ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS SELF-ASSESSMENT CHECKLIST COMPASS ASSURANCE SERVICES PTY LTD

Transcription

1 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS SELF-ASSESSMENT CHECKLIST COMPASS ASSURANCE SERVICES PTY LTD NOTE: THIS IS A SIMPLIFIED SUMMARY OF THE REQUIREMENTS OF ISO 9001:2008 QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR THE SPECIFIC PURPOSE OF HELPING ORGANISATIONS UNDERTAKE A PRELIMINARY CHECK OF THEIR READINESS FOR AN ISO 9001:2008 AUDIT OR ASSESSMENT.

2 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS SELF- ASSESSMENT CHECKLIST GENERAL MANDATORY PROCEDURES 1. Document Control (as per 4.2.3) 2. Control of Records (as per 4.2.4) 3. Quality Policy (as per 5.3) 4. Internal Audit (as per 8.2.2) 5. Nonconforming Product (as per 8.3) 6. Corrective Action (as per 8.5.2) 7. Preventative Action (as per 8.5.3) KEY RECORDS 1. Management Review (as per 5.6.1) 2. Education, Training, Skills and Experience (as per 6.2.2) 3. Product Realization (as per 7.1) 4. Product Requirements (as per 7.2.2) 5. Design and Development Review (as per 7.3.4) 6. Design and Development Verification (as per 7.3.5) 7. Design and Development Validation (as per 7.3.6) 8. Design and Development Changes (as per 7.3.7) 9. Supplier Evaluation (as per 7.4.1) 10. Validation of Processes (as per 7.5.2) 11. Traceability Records (as per 7.5.3) 12. Customer Property (as per 7.5.4) 13. Calibration and Verification (as per 7.6) 14. Audits and results (as per 8.2.2) 15. Release of Product (as per 8.2.4) 16. Nonconforming Products (as per 8.3) 17. Corrective Actions (as per 8.5.2) 18. Preventative Actions (as per 8.5.3) 1

3 1. SCOPE 1.2 APPLICATION NOTES What is the scope of certification? Are there any exclusions such as sites/branches or business processes? 2

4 4. QUALITY MANAGEMENT SYSTEM 4.1 GENERAL REQUIREMENTS NOTES Have we: (a) determined the processes for the system and how they are to be applied (b) determined how processes interrelate (c) determined how we ensure processes are effective (d) ensured the availability of resources for the system (e) monitored, measured and analysed our processes (f) implemented plans to achieve outcomes and improve 4.2 DOCUMENTATION REQUIREMENTS NOTES GENERAL Do we have: (a) A documented Quality Policy and objectives (b) A Quality Manual (c) Quality Procedures (d) Quality documents and records QUALITY MANUAL Does our manual include: (a) scope (b) procedures (c) description of how processes relate (diagram?) 3

5 4.2.3 CONTROL OF DOCUMENTS Do we have a documented procedure for control of documents including processes to manage: (a) approval (b) review and updates (c) revision status (d) versions (e) legibility (f) required external documents (g) obsolete documents CONTROL OF RECORDS Do we have a documented procedure for control of records including processes to manage identification, storage, protection, retrieval, retention and disposition? Are records legible, identifiable and retrievable? 5. MANAGEMENT RESPONSIBILITY 5.1 MANAGEMENT COMMITMENT NOTES Can we provide evidence that top management demonstrate commitment to the system by: (a) communicating to the organisation importance of meeting customer and regulatory requirements (b) establishing the quality policy (c) conducting management reviews (d) ensure system resources 5.2 CUSTOMER FOCUS NOTES Has top management ensured customer requirements are determined and met? 4

6 5.3 QUALITY POLICY NOTES Have we ensured the Policy: (a) is appropriate to the organisation (b) has a commitment to meet requirements and continually improve the system (c) has a framework to establish and review objectives (d) is communicated and understood (e) is reviewed regularly 5.4 PLANNING NOTES QUALITY OBJECTIVES Have our top management ensured objectives established at relevant functions and levels. Are they measurable and consistent with Quality Policy? SYSTEM PLANNING (a) Has system planning taken place to meet requirements of 4.1 and objectives? (b) Have we ensured the system is maintained when system changes are planned and implemented? 5.5 RESPONSIBILITY, AUTHORITY, COMMUNICATION NOTES RESPONSIBILITY & AUTHORITY Have we ensured responsibilities and authorities defined and communicated? MANAGEMENT REPRESENTATIVE Has someone been appointed who: (a) ensures quality management system processes are established, implemented and maintained (b) reports to top management on system performance (c) ensures awareness of customer requirements Note: this person may also have other responsibilities within the organisation 5

