ISO 9001 QMS Implementation Workbook

Transcription

1 ISO 9001 QMS Implementation Workbook Contents Section 1: Introduction to the ISO 9001 Standard Section 2: ISO 9001:2015 Documentation Requirements Section 3: Project Plan Section 4: ISO 9001:2015 Document Templates Section 5: The Process of Implementing ISO 9001 Section 6: Quality Management System Compliance Checklist Section 7: Final Steps Section 8: ISO 9001 Certification Process 1

2 Communication Relevant Documented Information Monitoring of Processes Continual Improvement ISO 9001 Requirements Retaining Documented Information Review of the Processes & QMS Appropriate Corrective Action Assessing Risk and Opportunities The ISO9001:2015 Standard consists of the following sections: Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Context of the Organization Section 5: Leadership Section 6: Planning Section 7: Support Section 8: Operation Section 9: Performance Evaluation Section 10: Improvement. 7

3 confidence that your products will meet their needs and increase their satisfaction. Continual improvement is the process focused on continually increasing the effectiveness and/or efficiency of the organization to fulfil its policies and objectives. Typical factors that are useful to consider when identifying measures of process control and process performance include: Product/Service Conformity with requirements Customer satisfaction Supplier performance On time delivery Lead times Incident numbers and Failure rates Percentage Waste Process costs Order completion What is the difference between a process and a procedure? A process may be explained as a set of interacting or interrelated activities, which are employed to add value. A procedure is a method of describing the way or in which all or part of the process activities should be performed. ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process", which does not necessarily have to be documented. When initially starting to use ISO 9001, you should familiarize yourself with the Quality Management System standards, especially ISO 9000, ISO 9001 and ISO 9004, and consider their requirements. If you wish to proceed to certification, you should follow our guides and checklists and implement the 10

4 Types of documents that are useful: Process maps, process flow charts and/or process descriptions Organization charts Specifications Work and/or test instructions Documents containing internal communications Production schedules Approved supplier lists Test and inspection plans Quality plans The management of an organization should be able to view the adoption of the ISO9001 Quality Management System standards as a profitable business investment, not just as a required certification issue: The discipline of the standard drives the connection of quality management systems to organizational processes The disciplines involved give improved organizational performance, by: Using the 8 Quality Management Principles Using a "process approach" Commitment from Top management Using measurable objectives A focus on "continual improvement" and "customer satisfaction" Measurement of the quality management system effectiveness Assessing resource requirements Assessing risks and opportunities 19

5 Section 3: ISO 9001 Implementation Plan When developing an ISO 9001 Quality Management System you will need to have an implementation plan. Here is a template that you can use: Project Planning Tasks Responsibility Comments Top management commit to 1 implementing ISO 9001 A copy of the ISO 9001 Standard is 2 purchased Top Management decide on the scope 3 of the quality management system The Management becomes familiar 4 with the ISO 9001 Standard The Management becomes familiar 5 with the Implementation and training presentations The Management becomes familiar 6 with the Quality Management System Procedures and Record Templates The Management becomes familiar 7 with the ISO 9001 Implementation workbook 8 Top management Confirm their Due Date for Completion Date Completed 21

6 Section 4: Documented Information The package includes document templates that cover the requirements of the ISO 9001:2015 standard: Quality Management System Section 1 Section 2 Section 3 Section 4 Section 4.1 Section 4.2 Section 4.3 Section 4.4 Section 5 Section 5.1 Section Section 5.2 Section 5.3 Section 6 Section 6.1 Section 6.2 Section 6.3 Section 7 Section 7.1 Section Section Section Section Scope Normative References Terms and Definitions The Organization The Organization and its Context Needs and Expectations of Interested Parties Scope of the Quality Management System Quality Management System Processes Leadership Leadership and Commitment Customer focus Quality Policy Organizational Roles, Responsibilities and Authorities Risks and Opportunities Quality Objectives Planning of Changes Resources General Resources People Infrastructure Planning Support Environment for Operations 27

