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Have you completed these tasks?
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Tick when completed
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Documentation & Top Management Responsibilities
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Produced a Quality Manual, which meets the requirements of Clause 4.2.2?
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Does it
contain
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- a description of the scope of the system (and any exclusions, with
justifications)?
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- a description (or flowchart, etc) which explains how the processes
interact?
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- (or refer to) all six mandatory procedures:
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(1) - Control of documents (Clause 4.2.3)
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(2) - Control of records (Clause 4.2.4)
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(3) - Control of Internal Auditing (Clause 8.2.2)
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(4) - Control of Nonconforming Product (Clause 8.3)
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(5) - Corrective actions (Clause 8.5.2)
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(6) - Preventive actions (Clause 8.5.3)
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Produced your Quality Policy? (Clause 5.3)
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Established measurable objectives? (Clause 5.4.1)
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- are there objectives for all relevant functions/departments?
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- are they measurable?
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- are they quality related? (i.e. something that affects how well your
services/products meet requirements)
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Defined the roles and responsibilities of your staff? (Clause 5.5.1)
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Identified the Management Representative and defined the responsibilities? (Clause
5.5.2)
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Held Management reviews of the system (Clause 5.6), and kept records of the
reviews? (Clause 4.2)
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Resources
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Considered what resources (people, equipment, processes, etc) are required to
correctly supply your services or products? (clauses 6.1, 6.2, 6.3, &
6.4)
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Made sure that you supply them (clauses 6.1, 6.2, 6.3, & 6.4) and keep
reviewing them? (clause 5.6)
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Conducted training as appropriate, and considered if it was effective? (Clause
6.2)
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Kept records of the training? (Clauses 4.2.4 & 6.2)
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Production of goods & services
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Defined the processes involved in the production of your goods/services? (Clauses 7.1 and
4.1)
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Defined the processes required to support the production processes? (Clauses
4.1, 6.1, 6.3 & 6.4)
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Defined the sequence of the processes? (Clauses 7.1 and 4.1)
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Considered if design is applicable to you, or else excluded it from your
system?
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If you conduct design activities and have decided that you want this activity
certified, have you:
- kept records of the the design requirements and any information required
for the design process ("design inputs")? (clauses 7.3.1
& 7.3.2)
- created design plans/documents that show the key design stages and the
key responsibilities? (clause 7.3.1)
- ensured that the design outputs are in line with the design requirements
and that they contain adequate information to enable purchasing and
production and service activities to be properly conducted? (clause 7.3.3)
- kept records of design verification (e.g. in-house testing you may have conducted
or theoretical calculations etc)? (clause 7.3.5)
- kept records of design validation (e.g. real-world testing, customer
acceptance testing etc)? (clause 7.3.6)
- if the design requirements were changed or if the design process was
changed from the original planning, have you kept records of the changes,
with descriptions of the required actions? (clause 7.3.7)
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Produced instructions where necessary? (Clause 7.5.1)
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Made sure that your measuring equipment is working and suitable for the task?
(Clause 7.6)
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Made sure that goods and components are traceable (where required) and that
they are stored and handled so as to avoid damage? (Clauses 7.5.3 and 7.5.5)
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Improvements
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Started to monitor Customer perception of your products and services? (Clause
8.2.1)
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Conducted Internal Quality Audits? (Clause 8.2.2)
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Started to monitor and measure the effectiveness of your processes? (Clause
8.2.3)
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Measured the suitability of your product/service (Clause 8.2.4) - e.g. final inspection results, etc?
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Kept records of your nonconforming product - inspection rejects, Customer returns, warranty repairs, etc? (Clause
8.3)
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Reviewed (analyzed) all of this information in order to improve the system and products? (Clauses 8.4 &
8.5)
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Taken corrective actions where appropriate, and kept records? (Clause 8.5.2)
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Considered and undertaken preventive actions, and kept records? (Clause
8.5.3)
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Reviewed all the improvement possibilities and used them for the benefit of the system, so that your products become better, you ensure that your Customers get what they wanted (and perhaps a little more!) -
(No specific clause, but good business sense, and in line with the overall aim of ISO
9001:2008)
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on September 5th, 2011