7 5.5.3 INTERNAL COMMUNICATION Have we established communication processes? Do we communicate the effectiveness of our quality management system? 5.6 MANAGEMENT REVIEW NOTES GENERAL Have top management reviewed the system at planned intervals? Have records been maintained? REVIEW INPUTS (a) audits (b) customer feedback (c) process performance and product conformity (d) preventative and corrective actions (e) actions from previous management reviews (f) changes that could affect the system (g) recommendations to improve REVIEW OUTPUTS (a) improvements to the system and processes (b) product improvements (c) resource needs 6. RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES NOTES Have we determined and provided resources to: (a) implement, maintain and continually improve the system (b) meet customer requirements and enhance customer satisfaction 6

8 6.2 HUMAN RESOURCES NOTES GENERAL Personnel are competent on the basis of education, training, skills and experience COMPETENCE, TRAINING AND AWARENESS Do we: (a) determine necessary competence for personnel (b) as applicable train to achieve competence (c) evaluate effectiveness (d) ensure people aware how their activities contribute to quality objectives (e) maintain records of education, training, skills and education 6.3 INFRASTRUCTURE NOTES Have we determined, provided and maintained the appropriate infrastructure such as: (a) buildings, workspace (b) process equipment (such as hardware / software) (c) support services (such as communication and IT) 6.4 WORK ENVIRONMENT NOTES Do we manage the work environment to meet product requirements? (such as noise, temperature, lighting, weather etc) 7

9 7. PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION NOTES Is planning for product realization consistent with 4.1? As appropriate have we determined the following: (a) quality objectives and requirements for our product(s) (b) processes, documents, resources specific to products(s) (c) verification, validation, monitoring, measurement, inspection, test specific to product and acceptance (d) product records (product meets requirements) 7.2 CUSTOMER RELATED PROCESSES NOTES DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT Have we determined: (a) requirements specified by customer (b) requirements necessary for intended use (c) product statutory and regulatory requirements (d) any other product requirements REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT Before we have made a commitment to supply to a client have we ensured: (a) product requirements are defined (b) contract or order requirements are resolved (c) we can meet the defined requirements Do we maintain records of the review and actions arising? CUSTOMER COMMUNICATION Have we effective arrangements to communicate with customers relating to: (a) product information (b) enquiries, contracts, orders (c) customer feedback, complaints 8

10 7.3 DESIGN & DEVELOPMENT NOTES DESIGN & DEVELOPMENT PLANNING During design and development planning, have we determined: (a) design and development stages (b) review, verification, validation at each stage (c) responsibilities and authorities DESIGN & DEVELOPMENT INPUTS Do our inputs include: (a) functional and performance requirements (b) applicable regulatory and statutory requirements (c) information from similar designs (as appropriate) (d) other requirements DESIGN & DEVELOPMENT OUTPUTS Do our outputs: (a) meet the input requirements (b) provide information for purchasing, production and services (c) contain or reference acceptance criteria (d) specify characteristics essential for safe and proper use DESIGN & DEVELOPMENT REVIEW At suitable stages do we review design and development to: (a) evaluate results of design and development to meet requirements (b) identify any problems and propose actions Do we maintain records of results of reviews? DESIGN & DEVELOPMENT VERIFICATION Have we verified that the design and development outputs have met the input requirements? Do we maintain records of the verification? 9

11 7.3.6 DESIGN & DEVELOPMENT VALIDATION Have we validated that the resulting product is capable of meeting the requirements for the intended use (where known)? Do we maintain records of the validation? CONTROL OF DESIGN AND DEVELOPMENT CHANGES Are changes reviewed, verified and validated (as appropriate) before implementation? Do we maintain records of the review of changes and necessary actions? 7.4 PURCHASING NOTES PURCHASING PROCESS Do we ensure purchased products conform to requirements? Have we evaluated and selected suppliers based on our requirements? Have we established criteria for selection, evaluation and re-evaluation? Do we maintain records of evaluations and necessary actions? PURCHASING INFORMATION Does our purchasing information describe the product to be purchased including (where appropriate): (a) requirements for approval (b) requirements for qualification of personnel (c) quality management system requirements VERIFICATION OF PURCHASED PRODUCT Do we have processes to ensure purchased products meet requirements? 10

