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