7 Section Section Section 7.2 Section 7.3 Section 7.4 Section 7.5 Section Section Section Section 8 Section 8.1 Section 8.2 Section Section Section Section Section 8.3 Section Section Section Section Section Section Section 8.4 Section 8.5 Section Monitoring and Measuring Resources Organizational Knowledge Competence Awareness Communication Documented Information General Documented Information Requirements Creating and Updating Control of Documented Information Operation Operational Planning and Control Requirements for Products and Services Customer Communication Determining Requirements for Products and Services Review of requirements for Products and Services Changes to Requirements for Products and Services Design and Development of Products and Services General Design and Development Process Design and Development Planning Design and Development Inputs Design and Development Controls Design and Development Outputs Design and Development Changes Control of Externally provided Processes, Products and Services Production and Service Provision Control of Production and Service Provision 28

8 Section Section Section Section Section Section 8.6 Section 8.7 Section 9 Section 9.1 Section Section Section Section 9.2 Section Section Section 9.3 Section Section Section Section 10 Section 10.1 Section 10.2 Section 10.3 Identification and Traceability Property Belonging to Customers or External Providers Preservation Post-Delivery Activities Control of Changes Release of Products and Services Control of Nonconforming Outputs Performance Evaluation Monitoring, Measurement, Analysis and Evaluation General Requirements Customer Satisfaction Analysis and Evaluation Internal Audit Internal Audits Scope Internal Audits Programme Management Review Top Management Review Management Review Inputs Management Review Outputs Improvement Opportunities for Improvement and Actions Nonconformity and Corrective Actions Continual Improvement 29

9 In this section there are examples of the documented information required by ISO 9001: 4.3 The scope of the organization s quality management system shall be available and be maintained as documented information. 30

10 Section 5: Stage 5 Process of Implementing a Quality Management System Process Owner Example Planning Process Owner Planning Manager Responsibe for: implementation of the planning process maintenance of the planning process improvement of planning process Interacting effectively with Sales and Production Processes and Owners Objectives from Company Objectives are: 100% Accurate Production Plan 100% Order Completion < 1% Wastage 59

11 Section 6: Quality Management System Compliance Analysis The following checklist should now be used to check that your Quality Management System complies with the requirements of the ISO 9001 Standard and identify gaps in your system that need to be filled. Based on your findings use the template to formulate an action plan: Read each clause in the standard carefully and complete this form to assess if your system meets the requirements of the standard, firstly identifying your relevant processes and process owners, current activities and existing documentation (including the templates provided). Decide what future actions are required to ensure compliance. Allocate Responsibility and formulate an action plan. ISO 9001 Clause ISO 9001 Requirement Process and Process Owner Current Activities Existing Documents ISO 9001 Section 4 Context of the organization Action Required to Comply Responsibility Completion Date External and internal issues determined Information about issues monitored and reviewed Interested parties determined 64

12 Section 7: Final Steps Internal Auditing, Corrective Action & Management Review Internal Auditing QMS Verification Verify the process against its planned objectives Confirm that the characteristics of the processes are consistent with the purpose of your company Verify that all the requirements identified in the first stage are satisfied. If not, consider what additional process activities are required in the first stage Once you have established your Quality Management System it needs to be audited to verify that it is effective. The Management should manage internal auditing by ensuring there are an adequate number of trained internal auditors to audit the entire Quality Management System on a schedule determined by the importance and issues related to each area to be audited. The scope of the Internal Audit System should include all products & services included in the quality management system scope. The Internal Audit Schedule should be planned annually and designed to comprehensively cover all areas of the Quality Management system including procedures, policies and activities. 114

13 Management Review Top management now need to review the company quality management system and continue to do so at a minimum annually to ensure their continuing suitability, adequacy and effectiveness. The review includes assessing opportunity for improvements and the need for amendments to the systems. The proceedings of all reviews should be documented. The review meeting should chaired by the Managing Director and include Top Management. Review inputs should include: - Review of the quality policy and if quality objectives are being met - Review of management changes - Minutes and follow-up actions from previous review meetings - Outstanding non-conformances as a result of internal and external audits - Trends analysis of the results of internal and external audits - Results of internal, second and third-party audits - Trend analysis of customer and supplier complaints - Customer satisfaction and feedback - Quality key performance indicators review and trend analysis - Quality incidents, recalls, withdrawals - Process performance and product conformity - Non-conformances and corrective action status - Review of changes which could affect the control plans - Changes to policies and objectives - Effectiveness of actions taken to address risks and opportunities 115