Preparing ISO 9001 Quality Manual

Preparing ISO 9001 Quality Manual
The standard requires a quality manual to be established and maintained that includes the scope of the quality management system, the documented procedures or reference to them and a description of the sequence and interaction of processes included in the quality management system.
ISO 9001 defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the quality manual be a response to the requirements of ISO 9001. As the top-level document describing the management system it is a system description describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9001:2008, were no more than 20 sections that paraphrased the requirements of the standard. Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate.
A description of the management system is necessary as a means of showing how all the processes are interconnected and how they collectively deliver the business outputs. It has several uses as :
1. a means to communicate the vision, values, mission, policies and objectives of the organization
2. a means of showing how the system has been designed
3. a means of showing linkages between processes
4. a means of showing who does what an aid to training new people
5. a tool in the analysis of potential improvements
6. a means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes to achieve them, the manual provides a convenient vehicle for containing such information. If left as separate pieces of information, it may be more difficult to see the linkages.
The requirement provides the framework for the quality manual. Its content may therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization – its scope of activity, its products and services
(b) The organization’s interested parties (customers, employees, regulators, shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its external environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how they are interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order fulfilment process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety, CAA etc.)
8 Approvals (List of current product, process and system approvals)
The process descriptions can be contained in separate documents and should cover the topics identified previously (see Documents that ensure effective planning, operation and control of processes ).
As the quality manual contains a description of the management system a more apt title would be a Management System Manual (MSM) or maybe a title reflecting its purpose might be Management System Description (MSD).
In addition a much smaller document could be produced that does respond to the requirements of ISO 9001, ISO 14001, and the regulations of regulatory authorities. Each document would be an exposition produced purely to map your management system onto these external requirements to demonstrate how your system meets these requirements. When a new requirement comes along, you can produce a new exposition rather than attempt to change your system to suit all parties. A model of such relationships is illustrated in Figure 4.10. The process descriptions that emerge from the Management System Manual describe the core business processes and are addressed in Chapter 4 under the heading of Documents that ensure effective operation and control of processes.

PRELIMINARY GAP ANALYSIS FOR ISO 9001:2008

Quality Management System Preliminary Gap Analysis
Decide on a number from 0 to 5 for each item below. The scoring criteria are given in a table at the end. 1 to 5 Make notes to explain your score for future reference.
1. Have you established, documented, implemented and now maintain a Quality Management System (QMS) to any system including ISO 9001?
2. Have you identified the processes needed for your QMS and
a. the sequence of your production and service delivery processes,
b. the criteria and methods needed to ensure the processes are effective, and
c. have the resources and the information you need to support the processes?

3. Do you have
a. a Quality Manual including your Quality Policy and quality objectives, and
b. written procedures and work instructions?
4. Do your records provide evidence that your business processes are effective?
5. Is your Top Management committed to the development and implementation of a new QMS (i.e. based on the 2008 version of ISO 9001)?

6. Has your Top Management communicated the importance of meeting customer and other business requirements to all the employees?
7. Has your Top Management made a commitment to ensure your customers’ requirements are top priority?
8. Do your quality objectives include requirements for production and delivery?
9. Are your quality objectives measurable?
10. Have the responsibilities and authorities of managers and employees been defined and communicated to them?
11. Does your management have the drive and resources needed
a. to implement, and maintain a QMS and continually improve its effectiveness, and
b. to enhance customer satisfaction by meeting customer requirements?
12. Does your organization have procedures to select competent personnel for work activities?
13. Does your organization provide training or take other action to help develop your people?
14. Does your organization provide adequate:
a. buildings, workspace and utilities,
b. process equipment, and
c. supporting services such as transport or communication?
15. When you receive a customer order do you review it for
a. requirements specified by the customer, including the delivery and post-delivery activities,
b. requirements not stated by the customer but necessary for specified use or known and intended use, and
c. statutory and regulatory requirements related to the product?
16. Do you inform your customers concerning
a. product information,
b. enquiries, contracts or order handling, including changes, and
c. channels for customer feedback and complaints?
17. Does your organization plan and control product design and development activities?
18. Does your organization maintain records of design or development review, verification and validation activities and resulting action?
19. Does your organization inspect or otherwise confirm that purchased products, materials, components and services conform to your specified purchase requirements?
20. Does your organization select suppliers depending on how important the purchased product is for production?
21. Does your organization evaluate suppliers (subcontractors or vendors) based on their ability to satisfy your requirements?
22. Do you ensure production has
a. the information that describes the characteristics of the product,
b. the necessary work instructions,
c. suitable equipment, and
d. the monitoring and measuring devices needed?
23. Does your organization regularly confirm that your production and service processes are capable of consistently meeting your requirements?
24. Are parts, components, subassemblies and products identified throughout production or service delivery?
25. Are monitoring and measurement requirements clearly shown with the status of the product?
26. Where traceability is a requirement, does production keep records of unique product identification?
27. Do you care for and protect customers’ property under your control or being used by your people?
28. Do you look after your product (including the parts or components) during both production and delivery to the customer, by providing suitable identification, packaging, storage, preservation and handling?
29. Do you have instructions needed to identify inspection or monitoring activities to be done during production or service delivery and the devices to be used?
30. Is your measuring equipment:
a. Calibrated or verified at specified intervals, or prior to use?
b. Adjusted or re-adjusted as necessary?
c. Identified to enable the calibration status to be determined?
d. Safeguarded from adjustments that would invalidate the measurement result?
e. Protected from damage and deterioration during handling, maintenance and storage?
31. Does your organization monitor customer information that shows you have satisfied customer requirements?
32. Does your organization conduct internal quality audits at planned intervals?
33. Does your organization use suitable methods to monitor and, where practical, measure the performance of your processes?
34. Does your organization inspect or measure the characteristics of finished products and record the results?
35. Does your organization identify nonconforming products and review them for disposition?
36. Does your organization collect and analyze data to assess the suitability and effectiveness of the QMS?
37. Does your organization use data to evaluate or identify where continual improvement of the QMS can be made?
38. Does your organization continually improve the effectiveness of the QMS?
39. Does your organization take corrective action to eliminate the causes of problems and to prevent their recurrence?
40. Does your organization determine and eliminate potential nonconformities in order to prevent their occurrence?
To score this table:
0 – You do not understand what is required or believe it is necessary
1 – Your organization does not perform this activity
2.- You understand this activity is a good thing to do but do not do it
3 – You do this sometimes
4 – You do this but not very well
5 – You do this quite well.
Add all the points together.
150 – 200
You are almost ready to complete your ISO 9001 QMS and apply for certification/
registration.
100 – 149
You are ready to implement the QMS. This will likely improve your business results.
0 – 99
You have a lot to do but should begin. You could consider seeking help from a
consultant or specialist.