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Quality Management System Process Descriptions

Quality Management System Requirements Process

ISO 9001 Toolkit Version 2 ŠCertiKit

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Quality Management System Requirements Process

Implementation Guidance (The header page and this section must be removed from final version of the document)

Purpose of this document This document describes the process for establishing requirements for products and services.

Areas of the standard addressed The following areas of ISO9001 are addressed by this document: 8. Operation 8.2 Requirements for products and services

General Guidance This process must work closely with the other processes of the QMS to ensure that all business operations are based on a clear understanding of the requirements of the customer and other interested parties. The identification of requirements is a key part of the QMS. The procedures underlying the process will be specific to the organization and its circumstances and products and services and so are not templated within the toolkit.

Review Frequency This document should be reviewed when significant changes to business processes happen, or annually otherwise.

Toolkit Version Number ISO9001 Toolkit Version 2 ŠCertiKit.

Document Fields This document may contain fields which need to be updated with your own information, including a field for Organization Name that is linked to the custom document property “Organization Name�. To update this field (and any others that may exist in this document):

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1. Update the custom document property “Organization Name” by clicking File > Info > Properties > Advanced Properties > Custom > Organization Name 2. Replace the text [Organization Name] with the name of your organization and click the Modify button to update it 3. Press Ctrl a on the keyboard (if using a Mac, this is Command a) to select all text in the document (or use Select, Select All on the ribbon) 4. Press F9 on the keyboard to update all fields. If using a Mac, right-click (if enabled) or Control-click, and select Update Field 4. 5. When prompted, choose the option to just update TOC page numbers If you wish to permanently convert the fields in this document to text i.e. so that they are no longer updateable, then you will need to click into each occurrence of the field and press Ctrl Shift F9. If you would like to make all fields in the document visible then go to File > Options > Advanced > Show document content > Field shading and set this to “Always”. This can be useful to check that you have updated all fields correctly. Further detail on the above procedure can be found in the Toolkit Completion Instructions within the Implementation Resources folder.

Copyright notice Except for any third party works included in this document, as identified in this document, this document has been authored by CertiKit, and is © copyright CertiKit except as stated below. CertiKit Limited is a company registered in England and Wales with company number 6432088.

Licence terms This document is licensed on and subject to the standard licence terms of CertiKit, available on request, or by download from our website. All other rights are reserved. Unless you have purchased this product you only have an evaluation licence. If this product was purchased, a full licence is granted to the person identified as the licensee in the relevant purchase order. The standard licence terms include special terms relating to any third party copyright included in this document.

Disclaimer Please Note: Your use of and reliance on this document template is at your sole risk. Document templates are intended to be used as a starting point only from which you will create your own document and to which you will apply all reasonable

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quality checks before use. Therefore please note that it is your responsibility to ensure that the content of any document you create that is based on our templates is correct and appropriate for your needs and complies with relevant laws in your country. You should take all reasonable and proper legal and other professional advice before using this document. CertiKit makes no claims, promises, or guarantees about the accuracy, completeness, or adequacy of our document templates, assumes no duty of care to any person with respect its document templates or their contents, and expressly excludes and disclaims liability for any cost, expense, loss or damage suffered or incurred in reliance on our document templates, or in expectation of our document templates meeting your needs, including (without limitation) as a result of misstatements, errors and omissions in their contents.

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Quality Management System Requirements Process

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Quality Management System Requirements Process

Document Ref. Version: Dated: Document Author: Document Owner:

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QMS-DOC-08-1 1 [Insert date]

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Quality Management System Requirements Process

Revision History Version Date

Revision Author

Summary of Changes

Distribution Name

Title

Approval Name

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Quality Management System Requirements Process

Contents 1

INTRODUCTION ....................................................................................................................................... 8

2

REQUIREMENTS PROCESS .................................................................................................................. 9 2.1 OVERVIEW AND PROCESS DIAGRAM ......................................................................................................... 9 2.2 PROCESS INPUTS ..................................................................................................................................... 11 2.3 PROCESS ACTIVITIES ............................................................................................................................... 11 2.3.1 Customer Communication ............................................................................................................ 11 2.3.2 Determine Requirements for Products and Services .................................................................... 12 2.3.3 Review Requirements for Products and Services .......................................................................... 12 2.3.4 Confirm Customer Requirements .................................................................................................. 12 2.3.5 Changes to Customer Requirements ............................................................................................. 12 2.4 PROCESS OUTPUTS .................................................................................................................................. 13

