ISO 9001 QMS Implementation Workbook
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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
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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.
ISO 9001 Requirements
Relevant Documented Information
Monitoring of Processes
Retaining Documented Information
Assessing Risk and
Opportunities Appropriate Corrective
Action
Review of the Processes &
QMS
Continual Improvement
Communication
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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
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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
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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 Due Date for Completion
Date Completed
1 Top management commit to implementing ISO 9001
2 A copy of the ISO 9001 Standard is purchased
3 Top Management decide on the scope of the quality management system
4 The Management becomes familiar with the ISO 9001 Standard
5 The Management becomes familiar with the Implementation and training presentations
6 The Management becomes familiar with the Quality Management System Procedures and Record Templates
7 The Management becomes familiar with the ISO 9001 Implementation workbook
8 Top management Confirm their
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Section 4: Documented Information
The package includes document templates that cover the requirements of the ISO 9001:2015 standard:
Quality Management System
Section 1 Scope
Section 2 Normative References
Section 3 Terms and Definitions
Section 4 The Organization
Section 4.1 The Organization and its Context
Section 4.2 Needs and Expectations of Interested Parties
Section 4.3 Scope of the Quality Management System
Section 4.4 Quality Management System Processes
Section 5 Leadership
Section 5.1 Leadership and Commitment
Section 5.1.2 Customer focus
Section 5.2 Quality Policy
Section 5.3 Organizational Roles, Responsibilities and Authorities
Section 6 Planning
Section 6.1 Risks and Opportunities
Section 6.2 Quality Objectives
Section 6.3 Planning of Changes
Section 7 Support
Section 7.1 Resources
Section 7.1.1 General Resources
Section 7.1.2 People
Section 7.1.3 Infrastructure
Section 7.1.4 Environment for Operations
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Section 7.1.5 Monitoring and Measuring Resources
Section 7.1.6 Organizational Knowledge
Section 7.2 Competence
Section 7.3 Awareness
Section 7.4 Communication
Section 7.5 Documented Information
Section 7.5.1 General Documented Information Requirements
Section 7.5.2 Creating and Updating
Section 7.5.3 Control of Documented Information
Section 8 Operation
Section 8.1 Operational Planning and Control
Section 8.2 Requirements for Products and Services
Section 8.2.1 Customer Communication
Section 8.2.2 Determining Requirements for Products and Services
Section 8.2.3 Review of requirements for Products and Services
Section 8.2.4 Changes to Requirements for Products and Services
Section 8.3 Design and Development of Products and Services
Section 8.3.1 General Design and Development Process
Section 8.3.2 Design and Development Planning
Section 8.3.3 Design and Development Inputs
Section 8.3.4 Design and Development Controls
Section 8.3.5 Design and Development Outputs
Section 8.3.6 Design and Development Changes
Section 8.4 Control of Externally provided Processes, Products and Services
Section 8.5 Production and Service Provision
Section 8.5.1 Control of Production and Service Provision
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Section 8.5.2 Identification and Traceability
Section 8.5.3 Property Belonging to Customers or External Providers
Section 8.5.4 Preservation
Section 8.5.5 Post-Delivery Activities
Section 8.5.6 Control of Changes
Section 8.6 Release of Products and Services
Section 8.7 Control of Nonconforming Outputs
Section 9 Performance Evaluation
Section 9.1 Monitoring, Measurement, Analysis and Evaluation
Section 9.1.1 General Requirements
Section 9.1.2 Customer Satisfaction
Section 9.1.3 Analysis and Evaluation
Section 9.2 Internal Audit
Section 9.2.1 Internal Audits Scope
Section 9.2.2 Internal Audits Programme
Section 9.3 Management Review
Section 9.3.1 Top Management Review
Section 9.3.2 Management Review Inputs
Section 9.3.3 Management Review Outputs
Section 10 Improvement
Section 10.1 Opportunities for Improvement and Actions
Section 10.2 Nonconformity and Corrective Actions
Section 10.3 Continual Improvement
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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.
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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
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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
Action Required to
Comply Responsibility
Completion Date
ISO 9001 Section 4 Context of the organization
4.1 External and internal issues determined
4.1 Information about issues monitored and reviewed
4.2 Interested parties determined
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Section 7: Final Steps Internal Auditing, Corrective Action & Management Review
Internal Auditing QMS Verification
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.
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
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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