12 7.5 PRODUCTION & SERVICE PROVISION NOTES CONTROL OF PRODUCTION & SERVICE PROVISION Do we plan and carry out production under controlled conditions including as applicable: (a) availability of information describing product characteristics (b) work instructions/operating procedures (c) suitable equipment (d) monitoring and measurement equipment (e) monitoring and measurement implemented (f) product release, delivery and post-delivery activities VALIDATION OF PROCESSES FOR PRODUCTION & SERVICE PROVISION Do we validate processes for production and service provision where the resulting output cannot be verified by monitoring or measurement (such as when the verification process would destroy the product) Eg: casting, forging, bending For these processes do we have established arrangements such as: (a) criteria for review and approval of process (b) approval of equipment and qualification of personnel (c) approved methods/procedures (d) records (e) revalidation IDENTIFICATION & TRACEABILITY Do we have processes to identify the product throughout realization (as appropriate)? Do we identify product status throughout realization? Where traceability is required do we control unique identification of the product and maintain records? 11

13 7.5.4 CUSTOMER PROPERTY Do we identify, verify, protect and safeguard customer property provided to us? Do we report and maintain records if customer property is lost, damaged or found to be unsuitable? PRESERVATION OF PRODUCT Do we preserve the product and its constituent parts during internal processes and delivery? 7.6 CONTROL OF MONITORING & MEASUREMENT EQUIPMENT Have we determined the monitoring and measurement activity required and the equipment needed to perform the activities? Have we established monitoring and measurement processes? Is measuring equipment: (a) calibrated or verified at specific intervals (b) adjusted as necessary (c) identifiable to confirm calibration status (d) safeguarded to ensure accuracy (e) protected from damage and deterioration Do we re-assess validity of previous measurements when equipment is found not to conform and take appropriate action on product and equipment affected? Do we maintain records of calibration and verification? NOTES 12

14 8. MEASUREMENT, ANALYSIS & IMPROVEMENT 8.1 GENERAL NOTES Do we plan and implement monitoring, measurement, analysis and improvement processes to: (a) demonstrate conformity to product requirements (b) ensure conformity to our quality management system (c) continually improve the quality management system 8.2 MONITORING & MEASUREMENT NOTES CUSTOMER SATISFACTION Do we monitor customer perception information and have we determined our methods for obtaining and using this information? INTERNAL AUDIT Do we conduct internal audits at planned intervals to determine whether the quality management system: (a) conforms to planned arrangements (as per 7.1), ISO 9001 and our quality management system (b) is effectively implemented and maintained Have we developed an audit programme taking into consideration importance of processes/areas and findings of previous audits? Have we defined criteria, scope, frequency and methods? Do we have a documented procedure that defines responsibilities and requirements for planning and conducting audits, reporting results and records? Do we maintain records of audits and results? MONITORING & MEASUREMENT OF PROCESSES Do we apply suitable methods for monitoring and/or measurement of quality management system processes? When planned results are not achieved is suitable correction and corrective action taken? 13

15 8.2.4 MONITORING & MEASUREMENT OF PRODUCT Do we monitor and measure the characteristics of the product to verify that product requirements have been met throughout the realization process? Do we maintain evidence of conformity with criteria? Do we maintain records of person(s) authorizing release of product to customer? 8.3 CONTROL OF NONCONFORMING PRODUCT NOTES Do we ensure nonconforming products are identified and controlled to prevent unintended use? Do we have a documented procedure that defines the controls and responsibilities/ authorities and processes for nonconforming products? Do we re-verify corrected products to demonstrate conformity? Do we maintain records of nonconformities and action taken? 8.4 ANALYSIS OF DATA NOTES Do we collect and analyse data relating to: (a) customer satisfaction (see 8.2.1) (b) product conformity (see 8.2.4) (c) processes and product trends including opportunities for preventative action (see and 8.2.4) (d) suppliers (see 7.4) Do we use this for the continual improvement and effectiveness of the quality management system? 8.5 IMPROVEMENT NOTES CONTINUAL IMPROVEMENT Do we continually improve the system through the use of the quality policy, objectives, audits, analysis of data, corrective and preventative actions and management review? 14

16 8.5.2 CORRECTIVE ACTION Do we take action to prevent the causes of nonconformities? Do we have a documented procedure that defines requirements for: (a) reviewing nonconformities (including complaints) (b) determining causes (c) evaluating action to ensure non recurrence (d) determining and implementing actions (e) records of results of actions taken (f) reviewing effectiveness of corrective action taken PREVENTATIVE ACTION Do we take action to prevent the causes of potential nonconformities? Do we have a documented procedure that defines requirements for: (a) determining potential nonconformities and their causes (b) evaluating need for action (c) determining and implementing actions (d) records of results of actions taken (f) reviewing effectiveness of preventative action taken 15