3

PROCESS MEASUREMENT AND REPORTING ............................................................................... 14 3.1 3.2 3.3

4

PROCESS MEASUREMENT ........................................................................................................................ 14 PROCESS REPORTING .............................................................................................................................. 14 PROCESS REVIEWS AND AUDITS ............................................................................................................. 14

ROLES AND RESPONSIBILITIES ....................................................................................................... 16 4.1 4.2 4.3 4.4

ROLES ..................................................................................................................................................... 16 RACI MATRIX ........................................................................................................................................ 16 PROCESS OWNER .................................................................................................................................... 16 PROCESS MANAGER ................................................................................................................................ 17

List of Figures FIGURE 1 - REQUIREMENTS PROCESS DIAGRAM ..................................................................................................... 10

List of Tables TABLE 1 - RACI MATRIX ...................................................................................................................................... 16

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1 Introduction The success of [Organization Name] depends upon providing quality products and services that customers want. In order to do this, it is important that the requirements for our products and services are clearly understood, particularly before any design and development work is undertaken. The purpose of this document is to define in overview the process to determine requirements within [Organization Name], including its inputs, the specific activities involved in each step of the process and its outputs. It also defines how the process is measured and reported on and the roles involved. The following key QMS processes are related to this process and are covered in separate documents: • • •

Design and development External provider management Production and service provision

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2 Requirements Process 2.1

Overview and Process Diagram

This process links closely with the design and development process and provides essential inputs to it. From a quality viewpoint, it is important that everything we do is based on a clear understanding of what the customer wants, and the other factors that must be taken into account when designing, developing, producing, testing, releasing and supporting our products and services. The key to establishing the requirements for products and services is customer communication, and this takes place in a number of ways, including pre-sales enquiries, regular contact as part of ongoing service delivery and via more formal methods such as surveys and complaints. From this managed communication, a set of detailed requirements are identified that the products and services must meet if they are to be acceptable to the customer. Other factors are also taken into account, such as legal and regulatory guidance in order to arrive at a full set of requirements. These requirements are then reviewed to ensure that they can be delivered and that we, as an organization, are not placing ourselves in a situation of unacceptable risk. As part of this, the requirements are confirmed with the customer before design and development commences. Lastly, changes to the requirements, which may occur at any stage, are managed so that their implications are recognised and allowed for. The process of establishing requirements is shown in Figure 1.

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Customer enquiries

Contracts and orders

Customer feedback

Customer complaints

Other sources

Customer communication

Statutory and regulatory requirements

Determine requirements for products and services

Review requirements for products and services

Confirm customer requirements

Yes

Other necessary requirements

Requirements Review

Confirmed requirements

Change to requirements?

No

Design and development process

Figure 1 - Requirements process diagram

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2.2

Process Inputs

The following areas may act as inputs to the requirements process at one or more stages: • • • • • • • • •

Customer details and contacts Customer enquiries Customer feedback Customer complaints Customer contracts Statutory requirements Regulatory requirements Policies on products and services Changes to requirements

These may come from a number of different sources.

2.3

Process Activities

The following activities are carried out as part of this process. 2.3.1

Customer Communication

As part of identifying requirements for products and services, various forms of communication will happen with customers. These will include: • • • • • • •

Handling of pre-sales enquiries about our organization and its products and services The provision of information about existing products and services, and about our capabilities in the relevant areas Regular meetings with existing customers as part of an established relationship Customer feedback surveys and discussions Complaints raised about our products, services or other aspects of our organization Arrangements regarding the handling of property belonging to the customer Discussions about risk and appropriate actions to take if they occur

This communication will be via a variety of channels, including email, telephone, face-to-face meetings, online methods such as chats, survey forms and social media.

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2.3.2

Determine Requirements for Products and Services

Based on the level of communication with customers and the results from that, requirements for products and services will be identified and documented. These could be at the generic level i.e. applying to all customers, or at the customerspecific level e.g. in the case of bespoke services. Incorporated into these customer requirements will also be any other requirements from sources such as relevant laws and regulations, best practice standards, industry guidance etc. as well as requirements that, based on our organization’s experience, have been found to be desirable. Current claims for our current products and services, and our capabilities in creating new ones, will be evaluated against the identified requirements to make sure that they can be met i.e. that our organization is not “over-promising� to the customer.

