Summary of changes between ISO 9001:2008 and ISO/CD 9001

Transcription

1 Summary of changes between ISO 9001:2008 and ISO/CD 9001 Introduction This document is intended to summarise the proposed changes to ISO 9001:2008 as detailed in the Committee Draft (CD). It does not contain the requirements themselves, these should be accessed through the standard itself. General Proposed 3 year transition period for organisations to adopt the new standard expected to be published late The shape, structure and feel of the document has changed it is being issued under the common document format, with common text and terminology used across various management system standards. It is intended to be more generic in its nature and more easily applied to service industries. Product has now become goods and services. Exclusions are now detailed in clause 4.3 Determining the scope of the QMS. New clauses 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties Process approach is now a clause, not just a principle Continual improvement has become just improvement. Preventive action clause removed risk and preventive action integrated into rest of standard under the title of risks and opportunities. Documents and records are now referred to as documented information. Purchasing and outsourcing control of external provision of goods and services risk based approach to the amount of control applied. Annex A added Colin Partington Associates Ltd Page 1 of 10 August 13

2 New Clause No Existing Summary of Changes Clause No 1 Scope Unchanged apart form Note 1 b) realisation processes becomes operational processes 1.2 Removed 2 Normative References 2 ISO 9000:2005 becomes ISO 9000: Terms & Definitions 3 Reference to product = service removed A list of common definitions included but may be removed later and put into ISO 9000: Context of the organisation Understanding the organisation and its context new clause This is a new requirement in which the organisation is required to demonstrate that it understands what influences there are on it with regard to both internal and external issues and may affect its strategic direction e.g. where it sits in the marketplace and what effect changes may have on its future. 4.2 Determining the scope of the quality management system This is now a stated requirement of the standard and requires the organisation to determine the boundaries and applicability of the QMS. It also makes reference to 4.1 (the context of the organisation). There is a requirement to state the scope in terms of the goods and services delivered and the sites of the organisation to be included. There is a requirement to document and justify any exclusions from the standard limited to clauses to 8. Exclusions cannot be justified by a decision to arrange for an external provider to perform a function or process Quality management system General - Still a requirement establish, implement, etc a QMS Process approach now a stated requirement but the content is largely the same as previous clause 4.1 apart from a requirement to determine the risks to conformity if processes are ineffective. Colin Partington Associates Ltd Page 2 of 10 August 13

3 5 Leadership Planning Leadership and commitment This is a new clause title but it contains much of what is currently in section This relates to commitment to the QMS - There is a requirement for top management to demonstrate leadership and commitment with respect to the QMS e.g. ensuring the policy and objectives are compatible with the strategic direction, the policy is understood and followed, the QMS is integrated into the organisation s business processes, etc This relates to commitment to customers there are additional requirements based on the need to identify and address any risks to conformity of goods and services to customers. 5.2 Quality policy Largely unchanged from current version but does have some additional requirements about its availability to interested parties and being available as documented information. 5.3 Organisational roles, responsibilities and authorities Small changes to existing requirements, no longer requires a specific position of a management representative. Whilst this is a familiar title, it is mostly a new section which relates to the establishment of the QMS. 6.1 Actions to address risks and opportunities The general requirement here is that the QMS must be able to achieve its intended outcomes and consistently satisfy customers by integrating the QMS into the business and by identifying and managing risks and opportunities Quality objectives and planning to achieve them This is the existing requirement for quality objectives (currently 5.4.1) but has additional requirements for them to be measurable and be relevant to conformity of goods and services and customer satisfaction. There is additional information regarding the planning of objectives. 6.3 Planning of changes This is mostly what was in and relates to the need to manage changes to the QMS and to ensure that risks and opportunities are considered when changes are made. Colin Partington Associates Ltd Page 3 of 10 August 13

4 7 Support This is a new title but it contains mostly what is currently in section 6 (resource management) plus some additional requirements. 7.1 Resources General A basic requirement to determine and provide sufficient resources to establish and maintain a QMS. It also calls for consideration of which resources will be provided internally as opposed to those which will be sourced externally Infrastructure Virtually unchanged from present 6.3 but brings in customer satisfaction. The examples are now in a note rather than in the main text Process environment This is also largely unchanged from the current 6.4 but again brings in customer satisfaction Monitoring and measuring devices Whilst the clause title is the same as the current 7.6, the requirements of this clause have been considerably reduced. Specific industry requirements will most likely dictate the amount of control applied Knowledge This is a new requirement. 7.2 Competence This is currently addressed under clause 6.2 and is mostly unchanged it has been spread out across a number of clause headings Awareness Colin Partington Associates Ltd Page 4 of 10 August 13

5 This was previously addressed under clause Communication This was previously included in clause and related to internal communication. It now includes external communication too and has been expanded & Documented information General Whereas the current version of ISO 9001 has 2 clauses relating to the control of documents and records, the proposed changes include changing the title to documented information which includes both documents and records Creating and updating This is a new clause, though the intent to do these actions has always been there Control of documented information These requirements are virtually the same as are currently in clauses & of ISO 9001: Operation Operational planning and control This is the equivalent of the current clause 7.1 and is largely unchanged though there are a few small additions and clarifications. 8.2 Determination of market needs and interactions with customers Very little change from the existing requirements General A broad statement regarding the need to implement a process for these activities. Colin Partington Associates Ltd Page 5 of 10 August 13

