to use Quality Procedures for ISO 9001 implementation. You will learn what ISO 9001 is all about, how to produce an ISO 9001 Quality Manual, and how to write ISO 9001 Quality Procedures. The Bizmanualz ISO 9001 Manual comes with practical documentation in proper ISO format and reflects 2008 changes to the standard. You also get a detailed explanation of ISO 9000 and helpful information and guidance on producing your own QMS quality manual. Includes five (5) modules: Instant download 1. Introduction and Table of Contents Available immediately 2. Guide to preparing a well written (no shipping required) manual 3. A Sample Quality Manual covering common requirements and practices Policies and 48 corresponding forms 5. Complete Index Sample Policy from ISO 9001 Quality Procedures For Quality Management Systems Document # QP1010 Revision # 0.0 Quality Procedures Section: Record Control Title RECORD CONTROL Prepared By Print Date Date Prepared Effective Date Reviewed By Date Reviewed Standard ISO 9001:2008, clause Approved By Date Approved Policy: Purpose: Records shall be established and maintained to provide evidence of the effective operation of the Company's Quality Management System (QMS). Demonstrate conformance to specified requirements and effective operation of the QMS; describe/explain how QMS records are to be maintained.

2 Document # QP1010 Scope: Responsibilities: Definitions: Title RECORD CONTROL Print Date Records are generated and analyzed to determine if a given process is achieving stated objectives and meeting process criteria and to determine defects for correction or if a trend indicates corrective action is needed. This procedure applies to all records regardless of their form that serve to record the Company s activities related to product/service quality and are required to demonstrate implementation of and conformance to the Company s QMS. Document Control is responsible for maintaining a list of the Company's quality records and controlling quality record distribution. All personnel are responsible for ensuring records they generate are accurate, timely, and legible. Record Anything retained to provide and preserve permanent evidence of, or information about, an event (e.g., physical or electronic document, photograph, or product sample). Procedure: 1.0 IDENTIFICATION OF QUALITY RECORDS 1.1 Typically, when a form either hard copy or electronic is filled, it becomes a quality record. Completed forms are controlled documents and are, therefore, part of the Company's document control system (see QP1000 DOCUMENT CONTROL). 1.2 Each Company department or functional group shall be responsible for generating and maintaining adequate records to demonstrate effective operations, as defined specifically by each QMS procedure, and to show conformance to customer, regulatory, and standards-based requirements. 1.3 Blank forms should be consistently formatted and grouped by department and/or function. Blank forms may be centrally located or distributed to departments, depending on the Company's needs. (The Company may choose to "distribute" blank forms via its intranet, for standardization and control purposes.) 1.4 Quality records shall contain the following, at a minimum: When the record was created (date and, if necessary, time of day); Information on the thing, situation, or event; and A unique record identifier. 1.5 Document Control shall maintain a QP QUALITY RECORDS LIST, a complete list of the Company's quality records. The QP should contain the following for each quality record: A unique identifier (e.g., sequentially numbered ID);

3 A description of the record; The location of the quality record; Minimum retention time; and Directions for record disposition. NOTE: Records required by ISO 9001 are indicated with the applicable clause number on the QP sample form at the end of this procedure. 2.0 RECORD GENERATION 2.1 Every employee may generate quality records in the course of performing their normal duties (e.g., production monitoring logs, receiving logs). Such records should be identified within an appropriate QMS procedure. Electronic records of quality management activity may be generated automatically (see QP1210 MONITORING AND MEASUREMENT OF PROCESS, QP1220 MONITORING AND MEASUREMENT OF PRODUCT; also see Reference "C"). 2.2 All quality records must be accurate, timely, legible, and readily accessible for reference and verification purposes. 2.3 Hardcopy quality records should be completed in ink or on word processing software, to help ensure legibility and to help protect them from unauthorized change. Electronic quality records should be write-protected and access restricted to enforce change control; Document Control or other manager-department authorized by Top Management should control access to electronic records. 2.4 Individual quality records should not be changed, as a rule. If necessary, changes or corrections to hardcopy records should be made with a single line through the incorrect entry. The change/correction should be written in ink and dated and initialed by the person making the change. Correction fluid or tape should not be used. Electronic records should not be changed. Instead, "corrections" should be initiated by Management. Disposition of old electronic records (purging, reversing, archiving, etc.) should be a matter of Company policy. 3.0 RECORD MAINTENANCE 3.1 The authority associated with a particular quality record (e.g., Production Manager for production records) shall ensure that records are maintained in an environment that prevents their damage, deterioration, alteration, or loss. Document Control shall control access to hardcopy, electronic, and other records (see References"). Relative to their importance to the Company, records should be backed up periodically in accordance with business, customer, and statutory/regulatory requirements.