2.3.3

Review Requirements for Products and Services

Prior to committing to supply the products and services involved, a formal review will be conducted to ensure that our organization has the capability to meet the requirements as specified by the customer and as defined by ourselves, also taking into account customer expectations (which may be unstated) and any external standards that are intended to be worked to. Particular attention will be paid to those cases where the new requirements are different from previous ones e.g. from the same customer, in order to confirm that the differences are genuine and not due to a misunderstanding.

2.3.4

Confirm Customer Requirements

If no written indication of requirements has been provided by the customer, there must be communication with the customer to check that our understanding of requirements is accurate and that nothing has been omitted or inadvertently included.

2.3.5

Changes to Customer Requirements

In the event that requirements are changed after they have been initially identified, a clear definition of the changes must be created and the implications of these changes assessed, as a minimum, in terms of viability, cost and timescale. Any consequences of the change to requirements, such as a revised price, must be communicated to the customer and agreed before progressing to design and development.

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2.4

Process Outputs

The major outputs of this process are as follows: • • • •

Documented requirements definition Review of requirements Customer confirmation of requirements Documentation of changes and their approval

These outputs will be included as part of the QMS.

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3 Process Measurement and Reporting 3.1

Process Measurement

In order to establish to what extent this process is working as intended, explicit, quantified targets (Key Performance Indicators, KPIs) will be set for the following metrics: • • •

Percentage of orders for which requirements are formally defined Percentage of requirements documents confirmed with the customer Time to complete requirements definition

Success against these targets will be evaluated as part of the management review process.

3.2

Process Reporting

In addition to those figures used as metrics, the following measurements will also be reported to management: • •

Number of requirements documents created Number of changes to requirements

These will be used to identify trends and quantify process throughput.

3.3

Process Reviews and Audits

Reviews will be carried out by the process owner in conjunction with the process manager on a three monthly basis to assess whether the process is operating effectively and delivering the desired results. These reviews will have the following as input: • • • • • • •

Follow-up action list from previous reviews Relevant changes and developments within the subject area KPI reports from the previous period Details of all complaints logged during the period Internal and external audit reports Feedback from employees and customers Identified opportunities for improvement

Each review will be documented by the process owner and actions arising agreed and published.

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Audits will be carried out on an annual basis by the internal auditing department. The scope and timing of the audit will be agreed in advance. Recommendations from the audit will be published and actions discussed and agreed with the process owner. All actions will be followed up by the internal auditor within the agreed timescales for each action.

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4 Roles and Responsibilities This section describes the main roles involved in the process, their interaction with it and their detailed responsibilities. 4.1

Roles

The following main roles participate in the process: • • •

Process Owner Process Manager Customer

There will also be interaction with business management at various points in the process. 4.2

RACI Matrix

The table below clarifies the responsibilities of these roles at each step using the RACI system, i.e.: R= Responsible

A= Accountable Role:

Step Customer Communication Determine Requirements for Products and Services Review Requirements for Products and Services Confirm Customer Requirements Changes to Customer Requirements

C= Consulted

I= Informed

Process Owner A A

Process Manager R R

Customer

A

R

I

A A

R R

C C

C C

Table 1 - RACI Matrix

4.3

Process Owner

The responsibilities of the process owner are: • • • • •

Sponsoring, designing and change managing the process and its metrics Assisting with process design Ensuring that appropriate process documentation is available and current Defining appropriate policies and standards to be employed throughout the process Periodically auditing the process to ensure compliance to policy and standards

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• • • • • • • •

4.4

Communicating process information or changes as appropriate to ensure awareness Providing process resources to support activities required Ensuring people participating in the process have the required knowledge and the required technical and business understanding to deliver the process and understand their role in the process Reviewing opportunities for process enhancements and for improving the efficiency and effectiveness of the process Addressing issues with the running of the process Identifying improvement opportunities Making improvements to the process Working with other process owners to ensure there is an integrated approach to this and related process delivery

Process Manager

The responsibilities of the process manager are: • • • • • • • • • • •

Working with the process owner to plan and co-ordinate all process activities Ensuring all activities are carried out as required Managing resources assigned to the process Monitoring and reporting on process performance Identifying improvement opportunities Making improvements to the process implementation Coordinating interfaces between this process and other quality management processes Driving the efficiency and effectiveness of the process Producing management information Managing the work of people involved in delivering the process Developing and maintaining the supporting systems

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