6 & & Determination of requirements related to the goods and services This is almost identical to the current clause Review of requirements related to the goods and services Once again, this is almost identical to the existing requirements in clause This is almost identical to clause but has a few small additions. 8.3 Operational planning process This is very similar to the existing clause 7.1 but also contains additional elements to be considered as part of the planning process. 8.4 Control of external provision of goods and services This requirement includes what is currently included in the purchasing clause (7.4) and it also any outsourced processes (addressed in clause 4.1) A simple statement that externally provided goods and services must conform to specified requirements Type and extent of control of external provision There is a general statement regarding the type and amount of controls to be applied should be dependant on the risks involved and their potential impacts. Similarly, as required currently by clause 7.4.1, the organisation must establish and apply methods for evaluating, selecting and re-evaluating external providers. Records of these activities are to be maintained Documented information for external providers This clause is based on what is currently in clause but there also a few additions. This clause now refers to handling customer property (currently clause 7.5.4) and also the need to monitor the performance of external providers and to keep documented information. 8.5 Development of goods and services The whole of this section (8.5.1 to 8.5.3) is new in comparison with the current version of ISO It largely takes over from the current design and development clause (7.3) but is considerably different in its content Production of goods and provision of services Colin Partington Associates Ltd Page 6 of 10 August 13

7 & Control of production of goods and provision of services This clause is the equivalent of clauses and of the current version of ISO It is not identical but contains very similar information plus a few additions Identification and traceability This is almost identical to the current requirement (currently clause 7.5.3) Property belonging to customers or external providers This is again almost identical to the existing clause on the subject (customer property, currently clause 7.5.4) Preservation of goods and services Very similar to the existing clause (7.5.5) but with a little more emphasis on process outputs in relation to provision of services rather than products Post delivery activities This is mostly a new requirement, though there was previously mention in clause 7.2 this clause provides more detail of the requirement Control of changes This is a new clause title but there are links into the existing clauses (controlling changes to documents) and clause (controlling changes to the QMS. This clause has brought these 2 elements together under 1 heading. 8.7 Release of goods and services Whilst this is a new title, the requirements are very similar to the existing clause (monitoring and measurement of product). 8.8 Nonconforming goods and services Almost the same as the existing clause 8.3 (control of nonconforming product) but slightly re-worded. An extra statement has been added to remind us that customer satisfaction must be achieved. Some of the detail has been taken out of the clause and put into a note. There is also a requirement to maintain documented information regarding the nature of nonconformities discovered and the actions taken. Colin Partington Associates Ltd Page 7 of 10 August 13

8 9 Performance evaluation Monitoring, measurement, analysis and evaluation The content of this clause is largely what is currently in clause 8.2 monitoring and measurement but it has been further developed. It requires the organisation to take into account the risks and opportunities to determine what they will monitor and measure in order to: Demonstrate conformity of goods and services Evaluate the performance of processes Ensure the conformity and effectiveness of the QMS Evaluate customer satisfaction Evaluate the performance of external providers In doing the above, the organisation must determine the methods to be used, when the activities will be performed, when the results will be analysed and determine the performance indicators. Overall, this clause has pulled together the monitoring and measuring activities, added to them and requires the organisation to consider what they expect to achieve and how closely they have met those expectations. More specific details are included below Customer satisfaction This is largely unchanged in its requirements though it has been clarified and re-worded Analysis and evaluation of data This is very similar to the existing clause 8.4 (though more clearly explained) in requiring the organisation to analyse the data obtained through the monitoring and measuring activities described in previous clauses to: Determine the suitability, adequacy and effectiveness of the QMS Assure that goods and services meet customer requirements Ensure that the processes are in control and effective Identify improvements The results are to be fed into management review. Colin Partington Associates Ltd Page 8 of 10 August 13

9 Internal audit Very similar in requirements to the existing clause but it has been re-worded and additional elements introduced such as the need to take into consideration the quality objectives and related risks when programming audits. 9.3 Management review The basic requirement to conduct management reviews of the QMS is much the same as in the existing clause 5.6 but it now requires the organisation to take into account the business strategic direction and changing business environment. What are currently labelled as inputs, are now considerations and whilst similar to the existing inputs, they are more clearly defined and rely heavily on utilising the data generated form monitoring and measuring activities as defined in earlier clauses. The outputs from management review are largely unchanged. 10 Improvement 8.3 & Nonconformity and corrective action These 2 previously separate clauses have now been put together and whilst worded differently, the intentions are the same Improvement Similar to the existing clause but the word continual has been dropped and the sources of information used to drive improvement have changed. Colin Partington Associates Ltd Page 9 of 10 August 13

10 1. Customer focus 2. Leadership 3. Engagement of people 4. Process approach 5. Improvement 6. Evidence based decision making 7. Relationship management Annex A Quality Management Principles The existing 8 quality management principles upon which ISO 9001 is founded are not currently in ISO 9001, but are in ISO There are now only 7 principles, they have been re-worded and included as a statement and also the rationale behind the principle. They are: Colin Partington Associates Ltd Page 10 of 10 August 13