4 3.2 Document Control shall ensure that quality records are readily retrievable. Records shall be made available for customer and/or regulatory review, in accordance with all contractual and regulatory requirements. Records shall be made available to auditors, as required by ISO 9001 and other applicable standards (e.g., ISO 14001). Records shall be available to employees for the purposes of monitoring, measurement, and trend analysis. Inactive quality records may be archived before minimum retention times are reached, if circumstances warrant. Archived records must be controlled and maintained and should be reasonably retrievable. 3.3 Quality records shall be retained for no less than the period of time required by applicable statutes, regulations, and/or contractual requirements. Unless otherwise indicated, quality records shall be disposed after their minimum retention time is attained (see QP QUALITY RECORDS LIST). Effectiveness Criteria: Quality records verify the Company's conformance to requirements Records are accurate and up-to-date References: A. ISO 9001:2008, Quality Management Systems-Requirements, International Organization for Standardization (ISO), Nov., B. Statutory/Regulatory Requirements The Company should be familiar with and be able to demonstrate conformance to applicable statutes and regulations pertaining to recordkeeping and control of records. Examples of laws governing recordkeeping include: The Eighth European Union (EU) Directive; Financial Instruments and Exchange Law (Japan); The Public Company Accounting Reform and Investor Protection Act of 2002, also known as "Sarbanes-Oxley" or "SOX" (USA); and Title 40, Code of Federal Regulations, Protection of the Environment (USA). C. Computer and Network Policies, Procedures, and Forms, Bizmanualz (ABR34M, ISBN-10 # ). Forms/Records:

5 Form # Required by ISO 9001:2008 Record/Form/Activity Name Satisfies ISO 9001 Clause Other Forms/Records QP Quality records list Revision History: Revision Date Description of changes 0.0 MM/DD/YY Initial Release Requested By

6 QP QUALITY RECORDS LIST ISO 9K Clause Record 1 Location 2 Minimum Retention Management Review records Administration 6.2.2(e) Records of employee training, education, skills, and experience Employee files (HR) Employment plus 7.1(d) Product Realization records (evidence that realization process, product meet requirements) Record of product requirement review (prior to committing to customer, review their requirements and keep record of review) Record of design & development (D&D) inputs pertaining to product requirements Record of results of D&D reviews Record of results of D&D verification and necessary actions Record of results of D&D validation and necessary actions Record of results of D&D change reviews (i.e., changes after the product is released) Record of results of supplier evaluations (and necessary actions arising from evaluations) Supplier file 7.5.2(d) Records to demonstrate validation of processes where process output (product) cannot be verified by subsequent monitoring/measurement (and deficiencies appear only after product/service is delivered/in use) Product file Product identification record (where traceability is a requirement) Product file Records of customer property that is lost, damaged, or found unsuitable for use Customer file 7.6 Results of calibration (verification) of monitoring & measuring (M&M) devices Maintenance 7.6 Validity of previous measurement results when M&M devices are found not conforming to requirements (i.e., are not accurate) Maintenance 7.6(a) Basis for calibration & verification of M&M devices where no international, national, or industry standard exists Maintenance 1 Records on this list are required by ISO 9001 (clause numbers are in first column); seek the advice of qualified legal counsel regarding statutory/legal recordkeeping requirements. 2 Location indicates who has responsibility for maintaining the files as much as where they re kept. 3 Retention periods shown are guidelines; your customer, regulatory, etc., requirements may differ.

7 ISO 9K Clause Record 1 Location 2 Internal Audit reports (results of the audit and followup activities) Record of person(s) authorizing release of a product (or service) to customers Nature of product nonconformities and actions taken as a result (e.g., nonconformance report, correction report), including concessions obtained Quality Quality Minimum Retention Records of results of corrective actions Quality Records of results of preventive actions Quality

8 ISO 9001 Quality Procedures For Quality Management Manual: 23 Prewritten Policies and Procedures Quality Procedures 1. Document control 2. Record control 3. Internal audits 4. Control of non-conforming product/material 5. Corrective action 6. Preventive action 7. Management reviews 8. Competence, training, and awareness 9. Sales orders 10. Project definition 11. Design and development 12. Design change 13. Vendor evaluation 14. Preproduction planning 15. Manufacturing 16. Identification and traceability 17. Customer property 18. Control of monitoring and measuring equipment 19. Process monitoring and measurement 20. Customer satisfaction 21. Data analysis and continual improvement 22. Receiving and inspection 23. Purchasing 48 Corresponding Forms and Records 1. Document Request 2. Document Control File 3. Quality Records List 4. Audit Program 5. Audit Plan 6. Quality Audit Checklist 7. Final Audit Report 8. Nonconformance Report 9. Nonconforming Material Log 10. Return Goods Authorization 11. Corrective Action Report 12. Corrective Action Log 13. Preventive Action Report 14. Preventive Action Log 15. Management Review Meeting 16. Employee Competence Matrix 17. Employee Development Plan 18. Group Training Record 19. Individual Training Record 20. Sample Job Descriptions 21. Customer Order Form 22. Project Plan 23. Design Review Checklist 24. Design Completion Checklist for Electromechanical Devices 25. Design Completion Checklist for Non- Electromechanical Devices 26. Sample verification checklist 27. Product test 28. Engineering change notice 29. Approved vendor list 30. Vendor audit checklist 31. Critical vendor-contractor evaluations 32. Vendor performance log 33. Product design release 34. Inspection/testing checklist 35. Product release authorization 36. Material return notice 37. Calibration record 38. Calibration database 39. Post-sale satisfaction report 40. Customer satisfaction survey 41. Customer service log 42. Receiving log 43. First article inspection report 44. Receiving inspection report 45. Purchase requisition 46. Purchase order form 47. Purchase order log 48. Purchase order follow-up